Biological Detectors Market Survey 2007

Biological Detectors
Market
Survey
2007 Edition
Peter A. Emanuel
and
Isaac R. Fruchey
Disclaimer
The findings in this report are not to be construed as an official Department of Defense
position unless so designated by other authorizing documents.
MARKET SURVEY: BIOLOGICAL DETECTORS 2007 Edition
Emanuel and Fruchey
Authors’ Letter
Dear Reader:
We revised our 2005 market survey on biological detectors to help inform and update the
research and scientific community on current and future detectors for biological threat
agents. Many of the detection devices and systems evaluated in this survey use PCR and/or
immunoassay technology, but other technologies were also included. We evaluated products
that are commercially available and some emerging technologies of interest. There are four
different scenarios considered within this document and each has a customized weighting
mechanism which reflects the needs of detection systems for that situation. We gathered the
product information by sending out a questionnaire to manufacturers and then ranking each
answer.
We would like to suggest the following methodology for using this guide. First, review the
scenarios in Section 7; choose one of interest to you and note how the devices or systems
ranked for that scenario. Second, take note of the portion the product ranked within and then
look at the raw score. Remember that scores have a subjective component and that all the
technologies are included in the ranking so don’t go by the raw score only. Next, go to Appendix
II and look up the product name for detailed information on the product. Finally, contact the
manufacturer for more information or visit their website.
Appendix I is a quick reference guide to each product in the survey. The name of each product
is color coded by technology to make it easier to find a product that may interest you. Appendix
II, which includes the product information, is alphabetized to make it easier to find a product
of interest. Appendix I also includes a maturity gauge so you can quickly tell if the product is
commercially available or not. We hope that you find this survey both helpful and interesting. If
you have any comments or suggestions, please contact us.
Sincerely,
Isaac R. Fruchey, M.S. Peter A. Emanuel, Ph.D.

Edgewood Chemical BioDefense Team
Biological Center 5183 Blackhawk Road
5183 Blackhawk Road E3150, Suite A118
E3330, Room 274 Aberdeen Proving Ground,
Aberdeen Proving Ground, MD 21010
MD 21010 peter.emanuel@us.army.mil
isaac.fruchey@us.army.mil

Executive Summary
Detection of biological warfare agents currently relies upon PCR and immunoassay-based
methods or the combination of both. There is a wide array of PCR and immunoassay
technologies available to today’s scientist. Products are typically designed for a specific
application, whether it is for environmental detection or diagnosis. In this report, information
pertaining to the use and performance of several leading PCR and immunoassay technologies
was collected and evaluated. Several new or alternative methods were also evaluated. The
effectiveness of these detection devices was evaluated for four different scenarios: field use,
mobile laboratory use, diagnostic laboratory use, and analytical laboratory use. The evaluation
criteria for each of these scenarios was based upon expert opinion.
Detection devices intended for field use were evaluated based upon the total agents that can
be detected, their maturity, size, set up time, time to detect, and the maintainability of the
device or system. Technologies that evaluated well in this scenario include small, versatile
detection cartridges, as well as several handheld PCR devices. Devices or systems that did
not fare as well in the evaluation often required several additional pieces of equipment for use
(e.g., centrifuges, water baths, vortexes), which decreased the ease of use and increased the
number of manual steps required for operation. Also the larger sized devices or systems did not
fare well in this scenario.
Detection devices intended for mobile laboratory use were evaluated based upon their ability
to detect bacteria, toxins, and total agents; operational conditions; size; and re-use ability.
Technologies that evaluated well in this scenario included reasonably sized, sensitive detection
devices that can detect many agents. Devices that did not fare as well in the evaluation often
required several manual steps and manpower requirements, while reducing the ease of use.
Detection devices intended for diagnostic laboratory use were evaluated based upon
their utility, total agents that can be detected, time to detect, ease of use, and sensitivity.
Technologies that evaluated well in this scenario included fast and effective detection devices
based upon PCR technology for clinical samples. Systems and devices that did not fare as well
in the evaluation often took a long time to detect, did not have a high level of sensitivity, or had
to use many consumables.
Detection devices intended for analytical laboratory use were evaluated based upon their
ability to obtain a high sensitivity, utility, volume of sample needed, total agents that can be
detected, and ability to multiplex. Detection devices or systems that did well in this scenario
include PCR focused technologies and those systems that used automated technologies
that combined PCR and immunoassay. Systems and devices that did not fare as well in this
evaluation were generally those that did not have a high sensitivity or were unable to multiplex.
ii
Emanuel and Fruchey
Instructions for the Use of This Guide
This report is most useful in the selection of a PCR or immunoassay based technology for
detection of biological, viral, and toxin targets. For the purpose of this report, evaluation models
were created to generate the ordered lists of technologies. These evaluation models are useful
in assessing emerging technologies and new products for the four scenarios discussed.
This report should be used as a guide and the information of each product was provided by the
manufacturer and assumed to be correct. When evaluating products based on the scenario,
observe the score in generalized blocks. Scoring summaries have been used to break analyzed
technologies into sections to help.
Appendix I is a quick guide to the products that were evaluated in this survey. The names of
the products are color coded according to the technology they utilize. There also is a maturity
gauge that indicates that (1) the device or system is commercially available and meets military
specification, (2) the device or system is commercially available, (3) a few devices exist, or (4)
only one incomplete device exists or only a concept on paper exists.
Appendix II is an alphabetized product information sheet with detailed information on each
product evaluated in the survey. Further information on a product of interest can be obtained by
contacting the manufacturer or visiting their website, if provided.
iii
Foreword
The Department of Defense (DoD) is concerned about the proliferation of biological warfare
agents and the nation’s ability to detect and diagnose the potential exposure of US troops
or an attack on the homeland. Therefore, periodic technology reviews and evaluations are
coordinated by the Edgewood Chemical Biological Center (ECBC) to assist the biological
defense community.
Presented here are assessments of the technologies available for biological agent detection,
including PCR- and immunoassay-based technologies as well as a few emerging technologies.
This market survey assesses these technologies within a variety of settings, including analytical
laboratories, medical diagnostic laboratories, mobile laboratories, and field use. It is the aim of
this guide to assist technology managers and research scientists in the field of biological agent
detection.
This guide includes information to assist research scientists and the scientific and technology
community to select or track detection technologies that meet their varied applications. It
includes a thorough market survey of detection devices or systems available, current through
September 2007. Brief technical discussions that consider the principles of operation and
technological basis of several pieces of equipment are presented.
Although Appendix II contains technical information provided by the vendor for each product,
it is considered supplementary. Readers that find this information too lengthy may bypass
the Appendix with no effect on their overall understanding of the evaluation. For readers who
desire more technical information, points of contact from the manufacturer as well as company
websites are listed with each product.
This guide describes devices or systems for detecting biological warfare agents important to
the biodefense community. It mainly focuses on PCR and immunoassay based technologies,
but does include other technologies in various stages of development. Please refer to Appendix
I for an overview of the detection devices and systems evaluated, the technologies available,
and the maturity of each device or system presented.
Reference herein to any specific commercial products, processes, or services by trade
name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its
endorsement or recommendation by the United States Government. The information and
statements contained in this guide shall not be used for the purpose of advertising, or to
imply the endorsement or recommendation of the United States Government. With respect
to the information provided in this guide, neither the United States Government nor any
of its employees make any warranty, expressed or implied, including but not limited to the
warranties of merchantability and fitness for a particular purpose. Further, neither the United
States Government nor any of its employees assume any legal liability or responsibility for the
accuracy, completeness, or usefulness of any information, apparatus, product, or process
disclosed.
The information in this guide on specific equipment and technologies was obtained through
literature, web searches, and other market surveys. Technical comments, suggestions, and
product updates are encouraged from interested parties. They may be addressed to the
Edgewood Chemical Biological Center, 5183 Blackhawk Road, E3150 Suite A118, Aberdeen
Proving Ground, MD 21010. It is anticipated that this guide will be updated every two years.
Questions pertaining to the specific products included in this document should be directed to
the manufacturer. Contact information for each evaluated equipment item is included in this
report.
iv
Emanuel and Fruchey
Preface
The use of either trade or manufacturers’ names in this report

does not constitute an official endorsement of any commercial
products. This report may not be cited for purposes of
advertisement. Reproduction of this document either in whole or
in part is prohibited except with permission of the Director, U.S.
Army Edgewood Chemical Biological Center, ATTN: AMSRD-ECB-
RT-OM, Aberdeen Proving Ground, MD 21010-5424. However, the
Defense Technical Information Center is authorized to reproduce
the document for U.S. Government purposes.
This report has been approved for public release.

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Emanuel and Fruchey
Table of Contents
Authors’ Letter.....................................................................................................................................i
Executive Summary.............................................................................................................................ii
Instructions for the Use of This Guide...............................................................................................iii
Foreword............................................................................................................................................ iv
Preface ................................................................................................................................................ v
1. Introduction . ..................................................................................................................................3
2. Four Different Scenarios Where Detection Devices or Systems Are Needed.................................3
3. Overview of PCR Techniques.........................................................................................................5
4. Overview of Immunoassay Techniques............................................................................................5
5. Evaluation Process...........................................................................................................................6
6. Selection Factors..............................................................................................................................7
7. Evaluation of Detection Devices or Systems.................................................................................10
8. Summary.......................................................................................................................................14
Appendix I: Technology Quick Reference Guide............................................................................I-1
Appendix II: Evaluation of Detection Products............................................................................. II-1

Emanuel and Fruchey
Market Survey: Biological Detectors

Guide for Selection of Detection Devices and Systems by Isaac Fruchey, M.S. and Peter Emanuel, Ph.D.
1. Introduction 2. Four Different Scenarios Where Detection

The purpose of this document is to provide the science and
Devices or Systems Are Needed
technology community and the research and development Several fundamentally different methods for detecting
scientist with information to aid in the pursuit of biological biological agents have been or are being developed.
assay and detection technology development. This report However, in different operational environments, one device
reviews vendor-supplied information about detection devices or system may be preferred over others based on situational
or systems that are currently used in biological research and circumstances. In the following scenarios, four distinctly
in biodetection assays. Also included in the report are several different environments demonstrate how different situations
immature devices or systems that have potential use in can require different devices or systems for biological agent
biological research and in biodetection assays. detection.
This document is divided into eight sections and includes FIELD SCENARIO
two appendices. Section 2 presents a description of the
four scenarios that address detection devices or systems Field use detection devices or systems are typically used
needs. Section 3 provides an overview of PCR based by the soldiers or researchers conducting research outside
detection technologies. Section 4 provides an overview of of a typical laboratory setting. These devices or systems
immunoassay based detection technologies. Section 5 is a would be used outdoors in a variety of environments (e.g.,
brief introduction to the decision analysis process used in desert, forest, plains, urban) and be subjected to various
the evaluation. Section 6 discusses the selection factors that environmental conditions (e.g., heat, cold, humidity). They
were used to compare and evaluate the different detection need to be small, lightweight, and easy to carry. They should
devices or systems. Section 7 presents an evaluation of be simple to operate and should not require other machinery
detection devices or systems and general recommendations such as centrifuges or heat blocks to operate. Kits or devices
pertaining to the four different scenarios. Section 8 concludes with limited electrical requirements are preferred. These
with a concise summary of the current state of biological devices can
agent detection devices or systems. Appendix I is a quick be disposable
reference table that divides the products by technology and with a single
also indicates the maturity level of the product. Appendix use only, or
II describes individual products that were evaluated in this they can be
guide. reusable
with minimal
cleaning
required for re-
use. Signature
is important in
the operation
of these
devices or
systems,
as large
ventilation
systems or
protective
gear could
jeopardize
covert
operations.
Field use
devices can have a narrow detection of agents range, (e.g.,
can be specific for one particular target) because several
different devices may be deployed on a mission.

MOBILE LABORATORY SCENARIO
Mobile laboratory detection devices or systems are located in consumables.
deployable laboratories. They would likely be semi-automated Ideally, the
or integrated analytical
into a system laboratory
that is capable detection
of a higher device or
throughput of system must
samples (20- be able
30 samples at to detect
a time). Some biological
additional agents from all
equipment encountered
such as samples with a consistently high level of effectiveness and
centrifuges and sensitivity. The ideal system or device would also be able to
vortexes can multiplex.
be used during
operation,
although DIAGNOSTIC LABORATORY SCENARIO
smaller
systems are Diagnostic laboratory detection devices or systems are
preferred. Size typically located in a hospital or a similar medical setting. They
is a concern with mobile laboratory components as space is would be fully
limited and because the detection device or system is likely automated
only one component of the laboratory. A mobile laboratory devices
would ideally be able to operate for a longer period of time capable of high
than a field use item, indicating that consumables and throughput
manpower are a concern. Signature is somewhat important for of samples.
the mobile laboratory, as extensive safety precautions could The device
hinder the mobility and camouflage of the mobile laboratory. or system
The mobile laboratory detection device or system should must be able
ideally be able to detect every biological warfare agent of to detect
concern. agents from
blood, tissue,
cultured cells,
and other typical samples.
ANALYTICAL
An ideal detection device
LABORATORY
would detect agents very
SCENARIO
quickly, detect a large variety
The forensic of agents, have a high level
analytical of sensitivity, and be easy to
laboratory operate. This type of device
scenario is would be used in a hospital
typically a setting where size, signature,
fixed site additional equipment, and
location that electrical requirements are of
processes less concern. Calibration and
samples accuracy are critical factors in a medical environment. The
with the highest scrutiny and validates previous assays. device should be easily maintained with regularly scheduled
Analytical laboratory detection devices or systems would be maintenance, and be relatively easy for a medical staff to
concerned with looking for the greatest amount of recovery operate.
possible. This would be very important when trying to detect
biological agents from small dilute samples. There are no real
concerns with logistical or operational concerns, such as size,
weight, signature, transportation, additional equipment, and

Emanuel and Fruchey
3. Overview of PCR Techniques 4. Overview of Immunoassay Techniques

Polymerase chain reaction (PCR) refers to a highly sensitive Immunoassays were first described in the 1950s, although
technique by which minute quantities of specific DNA or RNA they were not readily applied outside of clinical laboratories
sequences can be enzymatically amplified to the extent that a until the advent of economical automated plate-reading
sufficient quantity of material is available to reach a threshold systems and personal computers to analyze the data.
“signal” for detection. The impetus for development of this Immunoassays are quick and accurate tests that can be used
technology grew out of basic research carried out by Kary on-site and in the laboratory to detect specific molecules.
Mullis, who was awarded the 1993 Nobel Prize for chemistry Immunoassays rely on the inherent ability of an antibody to
for PCR, and co-workers and other scientists working at the bind to the specific structure of a molecule.
Cetus Corporation and Department of Human Genetics in
Antibodies are proteins generated by animals in response
Emerysville, California.
to the invasion of a foreign molecule (antigen) into the body.
The starting material for PCR, the target sequence, is a gene Because antibodies are developed based on the specific
or segment of DNA. The target sequence can be amplified a three-dimensional structure of an antigen, or analyte, they
million fold in a short amount of time. The complementary are highly specific and will bind only to that structure. There
strands of a double-stranded molecule of DNA are are four typical immunoassay formats: monoclonal-polyclonal
separated by heating. Two small pieces of synthetic DNA, sandwich, antigen-down, competitive inhibition, and rapid.
each complementing a specific sequence at one end of the
In a typical microtiter plate sandwich immunoassay, such as
target sequence, serve as primers. Each primer binds to its
the E. coli 0157 Visual Immunoassay (VIA™), a monoclonal
complementary sequence. Polymerase, a naturally occurring
antibody is absorbed onto a plastic microtiter plate. The
enzyme, starts at each primer and copies the sequence of that
test sample is added to the plate, the antibody on the plate
strand. Exact replicas of the target sequence have now been
will bind the target antigen, if present, and retain it in the
produced. In subsequent cycles, double-stranded molecules of
plate. Next, a polyclonal antibody is added and will also
both the original DNA and the copies are separated by heating
bind to the antigen, which is now ‘sandwiched’ between the
and the primers again bind to the complementary sequences
two antibodies. This binding reaction can be measured by
and the polymerase replicates them.
radio-isotopes or by enzymes. The radio-isotope or enzyme
After many cycles, there are a great number of small pieces of generates a color signal proportional to the amount of target
DNA of the target sequence and this unlimited quantity is then antigen present. The degree of color can be detected and
available for further analysis. measured with the naked eye, a scintillation counter, or
spectrophotometer depending on the immunoassay format.
The versatility of PCR has been astounding, and it has opened
new avenues of research. Applications for PCR include In an antigen-down or direct immunoassay, the analyte is
molecular cloning, DNA sequencing, archeology, forensics, coated onto a 96-well microtiter plate and used to bind
amplification of unknown sequences, clinical pathology, antibodies found in a sample. When the sample is added,
genetic diagnosis, characterizing unknown mutations, the antigen on the plate it is bound by antibodies from the
fingerprinting/population analysis, genome analysis, and sample, which are then retained in the well. A species-specific
quantitative PCR of RNA or DNA. It has become a constantly labeled antibody is added which binds to the antibody bound
changing tool with further potential in the future. For further to the antigen on the plate. The higher the signal, the more
information on PCR, please see the University of California, antibodies there are in the sample.
Berkeley PCR Project website at http://sunsite.berkeley.edu/
Competitive inhibition assays are often used to measure small
biotech/pcr/whatisPCR.html or contact Edgewood BioDefense
analytes because competitive inhibition assays only require
at 410-436-5562.
the binding of one antibody. In a sequential competitive
inhibition assay format, such as the AflaCup™ Test Kit, a
monoclonal antibody is coated onto a 96-well microtiter plate.
When the sample is added, the antibody captures free analyte
out of the sample. Next, a known amount of labeled analyte
is added. The labeled analyte will then also attempt to bind to
the monoclonal antibody absorbed onto the plate; however,
the labeled analyte is inhibited from binding to the monoclonal
by the presence of previously bound analyte from the sample.
The amount of unlabeled analyte in the sample is inversely
proportional to the signal generated by the labeled analyte.
The classic competitive inhibition assay format required the
simultaneous addition of labeled and unlabeled analyte.
Both analytes will then compete for the binding site on the

monoclonal capture antibody on the plate. Like the sequential 5. Evaluation Process
competitive inhibition format, the colored signal is inversely
proportional to the concentration of unlabeled target analyte Four scenarios of use were selected for the analysis. These
in the sample. scenarios represent distinctly different uses of detection
technologies; in essence, each scenario involves different
Rapid immunoassay tests use antibodies to react with objectives and requirements. Once the objectives and
antigens and can be developed as monoclonal-polyclonal requirements for the four scenarios were clearly defined, the
sandwich formats, competitive inhibition formats and antigen- authors generated an evaluation model. The foundation of the
down formats. With a rapid test, the antibody and antigen model is the evaluation criteria, which represent the important
reagents are bound to porous membranes, which react attributes for detection and are intended to differentiate the
with positive samples while channeling excess fluids to a various types of products. The criteria were structured in the
nonreactive part of the membrane. There are two common form of a hierarchy, as shown in Figure 1.
configurations: a lateral flow test, such as the Bio Threat Alert
test strips, where the sample is simply placed in a well and Detection Systems
the results are read immediately; and a flow through system,
which requires placing the sample in a well, washing the well, Effectiveness Logistics Operations Biological
adding an analyte-colloidal gold conjugate, and reading the Agents Detected
results after a few minutes. One sample is tested per strip or
cassette. Sensitivity Transportation Throughput Bacterial
For further information on immunoassay technology, please Utility Consumables Set Up Time Viral
refer to http://www.immunochemistry.com, contact the Critical
Volume Signature Speed Multiplex
Reagents Program at (410) 436-9111, or contact Edgewood
BioDefense at 410-436-5562. Operational Manpower Toxins
Conditions
Maintainability Total Agents
Re-use
Ease of Use
Training
Requirements
Maturity
Figure 1. Hierarchical representation of criteria for detection

devices or systems product evaluation.
Each evaluation criterion was defined, and then further
described with a performance scale. The scales provide
a means of measuring how well each product “performs”
relative to each criterion. The performance scales can be
quantitative (e.g., speed, measured in minutes) or qualitative
(e.g., utility, measured by assessing the best fit). Each level on
the scale was assigned a utility value, ranging from 0 for the
lowest expected performance, to 100 for the highest level of
expected performance. Intermediate levels of performance
were assigned values between 0 and 100. For this study,
products were assessed at discrete scale levels, as opposed to
continuous scales. The definitions and performance scales for
the evaluation criteria are shown in Section 6 of this report.
The final step in developing the evaluation model was to
weight the criteria. The weights indicate the relative value of a
criterion, as defined by its performance scale, compared to the
other criteria. The criteria were weighted by distributing 100
points amongst the lowest level criteria for each of the three
legs of the hierarchy. Because each scenario is concerned
with different objectives and requirements, the criteria weights
varied depending on the scenario. Table 1 shows how the
weights were distributed relative to the different scenarios.

Emanuel and Fruchey
FIELD MOBILE DIAGNOSTIC ANALYTICAL 6. Selection Factors

USE LAB LAB LAB 1.0 EFFECTIVENESS GOAL
Sensitivity 2.5 5.0 24.0 30.0
Ability of the detection system to effectively detect the
Utility 2.0 5.0 12.0 5.0 biological agent from the target source. Taking into
Volume 0.5 5.0 4.0 15.0 consideration the concentration of the biological agent being
Transportation 13.5 10.0 2.2 1.0 detected and the amount of sample needed for testing.
Consumables 4.5 5.0 2.2 1.0 1.1 Sensitivity Measure. Ability of detection system to detect
Signature 2.3 1.0 0.0 1.0 the lowest concentration of target agent possible.
100 Detects 1-100 colony forming units (CFUs) per ml
Operational 4.5 8.0 1.5 1.0
90 Detects 100-1,000 CFUs per ml
Conditions
75 Detects 1,000-10,000 CFUs per ml
Re-Use 4.5 8.0 1.5 1.0 50 Detects 10,000-100,000 CFUs per ml
Training 2.3 4.0 4.5 2.0 0 Detects greater than 100,000 CFUs per ml unknown
Requirements
Maturity 13.5 4.0 3.0 3.0 1.2 Utility Measure. The best setting in which to use the
detection device or system.
Throughput 4.5 0.7 2.5 2.0
• Small, lightweight, easy to carry, and/or for field use*
Set Up Time 9.0 0.4 2.5 1.0
• Small, lightweight, easy to carry, and/or for field use; and
Speed 9.0 1.5 10.0 2.0 small, little, or no additional equipment and/or suitable for
Manpower 4.5 2.2 1.2 1.0 a mobile or deployable lab*
• Small, little, or no additional equipment and suitable for a
Maintainability 13.5 5.2 1.2 1.0
mobile or deployable lab*
Ease of Use 4.5 4.9 7.5 3.0 • Large, relatively easy to use but best suited for a hospital
Bacterial 1.0 6.0 3.0 3.0 or other diagnostic setting*
Viral 1.0 4.5 3.0 3.0 • Large, relatively easy to use but best suited for a hospital
or other diagnostic setting and large, very sensitive, and
Multiplex 1.0 1.5 3.0 9.0 intended for an analytical lab*
Toxins 1.0 6.0 3.0 3.0 • Large, very sensitive, and intended for an analytical lab*
Total Agents 1.0 1.2 8.0 12.0 *Varies according to the scenario utilized
Table 1. Weighted Performance Criteria Used in the Evaluation Model 1.3 Volume Measure. The volume of sample needed to
Determined by Subject Matter Experts effectively detect the target agent with the detection system or
The evaluation criteria were then used to formulate a device.
questionnaire, which was sent to the various manufacturers 100 Less than 10 ul
of detection products. The information provided by the 75 Less than 50 ul
manufacturers was used as the basis for assessing the 50 Less than 100 ul
different products against the evaluation model. The authors 25 Less than 250 ul
also obtained information from subject matter experts 0 Greater than 250 ul
working in these particular fields concerning the performance
of detection products with which they were familiar. The 2.0 LOGISTICS GOAL
authors evaluated every product that submitted a completed
questionnaire. Effect of the detection system or device on support and
logistical systems.
Each product was scored relative to each criterion for each
scenario. Overall scores and rankings were generated by the 2.1 Transportation Measure. Ability to transport the detection
decision analysis software Logical Decisions® for Windows system or device. Takes into consideration the portability of
(LDW), using a linear additive approach where each criterion the system, as well as the weight and volume of the device or
score is multiplied by the criterion weight and summed over all system.
the criteria. • Approximately the size of a soda can*
The results were analyzed to determine each product’s overall • Approximately the size of a toaster*
effectiveness (utility) for each scenario. These scores were • Approximately the size of a carry-on luggage suitcase*
used to identify the best-fit scenario for each technology, • Approximately the size of a home dishwasher*
as well as determine its potential effectiveness in all four • Larger than a home dishwasher*
scenarios. *Varies according to the scenario utilized

2.2 Component Measure. Requirement of consumables 3.0 OPERATIONS GOAL
(items that would need to be re-supplied, such as water, fuel,
batteries, chemical, power, etc.) that have to be transported to Effect of the detection device or system on detection efforts
the site for detection. and operations during usage.
100 0-1 consumable or expendable 3.1 Throughput Measure. The throughput of the detection
80 2 consumables or expendables system or device, measured in samples/run and also related
60 3 consumables or expendables to batch size.
30 4 consumables or expendables 100 Can run 384 samples/batch or higher
0 5 or more consumables or expendables or unknown 80 Can run 96 samples/batch or higher
60 Can run 32 samples/batch or higher
2.3 Signature Measure. Effect of the detection system or 20 Can run 2 samples/batch or higher
device on the signature of covert operations. 0 Can only run 1 sample/batch
100 Less than 200 British Thermal Units (BTUs) generated
50 Between 200-500 BTUs generated 3.2 Set-up Measure. The amount of time need to start up
0 Greater than 500 BTUs generated or unknown the detection device or system, including quality assurance
procedures.
2.4 Operational Conditions Measure. Temperature ranges at 100 No set-up required
which the detection device or system can operate with little or 80 Less than 5 minutes
no loss of efficacy. 60 5-10 minutes
100 Can be used from 4°C to 45°C 40 10-20 minutes
95 Can be used from 4°C to 37°C 0 Greater than 20 minutes
80 Can be used from 15°C to 37°C
50 Can be used from 25°C to 37°C 3.3 Speed Measure. Total time required to detect a single
0 Can only be used at 25°C or unknown target agent from a single surface wipe in liquid.
100 20 minutes or less
2.5 Re-use Measure. Ability of device or system to be cleaned 90 Between 20 and 30 minutes
and returned to service, or designed for single use only. 75 Between 30 and 40 minutes
• Device or system is designed for a single use* 50 Between 40 and 50 minutes
• Device or system is intended for multiple detection 25 Between 50 and 60 minutes
assays* 0 Greater than 60 minutes
*Varies according to the scenario utilized
3.4 Manpower Measure. The potential for automation of the
2.6 Training Requirements Measure. The amount of training device or system.
required before being able to utilize the detection device or 100 The system or device is currently fully automated
system. 90 The system or device could easily be adapted into a
100 Very brief training fully automated system
80 An afternoon of training 60 The system or device could be adapted to a fully
50 A day of training automated system with some effort
0 More than a day of training 30 The system or device could be adapted to a semi-
automated system with some effort
2.7 Maturity Measure. The availability of the detection device 0 The system or approach is not amendable to
or system commercially. automation
100 Is commercially available and meets military
3.5 Maintainability Measure. The amount of times the
specifications
detection device or system needs to be serviced.
90 Is commercially available
30 A few devices or systems exist (brass board) 100 Never needs serviced
15 Only one incomplete device or system exist (bread 90 Needs service less than once a year
board) 60 Needs service once a year
0 Only a concept on paper exist (white board) 30 Needs service every 6 months
0 Needs service more often than every 6 months or
known

Emanuel and Fruchey
3.6 Ease of Use Measure. The complexity and number of 4.0 BIOLOGICAL AGENTS DETECTED GOAL
steps required to operate the detection device or system.
Ability of the detection device or system to detect biological
100 0-2 steps required agents, such as bacteria or viruses, detect toxins, or multiple
80 3-5 steps required agents at the same time.
50 6-8 steps required
20 9-12 steps required 4.1 Bacterial Measure. Number of assays that have been
0 Greater than 12 steps required or unknown developed to detect bacteria that are important to biodefense.
100 Can detect 4 or more bacterial agents
75 Can detect 3 bacterial agents
50 Can detect 2 bacterial agents
25 Can detect 1 bacterial agent
0 Can not detect any bacterial agents
4.2 Viral Measure. Number of assays that have been

developed to detect viruses that are important to biodefense.
100 Can detect 4 or more viral agents
75 Can detect 3 viral agents
50 Can detect 2 viral agents
25 Can detect 1 viral agent
0 Can not detect any viral agents
4.3 Multiplex Measure. Ability to detect multiple biodefense

agents or toxins at the same time.
100 Assay available and capable of detecting 4 or more
agents or toxins
50 Assay not available, but capable of detecting 4 or
more agents or toxins
75 Assay available and capable of detecting 2 or more
agents or toxins
50 Assay not available, but capable of detecting 2 or
more agents or toxins
0 Not capable of detecting multiple agents or toxins
4.4 Toxins Measure. Number of assays that have been

developed to detect toxins that are important to biodefense.
100 Can detect 4 or more toxins
75 Can detect 3 toxins
50 Can detect 2 toxins
25 Can detect 1 toxin
0 Cannot detect any toxins
4.5 Total Agents Measure. Total number of biological warfare

agents that assays have been developed for and can be
detected.
100 Can detect more than 20 total agents
83.3 Can detect 20-16 total agents
50 Can detect 10-6 total agents
16.7 Can detect only 1 agent
0 Cannot detect any agents

7. Evaluation of Detection Devices or Systems Ranking for Detection Goal
Alternative Utility
Invitrogen LUX 0.943
FIELD USE SMART Tickets

ANP NIDS
Advnt Pro Strips
0.906
0.903
0.903
MSD Sector PR 2 0.902
MSD Sector PR 0.893
In the evaluation of detection equipment for field use, factors PROFILE-1 ATP Lumin. Sys.
Advent BADD
0.890
0.890
Optical Immuno-assay 0.887
pertaining to the simplicity of transportation of the device MIT Panther Cub
VIP for EHEC
0.885
0.882
or system, time for set up, detection speed, maintainability,

Tetracore Bio Threat Alert Test Strips 0.882
Triage Meter Tickets 0.845
Enigma Diagnostics ENIGMA-FL 0.843
maturity, and total agents detectable were considered as

Dycor XMX 0.840
Response Biomedical RAMP 0.837
TSI FLAPS 0.831
the most important criteria. An ideal field use device would

Research International RAPTOR 0.831
Idaho Tech RAZOR 0.826
Clear Lake Medical CD-M 0.824
be small and easily transportable, require few manual steps Smiths Bio-Seeq Plus
Dycor CFLAPS
MesoSystems AirSentinel
0.823
0.822
0.818
to operate, easy to maintain, and be able to operate at a Cellex Rapid Flu Test
Alexeter Guardian Reader
BioVeris M1M
0.815
0.806
0.805
variety of environmental conditions. Small, easy to use, and Alexeter Defender TSR
Smiths Bio-Seeq
Cellex Rapid Flu Test - Automated
0.804
0.804
0.802
versatile detection devices topped the evaluation for field use LightTyper
MSD Cartridge Reader
Alexa Biosensors dotLab
0.800
0.798
0.796
detection products. The SMART Tickets Bio Threat Alert Test LightCycler PCR
ABI PRISM 7500 PCR Fast
0.792
0.791
NRL Array Biosensor 0.790
Strips and the RAMP Tickets scored well as field devices for Tetracore Bio Threat Alert ELISA
Handheld Fluor. Strip Reader
0.786
0.785
immunoassay technologies and represent the best fit for this

Beacon Aflatoxin Plate Kit 0.782
Idaho Tech RAPID 0.782
Idaho Tech JBAIDS 0.782
scenario.
BioVeris M1R 0.778
BioVeris BV Detection System 0.778
Handheld Fluor. Polar. Reader 0.778
MSD Sector Imager 6000 0.778
Microfluidic FRET Reader 0.775
The RAZOR scored well as field devices for the handheld PCR Clear Lake Medical - Automated Disposable
NucliSens EasyQ System
PROFILE-II
0.773
0.772
0.772
technologies. This PCR device ranges in size from 1 kg to 5 kg Ambion Ag-Path ID

MultiPhoton Detection Portable
Invitrogen PathAlert
0.767
0.759
0.758
and would likely be transportable via backpack for field use. MAR-Magnetic Assay Reader
Bio-Alloy Smart Material Sensor
IBI P-CAN
0.757
0.753
0.752
Systems and devices that did not fare as well in the evaluation AflaCup Test Kit ELISA
Idaho Tech FilmArray
0.752
0.749
Assurance EHEC EIA 0.747
often require several additional pieces of equipment (e.g., Palm-Cycler PCR
Rotor-Gene DNA Amp. Sys.
0.741
0.741
centrifuges, shaker, vortex) for use, which decreased the ease

UPT Handheld Sensor 0.739
Veritide Bacterial Spore Detector 0.732
MultiPhoton Detection Tabletop 0.732
of use and increased the number of manual steps. Figure 2

Mini-PCR Fluor. Reader 0.728
MIDI Sherlock 0.726
TSI BEAR 0.726
highlights the criteria specific to the evaluation of products

EAI BioHaz 0.726
iCycler iQ Thermocycler 0.724
AD 340 Absorb. Det. 0.723
and technologies for field use. ABI PRISM 7500 PCR

LD 400 Luminescence Detector
ABI PRISM 7300 PCR
0.723
0.722
0.722
Anthragen 0.717
CANARY Biosensor 0.717
Cepheid GX1 0.717
BDS2 0.714
Detection Systems DNA Engine Thermal Cycler

Threshold System
0.713
0.710
1.00 HandyLab-EIMB
Invitrogen MAPP-DS
0.708
0.706
BioMAPP 0.703
Research International ASAP II 0.693
Smart Cycler PCR 0.692
Effectiveness Logistics Operations Biological

ABI PRISM 7000 PCR 0.690
Sapidyne KinExA 3000 0.688
TECRA E. coli 0157 VIA 0.686
0.05 0.45 0.45 Agents Detected Smiths Bio-Seeq II
MIT Panther
0.679
0.677
0.05 ABI PRISM 7900 PCR
TECRA UNIQUE
0.674
0.674
JBPDS 0.673
Compact, Quantum Dots Biosens. 0.670
Sensitivity Transportation Throughput Bacterial Eppendorf Mastercycler
Research International BioHawk
0.669
0.663
0.025 0.135 0.045 0.010 TECRA Staph. Entero. VIA

BioVeris M384
0.663
0.661
ChemImage Handheld Raman Imager 0.661
HKDNA Human VDS AIV H5 Detection Kit 0.661
Utility Consumables Set Up Time Viral DTX 800 Multimode Detector

DTX 880 Multimode Detector
0.655
0.655
0.02 0.045 0.090 0.010 Northrop Grumman MCAD

Bio Detector (BD)
MatriCycler
0.655
0.652
0.651
BIODET-400 Hand-held 0.647
Sapidyne KinExA In-Line 0.642
Volume Signature Speed Multiplex Sapidyne KinExA Field Portable
ABI 2720
0.637
0.637
0.005 0.023 0.090 0.01 ABI 9700
ABI 9800
0.637
0.637
Chimera System 0.637
Stratagene Mx3000P 0.634
Operational Manpower Toxins RIDASCREEN ELISA
ChemImage RBI Robot
0.631
0.630
Conditions 0.045 0.01 AD 200 Absorb. Det.

Stratagene Mx 4000 Multiplex PCR Sys.
0.628
0.628
0.045 MatriXarray
ChemImage FALCON II
0.628
0.625
Maintainability Total Agents ABI StepOne

Nanosphere RuggID
0.615
0.608
Re-use 0.135 0.01 Vero Tect

CombiMatrix ElectraSense
0.606
0.594
0.045 Invader Assay

Verigene ID
0.592
0.591
Lunascan Biodetection Sys. 0.587
Ease of Use ECBC TAC-BIO 0.586
Training 0.045
Morphix Chem Bio Detector
ChemSensing
0.585
0.582
Requirements Smiths SBS

Luminex xMAP
0.579
0.579
0.023 HKDNA LOAC

Transgenomic WAVE Sys.
Celera IDIS
0.578
0.574
0.565
Maturity
Lockheed Martin BAWS 0.564
Sapidyne KinExa Bench Top 0.561
APSIS 0.543
0.135 Port. NanoChip Workstation
BIODET-400 Lab. Instr.
0.531
0.522
ACA-ABS 0.517
Immulite 2000 0.516
Smiths EPBD 0.511
Figure 2. Hierarchical representation of criteria for Evaluation of

ChemImage EAGLE 0.507
ZeptoMARK and SensiChip 0.507
NanoChip Workstation 0.498
Detection Products for Field Use Mail Sentry

Mobile Molecular Lab.
CANARY Bioaerosol Sensor
0.467
0.458
0.456
Sceptor IDS 0.456
ECBC STORM 0.438
APDS 0.421
IBIS T5000 0.415
ABCDS-Sentry 0.408
MAGIChip 0.395
SAIC BAND 0.343
Logistics Operations Effectiveness

Biological Agents
Preference Set = Field Use
10
Emanuel and Fruchey
MOBILE LABORATORY Ranking for Detection Goal
Alternative Utility
SMART Tickets 0.883
In the evaluation of detection equipment for mobile ANP NIDS
MSD Sector PR 2
0.869
0.846
laboratories, factors pertaining to the bacterial, total agents,

Idaho Tech FilmArray 0.844
MIT Panther Cub 0.839
and toxins detectable; transportation; operational conditions;

MSD Sector PR 0.834
and re-use ability were considered as the most important

PROFILE-1 ATP Lumin. Sys. 0.801
MSD Cartridge Reader 0.794
criteria. An ideal mobile laboratory device would require Advnt Pro Strips
Tetracore Bio Threat Alert ELISA
IBI P-CAN
0.794
0.790
0.789
few manual steps to operate; require no or little additional Idaho Tech RAPID
Idaho Tech JBAIDS
BioVeris M1M
0.785
0.785
0.782
equipment; and would have increased throughput, speed, and BioMAPP

EAI BioHaz
JBPDS
0.778
0.778
0.776
potential for automation. BioVeris M1R

BioVeris BV Detection System
MIT Panther
0.775
0.775
0.772
Easy transportation and the ability of a device to detect many

HandyLab-EIMB 0.765
ABI PRISM 7500 PCR Fast 0.763
Invitrogen PathAlert 0.759
agents topped the evaluation for mobile laboratory detection

Advent BADD 0.759
products. The ABI PRISM 7900 Sequence Detection System

Alexeter Defender TSR 0.743
LightCycler PCR 0.740
was the highest ranked PCR device. Combining a less than ABI PRISM 7500 PCR
ABI PRISM 7300 PCR
ABI PRISM 7000 PCR
0.739
0.739
0.738
once a year service requirement and ability to detect 25 Alexeter Guardian Reader
BDS2
PROFILE-II
0.735
0.733
0.724
agents, this system represents the best fit for this scenario. CANARY Biosensor
ChemImage RBI Robot
ChemImage Handheld Raman Imager
0.724
0.719
0.718
The SMART Tickets were the highest ranked immunoassay CombiMatrix ElectraSense
Research International ASAP II
0.717
0.714
0.711
devices with no service required and ability to detect 14 MAR-Magnetic Assay Reader
Smiths Bio-Seeq Plus
0.711
0.707
agents currently, with others in development. Systems and DNA Engine Thermal Cycler
Smiths Bio-Seeq
0.692
0.688
VIP for EHEC 0.683
devices that did not fare as well in the evaluation often Ambion Ag-Path ID
MSD Sector Imager 6000
0.682
0.681
required several manual steps for detection, which increased

Luminex xMAP 0.680
Rotor-Gene DNA Amp. Sys. 0.680
SAIC BAND 0.680
the process time and manpower requirements and reduced

Invitrogen MAPP-DS 0.678
Smiths Bio-Seeq II 0.675
ABI StepOne 0.671
the ease of use. Figure 3 highlights the criteria specific to the

MultiPhoton Detection Portable 0.667
Nanosphere RuggID 0.666
evaluation of products and technologies for mobile laboratory Optical Immuno-assay

Cepheid GX1
MultiPhoton Detection Tabletop
0.660
0.659
0.657
use. APDS
Bio Detector (BD)
Anthragen
0.653
0.651
0.650
ChemImage FALCON II 0.648
TSI BEAR 0.646
BioVeris M384 0.646
MIDI Sherlock 0.645
Detection Systems Triage Meter Tickets
0.644
0.641
1.00 NucliSens EasyQ System

Cellex Rapid Flu Test
0.638
0.637
Smiths EPBD 0.622
Effectiveness Logistics Operations Biological UPT Handheld Sensor

Clear Lake Medical - Automated Disposable
0.620
0.617
Agents Detected
Alexa Biosensors dotLab 0.614
0.15 0.4 0.15 Dycor XMX
TECRA E. coli 0157 VIA
0.611
0.611
0.3 Celera IDIS
HKDNA Human VDS AIV H5 Detection Kit
0.608
0.606
TECRA UNIQUE 0.605
IBIS T5000 0.604
Sensitivity Transportation Throughput Bacterial Assurance EHEC EIA
Handheld Fluor. Polar. Reader
0.602
0.600
0.05 0.1 0.007 0.06 Beacon Aflatoxin Plate Kit
TSI FLAPS
0.594
0.594
Handheld Fluor. Strip Reader 0.591
Palm-Cycler PCR 0.591
Utility Consumables Set Up Time Viral Sapidyne KinExA In-Line

Port. NanoChip Workstation
0.589
0.588
0.05 0.05 0.004 0.045 Clear Lake Medical CD-M

Mini-PCR Fluor. Reader
0.587
0.584
ECBC STORM 0.583
AflaCup Test Kit ELISA 0.581
Volume Signature Speed Multiplex MesoSystems AirSentinel

Microfluidic FRET Reader
Chimera System
0.579
0.578
0.577
0.05 0.01 0.015 0.015 APSIS
LightTyper
0.570
0.567
TECRA Staph. Entero. VIA 0.565
Operational Manpower Toxins

Bio-Alloy Smart Material Sensor
MatriXarray
Dycor CFLAPS
0.564
0.561
0.559
Conditions 0.022 0.06 CANARY Bioaerosol Sensor
Stratagene Mx 4000 Multiplex PCR Sys.
0.553
0.551
0.08 Lunascan Biodetection Sys.
ACA-ABS
0.541
0.540
Maintainability Total Agents Northrop Grumman MCAD

RIDASCREEN ELISA
0.539
0.539
Re-use 0.052 0.12 BIODET-400 Hand-held
Sceptor IDS
0.530
0.530
0.08 Compact, Quantum Dots Biosens.

ECBC TAC-BIO
0.528
0.528
Ease of Use Mobile Molecular Lab.

Stratagene Mx3000P
0.527
0.524
Training 0.049
NanoChip Workstation
Smiths SBS
0.521
0.518
Requirements HKDNA LOAC

Sapidyne KinExA 3000
0.517
0.515
0.04 ChemSensing
Sapidyne KinExA Field Portable
0.513
0.512
ABI 2720 0.506
ABI 9700 0.506
Maturity ABI 9800

Eppendorf Mastercycler
ABCDS-Sentry
0.506
0.493
0.492
0.04 Morphix Chem Bio Detector
Vero Tect
0.492
0.486
MatriCycler 0.486
Mail Sentry 0.484
Figure 3. Hierarchical representation of criteria for Evaluation of AD 340 Absorb. Det.

Invader Assay
0.484
0.484
0.478
Detection Products for Mobile Laboratories DTX 800 Multimode Detector

Verigene ID
0.473
0.473
0.472
Immulite 2000 0.435
Transgenomic WAVE Sys. 0.432
BIODET-400 Lab. Instr. 0.429
Threshold System 0.413
MAGIChip 0.379
Logistics Biological Agents Effectiveness

Operations
Preference Set = Mobile Laboratory
11
DIAGNOSTIC LABORATORY Ranking for Detection Goal
Alternative Utility
MSD Sector PR 0.909
In the evaluation of detection equipment for diagnostic MSD Sector PR 2
MIT Panther Cub
0.903
0.894
laboratories, factors pertaining to the sensitivity, utility, time

ANP NIDS 0.874
to detect, ease of use, and total agents detectable were

IBI P-CAN 0.871
MSD Sector Imager 6000 0.866
MIT Panther 0.865
considered as the most important criteria. An ideal diagnostic

JBPDS 0.853
laboratory device would require relatively quick performance BDS2

HandyLab-EIMB
0.849
0.848
0.846
and would have high sensitivity requirements. Idaho Tech FilmArray

BioVeris M1M
LightCycler PCR
0.837
0.837
0.834
BioVeris M1R 0.828
Effective, fast, and efficient detection devices topped the BioVeris BV Detection System
MultiPhoton Detection Tabletop
0.828
0.827
evaluation for diagnostic laboratory detection devices or ABI PRISM 7000 PCR
BioMAPP
0.819
0.818
systems. The ABI Prism 7900 Detection System was the

MAR-Magnetic Assay Reader 0.818
BioVeris M384 0.814
highest ranked PCR device. Combining high sensitivity and

few consumables, this system represents the best fit for this
TSI BEAR 0.796
scenario. The Sector Images 6000 and the Sector PR100 Cellex Rapid Flu Test - Automated
ChemImage RBI Robot
Anthragen
0.792
0.791
0.786
scored the highest among the immunoassay detection Idaho Tech RAZOR
ChemImage Handheld Raman Imager
Response Biomedical RAMP
0.782
0.779
0.778
devices. Systems and devices that did not fare as well in the Research International RAPTOR
LightTyper
0.774
0.773
0.773
evaluation were often not sensitive, used many consumables, Smiths Bio-Seeq
ABI PRISM 7500 PCR
ABI PRISM 7300 PCR
0.772
0.772
0.772
were slow to detect, and did not detect many agents. Advnt Pro Strips
0.770
0.770
Cellex Rapid Flu Test 0.769
CombiMatrix ElectraSense 0.769
Figure 4 highlights the criteria specific to the evaluation of

SMART Tickets 0.766
Research International ASAP II 0.765
Bio Detector (BD) 0.764
products and technologies for diagnostic laboratory use.

VIP for EHEC 0.758
APDS 0.756
Cepheid GX1 0.754
SAIC BAND 0.751
Detection Systems Handheld Fluor. Polar. Reader

Invitrogen MAPP-DS
0.744
0.738
1.00 Smiths Bio-Seeq Plus

Alexa Biosensors dotLab
Sceptor IDS
0.738
0.738
0.737
Bio-Alloy Smart Material Sensor 0.734
Effectiveness Logistics Operations Biological

Ambion Ag-Path ID 0.731
0.4 0.15 0.25 Agents Detected Advent BADD
Handheld Fluor. Strip Reader
0.727
0.727
0.2 NucliSens EasyQ System

UPT Handheld Sensor
0.726
0.725
ABCDS-Sentry 0.719
Sensitivity Transportation Throughput Bacterial Research International BioHawk

MatriXarray
0.716
0.715
0.24 0.22 0.025 0.03 EAI BioHaz

0.715
0.713
Alexeter Guardian Reader 0.710
Utility Consumables Set Up Time Viral Luminex xMAP

APSIS
0.708
0.706
0.12 0.22 0.025 0.03

DNA Engine Thermal Cycler 0.705
IBIS T5000 0.701
Volume Signature Speed Multiplex ChemSensing
ACA-ABS
0.699
0.698
0.04 0.0 0.1 0.03 MIDI Sherlock
Chimera System
0.684
0.672
Stratagene Mx 4000 Multiplex PCR Sys. 0.668
Operational Manpower Toxins Optical Immuno-assay
Smiths EPBD
0.667
0.667
Conditions 0.012 0.03 ECBC STORM
Assurance EHEC EIA
0.654
0.652
0.015 NanoChip Workstation

0.652
0.650
Maintainability Total Agents Celera IDIS

TECRA E. coli 0157 VIA
0.642
0.640
Re-use 0.012 0.08 Nanosphere RuggID

ZeptoMARK and SensiChip
0.630
0.623
0.015 Immulite 2000

Stratagene Mx3005P
Mail Sentry
0.611
0.604
0.603
Ease of Use Stratagene Mx3000P 0.598
Training 0.075
Lunascan Biodetection Sys.
0.597
0.587
Requirements HKDNA Human VDS AIV H5 Detection Kit

Tetracore Bio Threat Alert Test Strips
0.586
0.581
0.045
CANARY Bioaerosol Sensor 0.579
PROFILE-II 0.572
Northrop Grumman MCAD 0.569
Mobile Molecular Lab. 0.549
Maturity Clear Lake Medical CD-M
TSI FLAPS
0.543
0.541
0.03 Dycor XMX
0.537
0.531
Dycor CFLAPS 0.531
Smiths SBS 0.504
Figure 4. Hierarchical representation of criteria for Evaluation of ECBC TAC-BIO
0.502
0.499
Detection Products for Diagnostic Laboratories Sapidyne KinExA 3000
Sapidyne KinExa Bench Top
0.495
0.494
Invader Assay 0.492
LD 400 Luminescence Detector 0.489
Sapidyne KinExA Field Portable 0.479
DTX 800 Multimode Detector 0.478
ABI StepOne 0.456
MatriCycler 0.428
RIDASCREEN ELISA 0.410
Eppendorf Mastercycler 0.408
ABI 2720 0.408
ABI 9700 0.408
ABI 9800 0.408
TECRA UNIQUE 0.400
HKDNA LOAC 0.395
Verigene ID 0.364
Vero Tect 0.345
MAGIChip 0.321
Effectiveness Operations Biological Agents

Logistics
Preference Set = Diagnostic Laboratory
12
Emanuel and Fruchey
ANALYTICAL LABORATORY Ranking for Detection Goal
Alternative Utility
In the evaluation of detection equipment for analytical ABI PRISM 7000 PCR
Idaho Tech FilmArray
0.892
0.886
laboratories, factors pertaining to sensitivity, utility, volume,

MSD Sector PR 0.868
total agents detected, and ability to multiplex were considered

to be the most important criteria. An ideal analytical laboratory

BioMAPP 0.849
device would require the generation of a nearly perfect IBI P-CAN

BDS2
0.843
0.842
0.841
sensitivity, as well as ability to detect many agents in the ChemImage EAGLE

Luminex xMAP
MIT Panther
0.827
0.825
0.821
same sample. The ABI PRISM 7900 and 7000 detection LightCycler PCR
IBIS T5000
CANARY Biosensor
0.821
0.815
0.813
systems scored particularly well in the evaluation for analytical SAIC BAND
HandyLab-EIMB
ABI PRISM 7500 PCR
0.812
0.809
0.809
laboratory PCR detection products. The ABI PRISM 7900 was ABI PRISM 7300 PCR
ANP NIDS
0.809
0.797
JBPDS 0.796
the highest ranked device, combining high sensitivity and MSD Sector Imager 6000
DNA Engine Thermal Cycler
0.792
0.785
ECBC STORM 0.784
the ability to detect many agents and multiple agents in the ChemImage RBI Robot
0.777
0.775
same sample, and represents the best fit for this scenario.
APDS 0.763
Other devices, such as the BioMAPP and APDS systems, use

both PCR and immunoassay technologies and scored well in MAR-Magnetic Assay Reader
Bio Detector (BD)
0.755
0.752
0.750
this category due to their high sensitivity and ability to detect PROFILE-1 ATP Lumin. Sys.
iCycler iQ Thermocycler
0.750
0.743
0.742
multiple agents in a single sample. Most of the immunoassay Idaho Tech RAPID
Idaho Tech JBAIDS
CombiMatrix ElectraSense
0.737
0.737
0.733
devices did not fare well for this category due to lack of APSIS
Cellex Rapid Flu Test
BioVeris M1M
0.730
0.726
0.726
sensitivity and lack of multiplex capabilities with the exception EAI BioHaz
Cepheid GX1
0.725
0.722
of the Sector Images 6000. Systems and devices that did not BioVeris M1R
BioVeris BV Detection System
0.718
0.718
TSI BEAR 0.718
fare as well in the evaluation often had poor sensitivity. Figure ChemImage Handheld Raman Imager
BioVeris M384
0.717
0.715
5 highlights the criteria specific to the evaluation of products

Stratagene Mx 4000 Multiplex PCR Sys. 0.715
Anthragen 0.712
Sceptor IDS 0.712
and technologies for analytical laboratory use.

Smiths Bio-Seeq 0.707
MatriXarray 0.690
ABCDS-Sentry 0.686
MIDI Sherlock 0.681
Detection Systems Celera IDIS

Veritide Bacterial Spore Detector
Idaho Tech RAZOR
0.680
0.675
0.674
1.00 Stratagene Mx3005P
Handheld Fluor. Polar. Reader
0.673
0.670
Smiths Bio-Seeq Plus 0.668
Effectiveness Logistics Operations Biological Advnt Pro Strips
Palm-Cycler PCR
0.663
0.659
0.5 0.1 0.1 Agents Detected Research International RAPTOR

Research International ASAP II
0.659
0.653
0.3 LightTyper
NanoChip Workstation
0.650
0.648
Sensitivity Transportation Throughput Bacterial Immulite 2000

Invitrogen MAPP-DS
0.636
0.635
0.3 0.01 0.02 0.03 Nanosphere RuggID

Mail Sentry
0.631
0.629
0.627
Tetracore Bio Threat Alert ELISA 0.620
Utility Consumables Set Up Time Viral SMART Tickets
Compact, Quantum Dots Biosens.
0.618
0.614
0.05 0.01 0.01 0.03 VIP for EHEC
0.612
0.608
Volume Signature Speed Multiplex MesoSystems AirSentinel
Assurance EHEC EIA
0.604
0.604
0.15 0.01 0.02 0.09 BIODET-400 Lab. Instr.

0.602
0.602
Operational Manpower Toxins Microfluidic FRET Reader
Alexeter Guardian Reader
0.594
0.594
Conditions 0.01 0.03 Optical Immuno-assay

Alexeter Defender TSR
0.591
0.585
0.01 UPT Handheld Sensor

ChemSensing
0.575
0.567
Maintainability Total Agents

ACA-ABS 0.558
Advent BADD 0.553
Re-use 0.01 0.12

Invader Assay
CANARY Bioaerosol Sensor
Smiths EPBD
0.541
0.536
0.528
0.01 ABI StepOne
Lunascan Biodetection Sys.
0.511
0.488
Ease of Use Northrop Grumman MCAD 0.477
Training 0.03
Transgenomic WAVE Sys.
TECRA Staph. Entero. VIA
TECRA UNIQUE
0.473
0.445
0.440
Requirements Clear Lake Medical CD-M
TSI FLAPS
0.418
0.417
0.02 Sapidyne KinExA In-Line
0.404
0.400
Dycor XMX 0.385
Maturity Smiths SBS
Dycor CFLAPS
0.385
0.384
0.03 ECBC TAC-BIO
PROFILE-II
0.380
0.380
Figure 5. Hierarchical representation of criteria for Evaluation of LD 400 Luminescence Detector
Sapidyne KinExA 3000
0.362
0.361
Detection Products for Analytical Laboratories DTX 880 Multimode Detector
MAGIChip
0.350
0.346
ABI 2720 0.345
ABI 9700 0.345
ABI 9800 0.345
Morphix Chem Bio Detector 0.344
MatriCycler 0.334
HKDNA LOAC 0.323
Vero Tect 0.318
Verigene ID 0.313
Effectiveness Biological Agents Logistics

Operations
Preference Set = Analytical Laboratory
13
8. Summary
The process of comparison and contrast among competing
scientific technologies is a useful exercise to assist the
research community in deciding which product best fits their
particular needs. As a variety of fundamentally different
technologies now exist for the task of detection, a method
for comparison is particularly useful at this time. Product
information was collected from interested vendors and
compared with a model, as well as a handful of traditional
protocols. A set of important and discriminating criteria was
established to differentiate between competing technologies
and used to generate overall rankings for four different usage
scenarios. The overall ranking weights were based upon the
authors’ experiences and opinions, and would likely vary
slightly from person to person, although they tend to represent
the general opinions of the research community at large. The
model generated during this report permits sensitivity analysis
that could be used to consider other views.
A potentially useful way to use this guide would be to review
the research scenario that most relates to an area of interest,
identify which products scored well in the evaluation for each
technology, and then closely examine these products using
the product information contained within Appendix II. When
looking at the product score, do not judge the product base
solely on the raw score. Look at the product score in blocks
(top, middle, bottom); the products were evaluated in blocks of
thirds. Information for product representatives is included for
each product so that additional information can be obtained.
Appendix II is intended as an independent document that can
be used as a general guide to present information on several
options for detection products.
14
Emanuel and Fruchey
Appendix I: Technology Quick Reference

Both PCR &
PCR Based Immunoassay Other Technology: Maturity
Immunoassay
Technology Technology Specify Gauge
Technologies
ABCDS-Sentry 3
ABI 2720 3
ABI 9700 3
ABI 9800 3
ABI PRISM 7000 PCR 3
ABI PRISM 7500 PCR Fast 3
ABI StepOne 3
ACA-ABS 3
AD 200 Absorb. Det. 3
AD 340 Absorb. Det. 3
Advent BADD 3
Advnt Pro Strips 3
AflaCup Test Kit ELISA 3
Alexa Biosensors dotLab 3
Alexeter Defender TSR 3
Alexeter Guardian Reader 3
Ambion Ag-Path ID 3
ANP NIDS 3
Anthragen 3
I:1
APPENDIX I: TECHNOLOGY QUICK REFERENCE
Both PCR &

Immunoassay
Technologies
APDS 3
APSIS 3 PCR and Microarray
Assurance EHEC EIA 3
BDS2 Optical Sensor
Beacon Aflatoxin Plate Kit 3
Bio-Alloy Smart Material

3
Sensor
BIODET-400 Lab. Instr. 3
BIODET-400 Hand-held 3
Bio Detector (BD) 3
BioMAPP 3
BioVeris BV Detection
3
System
BioVeris M1M 3
BioVeris M1R 3
BioVeris M384 3
CANARY Bioaerosol Sensor 3 B cell based
CANARY Biosensor 3 B cell based
Celera IDIS 3
Cellex Rapid Flu Test Enzymatic
Cellex Rapid Flu Test -

Enzymatic
Automated
Cepheid GX1 3
ChemImage EAGLE Raman spectroscopy
ChemImage FALCON II Raman spectroscopy
I:2
Emanuel and Fruchey
Both PCR &

Immunoassay
Technologies
ChemImage Handheld
Raman spectroscopy
Raman Imager
ChemImage RBI Robot Raman spectroscopy
ChemSensing Colorimetric
Chimera System 3
Clear Lake Medical -

3
Automated Disposable
Clear Lake Medical CD-M Imaging system
CombiMatrix ElectraSense Microarray
Compact, Quantum Dots

3
Biosensor
DNA Engine Thermal Cycler 3
DTX 800 Multimode

3
Detector
DTX 880 Multimode
3
Detector
Non-specific biological
Dycor CFLAPS
particle detector
Dycor XMX
particle detector
Non-specific test for DNA
EAI BioHaz
and protein
ECBC STORM 3
ECBC TAC-BIO
particle detector
Enigma Diagnostics
3
ENIGMA-FL
Eppendorf Mastercycler 3
Handheld Fluor. Polar.

3
Reader
Handheld Fluor. Strip
3
Reader
HandyLab-EIMB 3
HKDNA Human VDS AIV H5

3
Detection Kit
I:3
Both PCR &

Immunoassay
Technologies
HKDNA LOAC Microarray
IBI P-CAN B cell based
PCR and mass

IBIS T5000 3
spectrometry
iCycler iQ Thermocycler 3
Idaho Tech FilmArray 3 Microarray
Idaho Tech JBAIDS 3
Idaho Tech RAPID 3
Idaho Tech RAZOR 3
Immulite 2000 3
Invader Assay Enzymatic
Invitrogen LUX 3
Resonance light
Invitrogen MAPP-DS
scattering
Invitrogen PathAlert 3
JBPDS 3
LD 400 Luminescence
Photometric
Detector
LightCycler PCR 3
LightTyper 3
Lockheed Martin BAWS
particle detector
Luminex xMAP 3
Optical Fiber with

Lunascan Biodetection Sys. 3
Fluorescence
MAGIChip 3 Microarray
Mail Sentry 3
I:4
Emanuel and Fruchey
Both PCR &

Immunoassay
Technologies
MAR-Magnetic Assay
3 Mutual Induction
Reader
MatriCycler 3
MatriXarray 3
particle detector
Mini-PCR Fluor. Reader 3
Microfluidic FRET Reader 3
MIDI Sherlock Gas chromatography
MIT Panther B cell based
MIT Panther Cub B cell based
Mobile Molecular Lab. 3
particle detector
MSD Cartridge Reader 3
MSD Sector Imager 6000 3
MSD Sector PR 3
MultiPhoton Detection
3
Portable
MultiPhoton Detection
3
Tabletop
NanoChip Workstation Microarray
Nanosphere RuggID 3
Northrop Grumman MCAD
particle detector
NRL Array Biosensor 3
NucliSens EasyQ System 3
Optical Immuno-assay 3
I:5
Both PCR &

Immunoassay
Technologies
Palm-Cycler PCR 3
Port. NanoChip Workstation 3 Microarray
PROFILE-1 ATP Lumin. Sys. Luminescence
PROFILE-II 3
Research International
3
BioHawk
3
RAPTOR
3
ASAP II
Response Biomedical
3
RAMP
RIDASCREEN ELISA 3
Rotor-Gene DNA Amp. Sys. 3
SAIC BAND 3
Sapidyne KinExA 3000 3
Sapidyne KinExA Bench Top 3
Sapidyne KinExA Field

3
Portable
Sapidyne KinExA In-Line 3
Sceptor IDS 3
Smart Cycler PCR 3
SMART Tickets 3
Smiths Bio-Seeq 3
Smiths Bio-Seeq II 3
Smiths Bio-Seeq Plus 3
Smiths EPBD 3
I:6
Emanuel and Fruchey
Both PCR &

Immunoassay
Technologies
Smiths SBS
particle detector
Stratagene Mx3000P 3
Stratagene Mx3005P 3
Stratagene Mx 4000
3
Multiplex PCR Sys.
TECRA E. coli 0157 VIA 3
TECRA Staph. Entero. VIA 3
TECRA UNIQUE 3
Tetracore Bio Threat Alert

3
ELISA
Tetracore Bio Threat Alert
3
Test Strips
Threshold System 3
Transgenomic WAVE Sys. 3 Liquid Chromatography
Triage Meter Tickets 3
TSI BEAR DNA hybridization
TSI FLAPS
particle detector
UPT Handheld Sensor 3
Verigene ID 3 Nanoparticle Probes
Veritide Bacterial Spore

Optical detection
Detector
Vero Tect
particle detector
VIP for EHEC 3
ZeptoMARK and SensiChip Microarray
Maturity Gauge Key:

Commercially available & meets military specs Only one incomplete device exists
Commercially available Only a concept on paper
A few devices exist
I:7
I:8
Emanuel and Fruchey
Appendix II: Evaluation of Detection Products
II:1
APPENDIX II: EVALUATION OF DETECTION PRODUCTS
ABI 2720
by Applied Biosystems
CAPABLE OF ANALYTICAL Laboratory Ranking

DETECTING THE ABI 2720 ranked in the bottom third of all evaluated
FOLLOWING: products for analytical laboratories and earned 38% of
Bacillus anthracis, the utility points of the best score.
E. coli 0157:H7, ALTERNATIVE UTILITY
Francisella tularensis, Best Score 0.901
Vibrio cholera,
ABI 2720 0.345
Corynebacterium
diptheria, Burkholderia Lowest Score 0.217
mallei, Burkholderia Effectiveness Biological Agents Logistics Operations
pseudomallei, Yersinia Preference Set: Analytical Laboratory
pestis, Coxiella burnetti,
Rickettsia prowazekii,
Brucella species,
Marburg virus, Rift
DIAGNOSTIC Laboratory Ranking
Valley fever virus, VEE ABI 2720 ranked in the bottom third of all evaluated
virus, Hanta virus, Yellow fever virus, Dengue fever virus, Ebola products for diagnostic laboratories and earned 45% of
viruses, Orthopox virus, MS-2 bacteriophage (Assays developed) the utility points of the best score.
ALTERNATIVE UTILITY
DESCRIPTION: Best Score 0.909
The Applied Biosystems 2720 Thermal Cycler is an automated
instrument, specifically designed for the amplification of nucleic ABI 2720 0.408
acids using the GeneAmp Polymerase Chain Reaction (PCR) Lowest Score 0.321
process. The instrument has an integrated 96-well sample block,
Effectiveness Operations Biological Agents Logistics
which houses an internal Peltier heating/cooling unit. The sample
Preference Set: Diagnostic Laboratory
block is made of aluminum to provide optimal thermal transfer
rate. Platinum sensors provide a wide temperature range (4°C to
99.9°C), accurate measurements (±0.25°C from 35°C to 100°C)
and long term stability and high reliability. The sample block MOBILE Laboratory Ranking
accommodates several different types of MicroAmp® disposable ABI 2720 ranked in the bottom third of all evaluated
tubes and plates, which must be used in order to create a sealed products for mobile laboratories and earned 57% of the
chamber. utility points of the best score.
TECHNOLOGY: ALTERNATIVE UTILITY
The Applied Biosystems 2720 Thermal Cycler uses peltier- Best Score 0.883
based elements to enable the PCR amplification process. PCR is ABI 2720 0.506
composed of three segments, which can be programmed on the Lowest Score 0.379
thermal cycler. In the pre-PCR segment, you define an incubation
temperature and hold time sufficient to denature double-stranded Logistics Biological Agents Effectiveness Operations
DNA. The PCR segment is the actual cycling segment that Preference Set: Mobile Laboratory
generates the amplified product. The key parameters are used for
template denaturation, primer annealing, and primer extension.
The post-PCR incubation temperature defines how to soak your FIELD USE Ranking
samples at a specified temperature until you are ready to analyze ABI 2720 ranked in the middle third of all evaluated
them.
products for field use and earned 68% of the utility
points of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
ABI 2720 0.637
Lowest Score 0.343
Logistics Operations Effectiveness Biological Agents

Preference Set: Field Use
II:2
Emanuel and Fruchey
Summary of Analysis Evaluation Criteria Provided by Vendor

System requirements: Ease of use/Utility::
• System or device has 110V • Can not view results “in real
electrical requirement time”
ANALYTICAL • The system or device does not • Multiple shaking or vortexing
require water steps
• System can not interpret raw
• The system or device does not
data or call a positive through
require an external air or gas
internal software
MOBILE FIELD source • One additional piece of
• The system or device does not equipment needed
require an external vacuum
source
Signature:
DIAGNOSTIC • No sounds produced that cannot
Throughput of product: be deactivated
• 384 sample/batch or higher • Greater than 500 BTUS
• The system or device could be generated
BEST FIT WORST FIT adapted into a semi automated
system with some effort Operational conditions:
• Operated from 15°C to 37°C
Training/Speed/Manpower: • The performance of the device
• Very brief (minutes-hours) or system is not influenced by
training and minimal technical relative humidity
skills
• 10-20 minutes is required for Sensitivity:
CONTACT INFORMATION system set-up
Applied Biosystems • Unknown
• 3-5 manual steps required for
850 Lincoln Center Drive detection
Foster City, CA 94494 Maturity gauge:
www.Appliedbiosystems.com • Is commercially available
Re-use: • Has been featured in peer
Point of Contact: • 4 step cleaning procedure reviewed scientific publications
Andy Felton or independent evaluation
(800) 248-0281 Maintenance:
(650) 638-6045 fax • Once a year service required t
feltonac@appliedbiosystems.com • Expected life is between 3-5
years
• No daily quality assurance MOST MATURE LEAST MATURE
procedures
COST
• $4,395.00/system or device
Transportation:
• Approximately the size of a
toaster
• Between 5 and 25 kg
II:3
ABI PRISM 7000 Sequence Detection System


DETECTING THE ABI PRISM 7000 Sequence Detection System ranked
FOLLOWING: in the top third of all evaluated products for analytical
Bacillus anthracis, laboratories and earned 99% of the utility points of the
E. coli 0157: best score.
H7, Francisella ALTERNATIVE UTILITY
tularensis, Best Score 0.901
Vibrio cholera,
Corynebacterium
diptheria, Lowest Score 0.217
Burkholderia mallei, Effectiveness Biological Agents Logistics Operations
Burkholderia pseudomallei, Yersinia pestis, Coxiella burnetti, Preference Set: Analytical Laboratory
Rickettsia prowazekii, Brucella species, Marburg virus, Rift Valley
fever virus, VEE virus, Hanta virus, Yellow fever virus, Dengue fever
virus, Ebola viruses, Orthopox virus, MS-2 bacteriophage (Assays
developed) ABI PRISM 7000 ranked in the top third of all evaluated
products for diagnostic laboratories and earned 90% of
DESCRIPTION: the utility points of the best score.
The instrument is an integrated system designed to perform
both real-time PCR and post-PCR analysis. The instrument is ALTERNATIVE UTILITY
capable of analyzing 96 samples simultaneously in a 96-well plate Best Score 0.909
format. The instrument provides specialized application specific ABI PRISM 7000 PCR 0.819
software that collects and analyzes the fluorescence data for the Lowest Score 0.321
application of absolute quantitation and allelic discrimination/
SNP (Single Nucleotide Polymorphism) detection. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The instrument support two homogeneous reaction chemistries,
the fluorogenic 5’ nuclease assay using TaqMan™ probes and MOBILE Laboratory Ranking
the SYBR™ Green I double stranded DNA binding dye chemistry. ABI PRISM 7000 ranked in the top third of all evaluated
The instrument utilizes a tungsten-halogen lamp, a cooled charge products for mobile laboratories and earned 84% of the
coupled device (CCD) camera, and a four position emission filter
utility points of the best score.
wheel, to enable multiple wavelength detection. Instrument
software utilizes a multicomponenting algorithm to provide ALTERNATIVE UTILITY
precise deconvolution of multiple dye signals, to enable the Best Score 0.883
simultaneous detection of multiple fluorophores with no crosstalk. ABI PRISM 7000 PCR 0.738
Lowest Score 0.379
Logistics Biological Agents Effectiveness Operations

Preference Set: Mobile Laboratory
FIELD USE Ranking

ABI PRISM 7000 ranked in the middle third of all
evaluated products for field use and earned 73% of the
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:4
Emanuel and Fruchey

System requirements: Transportation:
• System or device has 110V • Approximately the size of a home
electrical requirement dishwasher
ANALYTICAL • The system or device does not • Between 5 and 25 kg
require water • Shelf life between 1 and 3 years
require an external air or gas Ease of use/Utility:
source
MOBILE FIELD • The system or device does not
• Cannot view results “in real time”
• No centrifugation steps
require an external vacuum • Single shaking or vortexing step
source • System always able to interpret
raw data or call a positive
DIAGNOSTIC Throughput of product: through internal software
• Single sample detection greater • Assay available and capable of
than 60 minutes detecting two or more biological
• 96 samples/batch or higher agents or toxins within the same
BEST FIT WORST FIT • Less than 50 ul volume needed test
per test for detection • Two additional pieces of
• The system or device could be equipment needed
adapted into a semi automated
system with some effort Signature:
• No sounds produced that cannot
Training/Speed/Manpower: be deactivated
• Very brief training • Less than 200 BTUS generated
CONTACT INFORMATION • Less than 5 minutes required
Applied Biosystems for set-up
850 Lincoln Center Drive Operational conditions:
• 3-5 manual steps required for • Operated from 4°C to 37°C
Foster City, CA 94494 detection • Components must be stored at
www.Appliedbiosystems.com 4°C
Point of Contact: Re-use: • The performance of the device
• Device or system is intended for or system is not influenced by
Andy Felton
multiple use relative humidity
(800) 248-0281 • 0-1 solution or buffer used
(650) 638-6045 fax • 3 components
feltonac@appliedbiosystems.com • No cleaning required
Sensitivity:
• 1-100 CFU per ml
Maintenance: Maturity gauge:

COST • 2 consumables or expendables
• Is commercially available and
• $0.50/ sample plus Taq enzyme needed
meets military specifications
• $42,761 GSA price/system or device • Less than once a year service
required t
• Expected life is 5-10 years
• Less than 5 minutes required
for daily assurance procedures
MOST MATURE LEAST MATURE
II:5
ABI 7300 Real Time PCR System


DETECTING ABI 7300 System ranked in the top third of all
THE evaluated products for analytical laboratories and
FOLLOWING: earned 90% of the utility points of the best score.
Bacillus ALTERNATIVE UTILITY
anthracis, Best Score 0.901
Francisella ABI PRISM 7300 PCR 0.809
tularensis,
Lowest Score 0.217
Corynebacterium
diphtheria, Effectiveness Biological Agents Logistics Operations
Burkholderia Preference Set: Analytical Laboratory
pseudomallei,
Coxiella burnetti, Brucella species, E.coli O157:H7, Vibrio cholera,
Burkholderia mallei, Yersinia pestis, Rickettsia prowazekii,
Marburg virus, Influenza virus, Dengue fever virus, Orthopox virus,
Rift valley fever virus, Venezuelan equine encephalitis virus, Yellow
ABI 7300 System ranked in the top third of all
fever virus, Ebola virus, MS-2 bacteriophage (Assay developed) evaluated products for diagnostic laboratories and
earned 85% of the utility points of the best score.
DESCRIPTION: ALTERNATIVE UTILITY
The instrument is an integrated system designed to perform Best Score 0.909
both real-time PCR and post-PCR analysis. The instrument is ABI PRISM 7300 PCR 0.772
capable of analyzing 96 samples simultaneously in a 96-well plate Lowest Score 0.321
format. The instrument provides specialized application specific
software that collects and analyzes the fluorescence data for the Effectiveness Operations Biological Agents Logistics
application of absolute quantitation and allelic discrimination/SNP Preference Set: Diagnostic Laboratory
(Single Nucleotide Polymorphism) detection.
MOBILE Laboratory Ranking

TECHNOLOGY: ABI 7300 System ranked in the top third of all
The instrument support two homogeneous reaction chemistries,
the fluorogenic 5’ nuclease assay using TaqMan® probes and evaluated products for mobile laboratories and earned
the SYBR® Green I double stranded DNA binding dye chemistry. 84% of the utility points of the best score.
The instrument utilizes a tungsten-halogen lamp, a cooled charge ALTERNATIVE UTILITY
coupled device (CCD) camera, and emission filters, to enable Best Score 0.883
multiple wavelength detection. Instrument software utilizes a
multicomponenting algorithm to provide precise deconvolution
Lowest Score 0.379
of multiple dye signals, to enable the simultaneous detection of
multiple fluorophores with little crosstalk. Logistics Biological Agents Effectiveness Operations
FIELD USE Ranking

ABI 7300 System ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:6
Emanuel and Fruchey

• System or device has 110V • Approximately the size of a carry-
electrical requirement on luggage suitcase
require water • Shelf life measure not applicable
source
• Can view results “in real time”
require an external vacuum • No shaking or vortexing steps
• Single sample detection greater • Assay not available but capable
than 60 minutes of detecting four or more
• 96 samples/batch or higher biological agents or toxins within
BEST FIT WORST FIT • Less than 50 ul volume needed the same test
• A day of training • Greater than 500 BTUS
CONTACT INFORMATION • No set-up required generated
Applied Biosystems • 3-5 manual steps required for
Foster City, CA 94494
Operational conditions:
www.Appliedbiosystems.com
Re-use: • Components must be stored at
Point of Contact: • Device or system is intended for 4°C
Andy Felton multiple use • The performance of the device
• 0-1 solution or buffer used or system is not influenced by
(800) 248-0281
• 3 components relative humidity
(650) 638-6045 fax
• No cleaning required
feltonac@appliedbiosystems.com
Sensitivity:
Maintenance: • 1-100 CFU per ml
• 4 consumables or expendables
COST needed Maturity gauge:
• $0.50/sample plus Taq enzyme • Once a year service required • Is commercially available
• $34,900/system or device • Expected life is between 5-10
years t
• No daily quality assurance
procedures
II:7
ABI PRISM 7500 PCR Fast Analysis


DETECTING THE ABI PRISM 7500 Sequence Detection System ranked
FOLLOWING: in the top third of all evaluated products for analytical
Francisella tularensis, best score.
Corynebacterium ALTERNATIVE UTILITY
diphtheria, Best Score 0.901
Burkholderia
pseudomallei, Coxiella
burnetti, Brucella Lowest Score 0.217
species, E.coli Effectiveness Biological Agents Logistics Operations
O157:H7, Vibrio cholera, Burkholderia mallei, Yersinia pestis, Preference Set: Analytical Laboratory
Rickettsia prowazekii, Marburg virus, Influenza virus, Dengue
fever virus, Orthopox virus, Rift valley fever virus, Venezuelan
equine encephalitis virus, Yellow fever virus, Ebola virus, MS-2
bacteriophage (Assay developed) ABI PRISM 7500 ranked in the top third of all evaluated
The Applied Biosystems 7500 Fast Real-Time PCR System is an ALTERNATIVE UTILITY
integrated system designed to perform both real-time PCR and Best Score 0.909
post-PCR analysis. This instrument is capable of analyzing 96
samples simultaneously in a 96-well plate format.
Lowest Score 0.321
The 7500 Fast provides specialized application specific software
that collects and analyzes the fluorescence data for the Effectiveness Operations Biological Agents Logistics
application of absolute quantitation, gene expression,
genotyping and pathogen detection.
TECHNOLOGY: MOBILE Laboratory Ranking

The 7500 Fast utilizes a tungsten-halogen lamp, a cooled charge
coupled device (CCD) camera, and emission filters to enable
ABI PRISM 7500 ranked in the top third of all evaluated
multiple wavelength detection. Instrument software utilizes a products for mobile laboratories and earned 86% of the
multicomponenting algorithm to provide precise deconvolution utility points of the best score.
of multiple dye signals to enable the simultaneous detection of ALTERNATIVE UTILITY
multiple fluorophores with little crosstalk. The 7500 Fast supports Best Score 0.883
a variety of available chemistries and is fully validated with ABI PRISM 7500 PCR Fast 0.763
Applied Biosystems’ portfolio of assays and reagents.
Lowest Score 0.379

FIELD USE Ranking

ABI PRISM 7500 ranked in the top third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:8
Emanuel and Fruchey

require water • Reagent shelf life between 6
• The system or device does not months and 1 year
source Ease of use/Utility:
MOBILE FIELD • The system or device does not • Can view results “in real time”
require an external vacuum • No centrifugation steps
source • No shaking or vortexing steps
• System always able to interpret
DIAGNOSTIC Throughput of product: raw data or call a positive
• Single sample detection through internal software
between 30 and 40 minutes • Capable of detecting four or more
• Less than 10 ul volume needed the same test
BEST FIT WORST FIT per test for detection • No additional pieces of
system with some effort
Signature:
• A day of training and technical • Greater than 500 BTUS
CONTACT INFORMATION skills required generated
Applied Biosystems • No set-up required
850 Lincoln Center Drive • 3-5 manual steps required for
Foster City, CA 94494 detection Operational conditions:
www.Appliedbiosystems.com • Components must be stored at
Re-use: 4°C
Point of Contact: • Device or system is intended for • The performance of the device
Andy Felton multiple use or system is not influenced by
(800) 248-0281 • 0-1 solution or buffer used relative humidity
(650) 638-6045 fax • 3 components
feltonac@appliedbiosystems.com Sensitivity:
• Once a year service required
COST • Expected life is between 5-10 Maturity gauge:
• $0.50/sample plus cost of Taq enzyme years • Is commercially available
• $49,900/system or device • No daily quality assurance • Has been featured in peer
procedures reviewed scientific publications
or independent evaluation
II:9
ABI 7500 Real Time PCR System


DETECTING THE ABI 7500 Sequence Detection System ranked in
FOLLOWING: the top third of all evaluated products for analytical
diphtheria, Best Score 0.901
Burkholderia
pseudomallei,
Coxiella burnetti, Lowest Score 0.217
Brucella species, Effectiveness Biological Agents Logistics Operations
E.coli O157:H7, Preference Set: Analytical Laboratory
Vibrio cholera,
Burkholderia mallei,
Yersinia pestis, Rickettsia prowazekii, Marburg virus, Influenza
virus, Dengue fever virus, Orthopox virus, Rift valley fever virus, ABI 7500 ranked in the top third of all evaluated
Venezuelan equine encephalitis virus, Yellow fever virus, Ebola products for diagnostic laboratories and earned 85% of
virus, MS-2 bacteriophage (Assay developed) the utility points of the best score.
ALTERNATIVE UTILITY
DESCRIPTION:
The instrument is an integrated system designed to perform both Best Score 0.909
real-time PCR and post-PCR analysis. The instrument is capable ABI PRISM 7500 PCR 0.772
of analyzing 96 samples simultaneously in a 96-well plate Lowest Score 0.321
format. The instrument provides specialized application specific
software that collects and analyzes the fluorescence data for the
SNP (Single Nucleotide Polymorphism) detection.

The instrument support two homogeneous reaction chemistries, ABI 7500 ranked in the top third of all evaluated
the fluorogenic 5’ nuclease assay using TaqMan® probes and products for mobile laboratories and earned 84% of the
the SYBR® Green I double stranded DNA binding dye chemistry.
The instrument utilizes a tungsten-halogen lamp, a cooled charge
coupled device (CCD) camera, and multiple emission filters, ALTERNATIVE UTILITY
to enable multiple wavelength detection. Instrument software Best Score 0.883
utilizes a multicomponenting algorithm to provide precise ABI PRISM 7500 PCR 0.739
deconvolution of multiple dye signals, to enable the simultaneous Lowest Score 0.379
detection of multiple fluorophores with little crosstalk.
FIELD USE Ranking

ABI 7500 ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:10
Emanuel and Fruchey

require water • Shelf life measure not applicable
source
• Single sample detection greater • Assay not available but capable
• A day of training • Greater than 500 BTUS
CONTACT INFORMATION • No set-up required generated
www.Appliedbiosystems.com
Andy Felton multiple use • The performance of the device
• 0-1 solution or buffer used or system is not influenced by
(800) 248-0281
(650) 638-6045 fax
Sensitivity:
• 5 or more consumables or
COST expendables needed Maturity gauge:
• $0.50/sample plus cost of Taq enzyme • Once a year service required • Is commercially available
• $42,500.00/system or device • Expected life is between 5-10
years
t
procedures
II:11
ABI PRISM 7900HT Sequence Detection System


DETECTING THE ABI PRISM 7900HT Sequence Detection System
FOLLOWING: ranked in the top third of all evaluated products for
Bacillus anthracis, analytical laboratories and earned 100% of the utility
E. coli 0157: points of the best score.
H7, Francisella ALTERNATIVE UTILITY
Vibrio cholera,
Corynebacterium
diptheria, Lowest Score 0.217
Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis, Effectiveness Biological Agents Logistics Operations
Coxiella burnetti, Rickettsia prowazekii, Brucella species, Marburg Preference Set: Analytical Laboratory
virus, Rift Valley fever virus, VEE virus, Hanta virus, Yellow fever
virus, Dengue fever virus, Ebola viruses, Orthopox virus, MS-
2 bacteriophage, Botulinum toxins A, B, E, SEB, Ricin (Assays
developed) ABI PRISM 7900HT ranked in the top third of all
evaluated products for diagnostic laboratories and
DESCRIPTION: earned 91% of the utility points of the best score.
The instrument is an integrated system designed to perform both
ALTERNATIVE UTILITY
real-time PCR and post-PCR analysis. The instrument is capable
of analyzing 384 samples simultaneously in a 384-well plate Best Score 0.909
format. The instrument provides specialized application specific ABI PRISM 7900 PCR 0.829
software that collects and analyzes the fluorescence data for the Lowest Score 0.321
SNP (Single Nucleotide Polymorphism) detection. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The instrument can support two homogeneous reaction
chemistries, the fluorogenic 5’ nuclease assay using TaqMan™ MOBILE Laboratory Ranking
probes and the SYBR™ Green I double stranded DNA binding ABI PRISM 7900HT ranked in the top third of all
dye chemistry. The instrument has an argon ion laser excitation evaluated products for mobile laboratories and earned
source (488 nm), and utilizes a spectrograph and charge
84% of the utility points of the best score.
coupled device (CCD) camera to enable continuous wavelength
detection from 500-660 nm. Instrument software should utilize ALTERNATIVE UTILITY
a multicomponenting algorithm to provide precise deconvolution Best Score 0.883
of multiple dye signals to enable the simultaneous detection of ABI PRISM 7900 PCR 0.744
multiple fluorophores. The instrument can process at least 5,000
Lowest Score 0.379
real-time quantitative PCR sample wells per day (24 hour period),
and at least 30,000 SNP genotyping samples every 2.5 hours. Logistics Biological Agents Effectiveness Operations
FIELD USE Ranking

ABI PRISM 7900HT ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:12
Emanuel and Fruchey

source
• Single sample detection greater • Assay available and capable of
than 60 minutes detecting four or more biological
BEST FIT WORST FIT • Less than 10 ul volume needed test
per test for detection • No additional pieces of
• The system or device could equipment needed
easily be adapted into a fully
automated system Signature:
• A day of training • Less than 200 BTUS generated
CONTACT INFORMATION • No set-up required
850 Lincoln Center Drive Operational conditions:
detection • Operated from 4°C to 37°C
• Components must be stored at
www.Appliedbiosystems.com Re-use: 4°C
multiple use or system is not influenced by
Andy Felton
• 0-1 solution or buffer used relative humidity
(800) 248-0281 • 3 components
(650) 638-6045 fax • No cleaning required
Sensitivity:
Maintenance:
• 0-1 consumable or expendable Maturity gauge:
COST needed • Is commercially available and
• $0.50/sample plus cost of Taq enzyme • Less than once a year service meets military specifications
• $90,000.00 GSA price/system or device required
• Expected life greater than 10 t
years
procedures
II:13
ABI 9700

Vibrio cholera,
ABI 9700 0.345
Corynebacterium
pestis, Coxiella
burnetti, Rickettsia
prowazekii, Brucella
species, Marburg virus, Rift Valley fever virus, VEE virus, Hanta
virus, Yellow fever virus, Dengue fever virus, Ebola viruses, ABI 9700 ranked in the bottom third of all evaluated
Orthopox virus, MS-2 bacteriophage, Botulinum toxins A, B, E, products for diagnostic laboratories and earned 45% of
SEB, Ricin (Assays developed) the utility points of the best score.
ALTERNATIVE UTILITY
The GeneAmp PCR System 9700 is an automated instrument, ABI 9700 0.408
specifically designed for the amplification of nucleic acids using
Lowest Score 0.321
the Polymerase Chain Reaction (PCR) process. The user interface
consists of a control panel with a full numeric keypad, soft Effectiveness Operations Biological Agents Logistics
keys, and a graphical display screen that shows the time and Preference Set: Diagnostic Laboratory
temperature profile for each run. The sample compartment holds
up to 96 MicroAmp Reaction Tubes (0.2 mL). The internal Peltier
heating/cooling unit is housed in the sample block module.
Platinum sensors provide a wide temperature range (4°C to ABI 9700 ranked in the bottom third of all evaluated
99.9°C), accurate measurements (±0.25°C from 35°C to 100°C)
products for mobile laboratories and earned 57% of the
and long term stability and high reliability.
The Applied Biosystems 9700 Thermal Cycler uses peltier- Best Score 0.883
based elements to enable the PCR amplification process. PCR is
ABI 9700 0.506
composed of three segments, which can be programmed on the
thermal cycler. In the pre-PCR segment, you define an incubation Lowest Score 0.379
temperature and hold time sufficient to denature double-stranded Logistics Biological Agents Effectiveness Operations
DNA. The PCR segment is the actual cycling segment that Preference Set: Mobile Laboratory
generates the amplified product. The key parameters are used for
The post-PCR incubation temperature defines how to soak your
samples at a specified temperature until you are ready to analyze
FIELD USE Ranking
them. ABI 9700 ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
ABI 9700 0.637
Lowest Score 0.343

II:14
Emanuel and Fruchey

• System or device has 110V • Approximately the size of a
electrical requirement toaster
require water
• The system or device does not Ease of use/Utility:
require an external air or gas • Can not view results in “real
source
time”
• There are multiple shaking and
require an external vacuum vortexing steps required
source • System can not interpret raw
DIAGNOSTIC Throughput of product: internal software
• 384 samples/batch or higher • One additional piece of
BEST FIT WORST FIT Signature:
• There are sounds produced that
Training/Speed/Manpower: cannot be deactivated
• Very brief (minutes-hours) • Greater than 500 BTUS
training with minimal technical generated
skills
• 10-20 minutes is required for
set-up Operational conditions:
CONTACT INFORMATION • 3-5 manual steps required for • Operated from 15°C to 37°C
Applied Biosystems detection • The performance of the device
850 Lincoln Center Drive or system is not influenced by
relative humidity
Re-use:
www.Appliedbiosystems.com • Device or system is intended for Sensitivity:
Point of Contact: multiple use • 1-100 CFU per ml
Andy Felton • 0-1 solution or buffer used
• 3 components
(800) 248-0281 Maturity gauge:
(650) 638-6045 fax • Is commercially available
feltonac@appliedbiosystems.com Maintenance: • Has been featured in peer
• Once a year service required reviewed scientific publications
• Expected life is between 3-5 or independent evaluation
years
COST • No daily quality assurance t
• $0.50/sample plus cost of Taq enzyme procedures
II:15
ABI 9800

Vibrio cholera,
ABI 9800 0.345
Corynebacterium
Brucella species,
Marburg virus, Rift Valley fever virus, VEE virus, Hanta virus, Yellow
fever virus, Dengue fever virus, Ebola viruses, Orthopox virus, ABI 9800 ranked in the bottom third of all evaluated
MS-2 bacteriophage, Botulinum toxins A, B, E, SEB, Ricin (Assays products for diagnostic laboratories and earned 45% of
developed) the utility points of the best score.
ALTERNATIVE UTILITY
The Applied Biosystems 9800 Fast Thermal Cycler is an
ABI 9800 0.408
automated instrument, specifically designed for the amplification
of nucleic acids using the Polymerase Chain Reaction (PCR) Lowest Score 0.321
process. The user interface consists of a control panel with a Effectiveness Operations Biological Agents Logistics
full numeric keypad, soft keys, and a graphical display screen Preference Set: Diagnostic Laboratory
that shows the time and temperature profile for each run. The
instrument control panel consists of a display screen and 22
keys. The display screen shows a graphical representation of PCR
events, including pre-PCR holds, PCR cycling, and post-PCR holds. MOBILE Laboratory Ranking
You use the keys to enter information into fields on the display ABI 9800 ranked in the bottom third of all evaluated
screen. products for mobile laboratories and earned 57% of the
TECHNOLOGY:
The Applied Biosystems 9800 Thermal Cycler uses peltier- ALTERNATIVE UTILITY
based elements to enable the PCR amplification process. PCR is Best Score 0.883
composed of three Segments, which can be programmed on the ABI 9800 0.506
thermal cycler. In the pre-PCR segment, you define an incubation Lowest Score 0.379
temperature and hold time sufficient to denature double-stranded
DNA. The PCR segment is the actual cycling segment that Logistics Biological Agents Effectiveness Operations
generates the amplified product. The key parameters are used for Preference Set: Mobile Laboratory
The post-PCR incubation temperature defines how to soak your
samples at a specified temperature until you are ready to analyze FIELD USE Ranking
them. ABI 9800 ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
ABI 9800 0.637
Lowest Score 0.343

II:16
Emanuel and Fruchey

require water
require an external air or gas • Can view results “in real time”
source
• There are multiple shaking and
vortexing steps required
require an external vacuum • System can not interpret raw
source data or call a positive through
internal software
DIAGNOSTIC Throughput of product: • One additional piece of
• 384 samples/batch or higher equipment needed
• The system or device could be
BEST FIT WORST FIT • No sounds produced that cannot
be deactivated
Training/Speed/Manpower: • Greater than 500 BTUS
• Very brief (minutes-hours)
training and minimal technical generated
skills
• 10-20 minutes is required for Operational conditions:
set-up • Operated from 15°C to 37°C
CONTACT INFORMATION • 3-5 manual steps required for • The performance of the device
Applied Biosystems detection or system is not influenced by
850 Lincoln Center Drive relative humidity
Re-use:
www.Appliedbiosystems.com • 4 step cleaning process Sensitivity:
Point of Contact:
Andy Felton Maintenance:
(800) 248-0281 • Once a year service required Maturity gauge:
(650) 638-6045 fax • Expected life is between 3-5 • Is commercially available
feltonac@appliedbiosystems.com years • Has been featured in peer
• No daily quality assurance reviewed scientific publications
procedures or independent evaluation
COST t
• $0.50/sample plus cost of Taq enzyme
II:17
ABI StepOne™ Real-Time PCR System


DETECTING THE ABI StepOne ranked in the middle third of all evaluated
Francisella ALTERNATIVE UTILITY
Corynebacterium
ABI StepOne 0.511
diphtheria,
Burkholderia Lowest Score 0.217
pseudomallei, Effectiveness Biological Agents Logistics Operations
Coxiella burnetti, Preference Set: Analytical Laboratory
Brucella species,
E.coli O157:H7,
Vibrio cholera,
Burkholderia
mallei, Yersinia ABI StepOne ranked in the middle third of all evaluated
pestis, Rickettsia products for diagnostic laboratories and earned 50% of
prowazekii, the utility points of the best score.
Marburg virus, ALTERNATIVE UTILITY
Smallpox virus, Best Score 0.909
Influenza virus,
ABI StepOne 0.456
Dengue fever virus, Orthopox virus, Rift valley fever virus,
Venezuelan equine encephalitis virus, Yellow fever virus, Ebola Lowest Score 0.321
virus, MS-2 bacteriophage (Assays developed) Effectiveness Operations Biological Agents Logistics
DESCRIPTION:
The Applied Biosystems StepOne™ Real-Time PCR System is a
remarkably powerful real-time PCR instrument designed with
a user-friendly interface. Flexible and easy to use, the StepOne MOBILE Laboratory Ranking
system can be set up and operated with total confidence, even by ABI StepOne ranked in the middle third of all evaluated
researchers with little or no previous real-time PCR experience. products for mobile laboratories and earned 76% of the
Highly affordable and cost-effective, this new low-throughput utility points of the best score.
system adapts to every level of experience.
ALTERNATIVE UTILITY
TECHNOLOGY: Best Score 0.883
The StepOne System is a real-time TaqMan polymerase chain ABI StepOne 0.671
reaction amplification of genes on a peltier-based thermocycling Lowest Score 0.379
apparatus.
FIELD USE Ranking

ABI StepOne ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
ABI StepOne 0.615
Lowest Score 0.343

II:18
Emanuel and Fruchey

• System or device has 110V or • Approximately the size of a
220V electrical requirement toaster
require water • Reagent shelf life between 1 to
• The system or device does not 3 years
require an external vacuum with additional PC
• 48-96 samples/batch or higher • Capable of detecting four or more
• 10-30 ul volume needed per biological agents or toxins within
test for detection the same test
• The system or device is not • One additional piece is required
BEST FIT WORST FIT amenable to automation
Signature:
Training/Speed/Manpower: • No sounds produced that cannot
• A day of training be deactivated
• Greater than 20 minutes is • Greater than 500 BTUS
required for set-up generated
CONTACT INFORMATION
Applied Biosystems Re-use: Operational conditions:
850 Lincoln Center Drive • Device or system is intended for • Operated from 15°C to 30°C
multiple use • Components must be frozen
• 2 components • The performance of the device
www.Appliedbiosystems.com • Clean thermal cycling block with or system is not influenced by
Point of Contact: 10% bleach relative humidity
Andy Felton
(800) 248-0281 Maintenance: Sensitivity:
(650) 638-6045 fax • Once a year service required • 1-100 CFU per ml
feltonac@appliedbiosystems.com • Expected life is greater than 10
years Maturity gauge:
• No daily quality assurance • Is commercially available
procedures • Has not been featured in peer
COST reviewed scientific publications
• $0.50/sample plus cost of Taq enzyme or independent evaluations
t
II:19
AD 200 Absorbance Detector

by Beckman Coulter

DETECTING THE AD 200 ranked in the bottom third of all evaluated
None reported the utility points of the best score.
ALTERNATIVE UTILITY
The AD 200
Absorbance AD 200 Absorb. Det. 0.344
Detector is Lowest Score 0.217
intended to be
Effectiveness Biological Agents Logistics Operations
used for research
Preference Set: Analytical Laboratory
applications
including
colorimetric
immunoassays, such as ELISAs, reporter assays, and protein DIAGNOSTIC Laboratory Ranking
quantification assays. The AD 200 is capable of measuring assays AD 200 ranked in the bottom third of all evaluated
in 6-384 well plates and cuvettes. The AD 200 can perform products for diagnostic laboratories and earned 52% of
measurements in multiple modes including single wavelength, the utility points of the best score.
dual wavelength, kinetic, linear scan, area scan and spectral scan.
ALTERNATIVE UTILITY
Full programming and data analysis are available either through
powerful on-board software or via the use of a remote PC and Best Score 0.909
software. Preprogrammed cuvette applications make nucleic acid AD 200 Absorb. Det. 0.471
and protein quantitation quick and easy. Lowest Score 0.321
TECHNOLOGY: Effectiveness Operations Biological Agents Logistics

The AD 200 Absorbance Detector employs a controlled tungsten Preference Set: Diagnostic Laboratory
halogen lamp and a deuterium lamp as light sources and a
single silicon photodiode as the detector for measuring light
(absorbance) in the 190 – 1000nm wavelength range. It employs MOBILE Laboratory Ranking
the use a grating monochromator to select specific wavelengths AD 200 ranked in the bottom third of all evaluated
to measure, and has a dynamic range to 4.0 OD. In addition, the products for mobile laboratories and earned 52% of the
AD 200 features programmable shaking and temperature control
options for microplate measurements.
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

AD 200 ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:20
Emanuel and Fruchey

require water • Shelf life measure is not
• The system or device does not applicable
• System is able to interpret raw
DIAGNOSTIC Throughput of product: data or call a positive through
• Single sample detection in 20 internal software
min or less • Assay not available, but capable
• 96 samples/batch or higher of detecting 4 or more targets in
BEST FIT WORST FIT • Less than 50 ul volume needed a single well
per test for detection • 2 additional pieces of equipment
• The system or device could be needed
• An afternoon of training • Unknown BTUS generated
CONTACT INFORMATION • Less than 5 min required for
Beckman Coulter set-up
4300 N. Harbor Blvd. Box 3100 Operational conditions:
Fullerton, CA 92834 detection • Components storage conditions
www.beckmancoulter.com are not applicable
Point of Contact: Re-use: • Device or system has peak
• Device or system is intended for performance at normal relative
Matt Maloney, Margaret Kelly
multiple use humidity conditions only
(317) 808-4217, (714) 773-8022 • Number of solutions or buffers
(714) 773-6690 fax used is assay dependent
MJMaloney@beckman.com, • 1 component
Sensitivity:
mmkelly@beckman.com • Unknown CFU per ml

COST • Expected to be ready for
• Unknown/sample • 2 consumables or expendables
commercialization within one
• $15,950.00-$18,950.00/device needed
calendar year
• Needs service once a year
• A few systems or devices exist
• Expected system or device life
(brass board)
of 5-10 years
• No daily quality assurance t
procedures
II:21
AD 340 Absorbance Detector

by Beckman Coulter

DETECTING AD 340 ranked in the bottom third of all evaluated
THE products for analytical laboratories and earned 40% of
FOLLOWING: the utility points of the best score.
None reported ALTERNATIVE UTILITY
Best Score 0.901
Lowest Score 0.217


DESCRIPTION: AD 340 ranked in the bottom third of all evaluated
The AD 340 Absorbance Detector is intended to be used for products for diagnostic laboratories and earned 54% of
research applications including colorimetric immunoassays, such
the utility points of the best score.
as ELISAs, reporter assays, and protein quantification assays. The
AD 340 is capable of measuring assays in 6-384 well plates. The ALTERNATIVE UTILITY
AD 340 can perform measurements in multiple modes including Best Score 0.909
single wavelength, dual wavelength, kinetic, linear scan and area AD 340 Absorb. Det. 0.489
scan. Full programming and data analysis are available either Lowest Score 0.321
through powerful on-board software or via the use of a remote PC
and software. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The AD 340 Absorbance Detector employs a controlled tungsten
halogen lamp as a light source and a single silicon photodiode as
the detector for measuring light (absorbance) in the 340–750nm
wavelength range. It employs the use of filters to select specific AD 340 ranked in the bottom third of all evaluated
wavelengths to measure, and has a dynamic range to 4.0 OD. products for mobile laboratories and earned 55% of the
In addition, the AD 340 features programmable shaking and utility points of the best score.
temperature control options. ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

AD 340 ranked in the middle third of all evaluated
products for field use and earned 77% of the utility points
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:22
Emanuel and Fruchey

require water • Shelf life measure is not
• System sometimes able to
DIAGNOSTIC Throughput of product: interpret raw data or call a
• Single sample detection in 20 positive through internal software
• 96 samples/batch or higher of detecting four or more
• Less than 50 ul volume needed biological agents or toxins within
BEST FIT WORST FIT per test for detection the same test
• The system or device could be • Two additional pieces of
adapted into a semi-automated equipment needed
Signature:
• An afternoon of training
be deactivated
CONTACT INFORMATION • Less than 5 minutes required
• Unknown BTUS generated
Beckman Coulter for set-up
4300 N. Harbor Blvd. Box 3100 • 6-8 manual steps required for
Fullerton, CA 92834 detection Operational conditions:
www.beckmancoulter.com • Components storage conditions
Re-use: are not applicable
Point of Contact: • Device or system is intended for
Matt Maloney, Margaret Kelly • Device or system has peak
multiple use
performance at normal relative
(317) 808-4217, (714) 773-8022 • NA solutions or buffers used
humidity conditions only
(714) 773-6690 fax • 1 component
MJMaloney@beckman.com, • No cleaning required
mmkelly@beckman.com Sensitivity:
• Unknown CFU per ml
Maintenance:
• Unknown/sample • Once a year service required • Is commercially available
• $7,995.00-8,995.00/system or device • Expected life is 5-10 years
procedures required
II:23
Automated Bioaerosol Collection and Detection System (ABCDS)

by Constellation Technology
CAPABLE OF DETECTING THE ANALYTICAL Laboratory Ranking

FOLLOWING: ABCDS ranked in the top third of all evaluated products
Bacillus anthracis, MS-2 bacteriophage, SEB for analytical laboratories and earned 76% of the utility
(Assays developed) points of the best score.
ALTERNATIVE UTILITY
The Automated Bioaerosol Collection and
Detection System (ABCDS) is a fully automated ABCDS-Sentry 0.686
bio-warning system. This system can detect Lowest Score 0.217
bacteria and identify the genus and species as
well as detect and identify viruses and toxins. Effectiveness Biological Agents Logistics Operations
The goal of the technology is to provide remote Preference Set: Analytical Laboratory
point detection of multiple biological agents in
ambient air. The system integrates an aerosol
collector, a sensor and a processor which provide DIAGNOSTIC Laboratory Ranking
the ability to collect air samples, load samples
on the sensor, collect and analyze data and determine a positive signal without
ABCDS ranked in the top third of all evaluated products
manual intervention. All components of the sensing element, the waveguide for diagnostic laboratories and earned 79% of the
and reagents are reusable therefore operating costs are minimal, approximately utility points of the best score.
$0.57 per assay for four agents in duplicate (ROM estimate, not sale price).
ALTERNATIVE UTILITY
Low operating costs, reusable tests and quick analysis make it feasible for the
ABCDS to continuously monitor ambient air, obviating the need for a trigger. This Best Score 0.909
would allow the ABCDS to be used in the role of the traditional trigger as well as ABCDS-Sentry 0.719
a collector/identifier. Additional cost and weight benefits would also be realized. Lowest Score 0.321

The technology utilizes sandwich fluorescence immunoassays to detect and Preference Set: Diagnostic Laboratory
identify target analytes. The assays are performed on the surface of a planar
waveguide using a patterned array of immobilized antibodies to provide a
means of capturing a target analyte from the sample. Processing on the MOBILE Laboratory Ranking
planar waveguide with a cocktail of fluorescent tracer antibodies results in the
formation of fluorescent immunocomplexes, or “sandwiches.” Upon evanescent
ABCDS ranked in the bottom third of all evaluated
excitation of the fluorescent immunocomplexes by a small diode laser, a products for mobile laboratories and earned 56% of the
CCD camera detects the pattern of fluorescent tracer spots on the sensor utility points of the best score.
surface, and image analysis software correlates the position and intensity of
ALTERNATIVE UTILITY
the fluorescent signals with a signal that an agent has been detected and the
identity of that agent. Current laboratory testing has consistently achieved test Best Score 0.883
times of approximately 10 minutes in both manual and automated testing ABCDS-Sentry 0.492
modes. In the continuous assay configuration, each of the 14 lanes of the flow Lowest Score 0.379
cell intersects 12 separate tests on the waveguide. Each lane on the flow cell
has the ability to run a complete, independent automated assay. The outer Logistics Biological Agents Effectiveness Operations
two lanes of the flow cell are used for positive controls, leaving the inner 12 Preference Set: Mobile Laboratory
lanes for assaying individual samples. The 12 lanes are used to accomplish
batch analysis in continuous succession of sample fluid from an air collector.
An aliquot of fluid sample from the collector is introduced into the first lane FIELD USE Ranking
and an assay of that sample is initiated. This assay will take approximately 10
minutes to complete. During this time, subsequent aliquots are introduced into
ABCDS ranked in the bottom third of all evaluated
subsequent lanes and assays are initiated in each lane respectively. When the products for field use and earned 43% of the utility
assay in the last lane is completed, the next aliquot is introduced into the first points of the best score.
lane and the sequence is repeated. When a positive is detected in a particular
ALTERNATIVE UTILITY
lane, an alarm is indicated. It should be pointed out that reconfiguration of the
automated analysis to accommodate other test situations, such as simultaneous Best Score 0.943
analysis of different samples or other types of batch analyses that do not require ABCDS-Sentry 0.408
continuous succession, is easily accommodated. Lowest Score 0.343

II:24
Emanuel and Fruchey

ANALYTICAL • The system or device does not • More than 50 kg
require water • Shelf life between 6 months - 1
• The system or device does not year
• System can interpret raw data or
DIAGNOSTIC Throughput of product: call a positive through internal
• Single sample detection in 20 software
min or less • Assay available, and capable of
• 1 samples/batch detecting two or more biological
• Greater than 250 ul volume agents or toxins within the same
BEST FIT WORST FIT needed per test for detection test
• The system or device is • No additional pieces of
currently fully automated equipment needed
Training/Speed/Manpower: Signature:
• An afternoon of training • No sounds produced that cannot
• 10-20 min required for set-up be deactivated
CONTACT INFORMATION • 0-2 manual steps required for • BTUS generated unknown
7887 Bryan Dairy Road, Suite 100 detection
Largo, FL 33777
www.contech.com
Re-use: • Operated from 25°C to 37°C
• Device or system is intended for • Components must be stored at
multiple detections 4°C
Point of Contact: • 3 solutions or buffer used • The influence on performance of
Tammy Santana • 5 or more components the device or system by relative
727-547-0600 x6400 • No cleaning required humidity is unknown
727-545-6150 fax
santana@contech.com
Maintenance: Sensitivity:
• 5 or more consumables or • 1,000-10,000 CFU per ml
expendables needed
COST • Service needs are unknown Maturity gauge:
• $0.57/sample • Expected life measure unknown • Expected to be ready for
• $80,000.00/device or system • 10-20 minutes required for daily commercialization within one
quality assurance procedures calendar year
(brass board)
t
II:25
Automated Continuous Analysis Array Biosensor (ACA-ABS)

by Constellation Technology

DETECTING THE ACA-ABS ranked in the middle third of all evaluated
Bacillus anthracis, MS-2 the utility points of the best score.
bacteriophage, SEB (Assays ALTERNATIVE UTILITY
developed) Best Score 0.901
DESCRIPTION: ACA-ABS 0.558

The Automated, Continuous Lowest Score 0.217
Analysis – Array Bio-Sensor (ACA-ABS) is a fully automated bio-warning
system. This system can detect bacteria and identify the genus and species
as well as detect and identify viruses and toxins. The goal of the technology
is the simultaneous automatic analysis of up to 12 samples or a continuous
sampling stream for multiple biological agents in about 10 minutes. All
components of the sensing element, the waveguide and reagents are DIAGNOSTIC Laboratory Ranking
reusable therefore operating costs are minimal; approximately $0.57 per ACA-ABS ranked in the middle third of all evaluated
assay for four agents in duplicate (ROM estimate, not sale price). Low products for diagnostic laboratories and earned 77% of
operating costs, reusable tests and quick analysis make it feasible for the the utility points of the best score.
ACA-ABS to continuously monitor a sample stream, obviating the need for a
ALTERNATIVE UTILITY
trigger. This would allow the ACA-ABS to be used in the role of the traditional
trigger as well as an identifier. Additional cost and weight benefits would Best Score 0.909
also be realized. ACA-ABS 0.698
Lowest Score 0.321
TECHNOLOGY:
The technology utilizes sandwich fluorescence immunoassays to detect Effectiveness Operations Biological Agents Logistics
and identify target analytes. The assays are performed on the surface of Preference Set: Diagnostic Laboratory
a planar waveguide using a patterned array of immobilized antibodies to
provide a means of capturing a target analyte from the sample. Processing
on the planar waveguide with a cocktail of fluorescent tracer antibodies MOBILE Laboratory Ranking
results in the formation of fluorescent immunocomplexes, or “sandwiches.” ACA-ABS ranked in the bottom third of all evaluated
Upon evanescent excitation of the fluorescent immunocomplexes by a products for mobile laboratories and earned 61% of the
small diode laser, a CCD camera detects the pattern of fluorescent tracer
spots on the sensor surface, and image analysis software correlates the
position and intensity of the fluorescent signals with a signal that an ALTERNATIVE UTILITY
agent has been detected and the identity of that agent. Current laboratory Best Score 0.883
testing has consistently achieved test times of approximately 10 minutes ACA-ABS 0.540
in both manual and automated testing modes. In the continuous assay Lowest Score 0.379
configuration, each of the 14 lanes of the flow cell intersects 12 separate
tests on the waveguide. Each lane on the flow cell has the ability to run a Logistics Biological Agents Effectiveness Operations
complete, independent automated assay. The outer two lanes of the flow Preference Set: Mobile Laboratory
cell are used for positive controls, leaving the inner 12 lanes for assaying
individual samples. The 12 lanes are used to accomplish batch analysis in
continuous succession of sample fluid from an air collector. An aliquot of FIELD USE Ranking
fluid sample from the collector is introduced into the first lane and an assay
ACA-ABS ranked in the bottom third of all evaluated
of that sample is initiated. This assay will take approximately 10 minutes
to complete. During this time, subsequent aliquots are introduced into
subsequent lanes and assays are initiated in each lane respectively. When points of the best score.
the assay in the last lane is completed, the next aliquot is introduced into ALTERNATIVE UTILITY
the first lane and the sequence is repeated. When a positive is detected Best Score 0.943
in a particular lane, an alarm is indicated. It should be pointed out that ACA-ABS 0.517
reconfiguration of the automated analysis to accommodate other test
Lowest Score 0.343
situations, such as simultaneous analysis of different samples or other
types of batch analyses that do not require continuous succession, is easily Logistics Operations Effectiveness Biological Agents
accommodated. Preference Set: Field Use
II:26
Emanuel and Fruchey

ANALYTICAL • The system or device does not • Between 25-50 kg
require water • Shelf life between 6 months - 1
MOBILE FIELD source Ease of use/Utility:
• The system or device does not • Can view results “in real time”
DIAGNOSTIC • System can interpret raw data or
Throughput of product: call a positive through internal
BEST FIT WORST FIT • 2 samples/batch or higher of detecting four or more
• Less than 250 ul volume biological agents or toxins within
needed per test for detection the same test
• The system or device is • One additional pieces of
CONTACT INFORMATION • Very brief training • No sounds produced that cannot
Constellation Technology • 10-20 min required for set-up be deactivated
7887 Bryan Dairy Road, Suite 100 • 0-2 manual steps required for • BTUS generated unknown
Largo, FL 33777 detection
www.contech.com Operational conditions:
Point of Contact: multiple detections 4°C
Tammy Santana • 2 solution or buffer used • The influence on performance of
727-547-0600 x6400 • 5 or more components the device or system by relative
727-545-6150 fax • No cleaning required humidity is unknown
santana@contech.com
COST • 0-1 consumable or expendable • 1,000-10,000 CFU per ml
• $0.57/sample needed
• $40,000.00/device or system • Service needs are unknown Maturity gauge:
• Expected life measure unknown • Expected to be ready for
• 10-20 minutes required for daily commercialization within one
quality assurance procedures calendar year
(brass board)
t
II:27
AflaCup Test Kit

by International Diagnostic Systems

AflaCup Test Kit ranked in the bottom third of all
DETECTING
evaluated products for analytical laboratories and earned
THE
FOLLOWING:
Aflatoxins ALTERNATIVE UTILITY
Best Score 0.901
Lowest Score 0.217

DESCRIPTION: DIAGNOSTIC Laboratory Ranking

The AflaCup provides a fast, easy to use and reliable means to test AflaCup Test Kit ranked in the bottom third of all
for total aflatoxins. The result is easily interpreted by a simple color evaluated products for diagnostic laboratories and
change: a blue dot denotes a negative result, a white cup means
the sample contains aflatoxin above the detection limit. To comply
with various accuracy needs, test kits are available for a 10 to 20 ALTERNATIVE UTILITY
ppb detection limit. Dilution schemes allow for further detection Best Score 0.909
limits. AflaCup Test Kit ELISA 0.495
TECHNOLOGY: Lowest Score 0.321

The AflaCup is a qualitative test based on solid phase Effectiveness Operations Biological Agents Logistics
immunoassay technology in which an antibody binds specifically Preference Set: Diagnostic Laboratory
with aflatoxin. This rapid qualitative screen has been specifically
developed for grain elevator operators, cottonseed dealers, tree
nut handlers and pet food companies.
This technology could be adapted for other threats and is shown AflaCup Test Kit ranked in the middle third of all
as an example of current technology. evaluated products for mobile laboratories and earned
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

AflaCup Test Kit ranked in the top third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:28
Emanuel and Fruchey

• No electrical requirement • Approximately the size of a
• The system or device does toaster
ANALYTICAL require water aliquots • Between 1 and 5 kg
• The system or device does not • Shelf life between 6 months and
require an external air or gas 1 year
source
MOBILE FIELD require an external vacuum • Can view results “in real time”
source • No centrifugation steps
• There is a single shaking or
Throughput of product: vortexing step
DIAGNOSTIC • Single sample detection 20 • System never able to interpret
minutes or less raw data or call a positive
• 1 samples/batch or higher through internal software
• Greater than 250 ul volume • Not capable of detecting multiple
BEST FIT WORST FIT needed per test for detection biological agents or toxins within
• The system or device is not the same test
amendable to automation • Three additional pieces of
equipment needed
Training/Speed/Manpower:
• Very brief training Signature:
• 10-20 minutes required for • No sounds produced that cannot
set-up be deactivated
CONTACT INFORMATION • 6-8 manual steps required for • Less than 200 BTUS generated
Romer Labs, Inc. detection
1301 Stylemaster Drive
Union, MO 63084-1156
www.romerlabs.com Re-use: • Operated from 15°C to 37°C
• Device or system is intended for • Performance of the device or
multiple use system is not influenced by
Point of Contact: • 4 solutions or buffers used relative humidity
Sales Department • 4 components
(636) 583-8600 • No cleaning required Sensitivity:
(636) 583-6553 fax • NA CFU per ml
sales@romerlabs.com Maintenance:
• 5 or more consumables or Maturity gauge:
expendables needed • Is commercially available
COST • No service required
• Approx. $5.00-7.00/sample • Expected life is not applicable t
• $130.00-185.00/system or device • No daily quality assurance
procedures
II:29
AgPath-ID™ One-Step RT-PCR Kit

by Ambion

DETECTING AgPath ID ranked in the top third of all evaluated
Marburg virus, ALTERNATIVE UTILITY
Influenza virus, Best Score 0.901
Dengue fever Ambion Ag-Path ID 0.761
virus, Rift valley
Lowest Score 0.217
fever virus,
Venezuelan equine encephalitis virus, Yellow fever virus, Ebola Effectiveness Biological Agents Logistics Operations
virus (Assays developed); (Can be used on multiple real time Preference Set: Analytical Laboratory
thermocyclers)
DESCRIPTION:
AgPath-ID™ One-Step RT-PCR Kit obtains results in about 1 DIAGNOSTIC Laboratory Ranking
hour, consistently detects RNA pathogens with high specificity AgPath ID ranked in the top third of all evaluated
and sensitivity, contains ROX for quantitative fluorescent products for diagnostic laboratories and earned 80% of
signal normalization and has a simplified setup due to fewer the utility points of the best score.
components. ALTERNATIVE UTILITY
The AgPath-ID One-Step RT-PCR Kit is designed for sensitive, Best Score 0.909
robust amplification and detection of RNA pathogens and targets Ambion Ag-Path ID 0.731
using a rapid single-tube real-time reverse transcription PCR (RT- Lowest Score 0.321
PCR) strategy. The kit was developed using real-time detection of
reaction products via TaqMan® chemistry, but is fully compatible Effectiveness Operations Biological Agents Logistics
with both SYBR® Green real-time detection and end-point RT-PCR. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
The reactions are assembled in a single tube, minimizing sample MOBILE Laboratory Ranking
handling errors and reducing setup time. The RT-PCR Enzyme
AgPath ID ranked in the middle third of all evaluated
Mix included in the kit is composed of Ambion’s highly efficient
ArrayScript™ Reverse Transcriptase, a mutant MMLV RT capable
of producing high cDNA yields, and AmpliTaq® Gold, the preferred utility points of the best score.
hot-start DNA polymerase for specific target amplification. The ALTERNATIVE UTILITY
included RT-PCR Buffer contains the passive reference dye, ROX, Best Score 0.883
for quantitative fluorescent signal normalization. A Detection Ambion Ag-Path ID 0.682
Enhancer is also provided as an optional reagent for amplification
Lowest Score 0.379
of templates with a high GC content or persistent secondary
structure. Logistics Biological Agents Effectiveness Operations
FIELD USE Ranking

AgPath ID ranked in the top third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:30
Emanuel and Fruchey

• There is no electrical • Reagent shelf life is between 6
requirement months and 1 year
ANALYTICAL • The system or device does
require water aliquots Ease of use/Utility:
require an external air or gas • No centrifugation steps
source
• No shaking or vortexing steps
• System may be able to interpret
require an external vacuum raw data or call a positive
source through internal software in the
future
DIAGNOSTIC Throughput of product: • Capable of detecting two or more
• Single sample detection greater biological agents or toxins within
than 60 minutes the same test
• Less than 50 ul volume needed equipment needed
BEST FIT WORST FIT per test for detection
• The system or device could
be easily adapted into a fully Signature:
automated system • No sounds produced that cannot
be deactivated
• Very brief (minutes-hours) Operational conditions:
CONTACT INFORMATION training and minimal technical • Components must be frozen
Applied Biosystems skills • The performance of the device
850 Lincoln Center Drive • Less than 5 minutes is required or system is not influenced by
for set-up relative humidity
www.Appliedbiosystems.com • 3-5 manual steps required for
detection Sensitivity:
Point of Contact:
Andy Felton Re-use:
(800) 248-0281 • Device or system is intended for Maturity gauge:
a single use • Is commercially available
(650) 638-6045 fax
• 2 solutions or buffers used • Has not been featured in
feltonac@appliedbiosystems.com any peer reviewed scientific
• 2 components
publications or independent
evaluation
COST Maintenance:
• $1.35/sample • No service required t
• $135.00/100 reactions • Expected life is not applicable
procedures
II:31
AirSentinel 1000B
by MesoSystems

DETECTING THE AirSentinel 1000B ranked in the middle third of all
FOLLOWING: evaluated products for analytical laboratories and
None reported (Generic earned 67% of the utility points of the best score
detector) ALTERNATIVE UTILITY
Best Score 0.901
DESCRIPTION:
The AirSentinel 1000B MesoSystems AirSentinel 0.604
is a lightweight, Lowest Score 0.217
continuously-operating
monitor that may
be used to detect
potentially harmful
airborne biological
threats. It was designed specifically to detect aerosolized DIAGNOSTIC Laboratory Ranking
biological material in indoor environments, such as buildings AirSentinel 1000B ranked in the middle third of all
and other critical infrastructures. The AirSentinel facilitates the evaluated products for diagnostic laboratories and
process of identifying possible bio-terror agents to allow timely earned 78% of the utility points of the best score.
containment, treatment and remediation. AirSentinel works by
ALTERNATIVE UTILITY
monitoring the amount of particles in the air and examining their
fluorescence properties when illuminated by UV light. A particle Best Score 0.909
counter and an optional air prefilter are used for low concentration MesoSystems AirSentinel 0.713
threats and prefiltering particles respectively. AirSentinel runs Lowest Score 0.321
continuously, analyzing a new aerosol sample approximately every
30 seconds to 10 minutes, depending on user-set parameters. If a
sample emits sufficient fluorescence a second air sampler located
inside the AirSentinel operating at a higher flow rate is activated to
capture a second sample for further analysis. A separate system,
not manufactured by MesoSystems or a laboratory is required to MOBILE Laboratory Ranking
perform agent identification analysis. AirSentinel 1000B ranked in the middle third of all
evaluated products for mobile laboratories and earned
TECHNOLOGY: 66% of the utility points of the best score.
The AirSentinel 1000B uses a combination of particle
count information, ultraviolet (UV) particle fluorescence and ALTERNATIVE UTILITY
MesoSystems’ algorithm to determine whether an increased Best Score 0.883
aerosol event is a suspect biological release. Upon alert, a MesoSystems AirSentinel 0.579
secondary aerosol sample is collected for use in identification Lowest Score 0.379
tests. Sensitivity varies for each biological agent. The AirSentinel
detects biological particles in the 1-10 micron diameter range Logistics Biological Agents Effectiveness Operations
including bacteria, viral particles and toxins (production Preference Set: Mobile Laboratory
impurities).
FIELD USE Ranking

AirSentinel 1000B ranked in the top third of all
ALTERNATIVE UTILITY
Best Score 0.943
MesoSystems AirSentinel 0.818
Lowest Score 0.343

II:32
Emanuel and Fruchey

• System or device has 24 VDC • Approximately the size of a
require water
source
require an external vacuum • System always able to interpret
source raw data or call a positive
through internal software
DIAGNOSTIC Throughput of product: • No additional pieces of
• Single sample detection less equipment needed
than 20 minutes
• 384 samples/batch or higher
• The system or device could is Signature:
BEST FIT WORST FIT currently fully automated • No sounds produced that cannot
be deactivated
• Less than 200 BTUS generated
training and minimal technical Operational conditions:
skills • Operated from 15°C to 37°C
• 5-10 minutes is required for • Components must be stored at
CONTACT INFORMATION set-up room temperature
Mesosystems • 0-2 manual steps required for • The performance of the device
1001 Menaul Blvd. NE, Ste. A detection or system is not influenced by
relative humidity
Albuquerque, NM 87107
www.mesosystems.com Re-use: Sensitivity:
• 1 component • Can be set by the user
• Periodic cleaning for
Point of Contact: maintenance
Kenny Yeh Maturity gauge:
• Is commercially available
(801) 706-6141 Maintenance: • Has been featured in peer
kyeh@mesosystems.com • Every 6 months service required reviewed scientific publications
• Expected life is between 3-5 or independent evaluations
years
COST • No daily quality assurance t
• $25.00/sample procedures
• $4,500.00-6,000.00/system or device
II:33
Anthragen
by Collaborative Genetics

Anthragen ranked in the middle third of all evaluated
DETECTING
products for analytical laboratories and earned 84% of
THE
FOLLOWING:
Botulinum Anthragen 0.712
toxin A (Assays
Lowest Score 0.217
developed)
DESCRIPTION: Preference Set: Analytical Laboratory
We are currently developing our first product. The product will
be a qualitative device that can detect anthrax spores in an
environmental sample and the LF and PA in whole blood within
five minutes.
Anthragen ranked in the top third of all evaluated
TECHNOLOGY: products for diagnostic laboratories and earned 80% of
The device will be an antibody/antigen-based product that is a the utility points of the best score.
sandwich assay. The device will contain a filter that is treated with
biologics that will lyse the blood cells to extract the toxins and will ALTERNATIVE UTILITY
capture red blood cells and allow only plasma further down the Best Score 0.909
lateral flow device. Anthragen 0.786
Lowest Score 0.321


Anthragen ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.883
Anthragen 0.650
Lowest Score 0.379

FIELD USE Ranking

Anthragen ranked in the top third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Anthragen 0.717
Lowest Score 0.343

II:34
Emanuel and Fruchey

require water • Shelf life between 1 to 3 years
source
source • System is able to interpret raw
• Single sample detection 20 • Assay not available, but capable
minutes or less of detecting two or more agents
• 32 samples/batch or higher or toxins within the same test
BEST FIT WORST FIT • Less than 50 ul volume needed • One additional piece of
per test for detection equipment needed
• The system or approach could
easily be adapted to a fully Signature:
automated system • Sounds are produced that cannot
be deactivated
Training/Speed/Manpower: • Unknown BTUS generated
• Very brief training
CONTACT INFORMATION • Less than 5 min set-up required
Collaborative Genetics Operational conditions:
1152 Bond Ave detection • Components can be stored at
Rexburg, ID 83440
room temperature
www.collaborativegenetics.com Re-use: • Performance of the device or
• Device or system is designed for system is not influenced by
Point of Contact: multiple detection assays relative humidity
Bruce J. Tedeschi • 0-1 solution or buffer used
• 3 components
(208) 359-2446 Sensitivity:
• Cleaning with 70% isopropanol
btedeschi@collaborativegenetics.com required • 1-100 CFU per ml

• 0-1 consumable or expendable • Expected to be ready for
COST commercialization within one
needed
• Approximately $3.00/sample calendar year
• Needs service less than once
• $40.00/system or device a year • Only one incomplete device or
• Expected life measure is greater system exist (bread board)
than 10 years
• Less than 5 min required t
for daily quality assurance
procedures
II:35
APSIS (Assay Processing and Specific Identification System)

by Bruker Daltonik GmbH

APSIS ranked in the middle third of all evaluated products
DETECTING THE
for analytical laboratories and earned 81% of the utility
FOLLOWING:
Bacillus anthracis, E. coli points of the best score.
O157:H7, Orthopox virus, ALTERNATIVE UTILITY
Smallpox virus, MS-2 Best Score 0.901
bacteriophage APSIS 0.730
DESCRIPTION: Lowest Score 0.217

Bruker Daltonics -20 years Effectiveness Biological Agents Logistics Operations
of tradition, flexibility and Preference Set: Analytical Laboratory
performance in chemical,
biological and nuclear
detection. The newly developed APSIS is an identifier for harmful
pathogens, like bacteria, spores and viruses, based on their DIAGNOSTIC Laboratory Ranking
genomic fingerprint stored in their DNA or RNA. The system is APSIS ranked in the top third of all evaluated products
intended for the on site analysis of microorganisms (bacteria, for diagnostic laboratories and earned 78% of the utility
spores and viruses) in mobile labs and onboard vehicles. The points of the best score.
performance is not limited to harmful pathogens used as BWA but
ALTERNATIVE UTILITY
also covers pathogens for clinical diagnostic purposes.
Best Score 0.909
TECHNOLOGY: APSIS 0.706
APSIS cartridge combines two current technologies for detection: Lowest Score 0.321
In the first step the target DNA/RNA is amplified by PCR to
achieve a detectable amount of DNA/RNA. The second step is the Effectiveness Operations Biological Agents Logistics
hybridization against sample sequences on the glass substrate Preference Set: Diagnostic Laboratory
within the presence of the same buffer and the same volume
where PCR was performed. The fluorescence pattern is readout
by fluorescence detection giving a characteristic pattern. The MOBILE Laboratory Ranking
pattern is evaluated by a dedicated software tool. The design of APSIS ranked in the middle third of all evaluated products
the processing cartridge is optimized for minimal user interaction. for mobile laboratories and earned 65% of the utility
An integrated EPROM gives a complete process control and points of the best score.
enables the cartridge to be completely self describing for protocol
purposes. The APSIS System has a modular design consisting of ALTERNATIVE UTILITY
a process station with eight parallel but independently operating Best Score 0.883
processing slots for thermal and fluid processing and a reader APSIS 0.570
unit. Inside the reader unit the fluorescence readout is performed Lowest Score 0.379
using microscope optics.
FIELD USE Ranking

APSIS ranked in the bottom third of all evaluated products
for field use and earned 58% of the utility points of the
best score.
ALTERNATIVE UTILITY
Best Score 0.943
APSIS 0.543
Lowest Score 0.343

II:36
Emanuel and Fruchey

ANALYTICAL • The system or device requires • More than 50 kg
water aliquots • Shelf life between 1-3 years
source
require an external vacuum • A single shaking or vortexing
source steps
• Single sample detection in 50- software
60 min • Assay available, and capable of
• 2 samples/batch or higher detecting four or more biological
BEST FIT WORST FIT • Less than 50 ul volume needed agents or toxins within the same
per test for detection test
• The system or device could • Three additional pieces of
easily be adapted into a fully equipment needed
automated system
Signature:
• An afternoon of training be deactivated
CONTACT INFORMATION • Less than 5 min required for • Less than 200 BTUS generated
Bruker Daltonik GmbH set-up
Permoserstr. 15 • 3-5 manual steps required for
Leipzig, D-04318 Germany
www.bdal.de • Components can be stored at
Re-use: 25°C to 37°C
Point of Contact: • Device or system is intended for • Performance of the device or
Dr. Norbert Klöpper multiple detections system is not influenced by
• 3 solutions or buffers used relative humidity
+493412431448
• 3 components
+493412431404 fax • No cleaning required
nkl@bdal.de Sensitivity:
• 100-1,000 CFU per ml
Maintenance:
COST Maturity gauge:
needed
• $50.00/sample • Expected to be ready for
• $115,000/device or system • Expected life measure of 5-10 commercialization within one
years calendar year
• Less than 5 minutes required • A few systems or devices exist
for daily quality assurance (brass board)
procedures t
II:37
ASAP II
by Research International

DETECTING THE ASAP II ranked in the middle third of all evaluated
Bacillus anthracis, the utility points of the best score
Francisella tularensis, ALTERNATIVE UTILITY
Yersinia pestis Coxiella Best Score 0.901
burnetti, Brucella Research International ASAP II 0.653
species, E.coli O157:
Lowest Score 0.217
H7, Smallpox virus,
Venezuelan equine Effectiveness Biological Agents Logistics Operations
encephalitis virus, Preference Set: Analytical Laboratory
Botulinum toxin A,
Botulinum toxin B,
Staphylococcal toxin B (Assay developed); MS-2 bacteriophage,
Ricin toxin (Commercially available as a freeze-dried reagent)
ASAP II ranked in the top third of all evaluated products
DESCRIPTION: for diagnostic laboratories and earned 84% of the utility
The ASAP II collection/detection system continuously monitors points of the best score.
for the presence of aerosol biohazards and will identify biological ALTERNATIVE UTILITY
agents ranging from protein toxins to whole cells and spores
Best Score 0.909
as frequently as every 20 minutes. It is an integration at the
hardware and software levels, of Research International’s proven Research International ASAP II 0.765
SASS™ 2000 Plus multiple-effect air sampler technology and its Lowest Score 0.321
RAPTOR™ four-channel bioassay system. ASAP II is provided with
a small fixed-installation environmental enclosure that maximizes Effectiveness Operations Biological Agents Logistics
reagent life and unattended monitoring time. In operation, Preference Set: Diagnostic Laboratory
the SASS™ 2000 Plus collector samples air continuously and
transfers particulates in the air to a secondary water phase
of about 4-5 ml volume. Aerosol sampling is performed using
aerodynamically sound methods certified by fluid dynamic MOBILE Laboratory Ranking
software models. Water samples of 1-2 cc are periodically ASAP II ranked in the middle third of all evaluated
transferred from the SASS 2000 to the RAPTOR. The RAPTOR products for mobile laboratories and earned 81% of the
then automatically performs a multi-step bioassay for up to four utility points of the best score.
bio-targets on the liquid sample using a disposable assay coupon.
Each of these 4-channel assay coupons may be reused from 20 ALTERNATIVE UTILITY
to 50 times over a 36-hour unattended operating period before Best Score 0.883
replacement of the coupon and related reagents is necessary. Research International ASAP II 0.711
This provides extremely competitive per-assay costs and allows
Lowest Score 0.379
operation by minimally trained personnel.
TECHNOLOGY: Preference Set: Mobile Laboratory
The aerosol collector is a highly efficient, multiple-effect,
wetted-wall cyclone that extracts and transfers pathogens from
sampled air to a small fixed water volume for subsequent assay.
A unique and patented feature is the ability to perform this FIELD USE Ranking
function continuously for an extended time period without fluid ASAP II ranked in the top third of all evaluated products
sample loss. The biosensor is based on monolayer receptor- for field use and earned 73% of the utility points of the
ligand reactions taking place on the surface of injection molded
best score.
polystyrene waveguides. All fluidic and optoelectronic steps
associated with the assay are performed automatically. The ALTERNATIVE UTILITY
baseline protocol used to identify specific pathogens is the Best Score 0.943
‘sandwich format’ fluoroimmunoassay. In a typical waveguide- Research International ASAP II 0.693
based sandwich immunoassay, the cylindrical waveguide has
a monolayer of capture antibody immobilized on its surface. Lowest Score 0.343
Following incubation with sample and then with a fluorophore- Logistics Operations Effectiveness Biological Agents
labeled antibody, the signal is measured and results displayed
within 15 minutes.
II:38
Emanuel and Fruchey

ANALYTICAL • The system or device requires a • Between 25 and 50 kg
continual water supply • Reagent shelf life between 6
• The system or device does not months and 1 year
source
Ease of use/Utility:
• Single sample detection less through internal software
than 20 minutes • Capable of detecting four
• 2 samples/batch or higher; 4 biological agents or toxins within
BEST FIT WORST FIT different assays on a single the same test
sample simultaneously • No additional piece of equipment
• Less than 250 ul volume needed
needed per test for detection
• The system or device is Signature:
currently fully automated • No sounds produced that cannot
be deactivated
CONTACT INFORMATION Training/Speed/Manpower: • Between 200-500 BTUS
• Very brief (minutes-hours) generated
training and minimal technical
17161 Beaton Road SE skills
Monroe, WA 98272 Operational conditions:
• Greater than 20 minutes set-up • Operated from 4°C to 45°C
www.resrchintl.com required • Components must be stored at
• 0-2 manual steps required for room temperature
detection • The performance of the device
Point of Contact: or system is not influenced by
Elric Saaski Re-use: relative humidity
(360) 805-4930 • Device or system is intended for
elricsaaski@resrchintl.com multiple use Sensitivity:
• 3 solutions or buffers used • 1,000-50,000 CFU per ml
• 0 component
COST • Cleaning with buffer when dirty
Maturity gauge:
• $2.00/sample • Is commercially available
• $75,000.00/system or device Maintenance: • Has been featured in peer
• Less than once a year service reviewed scientific publications
required or independent evaluations
• Expected life is greater than 10
years
• 10-20 minutes required for daily
quality assurance procedures t
II:39
Assurance EHEC EIA

by BioControl Systems, Inc.

Assurance EHEC EIA ranked in the middle third of all
DETECTING THE
FOLLOWING:
E. coli 0157:H7 (Assay 67% of the utility points of the best score.
validated) ALTERNATIVE UTILITY
Best Score 0.901
DESCRIPTION:
Assurance EIAs are
enzyme immunoassays Lowest Score 0.217
(EIAs) for food and Effectiveness Biological Agents Logistics Operations
environmental testing. Preference Set: Analytical Laboratory
These tests have
been extensively validated through the AOAC Official Method
process. Assurance EIAs are used in industry and independent
and government laboratories. Results are read as a standard DIAGNOSTIC Laboratory Ranking
microplate reader printout. Assurance EHEC EIA ranked in the middle third of all
evaluated products for diagnostic laboratories and
Assurance EIAs are available for the detection of Salmonella (AOAC earned 72% of the utility points of the best score.
Official Method 992.11), Listeria (AOAC Official Method 996.14),
and E. coli O157:H7 (AOAC Official Method 996.10). Also available ALTERNATIVE UTILITY
is the Assurance Gold EIA format, a visually or instrumentally Best Score 0.909
read EIA, for Salmonella (AOAC Official Method 999.08), and Assurance EHEC EIA 0.652
Campylobacteria. Lowest Score 0.321

Proprietary antibodies with high specificity to EHEC antigens are Preference Set: Diagnostic Laboratory
bound to microwell plates. Appropriately enriched test samples
and positive controls are added to plates. Any EHEC antigens
present will bind to microwells, forming antibody-antigen complex. MOBILE Laboratory Ranking
Nonreactive material is washed away. Alkaline phosphatase
Assurance EHEC EIA ranked in the middle third of all
antibody conjugate is added and, after incubation, unbound
conjugate is washed away. The substrate p-nitrophenylphosphate,
is added and absorbance of resulting colored product is read 68% of the utility points of the best score.
spectrophotometrically at 405-410 nm. ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Assurance EHEC EIA ranked in the top third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:40
Emanuel and Fruchey

• System has a 110V electrical • Approximately the size of a
requirement toaster
ANALYTICAL • The system or device requires • Less than 1 kg
water aliquots • Shelf life between 1 and 3 years
source
require an external vacuum • A single shaking or vortexing step
source • System never able to interpret
• Single sample detection greater • Not capable of detecting multiple
than 60 minutes biological agents or toxins within
• 96 samples/batch or higher the same test
BEST FIT WORST FIT • Less than 100 ul volume • Two additional pieces of
needed per test for detection equipment needed
easily be adapted into a fully Signature:
automated system • No sounds produced that cannot
be deactivated
Training/Speed/Manpower: • Less than 200 BTUS generate
CONTACT INFORMATION • 5-10 minutes required for set-up
BioControl Systems, Inc. Operational conditions:
12822 SE 32nd St. detection • Components must be stored at
Bellevue, WA 98055
4°C
www.biocontrolsys.com Re-use: • Performance of the device or
• Device or system is designed for system is not influenced by
Point of Contact: multiple detection relative humidity
Maritta Ko • 3 solutions or buffers used
• 3 components
(425) 603-1123 x105 Sensitivity:
(425) 603-0070 fax • 1-100 CFU per ml
mko@biocontrolsys.com
Maintenance:
• 2 consumables or expendables Maturity gauge:
needed • Is commercially available
COST
• No service required
• $4.00-7.00/sample
• NA expected life
t
• $2.50-4.00/system or device • 5-10 minutes daily assurance
procedures required
II:41
Autonomous Pathogen Detection System (APDS)

by Lawrence Livermore National Lab (LLNL)

FOLLOWING: APDS ranked in the top third of all evaluated products
Bacillus anthracis, Francisella for analytical laboratories and earned 85% of the utility
tularensis, Yersinia pestis, Vibrio points of the best score.
cholera, Coxiella burnetti, Marburg ALTERNATIVE UTILITY
virus, VEE virus, Orthopox virus, MS-2 Best Score 0.901
bacteriophage, Botulinum toxins A, B,
APDS 0.763
E, SEB, Ricin (Assays developed)
Lowest Score 0.217
DESCRIPTION: Effectiveness Biological Agents Logistics Operations
A stand-alone system for rapid,
continuous monitoring of multiple
airborne biological threat agents in
the environment has been developed.
This system, the autonomous DIAGNOSTIC Laboratory Ranking
pathogen detection system (APDS), APDS ranked in the top third of all evaluated products
acts as a “biosmoke alarm” and is for diagnostic laboratories and earned 83% of the utility
targeted for protection of domestic points of the best score.
applications such as the Olympics,
mass transit systems, and other high ALTERNATIVE UTILITY
profile targets in which the public is at high risk to bioterrorist attacks. Best Score 0.909
The APDS is completely automated, offering aerosol sampling, in-line APDS 0.756
sample preparation fluidics, and orthogonal immunoassay and nucleic acid Lowest Score 0.321
detection device. This system has flexibility, cost, and system performance
and should be compared to competing technologies. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The objective of this research project is to develop a stand-alone pathogen
detection system capable of rapid, continuous, low cost environmental MOBILE Laboratory Ranking
monitoring of multiple airborne biological threat agents. The final APDS APDS ranked in the middle third of all evaluated products
will be completely automated, offering aerosol sampling, in-line sample
for mobile laboratories and earned 74% of the utility
preparation fluidics, multiplex detection and identification immunoassays,
and orthogonal, multiplexed PCR (nucleic acid) amplification and detection.
While the primary focus has been on protection of civilians from terrorist ALTERNATIVE UTILITY
attacks, the same system could also have a role in protecting military Best Score 0.883
personnel from biological warfare attacks. APDS instruments can be used at APDS 0.653
high profile events such as the Olympics for short-term, intensive monitoring
Lowest Score 0.379
or more permanent installation in major public buildings or transportation
nodes. All of these units can be networked to a single command center Logistics Biological Agents Effectiveness Operations
so that a small group of technical experts could maintain and respond to Preference Set: Mobile Laboratory
alarms at any of the sensors. The APDS has several key advantages over
competing technologies: (1) the ability to measure up to 100 different
agents and controls in a single sample, (2) the flexibility and ease with FIELD USE Ranking
which new bead-based assays can be developed and integrated into the
APDS ranked in the bottom third of all evaluated products
system, (3) the presence of an orthogonal, real-time detection module
for highly sensitive and selective nucleic acid amplification and detection,
(4) the ability to use the same basic system components for multiple best score.
deployment architectures, and (5) the relatively low cost per assay (<$1 per ALTERNATIVE UTILITY
10-plex or $0.10 per assay) and minimal consumables. The object of this Best Score 0.943
two year proposal is to complete development and testing of the APDS-II
APDS 0.421
(multiplexed immunoassay screen followed by nucleic acid confirmation)
Lowest Score 0.343
and APDS-III (multiplexed immunoassays and multiplexed nucleic acid
detection) platforms. Logistics Operations Effectiveness Biological Agents
II:42
Emanuel and Fruchey

• System or device has 110V • Larger than a home dishwasher
electrical requirement • Between 25 and 50 kg
ANALYTICAL • The system or device requires • Shelf life less than 1 month
water aliquots
source
DIAGNOSTIC Throughput of product: • Assay available and capable of
• Single sample detection detecting four or more biological
between 20 and 30 minutes agents or toxins within the same
• 1 sample/batch test
BEST FIT WORST FIT • Less than 50 ul volume needed • No additional pieces of
• The system or device is
currently fully automated Signature:
• An afternoon of training • Less than 200 BTUS generated
• Greater than 20 minutes
CONTACT INFORMATION required for set-up
Lawrence Livermore National Lab Operational conditions:
7000 East Ave, L-174 detection • Components can be stored at
Livermore, CA 94550
room temperature
Re-use: • Unknown performance of the
• Device or system is intended for device or system in relative
Point of Contact: multiple use humidity
Bill Colston • More than 4 solutions or buffers
used
(925) 423-0375 Sensitivity:
• 5 or more components
(925) 424-2778 fax • No cleaning required • 1,000-10,000 CFU per ml
colston@llnl.gov
• 3 consumables or expendables • A few devices or systems exist
COST (brass board)
needed
• $1.00/sample
• More often than every 6 months t
• $150,000.00/system or device service required
for daily assurance procedures MOST MATURE LEAST MATURE
II:43
BADD
by Sigma-Aldrich Fine Chemicals

BADD ranked in the middle third of all evaluated products
DETECTING THE
FOLLOWING:
Bacillus anthracis, points of the best score.
Botulinum toxins ALTERNATIVE UTILITY
A, B, E, Ricin, Best Score 0.901
Smallpox, SEB
Advent BADD 0.553
(Commercially
available as wet/ Lowest Score 0.217
frozen reagent) Effectiveness Biological Agents Logistics Operations
DESCRIPTION:
The BADD Anthrax
Rapid Detection Device is a test available that detects minute,
yet high amounts of Anthrax on environmental surfaces or in DIAGNOSTIC Laboratory Ranking
solutions. The BADD Device works without the need for extensive BADD ranked in the top third of all evaluated products
sample preparation steps or additional expensive equipment. for diagnostic laboratories and earned 80% of the utility
Each kit contains everything necessary to take a sample and points of the best score.
perform an immediate evaluation, anywhere in the world, with ALTERNATIVE UTILITY
results in 15 minutes or less. Accuracy, ease of use, a capacity to Best Score 0.909
detect credible threat levels, and no cross reactivity with Bacillus
Advent BADD 0.727
globigii or Bacillus thuringiensis makes the BADD Anthrax Rapid
Detection Device the perfect test for field detection. In addition to Lowest Score 0.321
anthrax detection, BADD devices are also available for ricin toxin Effectiveness Operations Biological Agents Logistics
and botulinum toxin. A test for First Responders evaluating threat Preference Set: Diagnostic Laboratory
credibility.
TECHNOLOGY:
Antigen and antibody rapid screening based on lateral flow MOBILE Laboratory Ranking
technology. BADD ranked in the top third of all evaluated products for
mobile laboratories and earned 86% of the utility points
of the best score.
ALTERNATIVE UTILITY
Best Score 0.883
Advent BADD 0.759
Lowest Score 0.379

FIELD USE Ranking

BADD ranked in the top third of all evaluated products for
field use and earned 94% of the utility points of the best
score.
ALTERNATIVE UTILITY
Best Score 0.943
Advent BADD 0.890
Lowest Score 0.343

II:44
Emanuel and Fruchey

• No electrical requirement • Approximately the size of a soda
• The system or device does not can
ANALYTICAL require water • Less than 1 kg
• The system or device does not • Shelf life between 1 and 3 years
MOBILE FIELD require an external vacuum
source • There is a single shaking or
vortexing step
Throughput of product: • System never able to interpret
DIAGNOSTIC • Single sample detection raw data or call a positive
between 20 and 30 minutes through internal software
• 1 samples/batch • Not capable of detecting multiple
• The system or device could be • No additional pieces of
Signature:
• Very brief training be deactivated
• No set-up required • Less than 200 BTUS generate
CONTACT INFORMATION • 3-5 manual steps required for
Sigma-Aldrich Fine Chemicals detection
3050 Spruce Street Operational conditions:
Saint Louis, MO 63103 Re-use: • Components can be stored at
www.SigmaAldrich.com • Device or system is designed for room temperature
single use • Performance of the device or
Point of Contact: • 0-1 solution or buffer used system is not influenced by
Dean Lyon • 3 components relative humidity
(314) 286-7786 x7156
(314) 652-0000 fax Sensitivity:
dlyon@sial.com Maintenance: • 10,000-100,000 CFU per ml
needed
• No service required Maturity gauge:
COST • Is commercially available and
• $50.00/sample meets military specifications
• $50.00/system or device procedures
t
II:45
Beacon Aflatoxin Plate Kit

by Beacon Analytical Systems, Inc.

DETECTING THE Beacon Aflatoxin Plate kit ranked in the bottom third of all
FOLLOWING: evaluated products for analytical laboratories and earned
Aflatoxin, T-2 44% of the utility points of the best score.
Mycotoxin (Assays ALTERNATIVE UTILITY
DESCRIPTION: Beacon Aflatoxin Plate Kit 0.398

The Beacon Lowest Score 0.217
Aflatoxin Plate Kit Effectiveness Biological Agents Logistics Operations
is a competitive Preference Set: Analytical Laboratory
immunoassay for
the quantification of Aflatoxin residues in grains and grain-based
products. The limit of detection is two parts per billion. A ground
sample is extracted by shaking with a 70% methanol solution. This DIAGNOSTIC Laboratory Ranking
extract is filtered and then analyzed in the immunoassay along Beacon Aflatoxin Plate kit ranked in the middle third of
with calibrator solutions of known Aflatoxin concentration and the all evaluated products for diagnostic laboratories and
Aflatoxin content of the sample is derived. The total assay time is earned 60% of the utility points of the best score.
less than 20 minutes.
ALTERNATIVE UTILITY
The Beacon Aflatoxin Plate Kit is based on the well-established Beacon Aflatoxin Plate Kit 0.549
technique of enzyme-labeled competitive immunoassays. This Lowest Score 0.321
technique has been utilized in clinical laboratories for well over 20
years. The antibodies utilized will detect Aflatoxin B1, B2, G1 and Effectiveness Operations Biological Agents Logistics
G2 but have minimal reactivity with M1. The kit requires minimal Preference Set: Diagnostic Laboratory
operator training and dedicated equipment and is capable of
yielding quantitative results in the range of 2-50 ppb in less than
20 minutes. MOBILE Laboratory Ranking
Beacon Aflatoxin Plate kit ranked in the middle third of
all evaluated products for mobile laboratories and earned
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Beacon Aflatoxin Plate kit ranked in the top third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:46
Emanuel and Fruchey

• No electrical requirement • Approximately the size of a carry-
• The system or device does on luggage suitcase
MOBILE FIELD • The system or device does not • Cannot view results “in real time”
source • Single shaking or vortexing step
• System able to interpret raw data
DIAGNOSTIC Throughput of product: or call a positive through internal
• Single sample detection 20 software
minutes or less • Assay not available, but capable
• 96 samples/batch or higher of detecting two or more
BEST FIT WORST FIT • Less than 100 ul volume biological agents or toxins within
• The system or device could • One additional piece of
automated system
Signature:
CONTACT INFORMATION • An afternoon of training be deactivated
Beacon Analytical Systems, Inc. • 5-10 minutes required for set-up • Less than 200 BTUS generated
383 Presumpscot St. • 3-5 manual steps required for
Portland, ME 04103 detection Operational conditions:
www.beaconkits.com • Operated from 15°C to 37°C
Re-use: • Components can be stored at
Point of Contact: • Device or system is intended for room temperature
Brian Skoczenski multiple use • Performance of the device or
(207) 761-2199 • 4 solutions or buffers used system is not influenced by
(207) 761-9238 fax • 1 component relative humidity
brians@beaconkits.com • No cleaning required
Sensitivity:
Maintenance: • NA CFU per ml
• Approx. $3.00/sample needed
• $240.00/96 test system or device Maturity gauge:
• Less than once a year service • Is commercially available
required
t
assurance procedures
II:47
BEAR™
by TSI

DETECTING THE BEAR ranked in the top third of all evaluated products
FOLLOWING: for analytical laboratories and earned 79% of the utility
Bacillus anthracis, points of the best score
Smallpox virus (Assay ALTERNATIVE UTILITY
DESCRIPTION: TSI BEAR 0.718

TSI’s CPATH system Lowest Score 0.217
is an identification
system based on Preference Set: Analytical Laboratory
the Bridged Element
Analyte Recognition (BEAR™) technology. The system currently
(1/2007) exists as a laboratory prototype. The BEAR™ approach
entails rapid (<15 seconds) multiplexed detection of unique DIAGNOSTIC Laboratory Ranking
bioagent DNA through hybridization to specific permanently BEAR ranked in the top third of all evaluated products
affixed DNA molecules bridging MEMS micro-circuits. Hybridization for diagnostic laboratories and earned 88% of the
events result in an increase of conductivity across specific circuits utility points of the best score.
at a magnitude that is directly related to the degree of match
ALTERNATIVE UTILITY
between the two molecules. Thus, the sensor is uniquely capable
Best Score 0.909
of accurate identification of known pathogens (100% match) and
unknown pathogen variants (<100% match). Once detection is TSI BEAR 0.796
confirmed, the bioagent DNA can be expelled from the bridged Lowest Score 0.321
circuit, and the sensor is reset for multiple (100’s) subsequent
detection events. The system requires minimal consumables,
infrastructure and support requirements. A fieldable system for
a broad array of applications including field and laboratory use
is scheduled for release in early 2008. The primary benefits are
minimal sample preparation, robustness with regards to sample MOBILE Laboratory Ranking
contamination, high sensitivity, and fast speed of detection BEAR ranked in the middle third of all evaluated
making it an ideal candidate for point of use detection. Initial products for mobile laboratories and earned 73% of the
product development requires manual sample introduction with utility points of the best score.
parallel development efforts incorporating continuous monitoring
capability: Detection capability has been developed for simulants ALTERNATIVE UTILITY
of Bacillus anthracis and Small Pox (Variola). Development Best Score 0.883
of additional markers for Yersinia pestis (plague), Francisella TSI BEAR 0.646
tularensis (tularemia), and Clostridium botulinum toxin (botulism) Lowest Score 0.379
are scheduled for 2007.
Bioagents within the collected samples are disrupted through
chemical lysis and pumped across the surface of a MEMS
chip containing individual single-stranded DNA elements FIELD USE Ranking
bridged across electrical circuit gaps. If the sample contains BEAR ranked in the middle third of all evaluated
DNA fragments matching those bridged DNA elements, DNA-
DNA hybridization occurs. Hybridization of the sample DNA to
the permanently bridged receptor DNA (bridging elements)
results in significant and reproducible changes in the electrical ALTERNATIVE UTILITY
characteristics of the MEMS circuit. Current increase beyond a Best Score 0.943
threshold indicates the presence of a specific bioagent, and the TSI BEAR 0.726
magnitude of increase indicates the degree of match between the Lowest Score 0.343
bridging element and the bioagent DNA.
II:48
Emanuel and Fruchey

System requirements: Ease of use/Utility:
• System or device has 110V • Can view results “in real time”
electrical requirement • No centrifugation steps
ANALYTICAL • The system or device does not • No shaking or vortexing steps
require water • System may be able to interpret
• The system or device does not raw data or call a positive
require an external air or gas through internal software in the
source future
MOBILE FIELD • The system or device does not • Capable of detecting multiple
require an external vacuum biological agents or toxins within
source the same test
• No additional pieces of
DIAGNOSTIC Throughput of product: equipment needed
• Single sample detection greater
in 20 minutes or less Signature:
• 32 samples/batch or higher • No sounds produced that cannot
• Less than 50 ul volume needed be deactivated
BEST FIT WORST FIT per test for detection • Between 200-500 BTUS
• The system or device could generated
automated system
Training/Speed/Manpower: • Components must be stored at
• Very brief (minutes-hours) 25°C to 45°C
CONTACT INFORMATION training and minimal technical • The effect of relative humidity is
TSI skills unknown
500 Cardigan Road • 5-10 minutes set-up required
Shoreview, MN 55126 • 0-2 manual steps required for
www.tsi.com detection Sensitivity:
Re-use:
Point of Contact: • Device or system is intended for Maturity gauge:
Darrick Niccum multiple use • A few devices or systems exist
(651) 490-3834 • 2 solutions or buffers used (brass board)
• 1 component • Is expected to be ready for
dniccum@tsi.com
• Flush system with buffer
calendar year
COST Maintenance: • $1,000,000-$2,000,000
• <$10.00/sample • Once a year service required required for device or system to
• Expected life is between 5-10
• ~$50,000.00/device or system advance to commercialization
years
• Has not been featured in
• 5-10 minutes daily quality
assurance procedures any peer reviewed scientific
evaluations
Transportation:
• Approximately the size of a t
toaster
• Reagent shelf life greater than
3 years
II:49
Bio-Alloy ‘Smart’ Material Sensor

by IatroQuest Corporation

DETECTING THE Bio-Alloy ranked in the middle third of all evaluated
MS-2 bacteriophage the utility points of the best score.
(Assays developed) ALTERNATIVE UTILITY
Best Score 0.901
DESCRIPTION: Bio-Alloy Smart Material Sensor 0.638
IatroQuest
Corporation’s Lowest Score 0.217
breakthrough, Effectiveness Biological Agents Logistics Operations
patented platform Preference Set: Analytical Laboratory
technology called
Bio-Alloy, supports
the development
of a new and cost-
effective approach to biosensing. Bio-Alloy technology converges Bio-Alloy ranked in the top third of all evaluated products
biotechnology, nanotechnology, advanced semiconductor for diagnostic laboratories and earned 81% of the utility
materials and photonics to create “smart materials.” Unique points of the best score.
attributes enable these materials to detect and identify, in a ALTERNATIVE UTILITY
label-free and real-time manner, a wide range of biological agents
Best Score 0.909
as well as specific toxic chemical agents, with a high degree of
sensitivity and selectivity. Applications in point and stand-off Bio-Alloy Smart Material Sensor 0.734
detection for biodefense are the primary focus with follow-on Lowest Score 0.321
applications in medical diagnostics, environmental and life
science sectors. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
The Bio-Alloy sensing technology platform combines elements
of nanotechnology, advanced semiconductor materials, MOBILE Laboratory Ranking
biotechnology and photonics to generate ‘smart materials’ Bio-Alloy ranked in the middle third of all evaluated
with unique biosensing attributes. These advanced materials products for mobile laboratories and earned 64% of the
are produced in four steps: 1) Silicon chip preparation: dicing utility points of the best score.
silicon chips to provide the basic material for Bio- Alloy, 2)
Nanostructuring: chemically treating silicon chips to produce ALTERNATIVE UTILITY
nanostructured, photoluminescent, materials (feature size Best Score 0.883
2–3 nanometers), 3) Surface chemistry: attachment of linker Bio-Alloy Smart Material Sensor 0.564
molecules (required to attach biorecognition moieties), and Lowest Score 0.379
4) Bioprocessing: immobilizing specific recognition elements
(e.g. antibody fragments, enzymes, sDNA) to produce specific Logistics Biological Agents Effectiveness Operations
biosensing capability. The underlying detection principle, based Preference Set: Mobile Laboratory
on a unique photoluminescence (green light emission) response
generated directly by the Bio-Alloy material, relies on quantum
confinement and changes in the surface energy when the surface FIELD USE Ranking
is excited with low-power blue light (micro-Watt LED; one second Bio-Alloy ranked in the top third of all evaluated products
integration time). Affinity binding of target agents to recognition for field use and earned 80% of the utility points of the
elements linked to the Bio-Alloy surface causes perturbations in
best score.
the surface energy states/photoluminescence response detected
as an increase in light intensity. ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:50
Emanuel and Fruchey

• System or device uses batteries • Approximately the size of a
• The system or device requires toaster
ANALYTICAL water aliquots • Less than 1 kg
• The system or device does not • Shelf life between 6 months-1
require an external air or gas year
source
MOBILE FIELD • The system or device does not Ease of use/Utility:
require an external vacuum • Can view results “in real time”
DIAGNOSTIC Throughput of product: • System may be capable of
• Single sample detection in 20 interpreting raw data or call a
min or less positive through internal software
• 384 samples/batch or higher in the future
BEST FIT WORST FIT • Less than 50 ul volume needed • Assay not available, but capable
per test for detection of detecting two or more
• The system or device could biological agents or toxins within
easily be adapted into a fully the same test
automated system • No additional pieces of
equipment needed
CONTACT INFORMATION • An afternoon of training Signature:
IatroQuest Corporation • Less than 5 min required for • No sounds produced that cannot
309-2183 Ogilvie Rd set-up be deactivated
Ottawa, Ontario K1J 1C8 • 0-2 manual steps required for • Less than 200 BTUS generated
www.IatroQuest.com detection
Point of Contact: • Device or system is intended for • Components must be stored at
David Armstrong multiple detections 4°C
(613) 990-0864 • 0-1 solution or buffer used • Performance of the device or
(613) 991-3843 fax • 1 components system is not influenced by
darmstrong@iatroquest.com • No cleaning required
relative humidity
• 100-1,000 CFU per ml
• $0.50-$1.00/sample needed
• $10,000.00/device or system • Needs service every 6 months
Maturity gauge:
• Expected life measure unknown
• Expected to be ready for
commercialization within two
procedures required
calendar years
(brass board)
t
II:51
Bio Detector (BD)

by Smiths Detection

BD ranked in the top third of all evaluated products for
DETECTING THE
analytical laboratories and earned 83% of the utility
FOLLOWING:
Burkholderia mallei, points of the best score.
MS-2 bacteriophage, ALTERNATIVE UTILITY
SEB, Ricin (Assays Best Score 0.901
developed); Bio Detector (BD) 0.750
Bacillus anthracis,
Lowest Score 0.217
Francisella tularensis,
Burkholderia Effectiveness Biological Agents Logistics Operations
pseudomallei, Preference Set: Analytical Laboratory
Coxiella burnetti,
Brucella species, VEE
virus, Smallpox virus, Botulinum toxin A (Assays validated) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: BD ranked in the top third of all evaluated products for
The Biological Detector (BD) was jointly developed and field- diagnostic laboratories and earned 84% of the utility
tested by Smiths Detection – Edgewood (formerly Environmental points of the best score.
Technologies Group, Inc.) and the U.S. Army for use in the U.S.
ALTERNATIVE UTILITY
Army’s BIDS. The BD simultaneously detects up to eight different
Best Score 0.909
biological agents. Additional assays have been developed
and validated for use for the BD and can be easily “swapped” Bio Detector (BD) 0.764
depending on the intelligence. The BD is an on-demand, portable, Lowest Score 0.321
system, or can run continuously for 14 hours. This is a mature
product that has been in production for seven years. The BD has
also been selected by the UK MoD for use in the IBDS. A total of
110 units have been fielded to date, and 42 more units will be
manufactured for the UK.
TECHNOLOGY: BD ranked in the middle third of all evaluated products
The BD uses the principles of Immuno-ligand Assay (ILA) for mobile laboratories and earned 74% of the utility
chemistries and the light-addressable potentiometric sensor points of the best score.
(LAPS), licensed to Smiths by Molecular Devices Corporation, to
specifically identify biological agents. The BD draws a one-milliliter ALTERNATIVE UTILITY
liquid sample, which is segmented and specifically analyzed Best Score 0.883
for eight different biological agents. The BD uses biotin and Bio Detector (BD) 0.651
fluorescein labeled antibodies, and a tape cassette using biotin Lowest Score 0.379
coated nitrocellulose membrane as the capture surface.
FIELD USE Ranking

BD ranked in the middle third of all evaluated products for
field use and earned 69% of the utility points of the best
score.
ALTERNATIVE UTILITY
Best Score 0.943
Bio Detector (BD) 0.652
Lowest Score 0.343

II:52
Emanuel and Fruchey

MOBILE FIELD source • Cannot view results “in real time”
• The system or device does not • No centrifugation steps
DIAGNOSTIC raw data or call a positive
Throughput of product: through internal software
• Single sample detection 20 • Assay available and capable of
minutes or less detecting four or more biological
BEST FIT WORST FIT • 2 samples/batch or higher agents or toxins within the same
• Greater than 250 ul volume test
needed per test for detection • No additional pieces of
• The system or device is equipment needed
currently fully automated
Signature:
Training/Speed/Manpower: • Sounds are produced that cannot
CONTACT INFORMATION • A day of training be deactivated
Smiths Detection-Edgewood • 10-20 minutes required for • Unknown BTUS generated
2202 Lakeside Blvd. set-up
Edgewood, MD 21040 • 0-2 manual steps required for Operational conditions:
www.smithsdetection.com detection • Can only be operated at 25°C
Point of Contact: Re-use: 4°C
Keith Uithoven • Device or system is intended for • Performance of the device or
(410) 510-9263 x263 multiple use system is not influenced by
(410) 510-9496 fax • More than 4 solutions or buffers relative humidity
keith.uithoven@smithsdetection.com used
• 3 components Sensitivity:
• Unit comes with a cleaning kit • 10,000-100,000 CFU per ml
COST
• $4.78/sample Maintenance:
Maturity gauge:
• 0-1 consumable or expendable • Is commercially available and
needed meets military specifications
• Expected life is 5-10 years t
• 10-20 min required for daily
quality assurance procedures
II:53
BioHAZ™ Kit
by EAI

DETECTING THE BioHAZ ranked in the top third of all evaluated products
Corynebacterium Best Score 0.901
diphtheria,
EAI BioHaz 0.725
Burkholderia
Lowest Score 0.217
pseudomallei,
Coxiella burnetti, Effectiveness Biological Agents Logistics Operations
Brucella species, Preference Set: Analytical Laboratory
E.coli O157:H7, Vibrio
cholera, Burkholderia
mallei, Yersinia
pestis, Rickettsia
prowazekii, Marburg BioHAZ ranked in the top third of all evaluated products
virus, Smallpox for diagnostic laboratories and earned 79% of the utility
virus, Influenza virus, points of the best score.
Dengue fever virus, ALTERNATIVE UTILITY
Orthopox virus, Rift Best Score 0.909
valley fever virus, Venezuelan equine encephalitis virus, Yellow
EAI BioHaz 0.715
fever virus, Ebola virus, MS-2 bacteriophage, Botulinum toxin B,
Staphylococcal toxin B, Ricin toxin (Assay developed) Lowest Score 0.321

DESCRIPTION: Preference Set: Diagnostic Laboratory
The BioHAZ is a portable field system designed for use by
emergency response personnel at incidents where biological
materials may be present, and sample collection, screening
and analysis are performed. This system contains all materials MOBILE Laboratory Ranking
necessary to collect liquid and solid samples for on-site biological BioHAZ ranked in the top third of all evaluated products
screening and off-site positive analysis, and prescribes detailed for mobile laboratories and earned 88% of the utility
instructions to ensure sample integrity. The system is designed points of the best score.
to allow the user to select the proper sampling package which
ALTERNATIVE UTILITY
includes sample sponges, sterile swabs, syringes, spatulas, bags,
Best Score 0.883
and culture tubes; chain-of-custody forms, markers, and custody
seals. Sample screening and possible identification is conducted EAI BioHaz 0.778
through fluorometry, luminometry, colorimetry and sample specific Lowest Score 0.379
analyses is performed through the use of sensitive membrane
antigen rapid tests. Step-by-step instructions from preparation
for entry into the hot zone through sample collection, screening,
identification, and transfer are included. The system is packaged
in rugged portable water-tight containers with each sample
collection kit and sample processing kit marked for easy locating FIELD USE Ranking
and use. All sampling/processing kits and other individual BioHAZ ranked in the top third of all evaluated products
components are designed to be disposable and replaceable. for field use and earned 77% of the utility points of the
best score.
TECHNOLOGY:
The BioHAZ is a dual instrument that performs two independent ALTERNATIVE UTILITY
tests with a luminometer and fluorometer. The luminometer Best Score 0.943
determines whether bacteria or spores are present and the EAI BioHaz 0.726
fluorometer determines whether DNA is present in the sample. Lowest Score 0.343
Protein Test strips are used to indicate the presence of a protein
and the pH test strip indicates the degree of acidity or alkalinity Logistics Operations Effectiveness Biological Agents
of the sample. The Assay tests check for the presence of specific Preference Set: Field Use
bacterial, toxin or viral biological agent.
II:54
Emanuel and Fruchey

• System or device uses batteries • Approximately the size of a carry-
• The system or device does not on luggage suitcase
ANALYTICAL require water • Between 5 and 25 kg
• The system or device does not • Reagent shelf life between 1 to
require an external air or gas 3 years
source
Throughput of product: • System cannot interpret raw data
DIAGNOSTIC • Single sample detection or call a positive through internal
between 20 and 30 minutes software
• 1 sample/batch • Capable of detecting multiple
• Greater than 250 ul volume biological agents or toxins within
BEST FIT WORST FIT needed per test for detection the same test
• The system or device is not • No additional pieces of
amenable to automation equipment needed
• A day of training • No sounds produced that cannot
• 10-20 minutes of set-up be deactivated
required • Less than 200 BTUS generated
CONTACT INFORMATION
EAI Corporation
1308 Continental Drive
detection Operational conditions:
Abingdon, MD 21009
www.eaicorp.com Re-use: • Components must be stored at
• Device or system is intended for 4°C
Point of Contact: multiple use • The performance of the device
• More than 4 solutions or buffers or system is not influenced by
Dan Decker
used relative humidity
Phone: 410-671-9375
(443) 372-1264 • 5 or more components
• No cleaning required Sensitivity:
(410) 671-9374 fax • 10,000-100,000 CFU per ml
ddecker@eaicorp.com
Maintenance:
• No service required Maturity gauge:
COST • Expected life is greater than 10 • Is commercially available
• $100.00-150.00/sample years • Has been featured in peer
• $19,995.00/system or device • 10-20 minutes of daily quality reviewed scientific publications
assurance procedures or independent evaluations
II:55
Biological Aerosol Warning System (BAWS)

by Lockheed Martin

DETECTING THE BAWS ranked in the bottom third of all evaluated products
None reported (Generic points of the best score.
Best Score 0.901
DESCRIPTION: Lockheed Martin BAWS 0.378
Lockheed Martin
Lowest Score 0.217
has developed a
ruggedized, deployable Effectiveness Biological Agents Logistics Operations
Biological Aerosol Preference Set: Analytical Laboratory
Warning System
(BAWS) which uses an
array of nonspecific
detectors to provide an
operational “detect- BAWS ranked in the bottom third of all evaluated products
to-warn” capability. for diagnostic laboratories and earned 48% of the utility
The BAWS provides points of the best score.
early warning of biological attack though deployment of Remote ALTERNATIVE UTILITY
Sensor Units (RSUs) in and around field sites and fixed facilities. Best Score 0.909
Information from the RSUs is evaluated at the Base Station and
appropriate alerts and alarms are issued for proper response.
BAWS detects medium-to-large releases of aerosolized biological Lowest Score 0.321
material, and is powered by rechargeable lithium ion batteries Effectiveness Operations Biological Agents Logistics
provided as part of the system, vehicle power, or other available Preference Set: Diagnostic Laboratory
power sources. The BAWS system is autonomous, small,
lightweight, and requires minimal consumables and training to
operate.
TECHNOLOGY: BAWS ranked in the bottom third of all evaluated products
The Lockheed Martin Biological Aerosol Warning System (BAWS) for mobile laboratories and earned 49% of the utility
is typically defined as a complete biological sensor network points of the best score.
comprised of 10 Remote Sensor Units (RSUs) and one Base
Station. The principle technology utilized in BAWS is Airborne ALTERNATIVE UTILITY
Particle Counting (APC)- utilizing proven light scattering techniques Best Score 0.883
for individual particles; and Ultraviolet Light-Induced Fluorescence Lockheed Martin BAWS 0.432
(UV-LIF)-utilizing mass integrated total particle fluorescence. BAWS Lowest Score 0.379
also has a dry filter and/or centrifugal impaction sample collection
capability for integration with other customer defined biological Logistics Biological Agents Effectiveness Operations
identifiers. Preference Set: Mobile Laboratory
FIELD USE Ranking

BAWS ranked in the middle third of all evaluated products
best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:56
Emanuel and Fruchey

• System or device can use • Can view results “in real time”
batteries, 110V or 220V
ANALYTICAL electricity
• The system or device does not • System always able to interpret
require water
MOBILE FIELD source • Capable of detecting multiple
• The system or device does not biological agents or toxins within
require an external vacuum the same test
source • No additional pieces of
DIAGNOSTIC equipment needed
Throughput of product:
• 1 sample/batch Signature:
• The system or device is • No sounds produced that cannot
BEST FIT WORST FIT currently fully automated be deactivated
training and minimal technical • Operated from -10°C to 50°C
skills
• Components must be stored from
• Greater than 20 minutes set-up
-20°C to 60°C
required
CONTACT INFORMATION • The performance of the device
Lockheed Martin MS2 Homeland Security Systems or system is not influenced by
9500 Godwin Drive Re-use: relative humidity
Manassas, VA 20110-4157 • Device or system is intended for
www.lockheedmartin.com multiple use
• 0-1 solution or buffer used Sensitivity:
• 1 component •Approx. 3000 CFU per L of air
Point of Contact:
Rick Read Maturity gauge:
(703) 367-1546 Maintenance: • Is commercially available
richard.read@lmco.com • Once a year service required • Has been featured in peer
• Expected life is greater than 10 reviewed scientific publications
years or independent review
COST procedures t
Transportation:
• Larger than a home dishwasher MOST MATURE LEAST MATURE
• More than 50 kg
• No reagents
II:57
BIODET-400 Handheld
by Ciencia Inc.
CAPABLE OF DETECTING THE FOLLOWING: ANALYTICAL Laboratory Ranking

Bacillus anthracis BioDET-400 handheld ranked in the middle third of all
DESCRIPTION: 42% of the utility points of the best score.
The BIODET-400 system provides the capability for rapid, highly multiplexed
ALTERNATIVE UTILITY
detection of biological pathogens and toxins. It uses on-chip immunoassay
technology with a novel evanescent wave sensing method that enables label-free Best Score 0.901
detection with high sensitivity. The evanescent wave is created either via grating- BIODET-400 Hand-held 0.607
coupled surface waveguides or via grating-coupled surface plasmon resonance Lowest Score 0.217
(GCSPR). The chip (1 cm2) is plastic, has an impressed grating, and surface
chemistry for immobilizing antibodies (up to 400 spots per chip). The sample Effectiveness Biological Agents Logistics Operations
to be analyzed (in liquid form) is caused to flow over the chip, either with Preference Set: Analytical Laboratory
microchannels and a manifold for multiple inputs, or uniformly for a single input.
Readout is accomplished with a beam of NIR light produced by an LED and
imaging detection is performed with CCD camera, whereby changes in the index DIAGNOSTIC Laboratory Ranking
of refraction at all antibody sites are simultaneously measured. Since no labels
are required (fluorescent, enzymatic, chemiluminescent, etc.) samples can be
BioDET-400 handheld ranked in the middle third of
processed directly with minimal or no preparation. The system can potentially be all evaluated products for diagnostic laboratories and
configured as an on-line, real-time continuous monitor, a laboratory instrument, earned 48% of the utility points of the best score.
or a hand-held portable device. ALTERNATIVE UTILITY
Appropriate antibodies are immobilized in array format on the chip, either at BIODET-400 Hand-held 0.711
manufacture or in the field using unique self-assembly methods. A manifold Lowest Score 0.321
assembly houses necessary buffers. Sample is introduced to manifold and
pumped across sensor chip. Manifold, chip, and pump parts are disposable. Effectiveness Operations Biological Agents Logistics
Microarray includes up to 400 spots, for simultaneous detection of up to 100 or Preference Set: Diagnostic Laboratory
more analytes (in duplicate or triplicate plus reference spots). Sensitivity is ~ 1
pg/mm2. We estimate that sensitivity is sufficient for detection of single spores
of Bacillus anthracis.
The technology and instrument described have been developed for proteomics BioDET-400 handheld ranked in the bottom third of all
and high throughput screening applications. Target proteins are fixed on the evaluated products for mobile laboratories and earned
chip surface, and liquid is caused to flow over this surface. In this manner, data 49% of the utility points of the best score.
on binding kinetics is rapidly collected for protein arrays of sizes of 400 spots.
The detection method does not require the use of labels (such as fluorescent, ALTERNATIVE UTILITY
enzymatic or chemiluminescent), which results in very simple protocols and Best Score 0.883
rapid detection. BIODET-400 Hand-held 0.530
In the past year, this instrument has been evaluated for on-chip immunoassay Lowest Score 0.379
purposes, and found to be of great value in terms of sensitivity, array format,
speed, and versatility. A number of applications are being developed at Ciencia
for NASA and National Institutes of Health. These include bioreactor product
monitoring in space, phenotyping of animal models and other proteomics
applications. Ciencia recently received a grant from the National Science
Foundation to explore the use of this system for detection of environmental FIELD USE Ranking
pathogens. Our results thus far indicate that this system would provide powerful BioDET-400 handheld ranked in the middle third of all
technology for rapid detection of biological agents, both in the laboratory and evaluated products for field use and earned 60% of the
the field. Based on the results of this year’s work, Ciencia intends to produce and
market the instrument for bio-agent detection as well as pathogen detection,
in general. Development is required to design apparatus to insert collected ALTERNATIVE UTILITY
samples in the chip buffer compartments, the channels themselves, and the Best Score 0.943
specific assays. A summary of position might show that an immunoassay system
was 85% developed with 15% remaining.
Lowest Score 0.343

II:58
Emanuel and Fruchey

source
source
DIAGNOSTIC • Single sample detection 20
vortexing step
minutes or less
• 1 sample/batch or higher
• Less than 100 ul volume through internal software
• Assay not available, but capable
BEST FIT WORST FIT needed per test for detection
• The system or device is not of detecting four or more
amendable to automation biological agents or toxins within
the same test
Training/Speed/Manpower: • No additional pieces of
• A day of training equipment needed
• 5-10 minutes required for set-up
CONTACT INFORMATION • 0-2 manual steps required for Signature:
detection • No sounds produced that cannot
Ciencia Inc.
111 Roberts St., Suite K be deactivated
East Hartford, CT 06108 Re-use: • Unknown BTUS generated
www.ciencia.com • Device or system is intended for
multiple use
Point of Contact: • 0-1 solution or buffer used
S. Fernandez, Ph.D • 1 components
• No cleaning required • Components can be stored at
(860) 528-9737 room temperature
(860) 528-5658 fax • Performance of the device or
Fernandez@ciencia.com Maintenance: system is not influenced by
• 0-1 consumable or expendable
relative humidity
needed
• Estimated once a year service
COST required Sensitivity:
• $50.00/sample • Expected life is 5-10 years •1-100 CFU per ml
• $40,000.00/system or device • 5-10 minutes required for daily
assurance procedures Maturity gauge:
• A few devices or systems exist
(brass board)
II:59
BIODET-400 Laboratory Instrument

by Ciencia Inc.

DETECTING THE BioDET-400 laboratory instrument ranked in the middle
FOLLOWING: third of all evaluated products for analytical laboratories
Bacillus anthracis and earned 67% of the utility points of the best score.
ALTERNATIVE UTILITY
The BIODET-400
system provides
the capability Lowest Score 0.217
for rapid, highly Effectiveness Biological Agents Logistics Operations
multiplexed Preference Set: Analytical Laboratory
detection of
biological
pathogens and
toxins. It uses on-chip immunoassay technology with a novel
evanescent wave sensing method that enables label-free BioDET-400 laboratory instrument ranked in the middle
detection with high sensitivity. The evanescent wave is created third of all evaluated products for diagnostic laboratories
either via grating-coupled surface waveguides or via grating- and earned 77% of the utility points of the best score.
coupled surface plasmon resonance (GCSPR). The chip (1 cm2)
ALTERNATIVE UTILITY
is plastic, has an impressed grating, and surface chemistry
for immobilizing antibodies (up to 400 spots per chip). The Best Score 0.909
sample to be analyzed (in liquid form) is caused to flow over BIODET-400 Lab. Instr. 0.701
the chip, either with microchannels and a manifold for multiple Lowest Score 0.321
inputs, or uniformly for a single input. Readout is accomplished
with a beam of NIR light produced by an LED and imaging Effectiveness Operations Biological Agents Logistics
detection is performed with CCD camera, whereby changes in
the index of refraction at all antibody sites are simultaneously
measured. Since no labels are required (fluorescent, enzymatic,
chemiluminescent, etc.) samples can be processed directly MOBILE Laboratory Ranking
with minimal or no preparation. The system can potentially BioDET-400 laboratory instrument ranked in the bottom
be configured as an on-line, real-time continuous monitor, a third of all evaluated products for mobile laboratories and
laboratory instrument, or a hand-held portable device. earned 49% of the utility points of the best score.
Appropriate antibodies are immobilized in array format on the Best Score 0.883
chip, either at manufacture or in the field using unique self- BIODET-400 Lab. Instr. 0.429
assembly methods. A manifold assembly houses necessary Lowest Score 0.379
buffers. Sample is introduced to manifold and pumped across
sensor chip. Manifold, chip, and pump parts are disposable. Logistics Biological Agents Effectiveness Operations
Microarray includes up to 400 spots, for simultaneous detection Preference Set: Mobile Laboratory
of up to 100 or more analytes (in duplicate or triplicate plus
reference spots). Sensitivity is ~ 1 pg/mm2. We estimate that
sensitivity is sufficient for detection of single spores of Bacillus FIELD USE Ranking
anthracis. BioDET-400 laboratory instrument ranked in the bottom
third of all evaluated products for field use and earned
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:60
Emanuel and Fruchey

require water • Shelf life between 6 months and
1 year
source
require an external vacuum • Cannot view results “in real time”
DIAGNOSTIC Throughput of product: vortexing step
• Single sample detection 20 • System always able to interpret
minutes or less raw data or call a positive
• 1 sample/batch through internal software
BEST FIT WORST FIT • Less than 100 ul volume • Assay not available, but capable
needed per test for detection of detecting four or more
• The system or device could be biological agents or toxins within
adapted into a fully automated the same test
system with some effort • No additional pieces of
equipment needed
CONTACT INFORMATION • A day of training Signature:
Ciencia Inc. • 5-10 minutes required for set-up • No sounds produced that cannot
111 Roberts St., Suite K • 0-2 manual steps required for be deactivated
East Hartford, CT 06108 detection • Unknown BTUS generated
www.ciencia.com
Re-use: Operational conditions:
• Device or system is intended for • Operated from 15°C to 37°C
Point of Contact: multiple use • Components can be stored at
S. Fernandez, Ph.D. • 0-1 solution or buffer used room temperature
(860) 528-9737 • 1 component • Performance of the device or
(860) 528-5658 fax • No cleaning required system is not influenced by
Fernandez@ciencia.com relative humidity
Maintenance:
• 0-1 consumable or expendable Sensitivity:
COST needed • 1-100 CFU per ml
• $50.00/sample • Needs service once a year
• $40,000.00/system or device • Expected life is 5-10 years Maturity gauge:
• 5-10 minutes required for daily • A few devices or systems exist
assurance procedures (brass board)
t
II:61
BioHawk
by Research International

DETECTING THE BioHawk ranked in the middle third of all evaluated
Bacillus anthracis, the utility points of the best score
Coxiella burnetti, Best Score 0.901
Brucella species, Yersinia
Research International BioHawk 0.602
pestis, Smallpox virus,
Lowest Score 0.217
Venezuelan equine
encephalitis virus, Effectiveness Biological Agents Logistics Operations
MS-2 bacteriophage, Preference Set: Analytical Laboratory
Botulinum toxin A,
Botulinum toxin B (Assay
developed)
DESCRIPTION: BioHawk ranked in the top third of all evaluated products
The BioHawk assay for diagnostic laboratories and earned 79% of the utility
system consists of a wetted-wall cyclone collector tightly points of the best score.
integrated with a rapid, automatic fluorometric detector. The
ALTERNATIVE UTILITY
BioHawk is portable (11.8 kg) and can test a single sample for
eight different toxins, viruses, bacteria, spores, fungi and other Best Score 0.909
diverse targets. Based on two proven technologies (the extremely Research International BioHawk 0.716
reliable third-generation SASS collector and RAPTOR detector), Lowest Score 0.321
users can anticipate this device will operate for two years or more
with no breakdowns or leaks, and that it will tolerate debris-laden Effectiveness Operations Biological Agents Logistics
samples (such as are produced in mailrooms and food processing Preference Set: Diagnostic Laboratory
facilities) - impressive feats for a fully automated wet assay
system. Originally developed for the Marine Corps, the instrument
can be operated by minimally trained personnel such as mail
room operators and first responders or by trained technical MOBILE Laboratory Ranking
personnel such as laboratory technicians. The completely self- BioHawk ranked in the middle third of all evaluated
contained instrument is the culmination of a careful integration of products for mobile laboratories and earned 81% of the
optics, fluidics, electronics, and software into one compact system utility points of the best score.
for both laboratory and field assays. It performs user-defined,
multi-step, assay protocols for collecting aerosols and monitoring ALTERNATIVE UTILITY
fluorescently-labeled immunoassays occurring on the surface of Best Score 0.883
disposable optical waveguide sensors. Toxins and bacteria such Research International BioHawk 0.714
as ricin and B. anthracis have been detected at levels below <1.0
Lowest Score 0.379
ng/ml and 100 CFU/ml.
The aerosol collector is a highly efficient, multiple-effect,
wetted-wall cyclone that extracts and transfers pathogens from
sampled air to a small fixed water volume for subsequent assay.
A unique and patented feature is the ability to perform this FIELD USE Ranking
function continuously for an extended time period without fluid BioHawk ranked in the middle third of all evaluated
sample loss. The biosensor is based on monolayer receptor- products for field use and earned 70% of the utility points
ligand reactions taking place on the surface of injection molded of the best score.
polystyrene waveguides. All fluidic and optoelectronic steps ALTERNATIVE UTILITY
associated with the assay are performed automatically. The
Best Score 0.943
baseline protocol used to identify specific pathogens is the
‘sandwich format’ fluoroimmunoassay. In a typical waveguide- Research International BioHawk 0.663
based sandwich immunoassay, the cylindrical waveguide has Lowest Score 0.343
a monolayer of capture antibody immobilized on its surface.
Following incubation with sample and then with a fluorophore- Preference Set: Field Use
labeled antibody, the signal is measured and results displayed
within 15 minutes.
II:62
Emanuel and Fruchey

System requirements: • Between 5 and 25 kg
• System or device uses BA- • Reagent shelf life between 6
5590/U batteries or 110V months and 1 year
ANALYTICAL electricity
require water • Can view results “in real time”
MOBILE FIELD source
require an external vacuum through internal software
source • Capable of detecting multiple
DIAGNOSTIC biological agents or toxins within
Throughput of product: the same test
• Single sample detection less • No additional pieces of
than 20 minutes equipment needed
BEST FIT WORST FIT • 2 samples/batch or higher
• Less than 250 ul volume Signature:
needed per test for detection • No sounds produced that cannot
• The system or device is be deactivated
currently fully automated • Less than 200 BTUS generated
Training/Speed/Manpower: Operational conditions:

• Very brief (minutes-hours) • Operated from 4°C to 37°C
CONTACT INFORMATION training and minimal technical • Components must be stored at
Research International skills room temperature
17161 Beaton Road SE • 10-20 minutes of set-up • The performance of the device
Monroe, WA 98272 required or system is not influenced by
www.resrchintl.com • 0-2 manual steps required for relative humidity
detection
Sensitivity:
Point of Contact:
Re-use: • 1,000-50,000 CFU per ml
• Device or system is intended for
Elric Saaski
(360) 805-4930
multiple use Maturity gauge:
• 2 solutions or buffers used • A few devices or systems exist
elricsaaski@resrchintl.com • 0 components (brass board)
• Automatic cleaning with water
• Is expected to be ready for
and buffer
COST commercialization within one
calendar year
• $50,000.00/system or device • Once a year service required • <$1,000,000 to be ready for
• Expected life is between 5-10 commercialization
years • Has not been featured in peer
• 10-20 minutes required for daily reviewed scientific publication or
quality assurance procedures independent evaluations
t
Transportation:
carry-on luggage suitcase
II:63
Biological Detection System – Generation 2 (BDS2)

by Echo Technologies, Inc.

BDS2 ranked in the top third of all evaluated products
DETECTING THE
FOLLOWING:
None reported points of the best score.
(Generic detector) ALTERNATIVE UTILITY
Best Score 0.901
DESCRIPTION: BDS2 0.842
Echo Technologies,
Inc. (ETI) has Lowest Score 0.217
developed an Effectiveness Biological Agents Logistics Operations
optical sensor array Preference Set: Analytical Laboratory
designed to detect and classify biological agents and toxins,
and to discriminate these materials from typical non-biological
interferents. The sensor array will generically detect BW threat
agents including bacteria, bacterial spores, toxins and viruses. The DIAGNOSTIC Laboratory Ranking
system was designed to be used in two primary configurations: as BDS2 ranked in the top third of all evaluated products
a handheld, or stand-alone point detector; or as a “smart trigger” for diagnostic laboratories and earned 93% of the utility
when integrated with a larger instrumentation suite. points of the best score.
The sensors are optical transducers that use optical substrates Best Score 0.909
and fluorescent reporter molecules to detect broad classes of BDS2 0.849
microorganisms. Using a multi-sensor array the nature of the Lowest Score 0.321
threat can be assessed and distinguished from non-biological
material, and from the naturally occurring biological background Effectiveness Operations Biological Agents Logistics
(e.g., airborne dead bacteria, fungi, molds and humic matter). Preference Set: Diagnostic Laboratory
Detection of broad classes of chemical and biological threats
is particularly well suited to situations where the nature of the
contaminants is unknown. The information from multiple sensors MOBILE Laboratory Ranking
in an array is analyzed as an ensemble using chemometric BDS2 ranked in the top third of all evaluated products for
algorithms, thereby providing more information than an individual mobile laboratories and earned 83% of the utility points
sensor for a single analyte. This presumptive determination can of the best score.
then be used to trigger an array of identification sensors or signal
the need for a more sophisticated confirmatory analysis. ALTERNATIVE UTILITY
Best Score 0.883
BDS2 0.733
Lowest Score 0.379

FIELD USE Ranking

BDS2 ranked in the middle third of all evaluated products
best score.
ALTERNATIVE UTILITY
Best Score 0.943
BDS2 0.714
Lowest Score 0.343

II:64
Emanuel and Fruchey

• The system or device does not toaster
ANALYTICAL requires water aliquots • Between 1 and 5 kg
• The system or device does not • Shelf life between 1-6 months
• The system or device could • No additional pieces of
automated system
Signature:
CONTACT INFORMATION • Very brief training required be deactivated
Echo Technologies, Inc. • 5-10 min required for set-up • Less than 200 BTUS generate
5250 Cherokee Avenue • 0-2 manual steps required for
Alexandria, VA 22312 detection
www.echotech.net • Can be operated from 4°C to
Re-use: 45°C
• Device or system is intended for • Components can be stored at
Point of Contact: multiple detections
Marilyn Ripin; Mary Beth Tabacco room temperature
• 0-1 solution or buffer used • Performance of the device or
703-658-7692; 617-443-0066 • 2 components system is not influenced by
703-941-8172; 617-204-3080 fax • No cleaning required relative humidity
mripin@erols.com; mtabacco@erols.com
COST • 0-1 consumable or expendable • 100-1,000 CFU per ml
• $10,000.00/device or system • Needs service less than once Maturity gauge:
a year • Expected to be ready for
• Expected life measure of 3-5 commercialization within one
years calendar year
• Less than 5 minutes required • A few systems or devices exist
for daily quality assurance (brass board)
procedures
t
II:65
BioMAPP
by BAE Systems

DETECTING THE BioMAPP ranked in the top third of all evaluated products
Bacillus anthracis, E. coli points of the best score.
0157:H7, Francisella
ALTERNATIVE UTILITY
tularensis, Vibrio cholera,
Best Score 0.901
Burkholderia mallei, Brucella
species, Rift Valley fever BioMAPP 0.849
virus, Venezuelan Equine Lowest Score 0.217
Encephalitis virus, Hanta virus, Yellow fever virus, Dengue fever virus, Orthopox
virus, MS-2 bacteriophage, Botulinum toxins A, B, E, Ricin (Assays developed) Effectiveness Biological Agents Logistics Operations
DESCRIPTION:
The BioMAPP (Biological Multi-Analyte Pathogen Profiler) Detection System has
the ability to perform a wide range of assays, including nucleic acid assays for DIAGNOSTIC Laboratory Ranking
both DNA and RNA and immunoassays. It also allows assays for antibodies in
BioMAPP ranked in the top third of all evaluated products
clinical samples that indicate prior exposure to a BW agent, even if that agent is
no longer present in the sample. This is a capability absent in systems that rely for diagnostic laboratories and earned 90% of the utility
solely on nucleic acid detection assays. The BioMAPP system can interrogate a points of the best score.
single 10-20 uL sample for up to 100 different analytes/agents and controls, ALTERNATIVE UTILITY
simultaneously. This large capacity not only allows testing for multiple targets at
Best Score 0.909
once, it also allows rejection of near neighbors, permits differentiation of target
strains, and supports inclusion of controls. In addition, the system allows for the BioMAPP 0.818
identification of multiple targets for each agent. This redundant identification Lowest Score 0.321
of each agent essentially eliminates false positive and false negative samples.
To help reduce logistic support requirements, the BioMAPP uses clinical or Effectiveness Operations Biological Agents Logistics
environmental sample sizes as small as 10-20 uL. Once a processed sample Preference Set: Diagnostic Laboratory
has been added to the device, detection and agent identification are completed
in a matter of seconds. An optional separate device (XY Platform) allows
automated assays of 96 different samples (again, with up to 100 assays MOBILE Laboratory Ranking
performed on each sample). A high-throughput version also exists, that can
BioMAPP ranked in the top third of all evaluated products
perform nearly one-half million assays per day. Thus, a great many sample
assays can be performed without needing a large number of analyzers; one for mobile laboratories and earned 88% of the utility
device can do the work of many. points of the best score.
ALTERNATIVE UTILITY
With xMAP technology, molecular reactions take place on the surface of
microscopic beads called microspheres. For each reaction in a xMAP profile, BioMAPP 0.778
thousands of molecules are attached to the surface of internally color-coded Lowest Score 0.379
microspheres. The assigned color-code identifies the reaction throughout the
test. The magnitude of the biomolecular reaction is measured using a second Logistics Biological Agents Effectiveness Operations
molecule called a reporter. The reporter molecule signals the extent of the Preference Set: Mobile Laboratory
reaction by attaching to the molecules on the microspheres. Because the
reporter’s signal is also a color, there are two sources of color, the color-code
inside the microsphere and the reporter color on the surface of the microsphere. FIELD USE Ranking
To perform a test, the color-coded microspheres, reporter molecules, and
sample are combined. This mixture is then injected into an instrument that uses
BioMAPP ranked in the middle third of all evaluated
microfluidics to align the microspheres in single file where lasers illuminate the products for field use and earned 75% of the utility points
colors inside and on the surface of each microsphere. Next, advanced optics of the best score.
capture the color signals. Finally, digital signal processing translates the signals ALTERNATIVE UTILITY
into real-time, quantitative data for each reaction. The BioMAPP utilizes xMAP
Best Score 0.943
technology which enables simultaneously assay detection up to 100 analytes in
a single well of a microtiter plate, using very small sample volumes. The system BioMAPP 0.703
delivers fast and cost-effective bioassay results on many assay formats including Lowest Score 0.343
nucelic acid assays, receptor-ligand assays, immunoassays and enzymatic
assays. Logistics Operations Effectiveness Biological Agents
II:66
Emanuel and Fruchey

• System or device has a 110V • Approximately the size of a carry-
source
require an external vacuum • Multiple centrifugation steps
source • A single shaking or vortexing step
• System is sometimes able to
• Single sample detection positive through internal software
between 30 and 40 minutes • Assay available and capable of
agents or toxins within the same
BEST FIT WORST FIT • Less than 50 ul volume needed
test
per test for detection
• The system or device could be • Four additional pieces of
adapted to a fully automated equipment needed
Signature:
CONTACT INFORMATION • A day of training be deactivated
BAE Systems, Inc. • Greater than 20 minutes • Between 200-500 BTUS
Integrated Defense Solutions required for set-up generated
Austin, TX 78725 • 6-8 manual steps required for
Woodinville, WA 98072 detection Operational conditions:
www.baesystems.com • Operated from 15°C to 37°C
• Device or system is intended for 25°C to 37°C
Point of Contact:
multiple use • Device or system has peak
Gary Morris
• 0-1 solution or buffer used performance at normal relative
(512) 926-2800
• 1 component humidity conditions only
(512) 929-4774 fax
• Daily washing with water
gary.k.morris@baesystems.com
required Sensitivity:
COST • 100-1,000 CFU per ml
• $70,000.00/system or device • 3 consumables or expendables Maturity gauge:
• Every 6 months service required
• Expected life is greater than 10 t
years
• Less than 5 minutes of daily
quality assurance procedures MOST MATURE LEAST MATURE
required
II:67
Bio-Seeq
by Smiths Detection

DETECTING THE Bio-Seeq ranked in the top third of all evaluated products
Francisella tularensis ALTERNATIVE UTILITY
(Commercially available Best Score 0.901
as a freeze-dried reagent),
Yersinia pestis (Assay
validated), Smallpox virus Lowest Score 0.217
(Assay developed) Effectiveness Biological Agents Logistics Operations
DESCRIPTION:
There is a growing need for portable, battery-powered instruments capable
of detecting and identifying biological agents that may be used against
military and civilian targets. The Bio-Seeq detection system, developed by DIAGNOSTIC Laboratory Ranking
Smiths Detection, is designed to address this need. The instrument weighs Bio-Seeq ranked in the top third of all evaluated products
6.5lbs, processes up to six samples at one time, and will operate for up to for diagnostic laboratories and earned 85% of the utility
2.5 hours with a rechargeable battery. Two independent optical channels points of the best score.
allow the simultaneous detection of an agent of interest along with an
ALTERNATIVE UTILITY
internal positive control to verify that the sample was correctly processed.
Best Score 0.909
The ease of sample preparation and reagent handling is a key component
in reliably performing PCR assays. The consumable developed by Smiths Smiths Bio-Seeq 0.772
Detection is complete and self-contained with all necessary reagents, Lowest Score 0.321
filtering, and reconstitution fluids. Processing of the assay involves a simple
wipe of the target powder followed by a simple rotating action and then
shaking on the part of the operator. No pipetting or other fluid transfer is
required to complete a test. The amplification of the sample is performed
by the instrument and results in an indication of positive, negative, or
indeterminate is displayed for samples that have been inhibited by an MOBILE Laboratory Ranking
environmental substance. Positive samples have cycle time or CT number Bio-Seeq ranked in the middle third of all evaluated
that indicate the approximate concentration. Test results and data are products for mobile laboratories and earned 78% of the
stored in non-volatile EEPROM for later retrieval using PC based software. utility points of the best score.
Processing time for most reagents is less than 40 minutes. Tests with
anthrax samples have shown that detection limits as low as 125 CFU’s per ALTERNATIVE UTILITY
test were reliably detected. The instrument is currently available with a menu Best Score 0.883
of Anthrax and Tularemia. Plague and Smallpox will be planned. Smiths Bio-Seeq 0.688
Lowest Score 0.379
TECHNOLOGY:
Polymerase Chain Reaction technology is a well known and researched Logistics Biological Agents Effectiveness Operations
technology used to rapidly identify a potential threat agent by its unique Preference Set: Mobile Laboratory
DNA. Six independently controlled thermocyclers are used to process real
time Taqman assays. Detection of amplification products uses fluorescent-
labeled probes designed for a specific agent of interest. Dual light paths FIELD USE Ranking
allow the simultaneous detection of two different fluorescent probes during Bio-Seeq ranked in the top third of all evaluated products
the amplification process. The speed, small size, and low power of the
thermocycler is what makes the Bio-Seeq unique in the field of portable
DNA detection.
best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:68
Emanuel and Fruchey

source • A single shaking or vortexing
steps
DIAGNOSTIC Throughput of product: • System always able to interpret
• Single sample detection raw data or call a positive
• 2 samples/batch or higher • Assay not available, but capable
• Less than 50 ul volume needed of detecting two or more
BEST FIT WORST FIT biological agents or toxins within
• The system or device could be the same test
adapted to a fully automated • No additional pieces of
system with some effort equipment needed
CONTACT INFORMATION • Very brief training • No sounds produced that cannot
Smiths Detection • Less than 5 minutes required be deactivated
2202 Lakeside Blvd. for set-up • Less than 200 BTUS generated
Edgewood, MD 21040 • 0-2 manual steps required for
www.smithsdetection.com detection Operational conditions:
Doug Green room temperature
multiple use • Performance of the device or
(410) 510-9209 • 0-1 solution or buffer used
(410) 510-9496 fax system is not influenced by
doug.green@smithsdetection.com • No cleaning required
Sensitivity:
COST Maintenance: • 100-1,000 CFU per ml
• $30.00/sample • 2 consumables or expendables
needed
• Approximately $30,000.00/system or device
• Once a year service required Maturity gauge:
• Expected life is 5-10 years • Is commercially available
procedures required
t
II:69
Bio-Seeq II
by Smiths Detection

DETECTING THE Bio-Seeq II ranked in the top third of all evaluated
tularensis, Yersinia Best Score 0.901
pestis, Orthopox Smiths Bio-Seeq II 0.694
virus (Commercially
Lowest Score 0.217
available as a
freeze-dried Effectiveness Biological Agents Logistics Operations
reagent); Ricin toxin Preference Set: Analytical Laboratory
(Assay developed)
DESCRIPTION:
The Bio-Seeq™ II DIAGNOSTIC Laboratory Ranking
is a new PCR thermocycler instrument from Smiths Detection. A Bio-Seeq II ranked in the top third of all evaluated
number of key features differentiate it from other portable PCR products for diagnostic laboratories and earned 80% of
instrumentation systems. The Bio-Seeq™ II uses Thermoelectric- the utility points of the best score.
Cooling for rapid and reliable thermocycling in high ambient
ALTERNATIVE UTILITY
temperatures and it contains four independent optical channels
Best Score 0.909
allowing four simultaneous measurements from a single sample.
The sealed operation utilizing fiber optics allows full immersion Smiths Bio-Seeq II 0.733
for decontamination. The machine employs a 5.4” Windows CE Lowest Score 0.321
LCD Touch screen and contains integral GPS to identify both
where and when sample are taken. The Bio-Seeq™ II supports
up to six thermocyclers in a reliable redundant configuration,
can be operated while wearing PPE and is rechargeable during
operation. All this is ruggedly packaged in an integral case. Assays
currently available for the Bio-Seeq™ II are Anthrax pX01 and MOBILE Laboratory Ranking
pX02, Tularemia, Plague, Orthopox and Training consumable. The Bio-Seeq II ranked in the middle third of all evaluated
Bio-seeq II is under development with a projected ready date of products for mobile laboratories and earned 76% of the
November 2007. utility points of the best score.
The Bio-Seeq™ II is a robust field deployable PCR instrument Best Score 0.883
designed to be used by field based personnel. The Bio-Seeq™ Smiths Bio-Seeq II 0.675
II uses both PCR and non-PCR based chemistries to detect a Lowest Score 0.379
range of Biological Warfare Agents including bacterial and viral
pathogens, as well as toxins on the same instrument. The Bio- Logistics Biological Agents Effectiveness Operations
Seeq™ II comprises six independent thermocycler modules each Preference Set: Mobile Laboratory
with four independent optical allowing up to four different tests of
six separate samples. The novel chemistry used by the Bio-Seeq™
II improves the reliability of the detection assays. These combined FIELD USE Ranking
features allow the field deployment of a rapid and reliable Bio-Seeq II ranked in the middle third of all evaluated
detection capability.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:70
Emanuel and Fruchey

• System or device uses batteries • Cannot view results “in real time”
or 110V electrical requirement • No centrifugation steps
ANALYTICAL • The system or device does not • There is a single shaking or
require water vortexing step
MOBILE FIELD source • Capable of detecting multiple
• Single sample detection Signature:
between 40 and 50 minutes • No sounds produced that cannot
• 2 samples/batch or higher be deactivated
BEST FIT WORST FIT • Less than 50 ul volume needed • Less than 200 BTUS generated
• The system or device is Operational conditions:
currently fully automated • Operated from 4°C to 37°C
Training/Speed/Manpower: room temperature
• Very brief (minutes-hours) • The performance of the device
CONTACT INFORMATION training and minimal technical or system is not influenced by
Smiths Detection skills relative humidity
2202 Lakeside Blvd. • No set-up required
• 3-5 manual steps required for Sensitivity:
Edgewood, MD 21040 • 100-1,000 CFU per ml
www.smithsdetection.com detection
Re-use: Maturity gauge:

Point of Contact: • Device or system is intended for • Only one incomplete device or
Doug Green multiple use system exists (bread board)
(410) 510-9209 • 0-1 solution or buffer used • Is expected to be ready for
(410) 510-9496 fax • 1 component commercialization within one
doug.green@smithsdetection.com • No cleaning required calendar year
• Less than $1,000,000 required
Maintenance:
to advance the device or system
• Less than once a year service
COST required
to commercialization
• $30.00/sample • Has not been featured in
• $33,000.00/device or system any peer reviewed scientific
years
evaluations
procedures
Transportation: t
• Between 5 and 25 kg MOST MATURE LEAST MATURE
• Reagent shelf life between 1 to
3 years
II:71
Bio-Seeq Mail Sentry System

by Smiths Detection – Edgewood

DETECTING Bio-Seeq Mail Sentry ranked in the middle third of all
THE evaluated products for analytical laboratories and earned
FOLLOWING: 70% of the utility points of the best score.
Francisella Mail Sentry 0.629
tularensis
Lowest Score 0.217
(Commercially
available as a Effectiveness Biological Agents Logistics Operations
freeze-dried Preference Set: Analytical Laboratory
reagent);
Yersinia
pestis (Assay DIAGNOSTIC Laboratory Ranking
validated);
Bio-Seeq Mail Sentry ranked in the middle third of all
Smallpox
virus (Assay evaluated products for diagnostic laboratories and
developed) earned 66% of the utility points of the best score.
ALTERNATIVE UTILITY
The Bio-Seeq Mail Sentry is a Bio Detection system for screening
Mail Sentry 0.603
mail and small parcels and is designed to provide reliable on-site
Lowest Score 0.321
mail screening capabilities. The Mail Sentry provides consistent
performance and maximum reliability through it’s automated, Effectiveness Operations Biological Agents Logistics
simple user-interface. All mail and parcels are processed through Preference Set: Diagnostic Laboratory
a sealed cabinet which minimizes exposure to the user and helps
to contain the threat. Utilizing Polymerase Chain Reaction (PCR)
technology, the same technology used in the U.S. Postal Service
biological detection screening system, the Mail Sentry provides
rapid, extremely accurate results. Bio-Seeq Mail Sentry ranked in the bottom third of all
Utilizing Polymerase Chain Reaction (PCR) technology, the same
ALTERNATIVE UTILITY
technology used in the U.S. Postal Service biological detection
screening system, the Mail Sentry provides rapid, extremely Best Score 0.883
accurate results. The mail and packages are contained within Mail Sentry 0.484
a protective cabinet maintained under negative pressure Lowest Score 0.379
designed to minimize agent exposure and prevent the spread
of contamination. The exhaust is filtered through HEPA filters to
capture aerosolized bio-agents, maximizing the safety of the mail
handler operating environment.
FIELD USE Ranking

Bio-Seeq Mail Sentry ranked in the bottom third of all
ALTERNATIVE UTILITY
Best Score 0.943
Mail Sentry 0.467
Lowest Score 0.343

II:72
Emanuel and Fruchey

electrical requirement • More than 50 kg
ANALYTICAL • The system or device requires • Shelf life between 1-3 years
water aliquots
require an external air or gas • Cannot view results “in real time”
source
• A single shaking or vortexing
require an external vacuum steps
source • System can interpret raw data or
call a positive through internal
DIAGNOSTIC Throughput of product: software
• Single sample detection in • Assay available, and capable of
greater than 60 min detecting four or more biological
BEST FIT WORST FIT • Less than 250 ul volume test
adapted into a fully automated
• An day of training
CONTACT INFORMATION • Greater than 500 BTUS
• Greater than 20 min required generated
Smiths Detection – Edgewood
for set-up
2202 Lakeside Blvd. • 6-8 manual steps required for
Edgewood, MD 21040 detection Operational conditions:
www.smithsdetection.com • Operated from 15°C to 37°C
• Components can be stored at
Re-use:
David Karmel multiple detections • Performance of the device or
(410) 510-9163 • 0-1 solution or buffer used system is not influenced by
(410) 510-9497 fax • 2 components relative humidity
David.Karmel@smithsdetection.com • Cleaning involves periodic rinse
cycles Sensitivity:
• 100-1,000 CFU per ml
COST Maintenance:
• $35.00/sample • 0-1 consumable or expendable Maturity gauge:
• $150,000.00/device or system needed • Is commercially available
• Needs service every six months
• Expected life measure of 5-10 t
years
for daily quality assurance MOST MATURE LEAST MATURE
procedures
II:73
Bio-Seeq Plus
by Smiths Detection

DETECTING THE Bio-Seeq Plus ranked in the middle third of all
Bacillus anthracis, earned 74% of the utility points of the best score.
Yersinia pestis, Best Score 0.901
Orthopox virus
(Commercially
available as a freeze- Lowest Score 0.217
dried reagent); Ricin Effectiveness Biological Agents Logistics Operations
toxin (Assay developed) Preference Set: Analytical Laboratory
DESCRIPTION:
The Bio-Seeq™ PLUS is an improved version of the original
Bio-Seeq™ product from Smiths Detection. It is capable of DIAGNOSTIC Laboratory Ranking
detecting bacterial and viral pathogens using an improved Bio-Seeq Plus ranked in the top third of all evaluated
‘Smiths Enhanced PCR’ system. It is a battery-operated hand- products for diagnostic laboratories and earned 81% of
held PCR detector, which addresses critical military and civilian the utility points of the best score.
requirements. A key feature of the Bio-Seeq™ PLUS is its ease
ALTERNATIVE UTILITY
of use by first responders at an incident. Operation of the unit is
Best Score 0.909
simple, even for an inexperienced operator wearing full IPE. The
new restyled design also benefits from improved thermocycler Smiths Bio-Seeq Plus 0.738
and battery reliability, and improves the ease of use of the original Lowest Score 0.321
product. The instrument is of robust, reliable construction.
The handheld is a fully field portable PCR identifier with results Preference Set: Diagnostic Laboratory
in less than 40 minutes. It supports up to six independent
simultaneous assays with a wide range of BW threat assays
available. Bio-seeq Plus can run up to 20 assays on a single MOBILE Laboratory Ranking
charge and a novel Ricin assay can be run alongside other BW Bio-Seeq Plus ranked in the middle third of all
assays. Ergonomic design allows operation while wearing IPE. The
handheld unit can be recharged while operating, has a low power
indicator and is CE approved. The Bio-seeq PLUS will be available
from April 2007. ALTERNATIVE UTILITY
Best Score 0.883
TECHNOLOGY:
The Bio-Seeq PLUS is a robust handheld field deployable PCR
instrument designed to be used by field based personnel. The Lowest Score 0.379
Bio-Seeq PLUS uses both PCR and non-PCR based chemistries Logistics Biological Agents Effectiveness Operations
to detect a range of Biological Warfare Agents including bacterial Preference Set: Mobile Laboratory
and viral pathogens, as well as toxins on the same instrument.
The Bio-Seeq PLUS comprises six independent thermocycler
modules allowing six different identification runs to be carried
out if necessary. The novel chemistry used by the Bio-Seeq PLUS
FIELD USE Ranking
improves the reliability of the detection assays. These combined Bio-Seeq Plus ranked in the top third of all evaluated
features allow the field deployment of a rapid and reliable products for field use and earned 87% of the utility
detection capability. points of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:74
Emanuel and Fruchey

• The system or device does not • Reagent shelf life is 1 to 3 years
source • 1 shaking or vortexing step
• Single sample detection • Not capable of detecting multiple
between 40-50 minutes biological agents or toxins within
• 6 samples/batch the same test
• Very brief (minutes-hours) • Less than 200 BTUS generated
CONTACT INFORMATION training and minimal technical
Smiths Detection skills Operational conditions:
2202 Lakeside Blvd. • No set-up required • Operated from 4°C to 37°C
Edgewood, MD 21040 • 3-5 manual steps required for • Components must be stored at
www.smithsdetection.com detection room temperature
• The performance of the device
Point of Contact: Re-use: or system is not influenced by
Doug Green • Device or system is intended for relative humidity
(410) 510-9209 multiple use
(410) 510-9496 fax • 0-1 solution or buffer used Sensitivity:
doug.green@smithsdetection.com • 1 component • 100-1,000 CFU per ml
Maturity gauge:
COST Maintenance: • Is commercially available
• $30.00/sample • Less than once a year service • Has not been featured in peer
• $33,000.00/system or device required reviewed scientific publications
• Expected life is greater than 10 or independent evaluations
years
procedures
II:75
BioThreat Alert Tests Strips & Optional Reader

by Tetracore Inc. and Alexeter Technologies

DETECTING Bio Threat Alert Tests Strips ranked in the bottom third
THE of all evaluated products for analytical laboratories and
Francisella Tetracore Bio Threat
tularensis, 0.371
Alert Test Strips
Brucella Lowest Score 0.217
species,
Yersinia pestis, Effectiveness Biological Agents Logistics Operations
Orthopox virus, Preference Set: Analytical Laboratory
Botulinum toxin A, Botulinum toxin B, Staphylococcal toxin B,
Ricin toxin, Abrin toxin (Commercially available as a freeze-dried
reagent)
Bio Threat Alert Tests Strips ranked in the middle third
DESCRIPTION: of all evaluated products for diagnostic laboratories and
The BioThreat Alert Test Strip is an antibody-based assay earned 64% of the utility points of the best score.
intended for biological agent screening in environmental samples.
ALTERNATIVE UTILITY
It is designed for both field and laboratory use but is not intended
for use on clinical samples. Although results can be read by eye, Best Score 0.909
an optical reader is available for use with the strips to analyze, Tetracore Bio Threat Alert Test Strips 0.581
quantify, and record the result, but usage of this reader is Lowest Score 0.321
optional.
TECHNOLOGY: Preference Set: Diagnostic Laboratory
The BioThreat Alert Test Strip from Tetracore, Inc is a lateral
flow immunochromatographic assay that uses two antibodies in
combination to specifically detect a biological agent in solution. MOBILE Laboratory Ranking
One of the specific antibodies is labeled with a colloidal gold Bio Threat Alert Tests Strips ranked in the top third of all
derivative and when sufficient target material is present, the evaluated products for mobile laboratories and earned
colloidal gold label provides a red line that is visualized after
accumulating in the test sample region of the strip. When a
sample is added to the BioThreat Alert Test Strip, the sample ALTERNATIVE UTILITY
begins to mix with the colloidal gold-labeled antibody and Best Score 0.883
simultaneously moves along the strip membrane by capillary Tetracore Bio Threat Alert Test Strips 0.768
action. If the target is present, the second specific antibody
Lowest Score 0.379
captures the colloidal gold-labeled antibody and bound target,
forming a colored band in the sample or “S” window of the Logistics Biological Agents Effectiveness Operations
strip. As an internal control, a second band visualized in the Preference Set: Mobile Laboratory
control or “C” window of the strip is an indication that the test
strip functioned properly. Two colored bands (in the “S” and
“C” windows) are required to determine a positive result. (Also FIELD USE Ranking
featured on page 122-123.)
Bio Threat Alert Tests Strips ranked in the top third of all
ALTERNATIVE UTILITY
Best Score 0.943
Tetracore Bio Threat Alert 0.882
Test Strips
Lowest Score 0.343

II:76
Emanuel and Fruchey

• System or device has no electrical • Approximately the size of a soda
requirement; optional reader has can; optional reader is the size of
ANALYTICAL 110V electrical requirement a toaster
• The system or device does not • Less than 1 kg; optional reader is
require water between 1 and 5 kg
• The system or device does not • Reagent shelf life between 1 and
MOBILE FIELD source
require an external vacuum • Can view results “in real time”
DIAGNOSTIC • There is a single shaking or
Throughput of product: vortexing step
• Single sample detection in 20 • Optional reader is able to
minutes or less interpret raw data or call a
• 1 sample/batch positive through internal software
BEST FIT WORST FIT • Less than 250 ul volume needed • Not capable of detecting multiple
per test for detection biological agents or toxins within
• The system or device could easily the same test
be adapted into a fully automated • One additional piece of
system equipment needed
CONTACT INFORMATION • Very brief (minutes-hours) training • No sounds produced that cannot
Tetracore, Inc. Alexeter Technologies and minimal technical skills be deactivated
• No set-up required; optional • Less than 200 BTUS generated
11 Firstfield Road 830 Seton Court,
reader requires 2 minutes set up
Gaithersburg, MD Suite 6 • 3-5 manual steps required for
20878 Wheeling, IL 60090 Operational conditions:
detection
www.tetracore.com www.alexeter.com • Operated from 15°C to 37°C
Point of Contact: Re-use: room temperature
Tom O’Brien Jim Whelan • Device or system is intended for • The performance of the device or
(301) 258-7553 (847) 419-1507 single use; optional reader is system is influenced by relative
(301) 258-9740 fax (847) 419-1648 fax designed for multiple use humidity
• 0-1 solution or buffer used
tobrien@tetracore.com jwhelan@alexeter.com
• No cleaning required • 10,000- >100,000 CFU per ml
COST
• $24.20/test
• $5,500.00/reader Maintenance: Maturity gauge:
• No service required; optional • Is commercially available and
reader needs once a year service
• Optional reader expected life is
• Has been featured in peer
between 5-10 years
procedures or independent evaluations
t
II:77
BioVeris (BV) Detection System

by BioVeris Corp.

DETECTING THE BV Detection System ranked in the top third of all
Bacillus anthracis, 80% of the utility points of the best score.
SEB, E. coli 0157:H7, ALTERNATIVE UTILITY
Botulinum toxins A, Best Score 0.901
B, E (Commercially BioVeris BV Detection System 0.718
available as wet/
Lowest Score 0.217
frozen reagent)
Francisella tularensis, Effectiveness Biological Agents Logistics Operations
Yersinia pestis, Smallpox Preference Set: Analytical Laboratory
virus, Orthopox virus,
Ricin (Commercially available as a freeze-dried reagent)

The BV Detection System is an automated analyzer designed for use with BV Detection System ranked in the top third of all
BV reagents. This system provides sample handling, detection based upon evaluated products for diagnostic laboratories and
BioVeris (BV) Technology, electrochemiluminescence, and analysis in a 50 earned 91% of the utility points of the best score.
tube carousel-based format. This system is designed for the detection of
ALTERNATIVE UTILITY
multiple analytes, from small molecules, to proteins, to microorganisms,
Best Score 0.909
in a wide variety of matrices. The system processes a single sample in
about one minute and an entire carousel in less than an hour. It can BioVeris BV Detection System 0.828
also run a partial or an entire carousel in a single or multi-test mode. The Lowest Score 0.321
instrument automatically performs a system check to ensure proper system
operation on start-up. The system allows for use of pre-set protocols or user
determined protocols, and real-time updates of system output and data
review.

BV Technology uses a paramagnetic microparticle as the solid support for BV Detection System ranked in the top third of all
formation of a reaction. Multiple compounds can be labeled with BV-TAG, evaluated products for mobile laboratories and earned
the product name for ruthenium (II) tris-bipyridine. Using a variety of linking
chemistries, the ruthenium molecule can be directly bound to proteins,
thiols, oligonucleotides, carbohydrates, and carboxyl groups using a simple ALTERNATIVE UTILITY
labeling and purification procedure. For BV technology, ruthenium serves Best Score 0.883
as the detector molecule for the system. At the core of the instrument BioVeris BV Detection System 0.775
system is a flow cell designed to measure the amount of ruthenium bound Lowest Score 0.379
to the paramagnetic microparticles through a chemical reaction known as
electrochemiluminescence. When the reaction mixture enters the flow cell, Logistics Biological Agents Effectiveness Operations
a magnet captures the microparticles on the surface of an electrode. Any Preference Set: Mobile Laboratory
components of the assay or sample that are not bound specifically to the
microparticles through the assay component interactions continue past the
electrode and exit the system as part of the waste stream. BV-TAG labeled FIELD USE Ranking
species on the microparticles are detected by introducing tripropylamine BV Detection System ranked in the top third of all
(TPA) to the flow cell, applying an oxidizing potential at the electrode and
measuring the integrated intensity of the emitted light. The flow cell is then
washed with a cleaning solution and prepared for the next sample. For
the electrochemiluminescent reaction, the system uses two bulk reagent ALTERNATIVE UTILITY
solutions that enter the flow cell via bulk solution containers attached Best Score 0.943
directly to the instrument system. The first bulk reagent, known as BV Assay BioVeris BV Detection System 0.778
Buffer contains TPA that is used in the electrochemiluminescent reaction
Lowest Score 0.343
process. The second bulk reagent is BV Cell Cleaner that is used by the
system to remove the previous reaction from the flow cell in preparation for Logistics Operations Effectiveness Biological Agents
receipt of the next sample. Preference Set: Field Use
II:78
Emanuel and Fruchey

between 20 and 30 minutes • Not capable of detecting multiple
BEST FIT WORST FIT • Less than 100 ul volume the same test
CONTACT INFORMATION • An afternoon of training • Less than 200 BTUS generated
BioVeris Corporation • 10-20 minutes required for
16020 Industrial Drive set-up
Gaithersburg, MD 20877
www.bioveris.com detection • Components can be stored at
room temperature
Point of Contact: Re-use: • Performance of the device or
Jill White system is not influenced by
(301) 869-9800 x1054 relative humidity
multiple use
(240) 632-2206 fax • 3 solutions or buffers used
jwhite@bioveris.com • 1 component Sensitivity:
• A decontamination protocol is • 100-1,000 CFU per ml
required for use one time per
COST week
• $<10.00/sample Maturity gauge:
• $42,604.00/system or device • Is commercially available
Maintenance: t
needed
procedures
II:79
CANARY BioAerosol Sensor

by MIT Lincoln Laboratory

CANARY ranked in the middle third of all evaluated
DETECTING THE
FOLLOWING:
E. coli O157: ALTERNATIVE UTILITY
H7, Francisella Best Score 0.901
tularensis, Vibrio CANARY Bioaerosol Sensor 0.536
cholera, Yersinia
Lowest Score 0.217
pestis, Brucella
species, Smallpox Effectiveness Biological Agents Logistics Operations
virus, VEE virus, Preference Set: Analytical Laboratory
Dengue fever virus,
Orthopox virus
(Assays developed) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: CANARY ranked in the middle third of all evaluated
CANARY is a cell-based biosensor technology that has products for diagnostic laboratories and earned 64% of
demonstrated a unique combination of speed and sensitivity for the utility points of the best score.
pathogen identification in a wide range of sample types including ALTERNATIVE UTILITY
bioaerosol samples, clinical samples, surface wipes, and food. Best Score 0.909
CANARY tests are simple, use few consumables, and can be
performed in small, lightweight equipment that is compatible with
battery power for field use. CANARY tests can be as simple as Lowest Score 0.321
adding a drop of cells to a sample (e.g., dry-impacted bioaerosol Effectiveness Operations Biological Agents Logistics
samples) and placing the mixture in a luminometer to detect Preference Set: Diagnostic Laboratory
antigen-specific light generation in less than one minute. For
maximum sensitivity in complex liquid samples, brief spins are
incorporated into a procedure that can provide identification in
three minutes after sample collection. MOBILE Laboratory Ranking
CANARY ranked in the middle third of all evaluated
TECHNOLOGY: products for mobile laboratories and earned 63% of the
CANARY utilizes B cells that have been genetically engineered utility points of the best score.
to produce aequorin, a calcium-sensitive bioluminescent protein
originally found in the Aequorea victoria jellyfish. The sensor ALTERNATIVE UTILITY
works as follows: (1) The B cells can be exposed to suspected Best Score 0.883
bioagents or other pathogens from an air sample or other source. CANARY Bioaerosol Sensor 0.553
(2) The B cells produce antibodies specific for certain bioagents. Lowest Score 0.379
If one of those agents is present in the sample, it will bind to
the antibodies on the surface of the B cell. (3) Crosslinking Logistics Biological Agents Effectiveness Operations
of a B cell’s antibodies by a bioagent triggers an intracellular Preference Set: Mobile Laboratory
enzymatic cascade that releases calcium inside the cell. (4) In
the presence of calcium, the aequorin emits blue-green light at
469 nm within seconds of antigen-specific crosslinking. (5) Light FIELD USE Ranking
from stimulated B cells can be detected using a photomultiplier CANARY ranked in the bottom third of all evaluated
tube or other photodetector. CANARY can currently identify 13 products for field use and earned 48% of the utility points
different bacterial and viral agents including Bacillus anthracis
of the best score.
spores, Yersinia pestis, Francisella tularensis, and vaccinia, and
development is underway to enable toxin identification. ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:80
Emanuel and Fruchey

no water aliquots • Shelf life between 1-3 years
MOBILE FIELD source • Can view results “in real time”
• The system or device does not • A single centrifugation step
source • System can interpret raw data or
DIAGNOSTIC call a positive through internal
Throughput of product: software
• Single sample detection in 20 • Assay available, and capable of
min or less detecting four or more biological
BEST FIT WORST FIT • 2 samples/batch or higher agents or toxins within the same
• Less than 10 ul volume needed test
Signature:
Training/Speed/Manpower: • Sounds produced that cannot be
CONTACT INFORMATION • More than a day of training deactivated
MIT Lincoln Laboratory • 5-10 min required for set-up • Between 200-500 BTUS
244 Wood St. • 0-2 manual steps required for generated
Lexington, MA 02420 detection
Point of Contact: Re-use: • Operated from 4°C to 37°C
Mark A. Hollis • Device or system is intended for • Components can be stored at
(781) 981-7840 multiple detections 4°C to 37°C
(781) 981-3867 fax • 0-1 solution or buffer used • Performance of the device or
hollis@ll.mit.edu • 2 components system is not influenced by
• No cleaning required relative humidity
COST • 5 or more consumables or •CFU per ml is not applicable
• Approximately $0.50/sample expendables needed
• >$100,000/device or system • Needs service more often than Maturity gauge:
every 6 months • Expected to be ready for
• Expected life measure of greater commercialization within three or
than 10 years more calendar year
• 5-10 minutes required for daily • A few systems or devices exist
quality assurance procedures (brass board)
t
II:81
CANARY Biosensor
by MIT Lincoln Laboratory

CANARY Biosensor ranked in the top third of all evaluated
DETECTING
THE
FOLLOWING:
anthracis, E. Best Score 0.901
coli O157:H7, CANARY Biosensor 0.813
Francisella Lowest Score 0.217
tularensis,
Vibrio cholera, Effectiveness Biological Agents Logistics Operations
Yersinia pestis, Preference Set: Analytical Laboratory
Brucella species,
Smallpox virus,
VEE virus, Dengue fever virus, Orthopox virus (Assays developed) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: CANARY Biosensor ranked in the top third of all evaluated
CANARY is a cell-based biosensor technology that has products for diagnostic laboratories and earned 89% of
demonstrated a unique combination of speed and sensitivity for the utility points of the best score.
pathogen identification in a wide range of sample types including ALTERNATIVE UTILITY
bioaerosol samples, clinical samples, surface wipes, and food. Best Score 0.909
CANARY tests are simple, use few consumables, and can be
performed in small, lightweight equipment that is compatible with
battery power for field use. CANARY tests can be as simple as Lowest Score 0.321
adding a drop of cells to a sample (e.g., dry-impacted bioaerosol Effectiveness Operations Biological Agents Logistics
samples) and placing the mixture in a luminometer to detect Preference Set: Diagnostic Laboratory
antigen-specific light generation in less than a minute. For
maximum sensitivity in complex liquid samples, brief spins are
incorporated into a procedure that can provide identification in
three minutes after the sample is collected. MOBILE Laboratory Ranking
CANARY Biosensor ranked in the top third of all evaluated
CANARY utilizes B cells that have been genetically engineered utility points of the best score.
to produce aequorin, a calcium-sensitive bioluminescent protein
originally found in the Aequorea victoria jellyfish. The sensor ALTERNATIVE UTILITY
works as follows: (1) The B cells can be exposed to suspected Best Score 0.883
bioagents or other pathogens from an air sample or other source. CANARY Biosensor 0.724
(2) The B cells produce antibodies specific for certain bioagents. Lowest Score 0.379
If one of those agents is present in the sample, it will bind to
the antibodies on the surface of the B cell. (3) Crosslinking Logistics Biological Agents Effectiveness Operations
of a B cell’s antibodies by a bioagent triggers an intracellular Preference Set: Mobile Laboratory
enzymatic cascade that releases calcium inside the cell. (4) In
the presence of calcium, the aequorin emits blue-green light at
469 nm within seconds of antigen-specific crosslinking. (5) Light FIELD USE Ranking
from stimulated B cells can be detected using a photomultiplier CANARY Biosensor ranked in the top third of all evaluated
tube or other photodetector. CANARY can currently identify 13 products for field use and earned 76% of the utility points
different bacterial and viral agents including Bacillus anthracis of the best score.
spores, Yersinia pestis, Francisella tularensis, and vaccinia, and
development is underway to enable toxin identification. ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

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Emanuel and Fruchey

• The system or device requires on luggage
ANALYTICAL no water aliquots • Between 1-5 kg
• The system or device does not • Shelf life between 1-3 years
• The system or device could be • One additional piece of
Signature:
CONTACT INFORMATION • A day of training required be deactivated
MIT Lincoln Laboratory • Less than 5 min required for • Less than 200 BTUS generated
244 Wood St. set-up
Lexington, MA 02420 • 3-5 manual steps required for Operational conditions:
Point of Contact: • Components can be stored at
Mark A. Hollis Re-use: room temperature
(781) 981-7840 • Device or system is intended for • Performance of the device or
(781) 981-3867 fax multiple detections system is not influenced by
hollis@ll.mit.edu • 2 solutions or buffers used relative humidity
• 4 components
•100-1,000 CFU per ml
COST Maintenance:
• Approximately $0.50/sample
• $6,000.00/device or system
needed • Expected to be ready for
• Never needs service commercialization within one
• Expected life measure of greater calendar year
than 10 years • A few systems or devices exist
• 5-10 minutes required for daily (brass board)
t
II:83
CFLAPS
by Dycor

DETECTING THE CFLAPS ranked in the bottom third of all evaluated
None reported (Generic the utility points of the best score.
Best Score 0.901
DESCRIPTION: Dycor CFLAPS 0.384
Our core technology,
CFLAPS, is a biological Lowest Score 0.217
detection system Effectiveness Biological Agents Logistics Operations
which functions on the Preference Set: Analytical Laboratory
principle that biological
agents will fluoresce
when subjected to
certain wavelengths
of ultraviolet laser CFLAPS ranked in the middle third of all evaluated
light. Our detection products for diagnostic laboratories and earned 58% of
system has at its the utility points of the best score.
core a Fluorescent ALTERNATIVE UTILITY
Laser Aerodynamic Best Score 0.909
Particle Sizer model 3317 (FLAPS3). Dycor’s purpose-built XMX
Dycor CFLAPS 0.531
high-volume aerosol concentrator draws in large volumes of air,
concentrates the constituent particles and passes them through Lowest Score 0.321
the FLAPS to determine the size and concentration of biological Effectiveness Operations Biological Agents Logistics
agents which may be present. Samples can also be collected Preference Set: Diagnostic Laboratory
for identification of such agents in the laboratory or in the field.
Dycor developed the highly accurate alarming algorithms for
the system, a critical factor in minimizing false alarms and
maintaining the highest standards of reliability and accuracy MOBILE Laboratory Ranking
in detecting and tracking biological agents in the air. Through CFLAPS ranked in the middle third of all evaluated
our extensive experience in the test and evaluation of a wide products for mobile laboratories and earned 63% of the
range of configurations and operational capability of biological utility points of the best score.
detection equipment, we have also developed control software
ALTERNATIVE UTILITY
for biological systems, as well as systems architecture that allows
Best Score 0.883
for rapid integration of our detection capability with nuclear,
radiological and chemical detection and identification capability Dycor CFLAPS 0.559
as desired, and which supplies valid samples and collection data Lowest Score 0.379
for biological identification systems. Combined with our CBNET
biodetection alarm algorithm, control and analysis software, this
fully integrated system is sold as the C-FLAPS Biological Detection
System.
TECHNOLOGY: FIELD USE Ranking

The CFLAPS System provides three key real-time measurements CFLAPS ranked in the top third of all evaluated products
of individual airborne particles in the concentrated airstream: for field use and earned 87% of the utility points of the
the scattered-light intensity and the fluorescence emissions in best score.
two wavelength regions measured using two highly-sensitive
photomultiplier tubes. These simultaneous single particle ALTERNATIVE UTILITY
measurements provide a robust data set for the rapid detection Best Score 0.943
of airborne biological threat agents under various background Dycor CFLAPS 0.822
environments and when processed using appropriate alarm Lowest Score 0.343
algorithm techniques, deliver exceptional agent discrimination
and interference rejection response for biological threat detection Logistics Operations Effectiveness Biological Agents
applications. Fluorescence and scattered-light signals are excited Preference Set: Field Use
using one reliable, stable, and commercially available laser diode.
II:84
Emanuel and Fruchey

or has a 110V or 220V electrical on luggage suitcase
ANALYTICAL requirement • Between 25 and 50 kg
require water Ease of use/Utility:
MOBILE FIELD source
source through internal software
DIAGNOSTIC • No additional pieces of
Throughput of product: equipment needed
• Single sample detection in 20
minutes or less Signature:
BEST FIT WORST FIT • 384 samples/batch or higher • No sounds produced that cannot
• Less than 10 ul volume needed be deactivated
per test for detection • Less than 200-500 BTUS
• The system or device is generated
Training/Speed/Manpower: • Operated from 4°C to 45°C
• As little as an afternoon and as
CONTACT INFORMATION • Components must be stored at
much as multiple days 25°C to 45°C
Dycor Technologies Ltd.
• Less than 5 minutes set-up • The performance of the device
1851 - 94 Street required or system is not influenced by
Edmonton, Alberta • 0-2 manual steps required for relative humidity
T6N 1E6, Canada detection
www.dycor.com
Sensitivity:
Point of Contact: Re-use: • 15 ACPLA (Agent Containing
Antony Roth • Device or system is intended for Particles per Liter of Air)
(780) 486-0091 x2326 multiple use
(780) 486-3535 fax
• 0-1 solution or buffer used Maturity gauge:
• Infrequent cleaning required • Is commercially available and
apr@dycor.com
meets military requirements
Maintenance: • Based on technology (FLAPS2)
COST • More often than every 6 months that has been featured in peer
• Unreported cost per sample service is required reviewed scientific publications
years
• Less than 5 minutes daily t
quality assurance procedure
II:85
ChemSensing Colorimetric Sensor

by ChemSensing, Inc.
ANALYTICAL Laboratory Ranking

CAPABLE OF DETECTING THE ChemSensing Colorimetric Sensor ranked in the middle
Able to Detect any Organisms for Which
Volatile Metabolites Are Known and earned 63% of the utility points of the best score.
ALTERNATIVE UTILITY
ChemSensing, Inc. (CSI) possesses a
unique chemical detection technology ChemSensing 0.567
in which colorimetric changes in an Lowest Score 0.217
array of dyes constitute a signal much
like that generated by the mammalian
olfaction system; each dye is a cross-
responsive sensor. This technology uses a disposable two-dimensional
array of chemoresponsive dyes as the primary sensor elements, making
it particularly suitable for detecting many of the odiferous compounds DIAGNOSTIC Laboratory Ranking
produced by microbiological agents. Striking visual identification of a wide ChemSensing Colorimetric Sensor ranked in the middle
range of volatile organic compounds (VOCs), including carboxylic acids, third of all evaluated products for diagnostic laboratories
alcohols, amines, ethers, thioethers, and thiols, are easily made at part and earned 77% of the utility points of the best score.
per billion (ppb) levels (i.e., sensitivities comparable to or better than gas
ALTERNATIVE UTILITY
chromatographic flame ionization (GC-FID) or mass spectrometric (GC-MS)
Best Score 0.909
detection). Our strategy toward detection of biological agents involves
recognition and differentiation based on the volatile metabolites generated ChemSensing 0.699
by a microorganism. Each species of organism emits a distinct profile of Lowest Score 0.321
enzymatic reaction products in the form of VOCs, e.g., amines, sulfides or
fatty acids. Based on cross-responsive sensor elements, this array records
the composite responses unique to each microorganism. We envision this
technology as having applications for real-time, portable, easy-to-use,
commercial sensors for detection of pathogens and hazardous substances
having applications in medicine, biotechnology, food safety, environmental MOBILE Laboratory Ranking
monitoring, in addition to detection of chemical and biological warfare ChemSensing Colorimetric Sensor ranked in the bottom
agents. third of all evaluated products for mobile laboratories and
TECHNOLOGY:
Metalloporphyrins are a natural choice for the detection of metal-ligating ALTERNATIVE UTILITY
vapors because of their open coordination sites for axial ligation, their Best Score 0.883
large spectral shifts upon ligand binding, and their intense coloration. ChemSensing 0.513
CSI’s technology takes advantage of the large color changes induced in Lowest Score 0.379
metalloporphyrins upon ligand binding to create a simple colorimetric
technique that minimizes the need for extensive signal transduction Logistics Biological Agents Effectiveness Operations
hardware. The large spectral changes (and readily observable color Preference Set: Mobile Laboratory
changes) that occur in solution during ligand binding to metalloporphyrins
have been well documented. Furthermore, the periphery of the
metalloporphyrin can be easily modified, thereby adjusting the accessibility FIELD USE Ranking
of the metal ion to the ligand and inducing shape-selective ligation. ChemSensing Colorimetric Sensor ranked in the middle
Using metal centers that span a range of chemical hardness and ligand third of all evaluated products for field use and earned
binding affinity and substituents that allow varying access to the metal,
a wide range of volatile analytes are differentiable. Porphyrins also show
significant solvochromic effects, so even weakly interacting vapors (e.g., ALTERNATIVE UTILITY
arenes, halocarbons, or ketones) show distinguishable colorimetric effects. Best Score 0.943
Estimates of our sensitivity based on initial experiments and the known ChemSensing 0.582
growth rates for E. coli are ~50 cells/mL after one hour of growth and ~103 Lowest Score 0.343
cell/mL for a 10 minute analysis time for a one mL culture volume with
0.25 mL headspace gas volume (based on demonstrated ChemSensing Logistics Operations Effectiveness Biological Agents
array limit of recognition for acetic acid (~50 ppb) and the production rate Preference Set: Field Use
of acetic acid by E. coli in glucose rich liquid media (1.5 x 10-16 moles/
bacteria/min at 37°C, pH 7, doubling time 55 min).
II:86
Emanuel and Fruchey

System requirements: • Between 1-5 kg
• System or device uses batteries • Shelf life between 6 months and
• The system or device does not 1 year
ANALYTICAL require water aliquots
MOBILE FIELD • The system or device does not • No shaking or vortexing steps
require an external vacuum • System can interpret raw data or
source call a positive through internal
software
DIAGNOSTIC Throughput of product: • Assay not available, but capable
• Single sample detection in less of detecting two or more
than 20 min biological agents or toxins within
• 1 sample/batch the same test
CONTACT INFORMATION • No set-up required
ChemSensing, Inc. • 0-2 manual steps required for Operational conditions:
60 Hazelwood Drive detection • Operated from 4°C to 37°C
Champaign, IL 61820 • Components can be stored at
www.chemsensing.com Re-use: 25°C to 37°C
Point of Contact: multiple detections system is not influenced by
Joel Dryer • 0-1 solution or buffer used relative humidity
(847) 412-0010 • 1 component
(847) 412-0008 fax • No cleaning required Sensitivity:
joel@chemsensing.com •100-1,000 CFU per ml
Maintenance:
• 0-1 consumable or expendable Maturity gauge:
COST needed • Expected to be ready for
• Approximately $0.25/sample • Needs service less than once commercialization within two
• $6,000.00/device or system a year calendar years
• Expected life measure of 5-10 • Only one incomplete device or
years system exist (bread board)
procedures necessary t
Transportation:
toaster
II:87
Chimera System
by Thermo Hybaid

Chimera System ranked in the top third of all evaluated
DETECTING THE
FOLLOWING:
Various biological the utility points of the best score.
agents ALTERNATIVE UTILITY
Best Score 0.901
DESCRIPTION:
The Thermo Hybaid Chimera System 0.688
Chimera System is a Lowest Score 0.217
dedicated real time
PCR machine capable Preference Set: Analytical Laboratory
of performing fast
and precise thermal
cycling combined
with sensitive and DIAGNOSTIC Laboratory Ranking
accurate fluorescent Chimera System ranked in the middle third of all
readings. This combination, along with intuitive software, enables evaluated products for diagnostic laboratories and
quantitative PCR, end-point analysis and SNP scoring on the one earned 74% of the utility points of the best score.
instrument.
ALTERNATIVE UTILITY
The unit is intended for use by both academic and industrial users Best Score 0.909
for the low level detection of both DNA and RNA in real time and Chimera System 0.672
its subsequent quantitation. Lowest Score 0.321

The Thermo Hybaid Chimera System uses a halogen lamp as Preference Set: Diagnostic Laboratory
excitation source and a PMT as the detection method. By using up
to eight filters per reaction it is possible to have an excitation and
emission range of 340 to 720nm. The Chimera uses a standard MOBILE Laboratory Ranking
96 well microplate format (with a gradient block for ease of
Chimera System ranked in the middle third of all
optimization) and is totally robot-compatible due to the CD drawer
mechanism employed. Detection of one copy up to 108 copies is
possible with a read speed of under 10 sec. per filter set. 65% of the utility points of the best score.
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Chimera System ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:88
Emanuel and Fruchey

require water • Shelf life between 1 and 3 year
• The system or device does not • Single centrifugation step
• Single sample detection greater • Assay not available, but capable
BEST FIT WORST FIT • 96 samples/batch or higher biological agents or toxins within
per test for detection • Three additional pieces of
automated system
Signature:
CONTACT INFORMATION Training/Speed/Manpower: be deactivated
Action Court • An afternoon of training • Unknown BTUS generated
2 Ashford Road • Less than 5 minutes required
Ashford, Middlesex TW15 1XB, UK for set-up
www.thermo.com • 0-2 manual steps required for
detection
Point of Contact: room temperature
Dr. Miles Schofield Re-use: • Performance of the device or
+44 1784 425033 • Device or system is intended for system is unknown at relative
+44 1784 248085 fax multiple use humidity
miles.schofield@thermo.com • 3 solutions or buffers used
• No cleaning required • 1-100 CFU per ml
COST
• Dependent on assay/sample Maintenance: Maturity gauge:
• Approx. $50,000.00/system or device • 2 consumables or expendables • A few devices or systems exist
needed (brass board)
required
t
procedures MOST MATURE LEAST MATURE
II:89
Clear Lake Medical Automated Disposable Assays

by Clear Lake Medical Foundation Inc.

DETECTING THE Clear Lake Medical Automated Disposable Assays ranked
FOLLOWING: in the bottom third of all evaluated products for analytical
Francisella best score.
tularensis, ALTERNATIVE UTILITY
diphtheria, Clear Lake Medical -
Burkholderia 0.400
pseudomallei, Lowest Score 0.217
Coxiella burnetti,
E.coli O157:H7, Vibrio cholera, Burkholderia mallei, Yersinia Preference Set: Analytical Laboratory
pestis, Rickettsia prowazekii, Marburg virus, Smallpox virus,
Influenza virus, Dengue fever virus, Orthopox virus, Rift valley fever
virus, Venezuelan equine encephalitis virus, Yellow fever virus, Clear Lake Medical Automated Disposable Assays ranked
Ebola virus, MS-2 bacteriophage, Botulinum toxin A, Botulinum in the middle third of all evaluated products for diagnostic
toxin B, Saxitoxin, Conotoxin, Alfatoxin, Staphylococcal toxin B, laboratories and earned 58% of the utility points of the
Ricin toxin, Abrin toxin, T-2 mycotoxin (Assay developed) best score.
ALTERNATIVE UTILITY
DESCRIPTION:
Best Score 0.909
The Clear Lake Medical Foundation Inc. is developing technologies Clear Lake Medical -
for at home healthcare diagnosis and management. Those tests Automated Disposable 0.531
range from microscopic imaging for home testing, colorimetric Lowest Score 0.321
based testing, immunochemical testing, to DNA/PCR testing.
A generic processing and analysis platform has been built to
accommodate a large panel of mixed mode tests. Testing is
designed to be fully automated and disposable; without any skill
or training requirements. MOBILE Laboratory Ranking
Clear Lake Medical Automated Disposable Assays ranked
TECHNOLOGY: in the middle third of all evaluated products for mobile
The platform technology provides a disposable cartridge that laboratories and earned 70% of the utility points of the
supports the automation of DNA, PCR, ELISA, and similar tests. best score.
Processing is fully automated; including washing, mixing, thermal
cycling, and analysis, and takes place within a disposable ALTERNATIVE UTILITY
cartridge that also serves as one level of biocontainment. Up to Best Score 0.883
a hundred different analyses can be grafted to one disposable Clear Lake Medical -
Automated Disposable 0.617
cartridge. A handheld battery operated instrument is used for Lowest Score 0.379
control, data acquisition, storage and communications. The patent
pending technology is being developed for home care testing. Logistics Biological Agents Effectiveness Operations
FIELD USE Ranking

Clear Lake Medical Automated Disposable Assays ranked
in the top third of all evaluated products for field use and
ALTERNATIVE UTILITY
Best Score 0.943
Clear Lake Medical - 0.773
Lowest Score 0.343

II:90
Emanuel and Fruchey

• System or device uses batteries • Approximately the size of a soda
can
ANALYTICAL • The system or device does not
• Less than 1k
require water
source • Can view results “in real time”
MOBILE FIELD • The system or device does not • System always able to interpret
• Capable of detecting multiple
biological agents or toxins within
DIAGNOSTIC Throughput of product: the same test
• Single sample detection in 20 • No additional pieces of
minutes or less equipment needed
per test for detection Signature:
currently fully automated be deactivated

CONTACT INFORMATION skills
Clear Lake Medical Foundation Inc. or system is not influenced by
• No set-up required relative humidity
2437 Bay Area Blvd., MS448 • 0-2 manual steps required for
Houston, TX 77058 detection
www.clearlakemedicalfoundation.com Sensitivity:
• Unknown sensitivity
Point of Contact: Re-use:
Glenn Spaulding • Device or system is intended for Maturity gauge:
single use • Only one incomplete device or
(281) 827-4707
• 1 component
(281) 488-1878 fax system exists (bread board)
gspaulding@clearlakemedicalfoundation.com • Is expected to be ready for
Maintenance: calendar year
COST required
to advance system or device to
• Unknown cost • Expected life is greater than 10
years commercialization
procedures
t
II:91
Clear Lake Medical CD-M™

by Clear Lake Medical Foundation Inc.

DETECTING Clear Lake Medical CD-M ranked in the bottom third of all
Francisella Clear Lake Medical CD-M 0.418
tularensis,
Lowest Score 0.217
Corynebacterium
diphtheria, Effectiveness Biological Agents Logistics Operations
Burkholderia pseudomallei, Coxiella burnetti, Brucella species, Preference Set: Analytical Laboratory
E.coli O157:H7, Vibrio cholera, Burkholderia mallei, Yersinia
pestis, Rickettsia prowazekii, Marburg virus, Smallpox virus,
Influenza virus, Dengue fever virus, Orthopox virus, Rift valley fever DIAGNOSTIC Laboratory Ranking
virus, Venezuelan equine encephalitis virus, Yellow fever virus,
Clear Lake Medical CD-M ranked in the middle third of
Ebola virus, MS-2 bacteriophage, Botulinum toxin A, Botulinum
toxin B, Saxitoxin, Conotoxin, Alfatoxin, Staphylococcal toxin B, all evaluated products for diagnostic laboratories and
Ricin toxin, Abrin toxin, T-2 mycotoxin (Assay developed) earned 60% of the utility points of the best score.
ALTERNATIVE UTILITY
The Clear Lake Medical Foundation Inc. has developed a compact
digital microscope for brightfield and fluorescent microscopy (CD-
Lowest Score 0.321
M™, patents pending). It is useful for microarray analysis such
as gene arrays, protein arrays, tissue arrays, and comparative Effectiveness Operations Biological Agents Logistics
genomic hybridization arrays; and other areas of microscopy Preference Set: Diagnostic Laboratory
including blood, urine and other analyses for bacteria. The digital
microscope if fully automated has supporting slide scanning and
analysis as well as remote operation. A four-slide analysis system
operates within the enclosure of a “Shuttle PC” – a personal
computer (PC) that is approximately the size of a shoebox. All Clear Lake Medical CD-M ranked in the middle third of all
the capabilities of a standard PC are available. A smaller version evaluated products for mobile laboratories and earned
digital brightfield and fluorescent microscope in development has 66% of the utility points of the best score.
a generic form factor and interface optimized to fit in the compact ALTERNATIVE UTILITY
disk bay (CD bay) of a PC, supporting single slide analyses. Both Best Score 0.883
units can operate as field units for various threat analyses and
treatment.
Lowest Score 0.379
TECHNOLOGY:
The compact digital microscope platform enables automated
imaging of slide based assays for bacteria and viruses; and
additionally supports rapid field assessment of body fluids such as
blood, urine, saliva, sputum, and nasopharyngeal samples. Since
slide scanning is automated, no operating skill is necessary; a FIELD USE Ranking
point-and-click interface. Images can be evaluated by PC software Clear Lake Medical CD-M ranked in the top third of all
or uplinked to a remote site for evaluation by medical personnel. evaluated products for field use and earned 87% of the
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:92
Emanuel and Fruchey

• System or device uses • Approximately the size of a
batteries or has 110V electrical toaster
• The system or device does not • Shelf life measure not applicable
require water
MOBILE FIELD source
• Single sample detection in 20 • One additional piece of
• Less than 10 ul volume needed Signature:
per test for detection • No sounds produced that cannot

CONTACT INFORMATION • Operated from 4°C to 37°C
training and minimal technical • The performance of the device
Clear Lake Medical Foundation Inc.
skills or system is not influenced by
2437 Bay Area Blvd., MS448 • Less than 5 minutes set-up relative humidity
Houston, TX 77058 required
www.clearlakemedicalfoundation.com • 0-2 manual steps required for Sensitivity:
detection • Unknown sensitivity
Point of Contact:
Glenn Spaulding
(281) 827-4707 Re-use: Maturity gauge:
(281) 488-1878 fax • Device or system is intended for • Is expected to be commercially
multiple use available with one calendar year
gspaulding@clearlakemedicalfoundation.com
• 2 components • Less than $1,000,000 required
to advance system or device to
Maintenance: commercialization
COST • Less than once a year service
• Unknown cost/sample required
• $3,000.00-10,000.00/system or device • Expected life is greater than 10 t
years
procedures
II:93
Compact, Quantum Dots Based Biosensor

by The Aerospace Corporation
CAPABLE OF DETECTING ANALYTICAL Laboratory Ranking

THE FOLLOWING: Compact, Quantum Dots Based Sensor ranked in the
Able to detect any organisms for middle third of all evaluated products for analytical
which an antibody based assay is laboratories and earned 68% of the utility points of the
available best score.

The Aerospace Corporation has Best Score 0.901
been carrying out work toward the Compact, Quantum Dots Biosens. 0.614
development of a miniaturized, Lowest Score 0.217
immunoassay-based, optical biosensor that has the ability to detect
multiple pathogens and/or biological toxins on a single sensing element Effectiveness Biological Agents Logistics Operations
(e.g., optical fiber or waveguide). This biosensor is based upon the Preference Set: Analytical Laboratory
use of a new class of fluorescent labels for antibodies: semiconductor
quantum dots. Fluorescent quantum dots are nanocrystals that can DIAGNOSTIC Laboratory Ranking
readily be tailored to emit different visible and infrared wavelengths of Compact, Quantum Dots Based Sensor ranked in the
light. An undesirable feature of fluorescent dyes used in the conventional middle third of all evaluated products for diagnostic
immunoassay sensors is that emission efficiencies of the dyes often laboratories and earned 77% of the utility points of the
degrade with time due to photo bleaching, which could cause the detection best score.
signal to drift with time and require frequent calibrations. Quantum dots,
on the other hand, are much less sensitive to photobleaching and are thus ALTERNATIVE UTILITY
ideal for field applications that require long-life and reliable service-free Best Score 0.909
operation. Aerospace has demonstrated that, upon being properly bound Compact, Quantum Dots Biosens. 0.704
to antibodies, the quantum dots can be used as optical taggant labels to Lowest Score 0.321
“color code” different antibodies that are selective for a variety of pathogens
and biological toxins. Despite their different color emissions, quantum dots Effectiveness Operations Biological Agents Logistics
can be all excited by the same UV wavelength. A single diode laser can Preference Set: Diagnostic Laboratory
thus be used to excite a mixture of optical labels producing emission from
each quantum dot. The use of quantum dots as antibody taggants will thus MOBILE Laboratory Ranking
allow the use of a very compact device to detect multiple pathogens and Compact, Quantum Dots Based Sensor ranked in
biological toxins. The use of quantum dots as optical labels for antibodies the bottom third of all evaluated products for mobile
will also have applications in a variety of compact biosensors, including laboratories and earned 60% of the utility points of the
array-based immunoassay detectors. Such biosensors will be well-suited
best score.
for use by the counterproliferation, force protection, and homeland defense
communities for detecting the clandestine manufacture, battlefield, or ALTERNATIVE UTILITY
terrorist use of biological weapons. Best Score 0.883
TECHNOLOGY:
In order for quantum dots to be successfully used for biosensor Lowest Score 0.379
applications, they must first be chemically bound to antibodies in such Logistics Biological Agents Effectiveness Operations
a way that the quantum dots retain their fluorescence under biologically Preference Set: Mobile Laboratory
compatible conditions while the selectivities and affinities of antibodies
to their antigens are not degraded. Aerospace has developed methods for FIELD USE Ranking
synthesizing water-soluble ZnS-capped, CdSe quantum dots as well as
Compact, Quantum Dots Based Sensor ranked in the
methods to chemically bind these quantum dots directly to antibodies. This
has enabled the production of a new class of fluorescent-tagged antibody
middle third of all evaluated products for field use and
molecules. Aerospace has carried out studies to characterize the antibody- earned 71% of the utility points of the best score.
quantum dot complexes spectroscopically, and also studied the stability ALTERNATIVE UTILITY
of these complexes. Aerospace was the first group to report the covalent Best Score 0.943
bonding of an antibody to a quantum dot surface as well as to demonstrate Compact, Quantum Dots Biosens. 0.670
that the quantum dot-labeled antibodies retain specificity to their antigens.
Lowest Score 0.343
Aerospace has developed improved approaches for synthesizing quantum
dots of varying sizes and with different emission wavelengths as well as Logistics Operations Effectiveness Biological Agents
has carried out studies to help understand and control the stability and Preference Set: Field Use
quantum yield of the water-soluble quantum dots.
II:94
Emanuel and Fruchey

ANALYTICAL require water aliquots • Less than 1 kg
between 30 and 40 minutes • Assay not available, but capable
BEST FIT WORST FIT • Less than 100 ul volume biological agents or toxins within
automated system
Signature:
CONTACT INFORMATION • Very brief training be deactivated
The Aerospace Corporation • 5-10 minutes required for set-up • Less than 200 BTUS generated
P.O. Box 92957 • 3-5 manual steps required for
Los Angeles, CA 90009 detection Operational conditions:
Point of Contact: Re-use: • Components must be stored at
Yat Chan • Device or system is intended for 4°C
(310) 336-5073 multiple use • Performance of the device or
(310) 336-6801 fax • 0-1 solution or buffer used system is not influenced by
yat.c.chan@aero.org • 3 components relative humidity
Sensitivity:
• Unknown/sample needed Maturity gauge:
• Unknown price/system or device • Every 6 months service required • Only one incomplete device or
• Expected life is 3-5 years system exist (bread board)
t
II:95
DNA Engine Thermal Cycler

by MJ Research, Inc.

DETECTING THE DNA Engine Thermal Cycler ranked in the top third of all
E. coli 0157:H7 (Assay developed); 87% of the utility points of the best score.
Bacillus anthracis, Francisella
tularensis, Yersinia pestis, Brucella ALTERNATIVE UTILITY
species, Smallpox virus, Orthopox Best Score 0.901
virus (Commercially available as a DNA Engine Thermal Cycler 0.785
freeze-dried reagent)
Lowest Score 0.217
With DNA assays that are either Preference Set: Analytical Laboratory
PCR-based, or sequence-based -- thermal cyclers are the primary instrument platform
required. MJ Research offers a modular design of Peltier-effect thermal cyclers that
have become the worldwide “industry standard” instrument since introduction of this
third-generation technology in 1994. Today, there are three platforms: the one-block “DNA DIAGNOSTIC Laboratory Ranking
Engine”; the two-block “DNA Engine Dyad”; and the four-block “DNA Engine Tetrad II”.
Each of these can be fit with modular “Alpha Unit” interchangeable sample-block/heat-
DNA Engine Thermal Cycler ranked in the middle third
pump assemblies. Standard Alpha Units are available to fit 96x0.2ml tubes (or one of all evaluated products for diagnostic laboratories and
96-well plate); 2x48x0.2ml tubes; 60x0.5ml tubes; 2x30x0.5ml tubes, 384-well plate, earned 78% of the utility points of the best score.
2x eight glass slides (15mmx30mm); or a flat surface for large microarrays or biochips.
With the 96-well blocks, all instrument platforms are capable of “gradient” operation, ALTERNATIVE UTILITY
where the block can incubate with a 1°-24°C thermal gradient across its surface, to Best Score 0.909
assist in optimizing protocols. These instruments could readily serve as part of a larger DNA Engine Thermal Cycler 0.705
system being designed for the detection/diagnosis/analysis of BW/BT pathogens, where
end-product analysis was conducted through gel-electrophoresis or a plate reader or Lowest Score 0.321
a fluorescence-detection thermal cycler (when using end-point analysis, as with melt
curves, 3-4 blocks can “feed” a single fluorescence-detection unit). Within the past year, Effectiveness Operations Biological Agents Logistics
MJ Research has introduced two major new accessories. The first is the “MotoAlpha”, Preference Set: Diagnostic Laboratory
which is a sophisticated motorized heated lid that allows reactions down to one microliter
volumes in 96- or 384-well plates. The second is the “Chromo4” Alpha Unit, which is a
unique four-color fluorescence-detection unit that allows real-time reactions on these
platforms (or end-point analysis of plates through melt-curve analysis). MOBILE Laboratory Ranking
DNA Engine Thermal Cycler ranked in the middle third of
TECHNOLOGY: all evaluated products for mobile laboratories and earned
The thermal cyclers are microprocessor-controlled precision incubators that operate
using the Peltier Effect, which is a fundamental physical phenomenon that pumps
heat electronically without any moving parts other than a fan to disperse excess heat. ALTERNATIVE UTILITY
It also allows for a precision and speed of control unrivaled by any other technology
Best Score 0.883
with instrumentation working at the scale of laboratory devices. MJ Research was the
first company to develop such instrumentation and introduce it commercially (although DNA Engine Thermal Cycler 0.692
according to the inventor of PCR and Nobel-laurate, Kary Mullis, the very first “PCR Lowest Score 0.379
machine” was a Peltier-effect instrument, custom-built circa 1984). MJ introduced
its first commercial unit in 1988, and since that time, the technology has virtually Logistics Biological Agents Effectiveness Operations
supplanted the four other technologies of thermal control used in this molecular-biology Preference Set: Mobile Laboratory
application. The DNA Engine line was MJ’s third generation of instrument offered. MJ
builds its thermal cyclers starting with extremely pure bismuth & tellurium, from which
semiconductor crystals are grown in furnaces using a proprietary process. These crystals
are then sliced, diced, treated, QC’d and assembled into working “thermoelectric FIELD USE Ranking
modules,” which are then incorporated into increasingly larger assemblies that eventually
compose the entire instrument. The result is the best performing, most reliable, and
DNA Engine Thermal Cycler ranked in the middle third of
most precise thermoelectric technology in any thermal cycler currently offered. Among all evaluated products for field use and earned 76% of the
the many features the instrument incorporates includes, 1) modularity, where individual utility points of the best score.
“Alpha Unit” sample-block/heat-pump assemblies can be swapped in seconds, 2) speed
of ramping that is quite rapid, to allow shorter protocols, 3) precision of control that ALTERNATIVE UTILITY
is NIST-traceable and highly reproducible well-to-well, run-to-run, and instrument-to- Best Score 0.943
instrument, 4) robust and time-proven circuit designs and software, 5) a gradient-block DNA Engine Thermal Cycler 0.713
function with the 96-well Alpha that allows a range of temperatures of 1°-24° across
the block during any incubation with no loss of NIST-traceable accuracy, 6) a worldwide Lowest Score 0.343
distribution (and repair) network, such that authorized distributors exist in over forty
nations with familiarity with the instrument and an ability to service them, 7) competitive Logistics Operations Effectiveness Biological Agents
pricing and commercial availability. Preference Set: Field Use
II:96
Emanuel and Fruchey

electrical requirements on luggage suitcase
require water • Greater than 3 year shelf life
• The system or device does not • Unknown centrifugation steps
require an external vacuum • Unknown shaking or vortexing
source step
DIAGNOSTIC • System may be able to interpret
Throughput of product: raw data or call a positive
• Single sample detection greater through internal software in the
than 60 minutes future
BEST FIT WORST FIT • 384 samples/batch or higher • Assay not available, but capable
• Less than 10 ul volume needed of detecting four or more
• The system or device could the same test
easily be adapted into a fully • Unknown additional pieces of
automated system equipment needed
CONTACT INFORMATION Training/Speed/Manpower: Signature:

MJ Research, Inc. • An afternoon of training • No sounds produced that cannot
590 Lincoln Street • Less than 5 min required for be deactivated
Waltham, MA 02451 set-up • Greater than 500 BTUS
www.mjr.com • Manual steps required for generated
detection NA
Point of Contact: Re-use: • Operated from 4°C to 37°C
John Hansen • Device or system is intended for • Unknown components storage
(617) 972-8157 x8157 multiple use • Performance of the device or
(617) 923-8080 fax • Unknown solution or buffer system is not influenced by
johnh@mjr.com used relative humidity
• Unknown components
COST • No cleaning required Sensitivity:
• $0.50/sample plus cost of Taq enzyme
• A one-block DNA Engine costs about $7000.00,
Maintenance:
• 5 or more consumables or Maturity gauge:
a two-block Dyad costs about $13,500.00, and a
expendables needed • Is commercially available
four-block Tetrad II costs about $24,000.00
• Needs service less than once
a year t
• No daily assurance procedures
needed MOST MATURE LEAST MATURE
II:97
dotLab
by Alexa Biosensors

DETECTING THE dotLAB Biosensor ranked in the middle third of all
None reported earned 72% of the utility points of the best score.
ALTERNATIVE UTILITY
The dotLab System
is an automated
bench-top instrument Lowest Score 0.217
designed for sensitive Effectiveness Biological Agents Logistics Operations
detection of proteins, Preference Set: Analytical Laboratory
viruses, cells and
DNA fragments. The
technology behind
the dot™ approach DIAGNOSTIC Laboratory Ranking
is user friendly: Highly selective receptor molecules (e.g. dotLAB Biosensor ranked in the top third of all
antibodies) specific to the target substance are deposited onto evaluated products for diagnostic laboratories and
the dotLab Sensor in specific line patterns known to generate earned 81% of the utility points of the best score.
diffractive images. Upon binding of target molecules, illumination
ALTERNATIVE UTILITY
by a laser results in a readily detectable light diffraction image
Best Score 0.909
that is analyzed quantitatively by the optical reader. The small
number of moving parts and the simplicity of the optical system Alexa Biosensors dotLab 0.738
ensure a high level of system reliability and precision. The Lowest Score 0.321
commercially available dotLab system is designed to allow rapid
assay development and validation in a laboratory environment.
These assays can then be deployed on companion systems for
point of care diagnostics under development that feature the
same basic technology but offer reduced complexity and fixed
assay menus in both a bench top and cartridge format. A wide MOBILE Laboratory Ranking
range of affinity reagents are suitable for use in the disposable dotLAB Biosensor ranked in the middle third of all
sensors including antibodies, peptides, aptamers, DNA and evaluated products for mobile laboratories and earned
others. Combined with the range of assay formats possible, this 70% of the utility points of the best score.
provides a rapid and sensitive method for detection of biological
species across wide concentration ranges. The optical design ALTERNATIVE UTILITY
provides direct compatibility with most biological samples such Best Score 0.883
as serum, plasma, urine, tissue lysates etc. with minimal sample Alexa Biosensors dotLab 0.614
preparation. Lowest Score 0.379
TECHNOLOGY: Logistics Biological Agents Effectiveness Operations

The dotLab System brings together two mature, well-understood Preference Set: Mobile Laboratory
technologies: grating-based light diffraction and immobilized
capture surfaces. This combination produces a sensitive and very
simple technique for the detection of molecular binding events FIELD USE Ranking
without the use of fluorescent labels. Protein-specific capture dotLAB Biosensor ranked in the top third of all
molecules are immobilized on the dotLab Sensor surface in evaluated products for field use and earned 84% of the
distinct locations, or assay spots. The capture molecules within
each spot are not randomly distributed, but are immobilized in a
series of parallel lines that produces a specific diffraction pattern ALTERNATIVE UTILITY
when illuminated with a laser. When a flowing stream of sample Best Score 0.943
is introduced into the flow cell, target molecules bind to the assay Alexa Biosensors dotLab 0.796
spots, resulting in an increased diffraction signal. The dotLab Lowest Score 0.343
System uses the intensity of the diffraction signal to generate real-
time binding curves. The illumination and detection beams never Logistics Operations Effectiveness Biological Agents
pass through the sample, which makes the dotLab System ideal Preference Set: Field Use
for the detection of proteins in complex biological samples such
as serum, plasma, and crude cell lysates.
II:98
Emanuel and Fruchey

• System or device is 100-240 • Approximately the size of a carry-
VAC self-regulating on luggage suitcase
water aliquots • Reagent shelf life between 6
months and 1 year
• There is one shaking or vortexing
source
step
• Single sample detection through internal software in the
between 20 and 30 minutes future
BEST FIT WORST FIT • 32 samples/batch or higher • Capable of detecting multiple
per test for detection the same test
• The system or device is • Two additional pieces of
CONTACT INFORMATION • Very brief (minutes-hours)
training and minimal technical be deactivated
Axela Biosensors Inc.
skills • Greater than 500 BTUS
480 University Avenue, Suite 910
• Less than 5 minutes set-up generated
Toronto, Ontario
M5G 1V2, Canada required
www.axelabiosensors.com • 0-2 manual steps required for Operational conditions:
Point of Contact:
4°C
Paul Smith, VP Sales & Business Development Re-use: • The performance of the device
(416) 260-9050 x2291 • Device or system is intended for
single use or system is not influenced by
(416) 260-9255
• 0-1 solution or buffer used relative humidity
dotlabinfo@axelabiosensors.com
• 3 components
COST • Optional cleaning with acid Sensitivity:
buffer and neutralizing buffer • 100-1000 CFU per ml
• $10.00-20.00/sample
• $59,300.00/system or device; Sensor kit
$180.00/12 sensors Maintenance: Maturity gauge:
• Once a year service required • Is commercially available
• Expected life is between 3-5 • Has been featured in a peer
years reviewed scientific publication or
• Less than 5 minutes daily independent evaluation
quality assurance procedures t
II:99

by Beckman Coulter

DETECTING THE DTX800 ranked in the bottom third of all evaluated
None reported
ALTERNATIVE UTILITY
The DTX 800
Multimode detector
allows detection Lowest Score 0.217
via fluorescence, Effectiveness Biological Agents Logistics Operations
luminescence Preference Set: Analytical Laboratory
and absorbance
modes. It can
operate as
standalone DIAGNOSTIC Laboratory Ranking
instrument or can be integrated seamlessly with automated DTX800 ranked in the bottom third of all evaluated
systems. The DTX 800 is ideal for a broad range of systems biology products for diagnostic laboratories and earned 81% of
applications including drug discovery, genomics, proteomics and the utility points of the best score.
cell-based research. The DTX 800 unique optics design (patents ALTERNATIVE UTILITY
pending) ensures precise performance and sensitivity across all
Best Score 0.909
detection modes. The DTX 800 features fluorescence intensity (top
reading), absorbance (visible) and glow luminescence for 96- to
384-well plates. The DTX 800 intuitive software platform provides Lowest Score 0.321
instrument control and easy protocol development.
The DTX 800 Multimode Detector employs high powered LEDs
as light sources. A single silicon photodiode and photon counting
PMT are used for detection in the 340-650nm range. Filters are MOBILE Laboratory Ranking
used to select specific wavelengths to measure. DTX800 ranked in the bottom third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

DTX800 ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:100
Emanuel and Fruchey

requires water aliquots • Shelf life measure is not
• Single sample detection in 20 through internal software in the
min or less future
• Less than 50 ul volume needed of detecting 4 or more targets in
per test for detection a single well
• The system or device could • 2 additional pieces of equipment
easily be adapted into a fully needed
automated system
Signature:
CONTACT INFORMATION Training/Speed/Manpower: • No sounds are produced that
Beckman Coulter • An afternoon of training cannot be deactivated
4300 N. Harbor Blvd. Box 3100 • Less than 5 min required for • Unknown BTUS generated
Fullerton, CA 92834 set-up
www.beckmancoulter.com • 6-8 manual steps required for Operational conditions:
• Components storage conditions
Point of Contact: Re-use: are not applicable
Matt Maloney, Margaret Kelly • Device or system is intended for • Device or system has peak
(317) 808-4217, (714) 773-8022 multiple use performance at normal relative
(714) 773-6690 fax • Number of solutions or buffers humidity conditions only
MJMaloney@beckman.com used is assay dependent
mmkelly@beckman.com • 1 component Sensitivity:
• No cleaning required •Unknown CFU per ml
COST
• Unknown/sample
• $11,000.00/device
• 2 consumables or expendables • Will be ready for
needed commercialization within one
• Needs service once a year calendar year
• Expected system or device life • A few devices or systems exist
of 5-10 years (brass board)
procedures
II:101

by Beckman Coulter

DETECTING DTX880 ranked in the bottom third of all evaluated
Best Score 0.901
DESCRIPTION: DTX 880 Multimode Detector 0.350
The DTX 880
Multimode Lowest Score 0.217
detector allows Effectiveness Biological Agents Logistics Operations
detection via Preference Set: Analytical Laboratory
fluorescence,
luminescence
and absorbance
modes. It can DIAGNOSTIC Laboratory Ranking
operate as DTX880 ranked in the bottom third of all evaluated
standalone instrument or can be integrated seamlessly with products for diagnostic laboratories and earned 53% of
automated systems. The DTX 880 is ideal for a broad range of the utility points of the best score.
systems biology applications including drug discovery, genomics, ALTERNATIVE UTILITY
proteomics and cell-based research. The DTX 880 unique optics Best Score 0.909
design (patents pending) ensures precise performance and
sensitivity across all detection modes. The DTX 880 features
fluorescence intensity (top and bottom reading), time-resolved Lowest Score 0.321
fluorescence, fluorescence polarization, absorbance (UV and Effectiveness Operations Biological Agents Logistics
visible), glow luminescence and temperature control for 6- to Preference Set: Diagnostic Laboratory
1536-well plates. The DTX 880 intuitive software platform
provides instrument control and easy protocol development.

The DTX 880 Multimode Detector employs high powered LEDs and DTX880 ranked in the bottom third of all evaluated
a deuterium lamp for light sources. A single silicon photodiode and products for mobile laboratories and earned 54% of the
photon counting PMT are used for detection in the 230-750nm utility points of the best score.
range. Filters are used to select specific wavelengths to measure.
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

DTX880 ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:102
Emanuel and Fruchey

requires water aliquots • Shelf life measure is not
• Single sample detection in 20 through internal software in the
min or less future
• Less than 50 ul volume needed of detecting 4 or more targets in
per test for detection a single well
• The system or device could • 2 additional pieces of equipment
easily be adapted into a fully needed
automated system
Signature:
CONTACT INFORMATION Training/Speed/Manpower: • No sounds are produced that
Beckman Coulter • An afternoon of training cannot be deactivated
4300 N. Harbor Blvd. Box 3100 • Less than 5 min required for • Unknown BTUS generated
Fullerton, CA 92834 set-up
www.beckmancoulter.com • 6-8 manual steps required for Operational conditions:
• Components storage conditions
Point of Contact: Re-use: are not applicable
Matt Maloney, Margaret Kelly • Device or system is intended for • Device or system has peak
(317) 808-4217, (714) 773-8022 multiple use performance at normal relative
(714) 773-6690 fax • Number of solutions or buffers humidity conditions only
MJMaloney@beckman.com used is assay dependent
mmkelly@beckman.com • 1 component Sensitivity:
• No cleaning required •Unknown CFU per ml
COST
• Unknown/sample
• $19,950.00/device
• 2 consumables or expendables • Will be ready for
needed commercialization within one
• Needs service once a year calendar year
• Expected system or device life • A few devices or systems exist
of 5-10 years (brass board)
procedures
II:103
EAGLE
by ChemImage

DETECTING Eagle ranked in the top third of all evaluated products
THE for analytical laboratories and earned 92% of the utility
FOLLOWING: points of the best score.
Francisella ChemImage EAGLE 0.827
tularensis,
Lowest Score 0.217
Burkholderia
Brucella Preference Set: Analytical Laboratory
species, E.coli
O157:H7,
Vibrio cholera, DIAGNOSTIC Laboratory Ranking
Burkholderia
Eagle ranked in the top third of all evaluated products
mallei, Yersinia pestis, Influenza virus, MS-2 bacteriophage,
Botulinum toxin A, Staphylococcal toxin B, Ricin toxin (Assay for diagnostic laboratories and earned 89% of the utility
validated) points of the best score.
ALTERNATIVE UTILITY
The EAGLE transportable chemical/biological threat detection ChemImage EAGLE 0.806
system can rapidly identify organic and inorganic industrial
Lowest Score 0.321
chemicals, reveal the presence of chemical or biological weapons
of mass destruction, and equally important, identify the presence Effectiveness Operations Biological Agents Logistics
of a hoax material. With this critical material identification Preference Set: Diagnostic Laboratory
information in hand, HAZMAT teams can make informed and
accurate decisions in regard to potential evacuations of large
numbers of people, extensive clean up and decontamination
efforts.
Eagle ranked in the middle third of all evaluated products
TECHNOLOGY: for mobile laboratories and earned 72% of the utility
The EAGLE is the first transportable instrument to combine points of the best score.
the strengths of three powerful techniques: microscopic
ALTERNATIVE UTILITY
examination, Raman spectroscopy and fluorescence spectroscopy
Best Score 0.883
for rapid identification of chemical and biological threats. The
first step involves the coupling of fluorescence spectroscopy ChemImage EAGLE 0.637
and microscopic image analysis in a process developed by Lowest Score 0.379
ChemImage known as wide field Chemical Imaging. The EAGLE
uses fluorescence chemical imaging to determine the presence
and location of any small fluorescence particle (i.e., a biological).
The EAGLE uses Raman spectroscopy to identify the agent by
using the built in spectral library.
FIELD USE Ranking
Eagle ranked in the bottom third of all evaluated products
best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:104
Emanuel and Fruchey

System Requirements: Transportation:
dishwasher
ANALYTICAL electrical requirement
• More than 50 kg
require water • Reagent shelf life greater than 3
years
require an external vacuum • There is a single centrifugation
step
source
DIAGNOSTIC vortexing step
Throughput of product: • System always able to interpret
• Single sample detection in 20 raw data or call a positive
minutes or less through internal software
BEST FIT WORST FIT • 1 sample/batch • Capable of detecting multiple
adapted into a semi automated equipment needed
Signature:
CONTACT INFORMATION Training/Speed/Manpower: • No sounds produced that cannot
• A day of training and technical be deactivated
ChemImage skills are required • Between 200-500 BTUS
7301 Penn Ave • 10-20 minutes set-up required generated
Pittsburgh, PA 15208 • 3-5 manual steps required for
www.chemimage.com detection Operational conditions:
Point of Contact: • Operated from 15°C to 37°C
Charles W. Gardner. PhD Re-use: • Components must be stored at
• Device or system is intended for 25°C to 45°C
(412) 241-7335 x212 • The performance of the device
multiple use
(412) 241-7311 or system is not influenced by
cgardner@chemimage.com • 2 components relative humidity
• Cleaning required with 5%
bleach wipe Sensitivity:
COST • 100-1000 CFU per ml
• $184,000.00/system or device • Every 6 month service required Maturity gauge:
• Expected life is greater than 10 • Is commercially available
years
• 10 to 20 minutes daily quality
t
II:105
E. coli 0157 Visual Immunoassay (VIA)

by TECRA International Pty Ltd

DETECTING E.coli 0157 Visual Immunoassay ranked in the top third
E. coli 0157:H7 ALTERNATIVE UTILITY
(Commercially Best Score 0.901
available as a TECRA E. coli 0157 VIA 0.722
freeze-dried
Lowest Score 0.217
reagent)
A rapid and
specific screening
test for detection of E. coli O157 (including E. coli O157:H7 and
other enterohaemorrhagic E. coli O157 strains) in food and DIAGNOSTIC Laboratory Ranking
environmental samples. After an overnight enrichment, results E.coli 0157 Visual Immunoassay ranked in the middle
can be obtained within two hours. third of all evaluated products for diagnostic laboratories
and earned 70% of the utility points of the best score.
The ELISA can be used manually and the results read by eye.
However, it can also be semi-automated with the use of microtitre ALTERNATIVE UTILITY
plate readers and washers or fully automated for large scale Best Score 0.909
testing. The kit is available in a 96 and 48 well format. TECRA E. coli 0157 VIA 0.640
Lowest Score 0.321
TECHNOLOGY:
The TECRA E. coli O157 VIA is an Enzyme-linked Immunoassay Effectiveness Operations Biological Agents Logistics
(ELISA) performed in a sandwich configuration. Preference Set: Diagnostic Laboratory

E.coli 0157 Visual Immunoassay ranked in the middle
third of all evaluated products for mobile laboratories and
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

E.coli 0157 Visual Immunoassay ranked in the middle
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:106
Emanuel and Fruchey

• System never able to interpret
• Single sample detection greater through internal software
than 60 minutes • Not capable of detecting multiple
needed per test for detection • Two additional piece of
TECRA International Pty Ltd • Less than 5 min required for
13 Rodborough Rd. set-up Operational conditions:
Frenchs Forest, NSW 2086 Australia • 9-12 manual steps required for • Operated from 4°C to 45°C
www.tecra.net detection • Components must be stored at
4°C
Point of Contact: Re-use: • Performance of the device or
Nick Vale • Device or system is designed for system is not influenced by
+61 2 8977011 single use relative humidity
+61 2 9453 3422 fax • More than 4 solutions or buffers
nick.vale@tecra.net used Sensitivity:
• 5 or more components • 1-100 CFU per ml
• NA cleaning required
• $7.00/sample Maintenance: • Is commercially available
• $306.00 for 48 wells, $557.00 for 96 wells/ • 5 or more consumables or
system or device expendables needed t
• Expected life is not applicable
• Less than 5 minutes required MOST MATURE LEAST MATURE
II:107
ElectraSense™ Automated Microarray Hybridizer Reader

by CombiMatrix

THE FOLLOWING: ElectraSense ranked in the top third of all evaluated
Corynebacterium diphtheria, products for analytical laboratories and earned 81% of
Burkholderia pseudomallei, the utility points of the best score.
Coxiella burnetti, Vibrio ALTERNATIVE UTILITY
cholera, Burkholderia mallei,
Best Score 0.901
Ebola virus, Staphylococcal
toxin B, Ricin toxin (Assay Lowest Score 0.217
developed); Bacillus Effectiveness Biological Agents Logistics Operations
anthracis, Francisella Preference Set: Analytical Laboratory
tularensis, Brucella species,
Yersinia pestis, Influenza
virus, Venezuelan equine
encephalitis virus (Assay DIAGNOSTIC Laboratory Ranking
validated) ElectraSense ranked in the top third of all evaluated
The ElectraSense™ Automated Microarray Hybridizer Reader is a ALTERNATIVE UTILITY
small instrument that greatly simplifies use of the CombiMatrix Best Score 0.909
ElectraSense™ microarray for biothreat agent detection. Because
this array uses electrochemical detection (ECD) to measure
macromolecular interactions on each of >12,000 electrodes Lowest Score 0.321
(spots), the instrument does not use complex optical components. Effectiveness Operations Biological Agents Logistics
Rather, it takes electrical measurements directly off each Preference Set: Diagnostic Laboratory
electrode on the array in less than a minute. Eliminating optics
significantly reduces the size and complexity of the hybridizer
reader and permits integrated automation through the use of an
XY stage and a sampling robot to support liquid handling steps. MOBILE Laboratory Ranking
The instrument occupies about one cubic foot and has space ElectraSense ranked in the top third of all evaluated
for expansion to include sample preparation, amplification, and products for mobile laboratories and earned 81% of the
other assay processes that are required to achieve the desired utility points of the best score.
capability of detecting up to 50 different biothreats or pathogens.
ALTERNATIVE UTILITY
This instrument also includes options that allow the user to tailor
Best Score 0.883
how electrical measurements are made on the microarray along
with reagent combinations that are required for new assays and CombiMatrix ElectraSense 0.717
methods of detection. Lowest Score 0.379

The CombiMatrix ElectraSense™ microarray is a silicon chip Preference Set: Mobile Laboratory
with >12,000 individually addressable electrodes. Using
proprietary electrochemistry, unique oligonucleotide probes can
be synthesized at each electrode. Microarray synthesis is totally FIELD USE Ranking
automated, takes about 24 hours, and is totally customizable. ElectraSense ranked in the middle third of all evaluated
This gives the user an extremely versatile platform upon which products for field use and earned 63% of the utility points
to develop new microarray content and assays. While the array
of the best score.
can be used with fluorescence detection, CombiMatrix has
developed electrochemical detection (ECD) as an alternative ALTERNATIVE UTILITY
with comparable sensitivity and performance to fluorescence. Best Score 0.943
CombiMatrix has also developed methods for binding antibodies CombiMatrix ElectraSense 0.594
to specific electrodes on the microarray to support serological Lowest Score 0.343
assays and has demonstrated the feasibility of creating other
binding ligands that may be useful for biothreat agent detection. Logistics Operations Effectiveness Biological Agents
While still in development, serological assays performed array Preference Set: Field Use
demonstrate comparable sensitivity to ELISA plate assays.
II:108
Emanuel and Fruchey

• System or device has 110V • Cannot view results “in real time”
ANALYTICAL • The system or device does not • System always able to interpret
require water raw data or call a positive
• The system or device does not through internal software
require an external air or gas • Capable of detecting multiple
source biological agents or toxins within
MOBILE FIELD • The system or device does not the same test
require an external vacuum • One additional piece of
source equipment needed
DIAGNOSTIC Throughput of product: Signature:

• Single sample detection • No sounds produced that cannot
between 50 and 60 minutes be deactivated
• 384 samples/batch or higher • Less than 200 BTUS generated
BEST FIT WORST FIT • Less than 100 ul volume
needed per test for detection Operational conditions:
• The system or device is • Operated from 4°C to 37°C
currently fully automated • Components must be stored at
4°C
• An afternoon of training and or system is not influenced by
some technical skills required relative humidity
CONTACT INFORMATION
• Less than 5 minutes set-up
CombiMatrix Corporation Sensitivity:
required
6500 Harbour Heights Pkwy., Suite #303 • 0-2 manual steps required for • 100-1000 CFU per ml
Mukilteo, WA 98275 detection
http://www.combimatrix.com/aboutus_contact.htm Maturity gauge:
Re-use: • A few devices or systems exist
• Device or system is intended for (brass board)
Point of Contact: multiple use • Is expected to be ready for
(425) 493-2000 • 4 solutions or buffers used commercialization within one
(425) 493-2010 fax • 2 components calendar year
sales@combimatrix.com • Cleaning required • Less than $1,000,000 is
required to advance the device or
Maintenance: system to commercialization
COST • Expected life is between 3-5 • Has been featured in peer
• $150.00-450.00/sample years reviewed scientific publications
• $50,000.00/system or device • Quality assurance procedures or independent evaluations
have not been developed
t
Transportation:
carry-on luggage suitcase MOST MATURE LEAST MATURE
• Reagent shelf life between 6
months to 1 year
II:109
Enhanced Plasmon Bio-Detector (EPBD)

by Smiths Detection

DETECTING THE EPBD ranked in the middle third of all evaluated
Francisella the utility points of the best score.
tularensis, Coxiella ALTERNATIVE UTILITY
burnetti, Brucella Best Score 0.901
species, Yersinia
Smiths EPBD 0.528
pestis, MS-2
Lowest Score 0.217
bacteriophage,
Staphylococcal Effectiveness Biological Agents Logistics Operations
toxin B, Ricin toxin Preference Set: Analytical Laboratory
(Assay developed)
DESCRIPTION:
The EPBD instrument is designed as a fully automated DIAGNOSTIC Laboratory Ranking
instrument to perform identification of biological agents using EPBD ranked in the middle third of all evaluated
continuous flow-through sample analysis. All classes of biological products for diagnostic laboratories and earned 73% of
agents can be simultaneously identified with the sensor chips the utility points of the best score.
having multiplex capability, currently up to six agents can be
ALTERNATIVE UTILITY
simultaneously monitored with a planned increase in capacity to
Best Score 0.909
greater than twenty agents. The EPBD instrument is a continuous
monitoring device and, due to its rapid time to result, is intended Smiths EPBD 0.667
as an early warning of bio-agent release. The instrument is Lowest Score 0.321
designed to receive sample directly from a sample collection
system (SCS) that captures airborne samples into an aqueous Preference Set: Diagnostic Laboratory
buffer. The sample capture is a continuous process and the EPBD
continuously draws this sample buffer across the sensor chip. The
instrument is intended for installation within vehicles, for facilities
protection or within an enclosure, e.g., for perimeter protection. MOBILE Laboratory Ranking
The instrument will require the SCS to capture sample material for EPBD ranked in the middle third of all evaluated
the EPBD to monitor. If required, an associated forensic sampling products for mobile laboratories and earned 70% of the
system for retaining sample in the event of a threat release can utility points of the best score.
be incorporated.
ALTERNATIVE UTILITY
The EPBD is a single instrument that uses two detection Smiths EPBD 0.622
technologies, one based on Surface Plasmon Resonance for Lowest Score 0.379
proteins/toxins and small biological particles (e.g., viruses),
and the second based on light scattering for all other biological Logistics Biological Agents Effectiveness Operations
particles (e.g., larger viruses and bacteria/spores). In both Preference Set: Mobile Laboratory
detector units an immunoassay method utilizes direct binding
of the particles from environmental capture samples. For both
detectors a range of antibodies are coated at known positions FIELD USE Ranking
thus allowing multiple threat agents to be simultaneously EPBD ranked in the bottom third of all evaluated
monitored. The instrument is currently in development.
ALTERNATIVE UTILITY
Best Score 0.943
Smiths EPBD 0.511
Lowest Score 0.343

II:110
Emanuel and Fruchey

• System or device has 110V or • Reagents shelf life between 1 to
220V electrical requirement 3 years
ANALYTICAL • The system or device has an
installed solution tank (filled Ease of use/Utility:
weekly) or requires a water • Can view results “in real time”
• The system or device does not • No shaking or vortexing steps
MOBILE FIELD require an external air or gas
source
• Single sample detection in 20 • One additional piece of
• 20 simultaneous threats
BEST FIT WORST FIT monitored for with continuous Signature:
monitoring • No sounds produced that cannot
• Greater than 250 ul volume be deactivated
needed per test for detection • Greater than 500 BTUS
• The system or device is generated
CONTACT INFORMATION • Very brief (minutes-hours) or • Components must be stored at
Smiths Detection an afternoon of training with 4°C
varying degrees of technical • The performance of the device
549 Park Avenue
skills required or system is not influenced by
Bushey, Hertfordshire WD23 2BW relative humidity
England
required
www.SmithsDetection.com • 0-2 manual steps required for Sensitivity:
detection • 10,000-100,000 CFU per ml
Point of Contact:
Paul Pashby Re-use: Maturity gauge:
+44 (0) 1923 658213 • Device or system is intended for • A few devices or systems exist
+44 (0) 1923 236407 multiple use (brass board)
Paul.Pashby@SmithsDetection.com • More than 4 solutions or buffers • Is expected to be ready for
used commercialization within two
• 2 components calendar years
COST • No cleaning required • $1,000,000-$2,000,000
• $75.00/sample
requires for device or system to
• $80,000.00/device or system Maintenance:
advance to commercialization
reviewed scientific publications
years
or independent evaluations
procedures t
Transportation:
carry-on luggage suitcase MOST MATURE LEAST MATURE
II:111
ENIGMA-FL
by Enigma Diagnostics

DETECTING THE ENIGMA-FL ranked in the top third of all evaluated
Bacillus anthracis, Francisella the utility points of the best score.
tularensis, Corynebacterium ALTERNATIVE UTILITY
diphtheria, Burkholderia Best Score 0.901
burnetti, Brucella species,
E.coli O157:H7, Vibrio cholera, Lowest Score 0.217
Burkholderia mallei, Yersinia Effectiveness Operations Biological Agents Logistics
pestis, Rickettsia prowazekii, Preference Set: Diagnostic Laboratory
Marburg virus, Smallpox virus,
Influenza virus, Dengue fever
virus, Orthopox virus, Rift
valley fever virus, Venezuelan
equine encephalitis virus, ENIGMA-FL ranked in the top third of all evaluated
Yellow fever virus, Ebola virus, products for diagnostic laboratories and earned 96% of
MS-2 bacteriophage (Assay the utility points of the best score.
developed) ALTERNATIVE UTILITY

The Enigma-FL rapid biological agent detection system combines the Enigma Diagnostics ENIGMA-F 0.876
speed and sensitivity of PCR with the simplicity and ruggedness needed Lowest Score 0.321
for field-based operation. Portable and completely self-contained, every
aspect of its operation has been fully automated to provide ultra-rapid,
laboratory-standard results even when used in the field. The entire process
from collection of the raw sample to delivery of the end result can take
less than 40 minutes. Field hardened and rapidly deployable, it operates
with ambient stored reagents in a single disposable cartridge. This MOBILE Laboratory Ranking
eliminates the logistics and training burden associated with traditional ENIGMA-FL ranked in the top third of all evaluated
PCR instruments that require refrigerated reagents and manual sample products for mobile laboratories and earned 95% of
processing. Enigma’s products are specifically designed to deliver on-site the utility points of the best score.
results to first responders, security personnel and veterinary professionals
after minimal training. The instrument can process a range of sample types ALTERNATIVE UTILITY
including environmental samples, cyclone aerosol collection fluid, blood and Best Score 0.883
swabs. Analyzing the sample is a simple 40 minute, three-step process that Enigma Diagnostics ENIGMA-FL 0.835
minimizes hands-on time: dispense sample into a single-use cartridge; load Lowest Score 0.379
cartridge, select test and walk away; and the result is conveyed via a simple
traffic light system. Logistics Biological Agents Effectiveness Operations
TECHNOLOGY:
The Enigma-FL automates all steps in the PCR process from sample
processing to results calling. Automated sample processing is based on FIELD USE Ranking
robust magnetic bead DNA & RNA purification technology which includes ENIGMA-FL ranked in the top third of all evaluated
chemical extraction and sonication. Sample processing is fully integrated
with real-time PCR analysis using multiplexed fluorescent detection
technologies such as Taqman & LUX. Rapid thermal cycling is achieved
using unique Electrically Conducting Polymer (ECP) technology which ALTERNATIVE UTILITY
directly heats the reaction mix. This significantly benefits thermal transfer Best Score 0.943
rates and produces ultra-rapid thermal equilibration. Reagent stabilization Enigma Diagnostics ENIGMA-FL 0.843
(lyophilisation) delivers ambient storage of the test consumable. The test Lowest Score 0.343
result is automatically determined using a proprietary numerical fit for
specific and control target amplification combined with simple logic and Logistics Operations Effectiveness Biological Agents
displayed by a traffic light system. Preference Set: Field Use
II:112
Emanuel and Fruchey

• System or device uses • Approximately the size of a carry-
batteries or has 220V electrical on luggage suitcase
• The system or device does not • Reagent shelf life between 6
require water months and 1 year
• Single sample detection • Capable of detecting multiple
between 30 and 40 minutes biological agents or toxins within
BEST FIT WORST FIT • 1 sample/batch the same test
• Greater than 250 ul volume • No additional pieces of
• There are sounds produced that
Training/Speed/Manpower: cannot be deactivated
CONTACT INFORMATION • Very brief (minutes-hours) • Less than 200 BTUS generated
Enigma Diagnostics Ltd training and minimal technical
Building 224, Tetricus Science Park, skills Operational conditions:
Dstl Porton Down • No set-up required • Operated from 4°C to 45°C
Salisbury, Wiltshire SP4 0JQ • 0-2 manual steps required for • Components must be stored at
United Kingdom detection room temperature
www.enigmadiagnostics.com
or system is not influenced by
Point of Contact: Re-use: relative humidity
Dr. Ian George • Device or system is intended for
multiple use
+44 1980 590 131
• 3 solutions or buffers used
Sensitivity:
+44 1980 590 132 • 10-1000 CFU per ml
• 1 component
ian.george@enigmadiagnostics.com • Internal UV light
COST decontaminates, further Maturity gauge:
cleaning with alcohol, • Is commercially available and
• $30.00/sample
hypochlotite and DNAse meets military specifications
solutions if required. • Has been featured in peer
Maintenance: or independent evaluations
• Expected life is between 5-10 t
years
II:113
Eppendorf Mastercycler
by Eppendorf

DETECTING Eppendorf Mastercycler ranked in the bottom third of all
Able to detect ALTERNATIVE UTILITY
any organisms/ Best Score 0.901
toxins for which Eppendorf Mastercycler 0.315
assays can be
Lowest Score 0.217
developed
DESCRIPTION:
The Eppendorf Mastercycler gradient thermal cycler is a relatively DIAGNOSTIC Laboratory Ranking
small-sized instrument designed to quickly multiply DNA and Eppendorf Mastercycler ranked in the bottom third of
RNA by rapidly heating and cooling samples. Samples should be all evaluated products for diagnostic laboratories and
placed in tubes or PCR plates along with a Mastermix and run on earned 45% of the utility points of the best score.
the instrument for 30 to 40 cycles. ALTERNATIVE UTILITY
The Eppendorf Mastercycler gradient thermal cycler uses Peltier Eppendorf Mastercycler 0.408
heating and cooling technology. The instrument is designed to Lowest Score 0.321
perform temperature and time holding combinations from 4
degrees Celsius to 99 degrees Celsius and from one second Effectiveness Operations Biological Agents Logistics
to 99 hours 99 minutes and 99 seconds. The instrument is
also equipped with Triple Circuit Technology (TCT) which allows
for an almost linear 1 to 20 degree Celsius gradient function.
This function can be used to minimize assay optimization. MOBILE Laboratory Ranking
Mastercyclers come equipped with a removable Personal Card on Eppendorf Mastercycler ranked in the bottom third of all
which the user can store up to 10 protocols. It is relatively small evaluated products for mobile laboratories and earned
and lightweight and does not take up much bench space. 56% of the utility points of the best score.
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Eppendorf Mastercycler ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:114
Emanuel and Fruchey

source • System never able to interpret
• Single sample detection greater • Not capable of detecting multiple
BEST FIT WORST FIT • 96 samples/batch or higher the same test
• Less than 50 ul volume needed • Two additional pieces of
adapted into a semi-automated Signature:
system with some effort • No sounds produced that cannot
be deactivated
CONTACT INFORMATION Training/Speed/Manpower: • Between 200-500 BTUS
Brinkmann • Very brief training generated
One Cantiague Rd. • Less than 5 minutes required
Westbury, NY 11590 for set-up Operational conditions:
www.brinkmann.com • 3-5 manual steps required for • Operated from 15°C to 37°C
detection • Components must be frozen
Point of Contact: • Performance of the device or
Stefanie Ellis Re-use: system is unknown in humidity
(516) 334-7521 fax multiple use Sensitivity:
sellis@brinkmann.com • 0-1 solution or buffer used •Unknown CFU per ml
• 3 components
• $0.50 plus cost of Taq enzyme Maintenance: meets military specifications
• $7,885.00 GSA price/system or device • 3 consumables or expendables
needed t
• No daily quality assurance MOST MATURE LEAST MATURE
procedures
II:115
FALCON II
by ChemImage

DETECTING THE FALCON II ranked in the top third of all evaluated
tularensis, Burkholderia ALTERNATIVE UTILITY
pseudomallei, Brucella species,
Best Score 0.901
E.coli O157:H7, Vibrio cholera,
Burkholderia mallei, Yersinia
pestis, Influenza virus, MS-2 Lowest Score 0.217
bacteriophage, Botulinum toxin Effectiveness Biological Agents Logistics Operations
A, Staphylococcal toxin B, Ricin Preference Set: Analytical Laboratory
toxin (Assay validated)

The FALCON II Wide-field
Raman imaging system FALCON II ranked in the top third of all evaluated
combines the benefits of products for diagnostic laboratories and earned 90% of
wide-field Chemical Imaging the utility points of the best score.
with dispersive Raman spectroscopy. This combination of powerful analytical ALTERNATIVE UTILITY
multiple hardware options and unique, easy-to-use software makes the Best Score 0.909
FALCON II the most versatile and feature-rich Raman microscope platform
available.
Lowest Score 0.321
Chemical Imaging combines digital imaging and Raman spectroscopy to
provide molecular images that reveal material morphology, composition,
structure and concentration. Chemical Imaging takes advantage of the
microscope user’s natural visual senses and perception to make complex
analysis more intuitive and straightforward. The FALCON II produces two-
dimensional and three-dimensional molecular images with unequaled MOBILE Laboratory Ranking
speed and quality. Duet Vision Technology™ delivers real-time simultaneous FALCON II ranked in the top third of all evaluated
imaging and spectroscopy, allowing users to quickly and easily identify products for mobile laboratories and earned 73% of the
critical regions of interest. The ChemImage proprietary use of a liquid utility points of the best score.
crystal imaging spectrometer provides unparalleled image fidelity, spatial
and spectral resolution for high throughput hyperspectral screening of ALTERNATIVE UTILITY
materials. The FALCON II also performs dispersive Raman spectroscopy Best Score 0.883
at high spectral resolution for microscopy applications. Limited or no ChemImage FALCON II 0.648
sample preparation is required. Raman spectroscopy and Raman Chemical Lowest Score 0.379
Imaging are compatible with aqueous systems. Non-destructive sample
characterization can be performed through glass containers, thin plastic Logistics Biological Agents Effectiveness Operations
bags or blister packs. Application areas include drug content uniformity, Preference Set: Mobile Laboratory
particle size distribution, polymorph characterization, water quality
monitoring, cancer research, polymer characterization, biological and
chemical agent detection and identification. FIELD USE Ranking
FALCON II ranked in the middle third of all evaluated
TECHNOLOGY:
Chemical Imaging combines digital imaging and Raman spectroscopy to
provide molecular images that reveal material morphology, composition of the best score.
structure and concentration. The Falcon II system can be configured to ALTERNATIVE UTILITY
operate in visible as well as Raman with optional fluorescence or Near Best Score 0.943
Infrared (NIR) absorbance/reflectance capabilities. The Falcon II system ChemImage FALCON II 0.625
consists of three major subsystems all packaged in one convenient unit. The
Lowest Score 0.343
subsystems are an excitement source to provoke material response, imaging
optics to acquire sample response information and an optical detection Logistics Operations Effectiveness Biological Agents
system with optical filters and cameras to detect high resolution spatial and Preference Set: Field Use
spectral information.
II:116
Emanuel and Fruchey

• More than 50 kg
• Reagent shelf life greater than 3
require water years
• The system or device does not • There is a single centrifugation
require an external vacuum step
source
vortexing step
DIAGNOSTIC • System always able to interpret
• Single sample detection in 20 through internal software
minutes or less • Capable of detecting multiple
Signature:
• A day of training and technical
ChemImage skills are required
7301 Penn Ave Operational conditions:
• 10-20 minutes set-up required • Operated from 15°C to 37°C
Pittsburgh, PA 15208 • 3-5 manual steps required for • Components must be stored at
www.chemimage.com detection 25°C to 45°C
Point of Contact: • The performance of the device
Matthew P. Nelson. PhD Re-use: or system is not influenced by
• Device or system is intended for relative humidity
(412) 241-7335 x209
multiple use
(412) 241-7311
• 0-1 solution or buffer used Sensitivity:
nelson@chemimage.com • 2 components • 100-1000 CFU per ml
• Cleaning consist of wiping with
5% bleach Maturity gauge:
COST • Is commercially available
• $0.54/sample Maintenance: • Has been featured in peer
• $204,347.00/system or device • Every 6 months service required reviewed scientific publications
years
• 10-20 minutes daily quality t
II:117
FilmArray System
by Idaho Technology

DETECTING THE FilmArray System ranked in the top third of all
Burkholderia Idaho Tech FilmArray 0.886
pseudomallei,
Lowest Score 0.217
Coxiella burnetti,
E.coli O157:H7, Preference Set: Analytical Laboratory
Vibrio cholera,
Yersinia pestis,
Rickettsia prowazekii, Marburg virus, Smallpox virus, Influenza
virus, Dengue fever virus, Orthopox virus, Rift valley fever virus, FilmArray System ranked in the top third of all
Venezuelan equine encephalitis virus, Ebola virus, Botulinum toxin evaluated products for diagnostic laboratories and
A, Ricin toxin (Assay developed) earned 92% of the utility points of the best score.
ALTERNATIVE UTILITY
The FilmArray system is an automated system to identify dozens
of biological agents with very high sensitivity and specificity. The Idaho Tech FilmArray 0.837
FilmArray platform is evolved from the Razor - Idaho tech’s battery- Lowest Score 0.321
operated, plastic-pouch-based real-time PCR instrument. The
FilmArray system adds automated sample preparation and the
ability to analyze both bacteria and DNA. The result is a revolution
in diagnostic capability capable of automatically preparing a
sample and analyzing it for 100 agents simultaneously.
TECHNOLOGY: FilmArray System ranked in the middle third of all
The FilmArray system is an automated sample preparation and evaluated products for mobile laboratories and earned
biologic agent analysis system. It has the capability of automated
sample preparation, reverse transcription for RNA viruses, and
a two-stage nested multiplex PCR process. It has the diagnostic ALTERNATIVE UTILITY
capability capable of automatically preparing a sample and Best Score 0.883
analyzing it for 100 agents simultaneously. Idaho Tech FilmArray 0.844
Lowest Score 0.379

FIELD USE Ranking

FilmArray System ranked in the top third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Idaho Tech FilmArray 0.749
Lowest Score 0.343

II:118
Emanuel and Fruchey

System requirements: • Reagent shelf life between 6
• System or device has 110V months to 1 year
electrical requirement
ANALYTICAL • The system or device does not Ease of use/Utility:
require an external air or gas • No shaking or vortexing steps
MOBILE FIELD • The system or device does not raw data or call a positive
• Single sample detection • No additional pieces of
between 50 and 60 minutes equipment needed
BEST FIT WORST FIT
• Greater than 250 ul volume Signature:

training and minimal technical • Components must be stored at
CONTACT INFORMATION skills room temperature
Idaho Technology • Less than 5 minutes set-up • The performance of the device
390 Wakara Way required or system is not influenced by
Salt Lake City, UT 84108 • 0-2 manual steps required for relative humidity
www.idahotech.com detection
Sensitivity:
Point of Contact: Re-use: • 100-1,000 CFU per ml
Matt Scullion, Marketing Manager Applied Science • Device or system is intended for
(801) 736-6354 x327 multiple use
(801) 588-0507 • 0-1 solution or buffer used Maturity gauge:
• 2 components • A few devices or system exist
matt.scullion@idahotech.com
• Remove previous reagent pouch (brass board)
Maintenance: commercialization within two
COST • Less than once a year service calendar years
• less than $185.00/sample required • Greater than $2,000,000 is
• Expected life is between 5-10 required to advance the device or
years system to commercialization
• No daily quality assurance • Has not been featured in
procedures any peer reviewed scientific
Transportation: evaluations
toaster
II:119
Fluorescence Aerosol Particle Sensor (FLAPS III™) Model 3317

by TSI

DETECTING THE TSI FLAPS III ranked in the bottom third of all evaluated
Best Score 0.901
DESCRIPTION:
The TSI FLAPS TSI FLAPS 0.417
III™ Model 3317 Lowest Score 0.217
employs fluorescence
measurements on
individual airborne
particles for rapid biological threat detection (under one minute
response time) in military and homeland defense applications
where a trigger detector is required for biological point detection DIAGNOSTIC Laboratory Ranking
systems. The instrument delivers exceptional threat discrimination TSI FLAPS III ranked in the middle third of all evaluated
and interference rejection using real-time processing of the data products for diagnostic laboratories and earned 60% of
with advanced alarm algorithms. It has been tested with standard the utility points of the best score.
stimulants for bio-threat agents (spore & vegetative bacteria,
ALTERNATIVE UTILITY
viruses and toxins), and has undergone significant field testing
Best Score 0.909
to verify its performance. The instrument is designed for field
operation in terms of reliability, maintainability, and serviceability. TSI FLAPS 0.541
(A predecessor instrument, the TSI UVAPS Model 3312A, has Lowest Score 0.321
been fielded in the US Army P3I-BIDS enclosure.) The TSI FLAPS
III™ Model 3317 system simultaneously measures for each
individual airborne particle, the scattered-light intensity and the
fluorescence emissions in two wavelength regions. These single
particle measurements provide a robust data set for the rapid
detection of airborne biological threat agents under various MOBILE Laboratory Ranking
background environments. The instrument is generally used with TSI FLAPS III ranked in the middle third of all evaluated
a front-end aerosol concentrator to optimize performance, and products for mobile laboratories and earned 67% of the
is available in a stand-alone environmental enclosure with radio utility points of the best score.
communications for remote operation. It has been in production
since early 2004. The TSI FLAPS III™ Model 3317 is developed ALTERNATIVE UTILITY
under sole license of U.S. patent numbers 5701012, 5895922 , Best Score 0.883
and 6831279 from the Canadian Department of Defence. TSI FLAPS 0.594
Lowest Score 0.379
TECHNOLOGY:
The detection of biological aerosols by the TSI FLAPS III™ Model Logistics Biological Agents Effectiveness Operations
3317 is based on UV laser-induced fluorescence. The instrument Preference Set: Mobile Laboratory
uses a simplified optical train with a single, commercially available
405nm CW laser diode for both excitation and optical sizing
(nominal lifetime of 10,000 hours of continuous operation). An FIELD USE Ranking
opposed nozzle design, consisting of an inlet nozzle and an outlet TSI FLAPS III ranked in the top third of all evaluated
nozzle, prevents particle recirculation in the optical chamber, and
is used together with HEPA-filtered sheath air flow to eliminate
fouling of the optical components. Measurements are taken on
individual particles in the aerosol stream. ALTERNATIVE UTILITY
Best Score 0.943
TSI FLAPS 0.831
Lowest Score 0.343

II:120
Emanuel and Fruchey

require water
source
DIAGNOSTIC Throughput of product: • Capable of detecting multiple
• No liquid sample is required biological agents or toxins within
• No reaction or assay is the same test
performed • One additional piece of
BEST FIT WORST FIT currently fully automated
Signature:
• Very brief (minutes-hours) be deactivated
training and minimal technical • Less than 200 BTUS generated
skills
CONTACT INFORMATION required Operational conditions:
TSI Incorporated • 0-2 manual steps required for • Operated from 0°C to 45°C
500 Cardigan Road detection • The performance of the device
Shoreview, MN 55126
relative humidity
Richard Remiarz • Continuous use Sensitivity:
(651) 490-2773 • 0-1 solution or buffer used • Less than 25 ACPLA (Agent
• No components Containing Particles per Liter Air)
(651) 490-3824 fax
• Occasional cleaning with
rremiarz@tsi.com compressed air
www.tsi.com Maturity gauge:
Maintenance:
• Less than once a year service meets military specifications
COST required
• Expected life is greater than 10 reviewed scientific publications
years or independent evaluations
procedures t
II:121
Guardian Defender TSR (Test Strip Reader) Reader System™

by Alexeter Technologies

DETECTING THE Guardian Defender TSR ranked in the middle third of
FOLLOWING: all evaluated products for analytical laboratories and
Brucella species, Best Score 0.901
Yersinia pestis, Alexeter Defender TSR 0.585
Smallpox virus,
Lowest Score 0.217
Orthopox virus,
Botulinum toxin A, Effectiveness Biological Agents Logistics Operations
Botulinum toxin B, Preference Set: Analytical Laboratory
Abrin toxin (Assay
validated)

The first Guardian Defender TSR ranked in the middle third of
comprehensive solution all evaluated products for diagnostic laboratories and
for the detection earned 66% of the utility points of the best score.
and identification
ALTERNATIVE UTILITY
of biological
warfare agents was Best Score 0.909
introduced by Alexeter Alexeter Defender TSR 0.703
Technologies in the fall Lowest Score 0.321
of 2000: The Guardian
Reader System™. Effectiveness Operations Biological Agents Logistics
Developed specifically
for first responders,
the Guardian Reader System has since then become the first
choice for biological detection and identification among first MOBILE Laboratory Ranking
responders and security agencies around the world. The hand- Guardian Defender TSR ranked in the top third of all
held Defender TSR (Test Strip Reader) offers 15-minute results evaluated products for mobile laboratories and earned
in the field for the detection of anthrax, ricin , botulinum toxin, 55% of the utility points of the best score.
staphylococcal enterotoxin B (SEB), plague, tularemia, brucella,
abrin toxin and orthopox. Other biological agents can be detected ALTERNATIVE UTILITY
using the BioCheck Powder Screening test. Designed with the Best Score 0.883
first responder in mind, all tests can be run in parallel, yielding Alexeter Defender TSR 0.743
answers for all eight tests in 40 minutes. Alexeter also provides Lowest Score 0.379
on-site training and 24/7 worldwide technical support to our
customers. Logistics Biological Agents Effectiveness Operations
TECHNOLOGY:
The Defender Reader is a precision optical device which
interprets the results of our test strips (monoclonal and FIELD USE Ranking
polyclonal immunoassays). Hand-held, it features full wireless Guardian Defender TSR ranked in the top third of all
communication capabilities (802.11b, Bluetooth) and network
connectivity.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:122
Emanuel and Fruchey

• System or device has battery • Approximately the size of a soda
power, 110V or 220V electrical can
• The system or device does not • Reagent shelf life is between 1 to
require water 3 years
• Single sample detection less • Not capable of detecting two or
than 20 minutes more biological agents or toxins
BEST FIT WORST FIT • 9 different pathogen tests within the same test
simultaneously • No additional pieces of
• The system or device could be Signature:
adapted into a semi automated • No sounds produced that cannot
system with some effort be deactivated
CONTACT INFORMATION • Less than 200 BTUS generated
Tetracore, Inc. Alexeter Technologies
• An afternoon of training and Operational conditions:
11 Firstfield Road 830 Seton Court, • Operated from 15°C to 37°C
some technical skill
Gaithersburg, MD Suite 6 • Components must be stored at
20878 Wheeling, IL 60090 25°C to 37°C
for set-up
www.tetracore.com www.alexeter.com • The performance of the device
Point of Contact: detection
relative humidity
Tom O’Brien Tom Fryzel
(301) 258-7553 (847) 419-1507 x13 Re-use:
(301) 258-9740 fax (847) 419-1648 fax
Sensitivity:
• Device or system is intended for • 10,000-100,000 CFU per ml
tobrien@tetracore.com service@alexeter.com single use
COST • 2 components Maturity gauge:
• No cleaning required • Is commercially available
• $24.20/sample
• $5500.00/Guardian Reader
Maintenance: reviewed scientific publications
• $9995.00/Defender TSR
• Every 3 years service required or independent evaluations
years
procedures
II:123
Guardian Reader
by Tetracore Inc. and Alexeter Technologies

DETECTING Guardian Reader ranked in the middle third of all
Francisella
tularensis,
Yersinia pestis, Lowest Score 0.217
Brucella Effectiveness Biological Agents Logistics Operations
species, Preference Set: Analytical Laboratory
Orthopox virus,
Botulinum
toxins A, B, DIAGNOSTIC Laboratory Ranking
SEB, Ricin
Guardian Reader ranked in the middle third of all
(Commercially
available as evaluated products for diagnostic laboratories and
wet/frozen earned 78% of the utility points of the best score.
reagent) ALTERNATIVE UTILITY
Best Score 0.909
DESCRIPTION:
The Bio Threat Alert is intended for biological agent screening in Alexeter Guardian Reader 0.710
environmental samples. The Bio Threat Alert Test Strip is designed Lowest Score 0.321
for both field and laboratory use but is not intended for use on
clinical samples. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
The Guardian Reader is designed to accept and analyze only Bio
Threat Alert Test Strips and will automatically identify the type of MOBILE Laboratory Ranking
Bio Threat Alert Test Strip (i.e., anthrax, botulinum, etc.) prior to Guardian Reader ranked in the top third of all evaluated
analysis. The operator is automatically navigated through the test products for mobile laboratories and earned 83% of the
procedure via LCD displayed instructions. The Guardian Reader utility points of the best score.
provides an objective evaluation of the test result relative to the
assigned Bio Threat Alert Test Strip batch threshold, displays the ALTERNATIVE UTILITY
result, prints a report and records the full test result in non-volatile Best Score 0.883
memory. The operator has the option in selecting either MANUAL Alexeter Guardian Reader 0.735
or AUTO reading modes. MANUAL mode is selected for immediate Lowest Score 0.379
analysis of Bio Threat Alert Test Strips that have already
completed the test incubation outside the Reader. The AUTO mode Logistics Biological Agents Effectiveness Operations
is selected when the operator desires the Reader to precisely time Preference Set: Mobile Laboratory
the Bio Threat Alert Test Strip incubation before analysis.
FIELD USE Ranking

Guardian Reader ranked in the top third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

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Emanuel and Fruchey

• Single sample detection 20 through internal software
minutes or less • Not capable of detecting multiple
adapted into a semi-automated
Tetracore, Inc. Alexeter Technologies
11 Firstfield Road 830 Seton Court,
for set-up Operational conditions:
Gaithersburg, MD Suite 6
detection • Components can be stored at
20878 Wheeling, IL 60090
room temperature
www.tetracore.com www.alexeter.com
Re-use: • Peak performance at normal
Point of Contact: • Device or system intended for relative humidity conditions only
Tom O’Brien Tom Fryzel multiple use
(301) 258-7553 (847) 419-1507 x13 • 0-1 solution or buffer used Sensitivity:
(301) 258-9740 fax (847) 419-1648 fax • 5 components • Greater than 100,000 CFU per
tobrien@tetracore.com service@alexeter.com • No cleaning required ml
COST Maintenance: Maturity gauge:

• $24.20/sample • 4 consumables or expendables • Is commercially available
• $7,885.00 GSA price/system or device needed
t
procedures necessary MOST MATURE LEAST MATURE
II:125
GX1 Integrated Thermocycler

by Cepheid

DETECTING THE GX1 ranked in the top third of all evaluated products
pestis (Commercially Cepheid GX1 0.722
available as a freeze-
Lowest Score 0.217
dried reagent)
The GX1 combines
a closed cartridge-
based sample
preparation with
amplification and GX1 ranked in the top third of all evaluated products for
detection functions diagnostic laboratories and earned 83% of the utility
performed by points of the best score.
I-CORE modules ALTERNATIVE UTILITY
in an integrated Best Score 0.909
automated nucleic
Cepheid GX1 0.754
acid analysis instrument. The GX1 can purify, concentrate, detect,
Lowest Score 0.321
and identify targeted nucleic acid sequences, taking unprocessed
samples to results in less than 40 minutes. Current techniques Effectiveness Operations Biological Agents Logistics
for accomplishing the same complex series of procedures require Preference Set: Diagnostic Laboratory
extensive manual labor by skilled technicians taking anywhere
from six hours to three days. The GX1’s onboard computer,
software and barcode scanner easily manages data and results.
The GX1 has a small footprint and low power requirement making MOBILE Laboratory Ranking
it suitable for applications requiring portability. GX1 is a portable, GX1 ranked in the middle third of all evaluated products
single site instrument with an on-board user interface display for mobile laboratories and earned 75% of the utility
designed to cater to lower throughput areas such as Physician points of the best score.
Offices, ICU, ED, etc. for clinical applications as well as Industrial,
ALTERNATIVE UTILITY
and Biothreat applications. The GX1 instrument will perform
Best Score 0.883
amplification and detection without user intervention.
Cepheid GX1 0.659
The one site, nucleic acid analysis instrument integrates real-time
amplification and detection with automated sample preparation, Logistics Biological Agents Effectiveness Operations
delivering real-time PCR results from unprocessed samples in less Preference Set: Mobile Laboratory
than 40 minutes. The I-CORE (Intelligent Cooling/Heating Optical
Reaction) module incorporates state-of-the art microelectronic
optical design. The GX1 accommodates microfluidic cartridges FIELD USE Ranking
that automatically perform the complex steps of nucleic acid GX1 ranked in the middle third of all evaluated products
extraction. After the automated extraction is complete, the nucleic for field use and earned 76% of the utility points of the
acid concentrate is moved into the cartridge reaction chamber best score.
where amplification and detection takes place. The GX1 has a
small footprint and low power requirement making it suitable for ALTERNATIVE UTILITY
applications requiring portability. Best Score 0.943
Cepheid GX1 0.717
Lowest Score 0.343

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Emanuel and Fruchey

System Requirements: • Reagent shelf life between 1 to
• System or device has 110V or 3 years
ANALYTICAL 220V electrical requirement

MOBILE FIELD source • System always able to interpret
require an external vacuum • Capable of detecting multiple
DIAGNOSTIC the same test
Throughput of product: • One additional piece of
• Single sample detection equipment needed
between 30 and 40 minutes
BEST FIT WORST FIT • 3 samples/batch Signature:
• Greater than 250 ul volume • No sounds produced that cannot
needed per test for detection be deactivated
• The system or device is • Less than 200 BTUS generated
• Very brief (minutes-hours) • Components must be stored at
CONTACT INFORMATION training and minimal technical room temperature
Cepheid skills • The performance of the device
904 Caribbean Dr. • No set-up required or system is not influenced by
Sunnyvale, CA 94089 • 3-5 manual steps required for relative humidity
www.cepheid.com detection
Point of Contact: Sensitivity:
Francisco Dias Lourenco Re-use: • 100-1000 CFU per ml
Francisco.Diaslourenco@cepheid.com
• 2 solutions or buffers used • A few devices or systems exist
• 1 component (brass board)
• Cleaning required • It is expected to be ready for
COST Maintenance: calendar year
• $21.67/sample • Once a year service required • Less than $1,000,000 required
• $25,000.00/system or device • Expected life is between 5-10 to advance system or device to
procedures
Transportation:
II:127
Handheld Fluorescence Strip Reader

by OmniSite BioDiagnostics, Inc.

DETECTING Handheld Fluorescence Strip Reader ranked in the
THE middle third of all evaluated products for analytical
FOLLOWING: laboratories and earned 66% of the utility points of the
Able to detect best score.
any organisms/ ALTERNATIVE UTILITY
toxins for which Best Score 0.901
handheld assays
are developed.
Lowest Score 0.217
The Handheld
Fluorescence
Strip Reader detects biological warfare agents on
immunochromatographic test strips (similar to pregnancy test DIAGNOSTIC Laboratory Ranking
strips). In practice, three to four different agents can be detected Handheld Fluorescence Strip Reader ranked in the top
on a single strip at low levels. The unit also contains a wireless third of all evaluated products for diagnostic laboratories
data link to transfer detection data to a central location such as a and earned 80% of the utility points of the best score.
website. ALTERNATIVE UTILITY
A scanning epifluorescent head scans across the Handheld Fluor. Strip Reader 0.727
immunochromatographic test strip antibody capture lines and Lowest Score 0.321
reads the fluorescence intensity along each capture line. These
intensities are automatically compared with the intensity of control Effectiveness Operations Biological Agents Logistics
lines to determine if a biowarfare agent is present or not.

Handheld Fluorescence Strip Reader ranked in the
middle third of all evaluated products for mobile
laboratories and earned 67% of the utility points of the
best score.
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Handheld Fluorescence Strip Reader ranked in the top
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:128
Emanuel and Fruchey

• The system or device does not • Shelf life greater than 3 years
minutes or less • Not available, but capable of
BEST FIT WORST FIT • Less than 100 ul volume agents or toxins within the same
needed per test for detection test
automated system
Signature:
OmniSite BioDiagnostics, Inc. • No set-up required • Less than 200 BTUS generated
101 West 6th Street, Suite 200 • 0-2 manual steps required for
Austin, TX 78701 detection Operational conditions:
Point of Contact: Re-use: • Components stored at 25°C to
John G. Bruno • Device or system is intended for 45°C
(512) 479-7732 x2202 multiple use • Performance of the device or
bruno@spec.com • 1 component relative humidity
Sensitivity:
Maintenance: • 100-1,000 CFU per ml
COST • 0-1 consumable or expendable
• $0.10/sample plus cost of handheld assay needed Maturity gauge:
• Approx. $3,000.00/system or device • No service required • A few devices or system exist
• Expected life is greater than 10 (brass board)
years
procedures
II:129
Handheld Fluorescence Polarization (FP) Reader


DETECTING THE Handheld Fluorescence Polarization Reader ranked in
FOLLOWING: the middle third of all evaluated products for analytical
Able to detect any laboratories and earned 74% of the utility points of the
organisms/toxins best score.
for which assays ALTERNATIVE UTILITY
are developed. Best Score 0.901
DESCRIPTION: Handheld Fluor. Polar. Reader 0.670
This instrument Lowest Score 0.217
is a miniaturized
(16 x 16 x 9 cm)
fluorescence
polarization (FP) device (excluding the laptop controller and data
logger), capable of rapid one-step immunoassays (without wash DIAGNOSTIC Laboratory Ranking
steps). Although assays are currently performed in two mL of fluid Handheld Fluorescence Polarization Reader ranked in
in a cuvette, OmniSite is developing microfluidic cartridges that the top third of all evaluated products for diagnostic
will contain freeze-dried reagents that can be rehydrated by the laboratories and earned 82% of the utility points of the
sample and assessed within minutes. best score.
FP is popular technique in the research and clinical diagnostic Best Score 0.909
arenas, because it allows “homogenous” one-step assays (without Handheld Fluor. Polar. Reader 0.744
wash steps) that are especially well suited to small molecule Lowest Score 0.321
targets. However, FP measures rotational or tumbling speed of
fluorophores before and after a molecular complex (e.g., antibody- Effectiveness Operations Biological Agents Logistics
antigen or aptamer-target complex) and is adaptable to a variety Preference Set: Diagnostic Laboratory
of targets such as proteins and even whole bacteria or other
microbes. In the clinical diagnostic world, Abbott Laboratories has MOBILE Laboratory Ranking
dominated with its industry standard table top FP device called Handheld Fluorescence Polarization Reader ranked in
the “TDx” for therapeutic drug monitoring and assessing drugs of the top third of all evaluated products for field use and
abuse in serum samples. The OmniSite FP handheld instrument
has demonstrated comparable sensitivity to the much larger and
heavier table top Abbott TDx unit. ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Handheld Fluorescence Polarization Reader ranked in the
top third of all evaluated products for field use and earned
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:130
Emanuel and Fruchey

battery requirement toaster
ANALYTICAL • The system or device does not • Less than 1 kg
• Single sample detection 20 • Assay not available, but capable
minutes or less of detecting four or more
• Greater than 250 ul volume the same test
needed per test for detection • One additional piece of
OmniSite BioDiagnostics, Inc. • Very brief training • Less than 200 BTUS generated
101 West 6th Street, Suite 200 • No set-up required
Austin, TX 78701 • 0-2 manual steps required for Operational conditions:
Point of Contact: • Components can be stored at
John G. Bruno Re-use: 25°C to 45°C
(512) 479-7732 x2202 • Device or system is intended for • Performance of the device or
(512) 494-0756 fax multiple use system is not influenced by
bruno@spec.com • 3 solutions or buffers used relative humidity
• 1 component
•100-1,000 CFU per ml
COST Maintenance:
• $0.10/sample plus cost of immunoassay
needed • A few devices or system exist
• No service required (brass board)
years t
procedures
II:131
Handheld Raman Imager

by ChemImage

DETECTING Handheld Raman Imager ranked in the top third of all
Francisella ChemImage Handheld 0.717
tularensis, Raman Imager
Burkholderia Lowest Score 0.217
pseudomallei,
Brucella
species, E.coli
O157:H7,
Burkholderia
Handheld Raman Imager ranked in the top third of
mallei, Yersinia
pestis, Influenza virus, MS-2 bacteriophage, Botulinum toxin A, all evaluated products for diagnostic laboratories and
Staphylococcal toxin B, Ricin toxin (Assay validated) earned 86% of the utility points of the best score.
ALTERNATIVE UTILITY
The Handheld Raman Imager is primarily designed for use by ChemImage Handheld Raman Imager 0.779
military and municipal first responder organizations to detect
Lowest Score 0.321
the presence of hazardous bacterial spores, hazardous bacteria
or toxins. While it is designed for powder measurement, with Effectiveness Operations Biological Agents Logistics
additional sample treatment, it can be used to analyze liquid Preference Set: Diagnostic Laboratory
suspensions. By the use of a suitable surface sampler, the
Handheld Raman Imager can be used in the determination of
surface contamination. The system can simultaneously identify
the presence of over 1,000 biological and chemical materials,
both threat and non-threat. Handheld Raman Imager ranked in the top third of all
The Handheld Raman Imager design utilizes Raman Chemical
ALTERNATIVE UTILITY
Imaging (RCI) to provide better identification of materials in
Best Score 0.883
mixtures when compared to instruments that rely on a single
ChemImage Handheld
spectroscopic measurement. Raman chemical imaging combines 0.718
Raman Imager
molecular spectroscopy and digital imaging to provide rapid, non- Lowest Score 0.379
contact, non-invasive characterization of materials.
FIELD USE Ranking

Handheld Raman Imager ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
ChemImage Handheld 0.661
Raman Imager
Lowest Score 0.343

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Emanuel and Fruchey

System Requirements: Ease of use/Utility:
• System or device uses batteries • Can view results “in real time”
• There is a single centrifugation
step
require water
• The system or device does not • There is a single shaking or
vortexing step
source
MOBILE FIELD • The system or device does not through internal software
the same test
DIAGNOSTIC Throughput of product: • Two additional pieces of
• Single sample detection in 20 equipment needed
minutes or less
• 384 samples/batch or higher Signature:
BEST FIT WORST FIT • Less than 50 ul volume needed • No sounds produced that cannot
per test for detection be deactivated
• The system or device could be • Less than 200 BTUS generated
Training/Speed/Manpower: • Components must be stored at
• An afternoon of training and 25°C to 45°C
CONTACT INFORMATION some technical skills required • The performance of the device
ChemImage • 10-20 minutes set-up required or system is not influenced by
7301 Penn Ave • 3-5 manual steps required for relative humidity
Pittsburgh, PA 15208 detection
www.chemimage.com Sensitivity:
Point of Contact: Re-use: • 1,000-10,000 CFU per ml
Charles W. Gardner. PhD • Device or system is intended for
(412) 241-7335 x212
• 0-1 solution or buffer used • Only one incomplete device or
(412) 241-7311 • 2 components system exists (bread board)
cgardner@chemimage.com • Wipe exterior with 5% bleach • Is expected to be ready for
solution commercialization within one
calendar year
COST Maintenance: • $1,000,000-$2,000,000
• $0.54/sample • Every 6 months service required required to advance device or
• $35,000.00/device or system • Expected life is greater than 10 system to commercialization
years • Has not been featured in
• 10-20 minutes of daily quality
any peer reviewed scientific
evaluations
Transportation:
toaster
• Reagent shelf life greater than MOST MATURE LEAST MATURE
3 years
II:133
HandyLab-EIMB
by HandyLab Inc.

DETECTING HandyLab-EIMB ranked in the top third of all evaluated
Francisella HandyLab-EIMB 0.809
tularensis,
Lowest Score 0.217
Yersinia pestis,
species, E. Preference Set: Analytical Laboratory
coli 0157:H7,
Marburg virus,
Orthopox virus, DIAGNOSTIC Laboratory Ranking
VEE virus, Latrotoxin (Assay developed)
HandyLab-EIMB ranked in the top third of all evaluated
DESCRIPTION: products for diagnostic laboratories and earned 93% of
The components of the HandyLab-EIMB system have undergone the utility points of the best score.
extensive development and are being integrated into a portable, ALTERNATIVE UTILITY
low-cost, rapid, user-friendly DNA analysis system for commercial Best Score 0.909
medical applications. We can easily adapt our state-of-the-art
HandyLab-EIMB 0.848
technology to custom DOD applications. Military personnel could
use the handheld device, with minimal training and expense, to Lowest Score 0.321
perform multiplexed PCR testing for the presence of pathogens Effectiveness Operations Biological Agents Logistics
and have definitive results within 30 minutes or less. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
The HandyLab device is a microfluidic-based sensing system that
offers several key advantages: All wet chemistry, optical scans, MOBILE Laboratory Ranking
and DNA assays performed on HandyLab’s chips are proven HandyLab-EIMB ranked in the top third of all evaluated
analysis techniques that represent the gold standards in genetic products for mobile laboratories and earned 87% of the
BW identification (PCR). The HandyLab™ solution provides an utility points of the best score.
almost “hands-free” technology, other than the loading and
ALTERNATIVE UTILITY
unloading of the cartridge, reducing the risk of human error. The
sensitivity equals or exceeds that of existing PCR technology. Best Score 0.883
The technology utilizes nano-volume samples and reagent plugs HandyLab-EIMB 0.765
to perform analyses in less than 30 minutes. All operations Lowest Score 0.379
are performed on a single chip using a proprietary design with
minimal unused volume and reduced transport distances. Tests
for different pathogens will be performed in parallel on EIMB’s
chip array. HandyLab chips have been designed to operate with
independent series and parallel analysis paths for multi-step
biochemical analysis. Accordingly, each lab-on-a-chip system can FIELD USE Ranking
be custom designed to perform only those biochemical analysis HandyLab-EIMB ranked in the middle third of all evaluated
functions essential to assess specified samples. The technology products for field use and earned 75% of the utility points
allows the user to carry what is currently “bench-top” equipment of the best score.
in the palm of their hand. Every test will be accompanied by
on-board positive and negative controls to ensure the accuracy ALTERNATIVE UTILITY
of a result. The chips will be produced using inexpensive Best Score 0.943
microfabrication and injection molding techniques. HandyLab-EIMB 0.708
Lowest Score 0.343

II:134
Emanuel and Fruchey

• The system or device does not • Shelf life greater than 3 years
automated system
Signature:
HandyLab Inc. • No set-up required • Less than 200 BTUS generated
3985 Research Park Dr. • 0-2 manual steps required for
Ann Arbor, MI 48108 detection Operational conditions:
www.handylab.com • Operated from 4°C to 45°C
Point of Contact: • Device or system is designed for 25°C to 45°C
Dr. Charles Daitch single use • Performance of the device or
(734) 663-4719 x240 • 2 solutions or buffers used system is not influenced by
cdaitch@handylab.com • No cleaning required
Sensitivity:
Maintenance:
COST • 0-1 consumable or expendable
• $1.00-10.00/sample test cartridge needed Maturity gauge:
• $100.00-200.00 PDA reader/system or device • Unknown service required • A few devices or system exist
• Expected life is not applicable (brass board)
t
II:135

by Hai Kang Life Corporation Limited

DETECTING THE Human VDS AIV H5 Detection Kits ranked in the middle
Influenza virus and earned 67% of the utility points of the best score.
(Commercially available ALTERNATIVE UTILITY
as a wet/frozen Best Score 0.901
reagent) HKDNA Human VDS AIV H5 0.608
Detection Kit
Human VDS AIV H5
Detection Kits were Effectiveness Biological Agents Logistics Operations
first launched in Hong Preference Set: Analytical Laboratory
Kong in 2001 and were
the first commercially
available nucleic acid- DIAGNOSTIC Laboratory Ranking
based test kits for the Human VDS AIV H5 Detection Kits ranked in the
human avian influenza middle third of all evaluated products for diagnostic
virus (AIV). The kits laboratories and earned 62% of the utility points of the
combine advanced best score.
RNA amplification
technology and a proprietary detection system, making them ALTERNATIVE UTILITY
far more sensitive than existing testing methodologies. The MP Best Score 0.909
(microplate) version of the product has undergone stringent HKDNA Human VDS 0.586
AIV H5 Detection Kit
evaluations with data published in peer-reviewed scientific Lowest Score 0.321
journals. Besides Human VDS AIV H5 which specifically detects
nucleic acid of human AIV subtype H5, there are currently two Effectiveness Operations Biological Agents Logistics
other versions of kits available for AIV. Human VDS AIV H7 detects Preference Set: Diagnostic Laboratory
specifically nucleic acid of human AIV subtype H7 and Human
VDS AIV H1-16 detects specifically nucleic acid of human AIV MOBILE Laboratory Ranking
subtypes H1-16. Human VDS is an accurate, sensitive and specific Human VDS AIV H5 Detection Kits ranked in the middle
testing tool for developing comprehensive and routine surveillance third of all evaluated products for mobile laboratories
programs in hospitals, government health-related, inspection and earned 69% of the utility points of the best score.
and quarantine departments, the food and catering industry,
commercial and academic research laboratories, environmental ALTERNATIVE UTILITY
care and protection agencies. The kits can utilize virtually any kind Best Score 0.883
of sample for AIV testing—biological and environmental samples HKDNA Human VDS AIV 0.606
H5 Detection Kit
such as blood, cerebrospinal fluid, spleen and liver tissues, Lowest Score 0.379
cervical smears, pus, saliva, sputum, urine, feces, and pharyngeal
swabs. Results are available in as short as four hours. Together Logistics Biological Agents Effectiveness Operations
with its extremely high sensitivity and specificity, these properties Preference Set: Mobile Laboratory
make the diagnostic kit especially suitable for use in the Army
where accurate and rapid result or confirmation is often required.
FIELD USE Ranking
TECHNOLOGY: Human VDS AIV H5 Detection Kits ranked in the middle
Human VDS AIV H5 Detection Kits utilize the NASBA (nucleic
acid sequence-based amplification) technology, a continuous,
isothermal, enzyme-based method for the amplification of nucleic
acid (Compton, 1991; Romano et al., 1996). Amplification is ALTERNATIVE UTILITY
most suitable for RNA analytes and employs a mixture of reverse Best Score 0.943
transcriptase, ribonuclease-H, RNA polymerase and two specially HKDNA Human VDS AIV H5 0.661
designed DNA oligonucleotide primers. Under optimum conditions Detection Kit
Lowest Score 0.343
a 10^12-fold level of amplification is possible. For detection,
colorimetric signal is generated and measured in a standard 96- Logistics Operations Effectiveness Biological Agents
well microtitre plate spectrophotometer at 405nm. The system Preference Set: Field Use
is highly sensitive and specific and can be used to detect a wide
range of samples.
II:136
Emanuel and Fruchey

ANALYTICAL • The system or device requires a • Between 5 and 25 kg
continual supply of water • Reagent shelf life between 1 year
• The system or device does not to 3 years
require an external vacuum • There are multiple centrifugation
source steps
• There are multiple shaking or
DIAGNOSTIC Throughput of product: vortexing steps
• Single sample detection greater • System always able to interpret
than 60 minutes raw data or call a positive
BEST FIT WORST FIT • Less than 50 ul volume needed • Not capable of detecting multiple
adapted into a semi automated • Three additional pieces of
equipment needed
CONTACT INFORMATION • An afternoon of training and
be deactivated
Hai Kang Life Corporation Limited some technical skills required
8/F Hang Tung Resources Center • 10-20 minutes set-up required
18 A-Kung Ngam Village Road, Shau Kei Wan • Greater than 12 manual steps
Hong Kong required for detection Operational conditions:
www.hkdnachips.com • Operated from 4°C to 45°C
Point of Contact: Re-use: room temperature or frozen
Terence Lok Ting LAU, Ph.D. • Device or system is intended for • The performance of the device
(852) 2111-2123 single use or system is not influenced by
• More than 4 solutions or buffers relative humidity
(852) 2111-9762
used
terence.lau@hkdnachips.com • 5 or more components
Sensitivity:
COST
• $30.00/sample Maintenance: Maturity gauge:
• $1,200.00/device or system (50 tests) • No service required
years
procedures
t
II:137
HKDNA LOAC
by Hai Kang Life Corporation Limited

None reported HKDNA LOAC ranked in the bottom third of all evaluated
DNA chips have revolutionized genomics and proteomics analysis,
allowing large scale diagnostic testing and screening. This ALTERNATIVE UTILITY
technology can be categorized into two classes, conventional Best Score 0.901
DNA microarray and Lab-on-a-chip. The DNA microarray format HKDNA LOAC 0.323
is relatively more mature in terms of marketing, and has been Lowest Score 0.217
adopted for drug discovery, genomics research, etc. Typically,
a microarray contains nucleic acid fragments arranged in a Effectiveness Biological Agents Logistics Operations
predetermined pattern on a substrate, which can ‘capture’
complementary target nucleic acid sequences present in a
sample. The resulting binding pattern can be detected by optical
or electronic means by the appropriate detection mechanism DIAGNOSTIC Laboratory Ranking
(e.g., a fluorescently labeled detection probe complementary HKDNA LOAC ranked in the bottom third of all
to a different region of the target nucleic acid). Thus potentially evaluated products for diagnostic laboratories and
a large number of biological reactions and detections can be earned 74% of the utility points of the best score.
performed simultaneously on the same platform using only
minute amounts of reagents and analytes (pico- to nano-liter). ALTERNATIVE UTILITY
However, the microarray has many disadvantages. It is 1) Best Score 0.909
expensive, 2) difficult to use – during both experimentation HKDNA LOAC 0.395
and data analysis, and therefore requires operation by skilled Lowest Score 0.321
personnel 3) time consuming – around 10 or more hours for
hybridization. These concerns make the microarray an unsuitable Effectiveness Operations Biological Agents Logistics
tool for routine diagnostic uses. HKDNA aims to develop a non- Preference Set: Diagnostic Laboratory
microfluidic system encompassing these disadvantages, making
it suitable for routine use or on-site diagnosis e.g., differential
diagnosis and rapid, sensitive detection of biological agents as for MOBILE Laboratory Ranking
military uses, and for public purpose, to achieve routine clinical HKDNA LOAC ranked in the bottom third of all evaluated
diagnosis of various pathogens, rare diseases, and for utilization products for mobile laboratories and earned 65% of the
in biochemical research.
The HKDNA Lab-on-a-chip (LOAC) technology is a non-microfluidic Best Score 0.883
system where more than one step of a procedure can be carried HKDNA LOAC 0.517
out by technology incorporated into the chip. The research
Lowest Score 0.379
involves development of DNA chip into a multiple pathogen
detection cartridge that can simultaneously detect up to 300 Logistics Biological Agents Effectiveness Operations
DNA and/or RNA targets for specified pathogens, development Preference Set: Mobile Laboratory
of peripheral equipment to be used in conjunction with the chip
cartridge, development of reaction protocols, validation of system
performance and manufacture of the actual system.
FIELD USE Ranking
HKDNA LOAC ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
HKDNA LOAC 0.578
Lowest Score 0.343

II:138
Emanuel and Fruchey

• System or device has 110V or • Cannot view results “in real time”
220V electrical requirement • No centrifugation steps
ANALYTICAL • The system or device requires • No shaking or vortexing steps
water aliquots • System may be able to interpret
require an external air or gas through internal software in the
source future
MOBILE FIELD • The system or device does not • Capable of detecting four or more
• Single sample detection
between 50 and 60 minutes Signature:
• 2 samples/batch or higher • No sounds produced that cannot
BEST FIT WORST FIT • Less than 50 ul volume needed be deactivated
per test for detection • Less than 200 BTUS generated
easily be adapted into a fully Operational conditions:
automated system • Operated from 15°C to 37°C
• A day of training and technical • The performance of the device
CONTACT INFORMATION or system is not influenced by
Hai Kang Life Corporation Limited skills required
relative humidity
8/F Hang Tung Resources Center • 5-10 minutes set-up required
18 A-Kung Ngam Village Road, Shau Kei Wan • 0-2 manual steps required for
detection
Sensitivity:
Hong Kong • 1-100 CFU per ml
www.hkdnachips.com
Re-use:
Maturity gauge:
Prof. Albert Cheung Hoi YU, Ph.D. single use • A few devices or systems exist
(852) 2111-2123 • 4 solutions or buffers used (brass board)
(852) 2111-9762 • 1 component • Is expected to be ready for
achy@hkdnachips.com • No cleaning required commercialization within one
calendar year
Maintenance: • More than $2,000,000 required
COST • Once a year service required to advance device or system to
• $30.00/sample • Expected life is between 3-5 commercialization
• $1,200.00/device or system (50 tests) years • Has not been featured in
• No daily quality assurance any peer reviewed scientific
procedures publications or independent
evaluations
Transportation:
• Reagent shelf life between 1 to MOST MATURE LEAST MATURE
6 months
II:139
iCycler iQ Thermocycler
by Bio-Rad Laboratories

DETECTING iCycler iQ ranked in the top third of all evaluated products
Francisella iCycler iQ Thermocycler 0.742
tularensis,
Lowest Score 0.217
Yersinia pestis,
Orthopox virus,
Smallpox virus
(Commercially DIAGNOSTIC Laboratory Ranking
available as a
iCycler iQ ranked in the top third of all evaluated products
freeze-dried
reagent) for diagnostic laboratories and earned 82% of the utility
The iCycler iQ Real-Time Detection System is, in essence a system Best Score 0.909
that allows for the monitoring of up to four distinct fluorophores iCycler iQ Thermocycler 0.748
(used as markers for individual polymerase chain reactions–
Lowest Score 0.321
PCRs) from a sample at one time. PCR allows a researcher to
study different pieces of DNA or genes from specific organisms. Effectiveness Operations Biological Agents Logistics
The iCycler iQ allows a researcher to look for the presence of up to Preference Set: Diagnostic Laboratory
four targets in each sample being tested. And because this test is
based on the polymerase chain reaction—a way of amplifying the
amount of starting material a researcher has—it is a very sensitive
and quantitative method. A sample, e.g., a piece of tissue or a
soil sample, can be tested for the presence or absence of up to iCycler iQ ranked in the middle third of all evaluated
four different pieces of DNA from specific pathogens at one time, products for mobile laboratories and earned 76% of the
increasing the amount of information that can be gathered from utility points of the best score.
each sample. Real-time PCR is quickly becoming the accepted
ALTERNATIVE UTILITY
method for accurate qualitative and quantitative measurements of
Best Score 0.883
viral load, pathogen detection and gene expression.
The iCycler iQ uses a halogen lamp for broad excitation, then
employs both excitation and emission narrow band pass filters for Logistics Biological Agents Effectiveness Operations
discrimination between the many fluorescent reporter molecules Preference Set: Mobile Laboratory
that can be employed in real-time PCR. The system uses a
proprietary intensifier technology (like used in the U.S. military’s
night vision technology) and a 10-bit CCD. Our illumination and FIELD USE Ranking
detection strategy allows for the simultaneous capture of an iCycler iQ ranked in the middle third of all evaluated
image of a 96-well PCR plate – in this way up to 96 samples, can products for field use and earned 78% of the utility points
be read at one time. The thermal cycler that the detection system of the best score.
is mounted on is a Peltier-based cycler, with the best all-around
market specifications for thermal cyclers (gradient capable, ALTERNATIVE UTILITY
heating 3.3 C/sec.; cooling 2.0 C/sec.). A full description of the Best Score 0.943
technical specifications for the detector and the thermal cycler can iCycler iQ Thermocycler 0.724
be found at: www.bio-rad.com/amplification. Lowest Score 0.343

II:140
Emanuel and Fruchey

on luggage suitcase
• The system or device does
require water aliquots • Shelf life greater than 3 years
• The system or device does not • Single centrifugation step
• Single sample detection • Assay not available, but capable
between 40 and 50 minutes of detecting four or more
Bio-Rad Laboratories • An afternoon of training • Less than 200 BTUS generated
2000 Alfred Nobel Drive • 10-20 minutes required for
Hercules, CA 94547 set-up Operational conditions:
www.bio-rad.com/iCycler • 6-8 manual steps required for • Operated from 15°C to 37°C
detection • Components must be stored at
Point of Contact: 4°C and room temperature
Hilary Srere Re-use: • Performance of the device or
(510) 741-6940 • Device or system is intended for system is not influenced by
(510) 741-5811 fax multiple use relative humidity
hilary_srere@bio-rad.com • 0-1 solution or buffer used
• No cleaning required •1-100 CFU per ml
COST
• $0.50/sample plus Taq enzyme Maintenance: Maturity gauge:
• $40,000.00/system or device • 4 consumables or expendables • Is commercially available
needed
• Once a year service required t
II:141
Immulite 2000
by DPC

DETECTING Immulite 2000 ranked in the middle third of all evaluated
Best Score 0.901
DESCRIPTION: Immulite 2000 0.636
The IMMULITE
Lowest Score 0.217
2000 system
utilizes specific Effectiveness Biological Agents Logistics Operations
antibody-coated Preference Set: Analytical Laboratory
polystyrene
beads as a solid
phase. A bead is DIAGNOSTIC Laboratory Ranking
dispensed into a
Immulite 2000 ranked in the middle third of all evaluated
specially designed
Reaction Tube, which serves as the vessel for the incubation, products for diagnostic laboratories and earned 67% of
wash and signal development process. the utility points of the best score.
ALTERNATIVE UTILITY
After the sample is incubated with alkaline phosphatase-
labeled reagent, the reaction mixture is separated from the Immulite 2000 0.611
bead by spinning the Reaction Tube at a high-speed along its Lowest Score 0.321
vertical axis. The fluid is transferred to a coaxial sump chamber,
which is integral to the Bead/Tube Wash Station. Four discrete Preference Set: Diagnostic Laboratory
washes occur within seconds, allowing the Reaction Tubes to be
processed sequentially, with uniform timing. The bead is left with
no residual unbound label. The bound label is then quantified
using the dioxetane substrate to produce light. Light is emitted MOBILE Laboratory Ranking
when the chemiluminescent substrate reacts with the alkaline Immulite 2000 ranked in the bottom third of all evaluated
phosphatase label bound to the bead. The amount of light emitted products for mobile laboratories and earned 49% of the
is proportional to the amount of analyte originally present in the utility points of the best score.
sample. The light emission is detected by the photomultiplier tube
ALTERNATIVE UTILITY
(PMT) and results are calculated for each sample.
Best Score 0.883
Immulite 2000 0.435
Lowest Score 0.379

FIELD USE Ranking

Immulite 2000 ranked in the bottom third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Immulite 2000 0.516
Lowest Score 0.343

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Emanuel and Fruchey

• System or device has • Larger than the size of a home
dishwasher
ANALYTICAL greater than 220V electrical
• More than 50 kg
requirement
• The system or device requires • Shelf life between 6 months and
1 year
water aliquots
MOBILE FIELD require an external air or gas Ease of use/Utility:
source • Can view results “in real time”
• The system or device does not • A single centrifugation steps
DIAGNOSTIC source • System can interpret raw data or
call a positive through internal
software
• Single sample detection in • Not capable of detecting multiple
BEST FIT WORST FIT greater than 60 min
• Greater than 250 ul volume • No additional pieces of
• More than a day of training • Greater than 500 BTUS
DPC
• Greater than 20 min required generated
5700 W 96th Street for set-up
Los Angeles, CA 90045-5597 • 0-2 manual steps required for
www.dpcweb.com detection Operational conditions:
Mark Smith 4°C
(310) 642-5180 x7031 • Device or system has peak
multiple detections
(310) 642-0192 fax performance at normal relative
msmith@dpconline.com humidity conditions only
• 2 components
• 5 minutes/day cleaning
required Sensitivity:
COST •1-100 CFU per ml
• $2.00-13.00/sample
Maintenance:
• $124,500.00/device or system Maturity gauge:
• Needs service every 6 months t
• Expected life measure of 5-10
years
required for daily quality
II:143
Infectious Disease Identification System (IDIS)

ANALYTICAL Laboratory Ranking

Infectious Disease Identification System ranked in
the top third of all evaluated products for analytical
best score.
ALTERNATIVE UTILITY
CAPABLE OF DETECTING THE FOLLOWING: Best Score 0.901
Bacillus anthracis, Francisella tularensis, Corynebacterium diphtheria,
Celera IDIS 0.680
Burkholderia pseudomallei, Coxiella burnetti, Brucella species, E.coli O157:
H7, Vibrio cholera, Burkholderia mallei, Yersinia pestis, Rickettsia prowazekii, Lowest Score 0.217
Marburg virus, Influenza virus, Dengue fever virus, Rift valley fever virus, Effectiveness Biological Agents Logistics Operations
Yellow fever virus, Ebola virus, MS-2 bacteriophage (Assay developed) Preference Set: Analytical Laboratory
DESCRIPTION:
The Infectious Disease Identification System (IDIS) is a standardized DIAGNOSTIC Laboratory Ranking
system for identification and detection of a broad range of infectious Infectious Disease Identification System ranked in the
agents for epidemiological use. The system includes: ABIPRISM™ 6100 middle third of all evaluated products for diagnostic
Nucleic Acid PrepStation, the Applied Biosystems 7900HT Real-Time PCR laboratories and earned 71% of the utility points of the
System with TaqMan® Low Density Array Capability, the IDIS TaqMan® Low best score.
Density Array preloaded with primers and TaqMan probes, and reagents for
sample preparation and assays. The IDIS platform is capable of running ALTERNATIVE UTILITY
48 individual reactions per sample, up to eight samples, for a total of 384 Best Score 0.909
individual reactions. All in less than four hours from sample collection Celera IDIS 0.642
to result. The ABI PRISM™ 6100 Nucleic Acid PrepStation isolates and Lowest Score 0.321
purifies nucleic acids (DNA, RNA) from a variety of biological sample types,
including cultured cells, animal and plant tissue, primary cell isolates, and Effectiveness Operations Biological Agents Logistics
whole blood. During the sample preparation process, nucleic acids from
bacteria and viruses are lysed, then combined before analysis.
The IDIS TaqMan® Low Density Array functions as an array of reaction Infectious Disease Identification System ranked in
vessels for PCR/sequence detection. The wells of the Low Density Array the middle third of all evaluated products for mobile
contain Applied Biosystems TaqMan® primers and probes that detect the
real-time amplification of nucleic acids from specific bacterial and viral
targets. The Applied Biosystems 7900HT Sequence Detection System best score.
is designed for high-throughput detection of fluorescent PCR-related ALTERNATIVE UTILITY
chemistries. The instrument performs real-time analysis of the TaqMan® Best Score 0.883
Low Density Array and generates data files containing results that reflect
Celera IDIS 0.608
presence or absence of the pathogens. IDIS received DHS’s SAFETY Act
Designation and Certification. Lowest Score 0.379

Real-time Polymerase Chain Reaction (PCR) is the ability to monitor the
progress of the PCR as it occurs (in real time). Data is collected throughout
the PCR process, rather than at the end. This completely revolutionizes the
FIELD USE Ranking
way one approaches PCR-based quantitation of DNA and RNA. In real-time Infectious Disease Identification System ranked in the
PCR, reactions are characterized by the point in time during cycling when middle third of all evaluated products for field use and
amplification of a target is first detected rather than the amount of target earned 60% of the utility points of the best score.
accumulated after a fixed number of cycles. The higher the starting copy
ALTERNATIVE UTILITY
number of the nucleic acid target, the sooner an increase in fluorescence is
Best Score 0.943
observed.
Celera IDIS 0.565
Lowest Score 0.343

II:144
Emanuel and Fruchey

• System or device has 220V months to 1 year
electrical requirement and a
ANALYTICAL twist lock plug Ease of use/Utility:
require water • There is a single centrifugation
• The system or device does not step
require an external air or gas • There are multiple shaking or
MOBILE FIELD source vortexing steps
• The system or device does not • System may be able to interpret
DIAGNOSTIC Throughput of product: future
• 96 samples/batch or higher; 48 • Four or more additional pieces of
BEST FIT WORST FIT reactions per sample general lab equipment needed
• Less than 250 ul volume
needed per test for detection Signature:
• The system or device could be • No sounds produced that cannot
adapted into a fully automated be deactivated
system with some effort • Greater than 500 BTUS
generated
CONTACT INFORMATION Training/Speed/Manpower:
• An afternoon of training and Operational conditions:
Applied Biosystems
some technical skills required • Operated from 4°C to 37°C;
850 Lincoln Centre Drive
• Less than 5 minutes set-up optimal at 15°C to 37°C
required • Components must be stored at
www.appliedbiosystems.com
• Greater than 12 manual steps 4°C or frozen
required for detection • The performance of the device
Point of Contact: or system has peak performance
Brian Plew
Re-use: at normal relative humidity
• Device or system is intended for conditions
(650) 638-5787 • More than 4 solutions or buffers Sensitivity:
plewbp@appliedbiosystems.com used • 1,000-10,000 CFU per ml
COST • No cleaning required Maturity gauge:
• $3.25/sample Maintenance: meets military specifications
• $113,000.00/system or device • Once a year service required • Has not been featured in
• Expected life is between 5-10 any peer reviewed scientific
years publications or independent
• Less than 5 minutes daily evaluations
t
Transportation:
• Larger than a home dishwasher
• More than 50 kg
II:145
Integrated Detection System (IDS)

by Sceptor

FOLLOWING: Integrated Detection System ranked in the top third of
Bacillus anthracis, Francisella all evaluated products for analytical laboratories and
tularensis, Yersinia pestis earned 79% of the utility points of the best score.
(Commercially available as a freeze- ALTERNATIVE UTILITY
dried reagent) Best Score 0.901
DESCRIPTION: Sceptor IDS 0.712
The Integrated Detection System Lowest Score 0.217
(IDS) is a semi-automated system
for sampling and detecting the
presence of aerosolized biological
threat materials in indoor
environments. Incorporating the
SpinCon Air Sampler and Cepheid DIAGNOSTIC Laboratory Ranking
GeneXpert real-time PCR analysis, Integrated Detection System ranked in the top third of
the IDS provides a simple, cost all evaluated products for diagnostic laboratories and
effective method for protecting earned 81% of the utility points of the best score.
public buildings, transportation
facilities and postal operations from ALTERNATIVE UTILITY
potential biological threats such as Best Score 0.909
anthrax. The IDS protects personnel Sceptor IDS 0.737
and facilities by collecting and Lowest Score 0.321
concentrating biological particulates
from the surrounding air. At the end of the user defined sampling Effectiveness Operations Biological Agents Logistics
cycle, the IDS automatically injects the aerosol sample into a
GeneXpert sample cartridge. The sample is then analyzed using
the easy-to-use, automated and highly accurate real-time PCR
instrument. Following sample collection, the analytical method MOBILE Laboratory Ranking
purifies, concentrates, detects, and identifies targeted nucleic Integrated Detection System ranked in the bottom third
acid sequences, delivering answers from a collected sample in of all evaluated products for mobile laboratories and
less than 30 minutes. Current techniques for accomplishing the earned 60% of the utility points of the best score.
same complex series of procedures require extensive manual
labor by skilled technicians and can take anywhere from six hours ALTERNATIVE UTILITY
to three days. The IDS incorporates proven sample collection, the Best Score 0.883
GeneXpert cartridge-based sample preparation with amplification Sceptor IDS 0.530
and detection functions in a fully integrated and automated Lowest Score 0.379
nucleic acid analysis instrument. The system includes a simple,
user-friendly graphical display allowing use and operation for Logistics Biological Agents Effectiveness Operations
virtually any skill level. The IDS components are rack-mounted and Preference Set: Mobile Laboratory
powered by 120VAC.

The IDS uses the Cepheid GeneXpert® System to perform
Integrated Detection System ranked in the bottom third
biological detection, which utilizes real-time polymerase chain
reaction (PCR) to amplify and detect target DNA. Utilizing the
of all evaluated products for field use and earned 48%
unique sample/reagent cartridges, the system fully automates of the utility points of the best score.
and integrates all the steps required for PCR-based DNA testing: ALTERNATIVE UTILITY
sample preparation including cell lysis, DNA purification and Best Score 0.943
amplification, and detection. Designed to simplify hands-on Sceptor IDS 0.456
preparation, the system detects and identifies targeted nucleic
Lowest Score 0.343
acid sequences, delivering answers from unprocessed samples in
30 minutes or less, enabling time-critical DNA tests at the point of Logistics Operations Effectiveness Biological Agents
use. Preference Set: Field Use
II:146
Emanuel and Fruchey

ANALYTICAL • The system or device requires • No shaking or vortexing steps
water aliquots • System always able to interpret
require an external air or gas through internal software
MOBILE FIELD • The system or device does not biological agents or toxins within
equipment needed
DIAGNOSTIC • Single sample detection Signature:
between 30 and 40 minutes • No sounds produced that cannot
• 2 samples/batch or higher be deactivated
• Greater than 250 ul volume • Greater than 500 BTUS
BEST FIT WORST FIT needed per test for detection generated
easily be adapted into a fully Operational conditions:
automated system • Operated from 4°C to 37°C
training and minimal technical or system is not influenced by
CONTACT INFORMATION skills relative humidity
Sceptor • Less than 5 minutes set-up
8301 State Line Road required Sensitivity:
Suite 101 • 3-5 manual steps required for • 100-1,000 CFU per ml
detection
Kansas City, MO 64114 Maturity gauge:
www.sceptorindustries.com Re-use: • A few devices or systems exist
• Device or system is intended for (brass board)
Point of Contact: multiple use • Is expected to be commercially
Freeman Swank • 3 solutions or buffers used available within one calendar
(816) 360-3898 • 2 components
year
(816) 931-2451 • Cleaning required
fswank@sceptorindustries.com Maintenance: to advance device or system to
• More often than every 6 months commercialization
COST service required • Has not been featured in
• $75.00/sample • Expected life is between 5-10 any peer reviewed scientific
• $80,000.00/device or system years publications or independent
• No daily quality assurance evaluations
procedures t
Transportation:
• Approximately the size of a MOST MATURE LEAST MATURE
home dishwasher
• More than 50 kg
• Reagent shelf life between 6
months to 1 year
II:147
Invader Assay
by The Third Wave (TWT)

DETECTING Invader Assay ranked in the middle third of all evaluated
any organisms of Best Score 0.901
known specific
DNA or RNA Invader Assay 0.541
sequences.
Lowest Score 0.217

The Invader Assay is an easy to use molecular analysis test. It
can detect specific DNA or RNA sequences without the need for
Polymerase Chain Reaction (PCR). DIAGNOSTIC Laboratory Ranking
Invader Assay ranked in the bottom third of all evaluated
TECHNOLOGY: products for diagnostic laboratories and earned 54% of
The Third Wave™ Invader® DNA Assays use Cleavase® enzymes the utility points of the best score.
to recognize and cleave specific structures formed by the addition
of two oligonucleotides to a nucleic acid target. In the Invader® ALTERNATIVE UTILITY
DNA Assay, two oligonucleotides (a discriminatory Primary Probe Best Score 0.909
and an Invader® Oligo) hybridize in tandem to the target DNA Invader Assay 0.492
to form an overlapping structure. The 5’-end of the Primary Lowest Score 0.321
Probe includes a 5’-flap that does not hybridize to the target
DNA. The 3’-nucleotide of the bound Invader® Oligo overlaps Effectiveness Operations Biological Agents Logistics
the Primary Probe, but need not hybridize to the target DNA. The Preference Set: Diagnostic Laboratory
Cleavase® enzyme recognizes this overlapping structure and
cleaves off the unpaired 5’-flap of the Primary Probe, releasing
it as a target-specific product. The Primary Probe is designed to MOBILE Laboratory Ranking
have a melting temperature close to the reaction temperature. Invader Assay ranked in the bottom third of all evaluated
Thus, under the assay conditions, the Primary Probe cycles on products for mobile laboratories and earned 54% of the
the target DNA isothermally. This allows for multiple rounds of
Primary Probe cleavage for each target DNA, and amplification of
the number of released 5’-flaps. In the secondary reaction, each ALTERNATIVE UTILITY
released 5’-flap can serve as an Invader® Oligo on a fluorescence Best Score 0.883
resonance energy transfer (FRET™) cassette to create another Invader Assay 0.478
overlapping structure that is recognized and cleaved by the Lowest Score 0.379
Cleavase® enzyme. When the FRET™ cassette is cleaved, the
fluorophore (F) and quencher (Q) on the FRET™ cassette are Logistics Biological Agents Effectiveness Operations
separated, generating detectable fluorescence signal. Similar to Preference Set: Mobile Laboratory
the initial reaction, the released 5’-flap and the FRET™ cassette
cycle, resulting in amplified fluorescence signal. The initial and
secondary reactions run concurrently in the same well. The FIELD USE Ranking
biplex format of the Invader® DNA Assay enables simultaneous Invader Assay ranked in the bottom third of all evaluated
detection of two DNA sequences in a single well. Most often, this
involves detection of two variants of a particular polymorphism.
The biplex format uses two different discriminatory Primary
of the best score.
Probes, each with a unique 5’-flap, and two different FRET™ ALTERNATIVE UTILITY
cassettes, each with a spectrally distinct fluorophore. By design, Best Score 0.943
the released 5’-flaps will bind only to their respective FRET™ Invader Assay 0.592
cassettes to generate a target-specific signal. Lowest Score 0.343

II:148
Emanuel and Fruchey

on luggage suitcase
1 year
• The system or device does not • Cannot view results “in real time”
DIAGNOSTIC • System is never able to interpret
than 60 minutes • Assay not available, but capable
BEST FIT WORST FIT
• The system or device could • Four or more additional pieces of
automated system
Signature:
CONTACT INFORMATION Training/Speed/Manpower: • Sounds produced that cannot be
• More than a day of training deactivated
Third Wave Tech. • Greater than 20 minutes
502 South Rosa Rd. • Unknown BTUS generate
required for set-up
Madison, Wisconsin 53719 • Greater than 12 manual steps
www.twt.com required for detection Operational conditions:
Point of Contact: Re-use: • Components must be frozen
Bruce Neri • Device or system is intended for • Unknown performance of the
(608) 663-7030 multiple use device or system in humidity
bneri@twt.com • More than 4 solutions or buffers
used Sensitivity:
• 3 components • 1,000-10,000 CFU per ml
• $42,761.00 GSA price/system or device • 5 or more consumables or
expendables needed t
required
• Expected life is 5-10 years MOST MATURE LEAST MATURE
procedures required
II:149
JBAIDS Analysis
by Idaho Technology

DETECTING JBAIDS Analysis ranked in the top third of all evaluated
Bacillus anthracis, ALTERNATIVE UTILITY
Francisella Best Score 0.901
tularensis, Idaho Tech JBAIDS 0.737
Burkholderia
Lowest Score 0.217
pseudomallei,
E.coli O157:H7, Burkholderia mallei, Yersinia pestis, Rickettsia
prowazekii, Marburg virus, Smallpox virus, Influenza virus, Dengue
fever virus, Orthopox virus, Venezuelan equine encephalitis virus, DIAGNOSTIC Laboratory Ranking
Ebola virus, Botulinum toxin A, Ricin toxin (Commercially available
JBAIDS Analysis ranked in the top third of all evaluated
as a freeze-dried reagent); Vibrio cholera (Assay developed)
The Joint Biologic Agent Identification and Diagnostic System ALTERNATIVE UTILITY
(JBAIDS) is a portable real-time PCR system designed to identify Best Score 0.909
biological agents. Because of its rugged design, reliability, and
accuracy it has become the standard for the U.S. DoD. The JBAIDS
system is the ideal choice for mobile analytical labs and field Lowest Score 0.321
hospitals and is only available to the US Department of Defense. Effectiveness Operations Biological Agents Logistics
This instrument integrates Idaho Technology’s LightCycler® Preference Set: Diagnostic Laboratory
Instrument technology into a portable, impact resistant package.
Distinctive software allows simple “push-button” use of the
JBAIDS System by field personnel with minimal training. This
allows for field identification of pathogens quickly, safely, and MOBILE Laboratory Ranking
accurately. The system is FDA 510K approved, is capable of JBAIDS Analysis ranked in the top third of all evaluated
running both environmental and clinical samples with over 16 products for mobile laboratories and earned 89% of the
validated matricies and 17 validated freeze dried target assays. utility points of the best score.
The JBAIDS utilizes air driven real time PCR. Reactions are Best Score 0.883
performed in glass capillaries to accomplish high-speed Idaho Tech JBAIDS 0.785
thermocycling in less than 30 minutes. It is a three-color Lowest Score 0.379
instrument capable of using both Taqman™ and FRET™ based
assays. It can perform qualitative detection, quantitative Logistics Biological Agents Effectiveness Operations
detection, melting curve analysis with additional laboratory Preference Set: Mobile Laboratory
capabilities embedded within the advanced software.
FIELD USE Ranking

JBAIDS Analysis ranked in the top third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:150
Emanuel and Fruchey

• System or device has 110V or • Approximately the size of a carry-
220V electrical requirement on luggage suitcase
require water • Reagent shelf life 6 months to 1
MOBILE FIELD
require an external vacuum • There are multiple centrifugation
source steps
Throughput of product: • There is a single shaking or
DIAGNOSTIC • Single sample detection vortexing step
between 40 and 50 minutes • System always able to interpret
• 32 samples/batch or higher raw data or call a positive
• Less than 250 ul volume through internal software
BEST FIT WORST FIT needed per test for detection
adapted into a semi automated the same test
system with some effort • Four or more additional pieces of
equipment needed
• More than a day of training Signature:
and significant technical skills • No sounds produced that cannot
CONTACT INFORMATION required be deactivated
Idaho Technology • Less than 5 minutes set-up • Greater than 500 BTUS
390 Wakara Way required generated
Salt Lake City, UT 84108 • Greater than 12 manual steps
www.idahotech.com required for detection Operational conditions:
room temperature
Matt Scullion, Marketing Manager Applied Science • Device or system is intended for
multiple use • The performance of the device
(801) 736-6354 x327 or system is not influenced by
(801) 588-0507 • More than 4 solutions or buffers
matt.scullion@idahotech.com
• 5 or more components Sensitivity:
• Previous samples must be • 100-1000 CFU per ml
removed before next operation
• $30.00/sample Maintenance: • Is commercially available and
• Less than once a year service meets military specifications
required • Has not been featured in
procedures
t
II:151
Joint Biological Point Detection System ( JBPDS)

by General Dynamics-ATP

Bacillus anthracis, Francisella tularensis, Yersinia pestis and JBPDS ranked in the top third of all evaluated products
various other biological threat agents. for analytical laboratories and earned 88% of the utility
JBPDS provides automatic detection and identification of
Best Score 0.901
airborne biological agents at very low levels, triggers local and
remote warning systems, and communicates threat information JBPDS 0.796
over standard communication systems. Using laser-induced Lowest Score 0.217
fluorescence, the trigger/detector continuously evaluates the
atmospheric background for traces of potential biological agents.
When the system detects something of a suspicious nature, the
collector/concentrator is initiated to sample hundreds of liters
of air per minute, providing a small amount of liquid containing
the collected aerosol sample. This sample is then evaluated DIAGNOSTIC Laboratory Ranking
for specific biological agents using immunoassays (similar to a JBPDS ranked in the top third of all evaluated products
pregnancy test strip) with an automated reader assembly. If the for diagnostic laboratories and earned 94% of the utility
assay shows signs of biological agents, an alarm is sounded and points of the best score.
a portion of the collected sample is provided for gold-standard
ALTERNATIVE UTILITY
laboratory analysis.
Best Score 0.909
TECHNOLOGY: JBPDS 0.853
Using laser-induced fluorescence, the trigger/detector Lowest Score 0.321
continuously evaluates the atmospheric background for traces of
potential biological agents. When the system detects something Effectiveness Operations Biological Agents Logistics
of a suspicious nature, the collector/concentrator is initiated to Preference Set: Diagnostic Laboratory
sample hundreds of liters of air per minute, providing a small
amount of liquid containing the collected aerosol sample. This
sample is then evaluated for specific biological agents using MOBILE Laboratory Ranking
colloidal gold based immunochromatographic assays with an
JBPDS ranked in the top third of all evaluated products
automated reader assembly. If the assay shows signs of biological
agents, an alarm is sounded and a portion of the collected sample
for mobile laboratories and earned 89% of the utility
is provided for gold- standard laboratory analysis. points of the best score.
ALTERNATIVE UTILITY
Best Score 0.883
JBPDS 0.776
Lowest Score 0.379

FIELD USE Ranking

JBPDS ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
JBPDS 0.673
Lowest Score 0.343

II:152
Emanuel and Fruchey

require water • Reagent shelf life 1 to 3 years
source
• Single sample detection in 20 • Capable of detecting multiple
minutes or less biological agents or toxins within
• Less than 100 ul volume the same test
BEST FIT WORST FIT • The system or device is equipment needed
Signature:
training and minimal technical • Greater than 500 BTUS
skills generated
CONTACT INFORMATION • Greater than 20 minutes set-up
General Dynamics-ATP required
4205 Westinghouse Commons Dr. • 0-2 manual steps required for Operational conditions:
detection • Operated from -28°C to 50°C
Charlotte, NC 28273
www.gdatp.com 4°C to 45°C
Re-use: • The performance of the device
Point of Contact: • Device or system is intended for or system is not influenced by
Mike Bryce multiple use relative humidity
(980) 235-2214 • 2 solutions or buffers used
(980) 235-2393 • 2 components Sensitivity:
mbryce@gdatp.com • System is self cleaning • IAW Critical Reagents Program
Limit of Detection
Maintenance: (call 410-436-9111)
COST • Less than once a year service
• $52.00/sample required Maturity gauge:
• $359,000.00/device or system • Expected life is greater than 10 • Is commercially available and
years meets military specifications
• No daily quality assurance • Has been featured in peer
procedures reviewed scientific publications
II:153
KinExA 3000
by Sapidyne Instruments Inc.

FOLLOWING: KinExA 3000 ranked in the bottom third of all evaluated
Able to detect any organisms/toxins products for analytical laboratories and earned 40% of
for which assays can be developed. the utility points of the best score.
ALTERNATIVE UTILITY
The KinExA (Kinetic Exclusion Assay)
Sapidyne KinExA 3000 0.361
3000 is designed to measure
molecular interaction in solution Lowest Score 0.217
phase. The KinExA is distinct from Effectiveness Biological Agents Logistics Operations
both competition and sandwich Preference Set: Analytical Laboratory
assays, in that it measures directly
from a solution the amount of free
receptor or antibody. The KinExA
3000 was specifically designed to DIAGNOSTIC Laboratory Ranking
measure the interaction, equilibrium KinExA 3000 ranked in the bottom third of all evaluated
binding and kinetics, of biomolecule products for diagnostic laboratories and earned 54% of
binding partners (most commonly the utility points of the best score.
antibody and antigen) without
ALTERNATIVE UTILITY
the need to modify either partner.
Best Score 0.909
The KinExA has been used for the
characterization of antibody/antigen Sapidyne KinExA 3000 0.495
pairs numerous times. The KinExA 3000 has also been used to Lowest Score 0.321
measure environmental estrogens, organophosphates, and as a
biosensor for heavy metal ions in solution. Operation of the KinExA Preference Set: Diagnostic Laboratory
is simple, routine and easily handled by a semi-skilled operator.
TECHNOLOGY:
The KinExA is a general purpose flow fluorometer capable of MOBILE Laboratory Ranking
detecting low concentrations of free antibody or receptor in KinExA 3000 ranked in the bottom third of all evaluated
solution phase. The detection technology is based on capture of products for mobile laboratories and earned 58% of the
the free antibody or receptor on an immobilized ligand column. utility points of the best score.
The immobilized capture reagent is held in a capillary flow cell
embedded in a lens and backed by a reflective surface. Excitation ALTERNATIVE UTILITY
and emission collection is via a conventional epi-illumination filter Best Score 0.883
design. As the sample is passed over the capture reagent, free Sapidyne KinExA 3000 0.515
receptor or antibody is captured and subsequently detected with Lowest Score 0.379
a fluorescently labeled secondary antibody. When functioning
to measure equilibrium constants, the equilibrated sample Logistics Biological Agents Effectiveness Operations
is rapidly passed over the column, limiting the contact time Preference Set: Mobile Laboratory
between sample and immobilized ligand. This ensures that the
sample equilibrium is not disrupted during measurements. Larger
volumes can be accommodated allowing concentration of proteins FIELD USE Ranking
in dilute samples. This enables the KinExA to have sensitivities KinExA 3000 ranked in the middle third of all evaluated
in the low pico-molar range for some antibodies. The ability to products for field use and earned 73% of the utility points
handle large volumes (more than five mL) could conceivably allow
of the best score.
the user to measure extremely dilute samples and still obtain
reliable measurements. We routinely measure samples in the ALTERNATIVE UTILITY
low-picomolar concentration range with larger volumes. This could Best Score 0.943
apply to analysis of most any molecule if the proper bio-detection Sapidyne KinExA 3000 0.688
protein could be engineered. Lowest Score 0.343

II:154
Emanuel and Fruchey

dishwasher
require water • Shelf life unknown
source • Not capable of detecting multiple
• Single sample detection 20 • One additional piece of
• The system or device could be deactivated
automated system

CONTACT INFORMATION • A day of training • Operated from 15°C to 37°C
Sapidyne Instruments Inc. • Greater than 20 minutes • Components must be stored at
PMB #445 required for set-up 4°C
967 E. ParkCenter Blvd. • 0-2 manual steps required for • Performance of the device or
Boise, ID 83706-6700 detection system is not influenced by
www.sapidyne.com relative humidity
Re-use:
Point of Contact: • Device or system is intended for Sensitivity:
Steve Lackie or Mark Jones multiple use • Unknown
(208) 345-3400 x11 or x19 • 3 solutions or buffers used
(208) 345-5251 fax • 5 or more components Maturity gauge:
steve@sapidyne.com, rmark@sapidyne.com • Requires a buffer rinse between • Is commercially available
similar samples on the same
line, weekly rinse and monthly
COST t
rinse
• Unknown/sample
Maintenance:
• 5 or more consumables or MOST MATURE LEAST MATURE
expendables needed
required
years
procedures required
II:155
KinExA Bench Top


DETECTING THE KinExA Benchtop ranked in the bottom third of all
Able to detect any 38% of the utility points of the best score.
organisms/toxins for ALTERNATIVE UTILITY
which assays can be Best Score 0.901
developed.

The KinExA (Kinetic Effectiveness Biological Agents Logistics Operations
Exclusion Assay) Preference Set: Analytical Laboratory
technology is a
superior method of
measuring biological binding interactions. The KinExA is distinct
from both competition and sandwich assays, in that it measures
directly the free portion of antibody in a sample, while ignoring the KinExA Benchtop ranked in the bottom third of all
complexed portion. This is done without perturbing the mixture, evaluated products for diagnostic laboratories and
as competition assays do, and will work with small antigens, earned 54% of the utility points of the best score.
unlike sandwich assays. The KinExA benchtop instrument was ALTERNATIVE UTILITY
specifically designed to measure the concentration of a ligand
Best Score 0.909
in a liquid sample. The focus of the benchtop instrument is to
automate the assay steps, thus reducing the skill level needed to
perform the assay. Lowest Score 0.321
The KinExA technology (using the KinExA 3000 instrument) Effectiveness Operations Biological Agents Logistics
has been used for the characterization of antibody/antigen Preference Set: Diagnostic Laboratory
pairs numerous times. The KinExA 3000 has also been used
to prove the principle of using KinExA technology to measure
environmental estrogens, organophosphates, and as a biosensor MOBILE Laboratory Ranking
for heavy metal ions in solution. While the specific assays are not KinExA Benchtop ranked in the bottom third of all
yet developed for the benchtop instrument, proof of principle was evaluated products for mobile laboratories and earned
completed using the larger and more expensive laboratory version 55% of the utility points of the best score.
of the KinExA instrument.
ALTERNATIVE UTILITY
The KinExA is a method capable of rapidly detecting low Sapidyne KinExa Bench Top 0.485
concentrations of free antibody or receptor in solution phase. The
Lowest Score 0.379
detection technology is based on capture of the free antibody
or receptor on an immobilized ligand column. The immobilized Logistics Biological Agents Effectiveness Operations
capture reagent is held in a capillary flow cell, embedded in a Preference Set: Mobile Laboratory
lens, and backed by a reflective surface. Excitation and emission
collection is via a conventional epi-illumination filter design.
The high local concentration of ligand in the capture column FIELD USE Ranking
allows efficient and rapid capture of solution antibody. The
KinExA Benchtop ranked in the middle third of all
concentration of the solution antibody in the small volume of
the flow cell, coupled with the extremely efficient optical system
design, results in very sensitive detection capabilities. Finally, the utility points of the best score.
kinetic exclusion assay principle avoids the competition inherent ALTERNATIVE UTILITY
in typical small ligand immunoassays. These features combine Best Score 0.943
to create a system with much better performance than current Sapidyne KinExa Bench Top 0.561
technologies. In a direct comparison to ELISA assays, using the
Lowest Score 0.343
same reagents, an independent researcher found the KinExA
technology to be 10 to 1000 times more sensitive, with faster Logistics Operations Effectiveness Biological Agents
time to results (see Blake, DA et. al (2001) Analytica Chimica Acta; Preference Set: Field Use
444, 3-11).
II:156
Emanuel and Fruchey

require water • Shelf life unknown
source
• NA
DIAGNOSTIC Throughput of product: • Not capable of detecting multiple
• Single sample detection 20
minutes or less the same test
BEST FIT WORST FIT • Greater than 250 ul volume equipment needed
needed per test for detection
be deactivated
Training/Speed/Manpower: • Less than 200 BTUS generated
CONTACT INFORMATION Operational conditions:
for set-up
Sapidyne Instruments Inc. • Operated from 15°C to 37°C
PMB #445 detection • Components can be stored at
967 E. ParkCenter Blvd. 25°C to 45°C
Boise, ID 83706-6700 • Components must be stored at
www.sapidyne.com
Re-use: 4°C
multiple use • Performance of the device or
Point of Contact: • 2 solutions or buffers used system is not influenced by
Steve Lackie or Mark Jones • 3 components relative humidity
(208) 345-3400 x11 or x19 • Requires a buffer rinse between
(208) 345-5251 fax similar samples on the same Sensitivity:
steve@sapidyne.com, rmark@sapidyne.com line, weekly rinse and monthly • Unknown CFU per ml
rinse
• Unknown/sample Maintenance: • A few devices or systems exist
• $20,000.00/system or device • 2 consumables or expendables (brass board)
needed
• More often than every 6 months t
service required
years MOST MATURE LEAST MATURE
procedures required
II:157
KinExA Handheld

DETECTING THE KinExA Handheld ranked in the bottom third of all
Able to detect any 37% of the utility points of the best score.
developed. Sapidyne KinExA Field Portable 0.335
Lowest Score 0.217
DESCRIPTION:
The KinExA (Kinetic
Exclusion Assay)
Handheld instrument
is currently in
development in DIAGNOSTIC Laboratory Ranking
collaboration with Dr. KinExA Handheld ranked in the bottom third of all
Diane A. Blake at Tulane evaluated products for diagnostic laboratories and
University School of earned 52% of the utility points of the best score.
Medicine. The handheld
is based on the same ALTERNATIVE UTILITY
technology as the Best Score 0.909
KinExA 3000, but in a Sapidyne KinExA Field Portable 0.479
lightweight, portable Lowest Score 0.321
format. Developmental
experiments using Effectiveness Operations Biological Agents Logistics
the Handheld are investigating its application for the detection Preference Set: Diagnostic Laboratory
of heavy metals in solution utilizing antibodies developed by Dr.
Blake. The beta unit of the handheld is controlled by a hand held
computer for ease of transport, field operation, and data transfer. MOBILE Laboratory Ranking
KinExA Handheld ranked in the bottom third of all
TECHNOLOGY: evaluated products for mobile laboratories and earned
The KinExA handheld is a portable, general-purpose flow
fluorometer. The detection technology is based on capture of
the free antibody or receptor on an immobilized ligand column. ALTERNATIVE UTILITY
Excitation and emission collection is via a conventional epi- Best Score 0.883
illumination filter design. As the sample is passed over the capture Sapidyne KinExA Field Portable 0.512
reagent, free receptor or antibody is captured and subsequently
Lowest Score 0.379
detected with a fluorescently labeled secondary antibody.
FIELD USE Ranking

KinExA Handheld ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:158
Emanuel and Fruchey

• The system or device does not • Shelf life unknown
• NA to interpret raw data or call a
DIAGNOSTIC • Single sample detection 20
positive through internal software
• Unknown if assay is capable
minutes or less
• 1 samples/batch or higher of detecting multiple biological
• Greater than 250 ul volume agents or toxins within the same
BEST FIT WORST FIT needed per test for detection test
• The system or approach is not • No additional pieces of
amendable to automation equipment needed
• Greater than 20 minutes be deactivated
required for set-up
CONTACT INFORMATION • Less than 200 BTUS generated
Sapidyne Instruments Inc.
detection
PMB #445 Operational conditions:
967 E. ParkCenter Blvd. • Operated temperature unknown
Boise, ID 83706-6700 Re-use: • Components must be stored at
www.sapidyne.com 4°C
multiple use
• 2 solutions or buffers used • Unknown if performance of the
Point of Contact: • 4 components device or system is influenced by
Steve Lackie or Mark Jones • May requires a buffer rinse relative humidity
(208) 345-3400 x11 or x19 between similar samples on
(208) 345-5251 fax the same line, weekly rinse and Sensitivity:
steve@sapidyne.com, rmark@sapidyne.com monthly rinse • Unknown CFU per ml

• Unknown/sample • 4 consumables or expendables • A few devices or systems exist
• Projected $5,000.00/system or device needed (brass board)
• Unknown service required
• Expected life unknown
t
• Unknown daily quality
assurance procedures required
II:159
KinExA In-Line

Botulinum toxin A, Aflatoxin, Staphylococcal enterotoxin B; Assays KinExA In-line ranked in the bottom third of all evaluated
could be developed for any pathogen for which an antibody exists. products for analytical laboratories and earned 45% of
The KinExA® In-Line Biosensor is an automated competitive
Best Score 0.901
exclusion immunoassay system applicable to a wide variety
of matrices. KinExA In-Line technology provides an excellent Sapidyne KinExA In-Line 0.404
general purpose platform to exploit the measurement of true Lowest Score 0.217
binding affinity using unmodified molecules in solution phase to
determine the concentration of a sample. This laboratory based
fluorescence detector system is used for the measurement of
concentration using solution phase binding affinity on unmodified
molecules. The sensor can be regenerated in eight min and allows
a minimum of 40 repeated readings before human interaction is DIAGNOSTIC Laboratory Ranking
needed. The fluidics and software allow samples to be obtained KinExA In-line ranked in the middle third of all evaluated
from up to eight different sources. products for diagnostic laboratories and earned 58% of
TECHNOLOGY:
The KinExA In-Line Biosensor offers a platform that exploits the ALTERNATIVE UTILITY
measurement of true binding affinity using unmodified molecules Best Score 0.909
in solution phase to determine concentration of the sample. This Sapidyne KinExA In-Line 0.531
is accomplished by using a solid phase immobilized molecule to Lowest Score 0.321
probe for free concentration of one interaction component.

KinExA In-line ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

KinExA In-line ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:160
Emanuel and Fruchey

• The system uses both 110V and • Approximately the size of a carry-
220V on luggage suitcase
ANALYTICAL • The system does not require • Between 5 and 25 kg
water
• The system does not require an Ease of use/Utility:
external air or gas source
• Can view “real time” results
• The system does not require an
MOBILE FIELD external vacuum source • No centrifugation steps are
necessary
Throughput of product: vortexing step required
DIAGNOSTIC minutes or less
• The system can interpret raw
• 2 samples/batch or higher data or call a positive through
• Greater than 250ul volume internal software
needed per test for detection • The system detects a single
BEST FIT WORST FIT • The system is fully automated agent per reaction
Training/Speed/Manpower: equipment are necessary
• A day of training and technical
skills are required Signature:
• 5-10 minutes of required for • No sounds produced that cannot
• 0-2 steps required for detection
CONTACT INFORMATION
Sapidyne Instruments Inc. Operational conditions:
PMB #445 Re-use: • Can be used from 4° to 45°
967 E. ParkCenter Blvd. • System is intended for multiple
Boise, ID 83706-6700 use
4°C
• 3 solutions or buffers are used
www.sapidyne.com • Performance of system is not
• 1 component
• Self-cleans with buffer influenced by relative humidity
Point of Contact:
David Smith or Terrance Lackie Maintenance: Sensitivity:
(208) 345-3400 x25 • The system needs to be • Unknown CFU per ml
(208) 345-5251 serviced once a year
david@sapidyne.com • Expected life of the system is Maturity gauge:
5-10 years • A few devices or systems exist
COST • 5-10 minutes of daily quality (brass board)
• $72,000.00 procedures required
t
II:161

by Beckman Coulter, Inc.

DETECTING LD 400 Luminescence Detector ranked in the bottom
THE third of all evaluated products for analytical laboratories
FOLLOWING: and earned 40% of the utility points of the best score.
toxins with any LD 400 Luminescence Detector 0.362
luminescent
Lowest Score 0.217
or colormetric
assay with Effectiveness Biological Agents Logistics Operations
appropriate Preference Set: Analytical Laboratory
wavelength
range.
DESCRIPTION: LD 400 Luminescence Detector ranked in the bottom
The LD 400 Luminescence Detector is intended to be used
primarily for luminescent research applications, but it can also third of all evaluated products for diagnostic laboratories
perform photometric measurements as well. Typical assays that and earned 54% of the utility points of the best score.
can be performed include flash and glow assays, dual luciferase ALTERNATIVE UTILITY
assays, reporter gene and toxicity assays, ATP and biomass Best Score 0.909
assays, DNA assays, cellular function assays and colorimetric
immunoassays, such as ELISAs and protein quantification assays.
Lowest Score 0.321
The LD 400 is capable of measuring assays in 96 well plates. The
LD 400 can perform measurements in multiple modes including Effectiveness Operations Biological Agents Logistics
single wavelength, dual wavelength, photometric and luminescent Preference Set: Diagnostic Laboratory
kinetic, and linear scan. Full programming and data analysis are
available either through powerful on-board software or via the use
of a remote PC and software.
TECHNOLOGY: LD 400 Luminescence Detector ranked in the bottom
The LD 400 Luminescence Detector employs a controlled third of all evaluated products for mobile laboratories and
tungsten halogen lamp as a light source and a photon counting earned 55% of the utility points of the best score.
PMT as the detector for measuring light in the 300-700nm
ALTERNATIVE UTILITY
(luminescence) and 405–690nm (absorbance) wavelength
range. It employs the use of filters to select specific wavelengths Best Score 0.883
to measure, and has a luminescent dynamic range >8 decades. LD 400 Luminescence Detector 0.484
In addition, the LD 400 features programmable shaking and two Lowest Score 0.379
built-in dispensers for accommodating various types of reactions.
FIELD USE Ranking

LD 400 Luminescence Detector ranked in the middle third
of all evaluated products for field use and earned 77% of
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:162
Emanuel and Fruchey

require water • NA shelf life
source
BEST FIT WORST FIT • Less than 50 ul volume needed biological agents or toxins within
Signature:
CONTACT INFORMATION be deactivated
• Less than 5 minutes required • Unknown BTUS generated
Beckman Coulter, Inc.
for set-up
4300 N. Harbor Blvd. Box 3100 • 6-8 manual steps required for
Fullerton, CA 92834 detection Operational conditions:
www.beckmancoulter.com • Operated from 15°C to 37°C
• NA storage of components
Re-use:
Point of Contact: • Device or system is intended for • Device or system has peak
Matt Maloney or Margaret Kelly multiple use performance at normal relative
(317) 808-4217, (714) 773-8022 • NA solutions or buffers used humidity conditions only
(714) 773-6690 fax • 3 components
MJMaloney@beckman.com, mmkelly@beckman.com • Tubing cleaning required once Sensitivity:
a week • Unknown CFU per ml

• Unknown/sample • 2 consumables or expendables • Is commercially available
• $13,995.00-17,995.00/system or device needed
t
procedures required MOST MATURE LEAST MATURE
II:163
Light Upon Extension (LUX™)

by Invitrogen

DETECTING Light Upon Extension ranked in the top third of all
Francisella Invitrogen LUX 0.845
tularensis,
Lowest Score 0.217
Yersinia pestis,
Smallpox Effectiveness Biological Agents Logistics Operations
virus, Orthopox Preference Set: Analytical Laboratory
virus, Botulinum toxin B (Commercially available as a wet/frozen
reagent); Influenza virus (Assay developed); (Works on any real time PCR
thermocycler) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: Light Upon Extension ranked in the top third of all
Light Upon Extension (LUX™) married with Platinum™ Taq DNA polymerase evaluated products for diagnostic laboratories and
or Platinum Tfi DNA polymerase (LUX™ assays) represent a low cost, earned 98% of the utility points of the best score.
sensitive, specific, probe-less real time PCR solution for the detection of ALTERNATIVE UTILITY
biothreat agents. Key advantages are performance (sensitivity/specificity);
Best Score 0.909
cost (significantly reduced cost compared to current assays due to the
favorable freedom to operate position for these technologies as owned
by Invitrogen), and flexibility (assays can be run on any real time PCR Lowest Score 0.321
instruments). Unlike many other real-time detection technologies, LUX™
Fluorogenic Primers enable post-amplification melt curve analysis (without Preference Set: Diagnostic Laboratory
any additional manipulation) to confirm amplification of infectious agents.
A rapid post-amplification ramping protocol provides melting curve data
between two temperature points and the melting curve output provides
visual analysis of the amplified PCR product to verify correct sequence MOBILE Laboratory Ranking
amplifications and to discriminate against nonspecific amplification. These Light Upon Extension ranked in the top third of all
LUX™ Fluorogenic Primers provide, with little extra time investment, post- evaluated products for mobile laboratories and earned
amplification confirmation that the correct pathogen target was amplified 90% of the utility points of the best score.
– thus eliminating false positive results from non-specific amplification or
ALTERNATIVE UTILITY
from external control contamination. There is a considerable amount of
Best Score 0.883
data regarding the LUX™ assays and their use in the detection of biothreat
agents. Data from one government trial (TRA-04 at Dugway Proving Invitrogen LUX 0.799
Grounds) and two independent trials (performed by Midwest Research Lowest Score 0.379
Institute and Battelle Memorial Institute) is available to show the robustness
of the approach, as well as excellent sensitivity and reliability of the LUX™
assay system.
TECHNOLOGY:
Each LUX™ primer set includes a single-labeled fluorogenic primer FIELD USE Ranking
and corresponding unlabeled primer. LUX™ fluorogenic primers are Light Upon Extension ranked in the top third of all
oligonucleotides labeled with a single fluorophore, close to the 3’ end evaluated products for field use and earned 100% of
in a hairpin structure. The LUX™ Fluorogenic Primer is designed so that
the hairpin secondary structure quenches the attached fluorophore. The
corresponding unlabeled primer is designed to facilitate sequence-specific ALTERNATIVE UTILITY
amplification of pathogen domains. Upon incorporation into a double- Best Score 0.943
stranded PCR product, the primer releases this secondary structure and the Invitrogen LUX 0.943
fluorophore is dequenched. The fluorescent signal can be detected by all Lowest Score 0.343
existing real-time quantitative PCR instrumentation.
II:164
Emanuel and Fruchey

• Dependent on the instrument • Can view results “in real time”
being used; LUX assay only • Dependent on the instrument
ANALYTICAL being used; LUX assay only
• Dependent on the instrument Signature:
MOBILE FIELD being used; LUX assay only
• Dependent on the instrument Operational conditions:
DIAGNOSTIC being used; LUX assay only
Re-use:
• Device or system is intended for room temperature or frozen
multiple use • The performance of the device
• 3 solutions or buffers used or system is not influenced by
BEST FIT WORST FIT • 3 components relative humidity
• Dependent on the instrument
being used; LUX assay only Sensitivity:
Maintenance:
• Dependent on the instrument Maturity gauge:
being used; LUX assay only • Is commercially available
CONTACT INFORMATION • Has been featured in peer
Invitrogen Federal Systems reviewed scientific publications
7335 Executive Way Transportation:
• Dependent on the instrument or independent evaluations
Frederick, MD 21704
being used; LUX assay only t
http://www.invitrogen.com/content. • Reagents shelf life between 6
cfm?pageid=10275 months to 1 year
Point of Contact: MOST MATURE LEAST MATURE

Willem Folkerts, Business Director
(240) 379-4209
(240) 379-4750
willem.folkerts@invitrogen.com
COST
• $0.50-3.00/sample
II:165
LightCycler
by Roche Applied Science

DETECTING THE LightCycler ranked in the highest third of all evaluated
tularensis, Yersinia pestis, ALTERNATIVE UTILITY
Smallpox virus, Orthopox Best Score 0.901
virus, Botulinum toxin A
(Commercially available as a
Lowest Score 0.217
freeze-dried reagent)
The LightCycler is a Real-Time
PCR machine used for rapid
detection and analysis of DNA
and RNA targets. Targets are
both detected and quantified LightCycler ranked in the highest third of all evaluated
within 35 to 40 minutes using products for diagnostic laboratories and earned 92% of
the system in a real-time the utility points of the best score.
manner without additional ALTERNATIVE UTILITY
down stream analysis. Best Score 0.909
Running gels for confirmatory testing is eliminated due to Melting Curve
Analysis which makes it possible to analyze the quality and type of Nucleic
Lowest Score 0.321
acid being detected as compared to controls. PCR detection is very specific
using the LightCycler with FRET Probe chemistries. The LightCycler is a Effectiveness Operations Biological Agents Logistics
flexible instrument with the ability to detect nucleic acids using SYBR Green, Preference Set: Diagnostic Laboratory
Hybridization Probe Chemistry and TaqMan Chemistry. Target detection
sensitivity levels are down to 10 starting copies. The LightCycler is used
for the detection of Anthrax with the Roche LightCycler-Bacillus anthracis
Detection kit or with other anthrax assays. Other uses include the detection MOBILE Laboratory Ranking
of DNA and RNA viruses and the detection of bacteria nucleic acid. LightCycler ranked in the highest third of all evaluated
TECHNOLOGY: utility points of the best score.
The LightCycler uses air for rapid PCR temperature cycling. A heating coil
controlled by thermocouples in a single well thermal chamber is used for ALTERNATIVE UTILITY
heating. Cooling is accomplished by using a fan system to eject hot air Best Score 0.883
and bring ambient air into the thermal chamber. The design ensures a LightCycler PCR 0.740
programmed temperature accuracy of 0.3°C with temperature ramping Lowest Score 0.379
rates of 20°C per second. Amplification cycles take a little as 30 seconds
per cycle. PCR reactions take place in specially designed borosilicate glass Logistics Biological Agents Effectiveness Operations
capillaries, which hold up to 20ul of sample. The capillaries have a high Preference Set: Mobile Laboratory
surface to volume ratio for rapid sample heating and cooling. Detection of
specific Nucleic Acid sequences is achieved using FRET Probe chemistry,
either Hybridization Probe chemistry or TaqMan chemistry. The PCR products FIELD USE Ranking
are detected using an optical system with three filters. All three filter LightCycler ranked in the highest third of all evaluated
channels are recorded during each run. The Excitation of the chemical dyes products for field use and earned 84% of the utility points
is achieved by using a Blue Light LED. Qualitative analysis of PCR products of the best score.
is possible using a unique feature called Melting Curve Analysis (MCA).
All PCR products have a specific Tm (melting point) by which they can be ALTERNATIVE UTILITY
identified. Small differences in Tm are easily determined using MCA. This Best Score 0.943
allows a sample to be analyzed for small genetic variations such as point LightCycler PCR 0.792
mutations, for a more specific genetic analysis of the target sample. Results Lowest Score 0.343
are available on a computer and analysis takes as little as one minute.
Positive results can be achieved from samples with as little as 10 copies of Logistics Operations Effectiveness Biological Agents
target nucleic acid. Preference Set: Field Use
II:166
Emanuel and Fruchey

source
source • Single centrifugation step
required
DIAGNOSTIC Throughput of product:
• Single sample detection
between 30 and 40 minutes
• Assay not available, but capable
per test for detection of detecting two biological agents
• The system or device could be or toxins within the same test
adapted to a fully automated • Two additional pieces of
CONTACT INFORMATION • No sounds produced that cannot
• Less than 5 minutes required be deactivated
Roche Applied Science
for set-up • Greater than 500 BTUS
9115 Hague Rd., P.O. Box 50414 • 3-5 manual steps required for
Indianapolis, IN 46250-0141 generated
detection
www.roche-applied-science.com
Re-use:
Mary Pingitore multiple use • Components must be frozen
(800) 845-7355 x8015 • 3 solutions or buffers used • Performance of the device or
mary.pingitore@roche.com • No cleaning required relative humidity
COST • 2 consumables or expendables • 1-100 CFU per ml
• $53,500.00 GSA, $57,500.00 non-GSA price/ • Less than once a year service Maturity gauge:
system or device required • Is commercially available and
• Expected life is 5-10 years meets military specifications
t
II:167
LightTyper Thermocycler

DETECTING THE LightTyper ranked in the highest third of all evaluated
Able to detect any the utility points of the best score.
developed.
LightTyper 0.650

The LightTyper is a Effectiveness Biological Agents Logistics Operations
high through-put Preference Set: Analytical Laboratory
Genetic Analysis
System which uses
Melting Curve Analysis to identify and genotype Genetic Sequences in PCR
reactions. PCR reactions are preformed on a traditional block style thermal
cycler in either a 96 or 384 well format. Fluorescent probes are included in LightTyper ranked in the highest third of all evaluated
the PCR reaction. After PCR is completed, the PCR sample trays are placed products for diagnostic laboratories and earned 85% of
into the LightTyper. In eight minutes the samples are melted and fluorescent the utility points of the best score.
data collected from all samples. Data analysis can be conducted on the ALTERNATIVE UTILITY
computer or data can be down loaded to a LIMS system. Data Analysis Best Score 0.909
using the Call-It software will make allele calls for each sample. Samples
LightTyper 0.773
are identified by their Melting Temperature (Tm).
Lowest Score 0.321
The LightTyper uses a CCD camera and an LED light source of 470nm
which makes this a robust system. There are two long filters of 510nm and
600nm. The Temperature dynamic range is 40 to 98°C. The temperature
ramp rate is 0.5 – 0.20°C. Run times range from six to 15 minutes. Images
are acquired at 0.4 to 10 acquisitions/second. Thermal uniformity is 0.4°C. MOBILE Laboratory Ranking
Two fluorescent chemistries can be used on the LightTyper; the Hybridization LightTyper ranked in the middle third of all evaluated
Probe chemistry and the Single Probe chemistry. Software is included products for mobile laboratories and earned 64% of the
with the system for Probe and PCR primer design for both chemistries. The utility points of the best score.
Hybridization Probe chemistry is a well known FRET chemistry which uses
two fluorescent dyes and two oligo probes which must hybridize on the DNA ALTERNATIVE UTILITY
sequence of interest for detection. The Single Probe chemistry uses a probe, Best Score 0.883
which consists of one oligo with a linker and attached fluorescent dye. LightTyper 0.567
When the probe is bound to the DNA target sequence it will fluoresce. When Lowest Score 0.379
unbound (melted) the probe does not fluoresce. The change in fluorescence
in a sample is the basis of the identification of the PCR sample for both Logistics Biological Agents Effectiveness Operations
chemistries. Preference Set: Mobile Laboratory
Melting Curve fluorescent profiles are collected for all samples and
converted to melting peaks using the Analysis Software. The Tm for the FIELD USE Ranking
peaks is used to make sample identification calls. The calls can be made
LightTyper ranked in the highest third of all evaluated
automatically by the software. Autodetection of probe Tm shifts can be
done for shifts of 2.0°C or greater. Applications for the system include
Sequence Identification, SNP (Single Nucleotide Polymorphisms) Analysis, of the best score.
small deletion and insertion mutation analysis. For sample tracking a bar- ALTERNATIVE UTILITY
code reader is included. Other items included are a Pentium 4 computer Best Score 0.943
with 1.8 GHZ, 512 MB DDR, 40GB HD, CDRW and 17 inch flat screen LightTyper 0.800
monitor. Color Printer also included. The system is LIMS ready.
Lowest Score 0.343

II:168
Emanuel and Fruchey

source
require an external vacuum • Single centrifugation step
source required
DIAGNOSTIC Throughput of product: • System is sometimes able to
interpret raw data or call a
minutes or less positive through internal software
BEST FIT WORST FIT • Less than 100 ul volume of detecting four or more
needed per test for detection biological agents or toxins within
easily be adapted to a fully • Two additional pieces of
CONTACT INFORMATION • No sounds produced that cannot
for set-up
9115 Hague Rd., P.O. Box 50414 • Unknown BTUS generated
Indianapolis, IN 46250-0141 detection
www.roche-applied-science.com Operational conditions:
Re-use:
Point of Contact: • Device or system is intended for • Components can be stored at
Mary Pingitore or Dawn Coster multiple use 4°C
(800) 845-7355 x8015 or x8047 • 3 solutions or buffers used • Performance of the device or
mary.pingitore@roche.com, dawn.coster@roche.com • No cleaning required relative humidity
COST • 2 consumables or expendables • 1-100 CFU per ml
• less than $0.50/sample plus cost of Taq enzyme needed
• $45,000.00/system or device • Once a year service required Maturity gauge:
• Expected life is 5-10 years • Is commercially available
for daily assurance procedures t
II:169
Lunascan Biodetection System

by Luna Innovations

DETECTING Lunascan Biodetection System ranked in the middle third
Bacillus globigii, ALTERNATIVE UTILITY
MS-2 bacteriophage, Best Score 0.901
Ovalbumin (Assays Lunascan Biodetection Sys. 0.488
developed)
Lowest Score 0.217

DESCRIPTION:
The Lunascan Biodetection system is a multi-platform measurement device
that will reduce false-positives through independent, confirmation of binding DIAGNOSTIC Laboratory Ranking
events. Requiring multiple platforms to simultaneously return a positive
Lunascan Biodetection System ranked in the middle third
response before triggering a detection warning will address background
interference effects that may be more prevalent for a particular detection of all evaluated products for diagnostic laboratories and
technique. The Lunascan Biodetection system is based upon optical fiber earned 66% of the utility points of the best score.
technology licensed from Lucent Technologies and patented by Luna ALTERNATIVE UTILITY
Innovations. The detection system has been designed to integrate with field Best Score 0.909
portable instrumentation and be capable of detecting multiple agents in
Lunascan Biodetection Sys. 0.597
soil, water, biological fluids, or air. Tests are currently performed in a semi-
Lowest Score 0.321
automated process with results available in less than ten minutes. Results
have been recorded for simulants including BG, ovalbumin, and MS2. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The Lunascan platform utilizes direct detection optical fiber technology
coupled with fluorescence detection to determine the presence of biological
warfare agents. Optical fiber sensors are ideal for field portable applications MOBILE Laboratory Ranking
because they are small, lightweight, and rugged. Specifically, the system Lunascan Biodetection System ranked in the middle third
works by binding a target to an affinity film that has been coated to the fiber of all evaluated products for mobile laboratories and
surface. Luna systems have been flight qualified and initial performance earned 61% of the utility points of the best score.
demonstrated using biological simulants such as BG, MS2, and ovalbumin.
ALTERNATIVE UTILITY
For direct detection, patented long-period grating (LPG) technology is used.
Best Score 0.883
The LPG is a spectral loss element that scatters light out of an optical
fiber at a particular wavelength based in part on the refractive index of Lunascan Biodetection Sys. 0.541
the surrounding environment. Therefore, the technique is not based on Lowest Score 0.379
spectroscopy or absorption and is immune to background fluorescent
effects. LPG-based biological sensors operate with specially designed
affinity films that cause selective, quantitative changes in the refractive
index ‘seen’ by the LPG in the presence of target molecules. As the coating
absorbs target molecules the refractive index changes, causing a shift in the
wavelength of the scattered light. This wavelength change is demodulated FIELD USE Ranking
to determine target concentration enabling real-time monitoring of Lunascan Biodetection System ranked in the middle third
environmental conditions. The LPG sensor can be packaged with fluorescent of all evaluated products for field use and earned 62% of
probes to demonstrate orthogonal detection. The fluorescent probe is also the utility points of the best score.
based on optical fibers and uses a tag coupled to a target captured on
an affinity film on the fiber surface. Light from the optical fiber excites the ALTERNATIVE UTILITY
tag, which fluoresces. The resulting light is then captured and the intensity Best Score 0.943
measured to determine concentration. Results of detection will be produced Lunascan Biodetection Sys. 0.587
within 10 minutes for multiple targets. Audio and visual alarms can be Lowest Score 0.343
provided.
II:170
Emanuel and Fruchey

DIAGNOSTIC • Single sample detection 20 through internal software
• Less than 100 ul volume biological agents or toxins within
adapted into a fully automated equipment needed
Signature:
• 10-20 minutes required for
CONTACT INFORMATION • Unknown BTUS generated
set-up
Luna Innovations
2851 Commerce Street detection Operational conditions:
Blacksburg, VA 24060 • Operated from 4°C to 45°C
www.lunainnovations.com • Components must be stored at
Re-use: 4°C and at room temperature
Point of Contact: multiple use • Performance of the device or
Ben Plowman • 3 solutions or buffers used system is not influenced by
(770) 315-3115 • 3 components relative humidity
plowmanb@lunainnovations.com Sensitivity:
Maintenance: • 10,000-100,000 CFU per ml
• Approx. $3.00/sample • Less than once a year service • Only one incomplete device or
• $60,000.00/system or device required system exists (bread board)
• 5-10 minutes required for daily t
II:171
M Series M1M
by BioVeris Corp.

THE FOLLOWING: M Series M1M ranked in the highest third of all evaluated
Bacillus anthracis, Francisella products for analytical laboratories and earned 81% of
tularensis, Yersinia pestis, Smallpox the utility points of the best score.
virus, Orthopox virus, Botulinum toxins ALTERNATIVE UTILITY
A, B, E, Ricin, SEB (Commercially
Best Score 0.901
available as a freeze-dried reagent);
BioVeris M1M 0.726
E. coli O157:H7 (Commercially
available as wet/frozen reagent and Lowest Score 0.217
through the DoD’s Critical Reagents
Program) Preference Set: Analytical Laboratory
DESCRIPTION:
The M1M is an automated analyzer designed for use with BV™ reagents.
This system provides sample handling, detection based upon BioVeris™ DIAGNOSTIC Laboratory Ranking
(BV) Technology, electrochemiluminescence, and analysis in a 96-well M Series M1M ranked in the highest third of all evaluated
microplate or minitube format. This system is designed for the detection of products for diagnostic laboratories and earned 92% of
multiple analytes, from small molecules, to proteins, to microorganisms, in the utility points of the best score.
a wide variety of matrices. The system processes a single sample in about
ALTERNATIVE UTILITY
one minute and an entire plate in approximately 90 minutes. It can also
Best Score 0.909
run a partial or an entire microplate in a single or multi-test mode. The
instrument automatically performs a system check to ensure proper system BioVeris M1M 0.837
operation on start-up. The system also checks for reagent type and reagent Lowest Score 0.321
usage to ensure adequate supply and proper system function. The system
also has the capability to dispense reagents into sample tubes or wells. An Preference Set: Diagnostic Laboratory
intuitive graphical software interface provides wizards to assist with plate
set-up, allows for use of pre-set protocols or user determined protocols, and
real-time updates of system output and data review. This system has been
designed to meet applicable requirements of MIL-STD 810F. MOBILE Laboratory Ranking
M Series M1M ranked in the highest third of all evaluated
BV Technology uses a paramagnetic microparticle as the solid support for utility points of the best score.
formation of a reaction. Multiple compounds can be labeled with BV-TAG™,
the product name for ruthenium (II) tris-bipyridine. Using a variety of linking ALTERNATIVE UTILITY
chemistries, the ruthenium molecule can be directly bound to proteins, Best Score 0.883
thiols, oligonucleotides, carbohydrates, and carboxyl groups using a simple BioVeris M1M 0.782
labeling and purification procedure. For BV technology, ruthenium serves Lowest Score 0.379
as the detector molecule for the system. At the core of the instrument
system is a flow cell designed to measure the amount of ruthenium bound Logistics Biological Agents Effectiveness Operations
to the paramagenetic microparticles through a chemical reaction known as Preference Set: Mobile Laboratory
electrochemiluminescence. When the reaction mixture enters the flow cell,
a magnet captures the microparticles on the surface of an electrode. Any
components of the assay or sample that are not bound specifically to the FIELD USE Ranking
microparticles through the assay component interactions continue past the M Series M1M ranked in the highest third of all evaluated
electrode and exit the system as part of the waste stream. BV-TAG labeled products for field use and earned 85% of the utility points
species on the microparticles are detected by introducing tripropylamine
of the best score.
(TPA) to the flow cell, applying an oxidizing potential at the electrode and
measuring the integrated intensity of the emitted light. The flow cell is then ALTERNATIVE UTILITY
washed with a cleaning solution and prepared for the next sample. For Best Score 0.943
the electrochemiluminescent reaction, the system uses two bulk reagent
BioVeris M1M 0.805
solutions that enter the flow cell via bulk solution containers attached
directly to the instrument system. The first bulk reagent, known as BV Assay Lowest Score 0.343
Buffer contains TPA that is used in the electrochemiluminescent reaction Logistics Operations Effectiveness Biological Agents
process. The second bulk reagent is BV Cell Cleaner that is used by the Preference Set: Field Use
system to remove the previous reaction from the flow cell in preparation for
receipt of the next sample.
II:172
Emanuel and Fruchey

requires water aliquots • Shelf life between 1-3 years
source
• Single sample detection in • Multiplex assay not available
between 20-30 min • No additional pieces of
BEST FIT WORST FIT • Less than 100 ul volume
automated system be deactivated
• An afternoon of training Operational conditions:
CONTACT INFORMATION • Operated from 4°C to 37°C
• Less than 5 min required for
BioVeris Corporation • Components can be stored at
set-up
16020 Industrial Drive • 0-2 manual steps required for room temperature
Gaithersburg, MD 20877 detection • The performance of the device
www.bioveris.com or system is not influenced by
Re-use: relative humidity
Jill White multiple use Sensitivity:
(301) 869-9800 • 3 solutions or buffers used • 100-1,000 CFU per ml
(240) 632-2206 fax • 1 component
jwhite@bioveris.com • A decontamination protocol is
required for use one time per Maturity gauge:
week • Is commercially available
COST t
• $2,000.00/system or device • 0-1 consumable or expendable
needed MOST MATURE LEAST MATURE
• Expected system or device life
of 5-10 years
procedures
II:173
M SERIES M1R
by BioVeris Corp.

THE FOLLOWING: M Series M1R ranked in the highest third of all evaluated
Bacillus anthracis, E. coli 0157: products for analytical laboratories and earned 80% of
H7, Botulinum toxins A, B, E, SEB, the utility points of the best score.
Ricin (Commercially available as ALTERNATIVE UTILITY
wet/frozen reagent); Francisella Best Score 0.901
tularensis, Yersinia pestis,
BioVeris M1R 0.718
Orthopox virus, Smallpox virus
(Commercially available as a Lowest Score 0.217
freeze-dried reagent) Effectiveness Biological Agents Logistics Operations
DESCRIPTION:
The M1R is an automated
analyzer designed for use with BV™ reagents. This system provides
sample handling, detection based upon BioVeris™ (BV) Technology, DIAGNOSTIC Laboratory Ranking
electrochemiluminescence, and analysis in a 96-well microplate format. M Series M1R ranked in the highest third of all evaluated
This system is designed for the detection of multiple analytes, from small products for diagnostic laboratories and earned 91% of
molecules, to proteins, to microorganisms, in a wide variety of matrices. the utility points of the best score.
The system processes a single sample in about one minute and an entire ALTERNATIVE UTILITY
plate in approximately 90 minutes. It can also run a partial or an entire
Best Score 0.909
microplate in a single or multi-test mode. The instrument automatically
performs a system check to ensure proper system operation on start-up. The BioVeris M1R 0.828
system also checks for reagent type and reagent usage to ensure adequate Lowest Score 0.321
supply and proper system function. An intuitive graphical software interface
provides wizards to assist with plate set-up, allows for use of pre-set Preference Set: Diagnostic Laboratory
protocols or user determined protocols, and real-time updates of system
output and data review.

BV Technology uses a paramagnetic microparticle as the solid support for M Series M1R ranked in the highest third of all evaluated
formation of a reaction. Multiple compounds can be labeled with BV-TAG™, products for mobile laboratories and earned 88% of the
the product name for ruthenium (II) tris-bipyridine. Using a variety of linking utility points of the best score.
chemistries, the ruthenium molecule can be directly bound to proteins,
thiols, oligonucleotides, carbohydrates, and carboxyl groups using a simple ALTERNATIVE UTILITY
labeling and purification procedure. For BV technology, ruthenium serves Best Score 0.883
as the detector molecule for the system. At the core of the instrument BioVeris M1R 0.775
system is a flow cell designed to measure the amount of ruthenium bound Lowest Score 0.379
to the paramagenetic microparticles through a chemical reaction known as
electrochemiluminescence. When the reaction mixture enters the flow cell, Logistics Biological Agents Effectiveness Operations
a magnet captures the microparticles on the surface of an electrode. Any Preference Set: Mobile Laboratory
microparticles through the assay component interactions continue past the
electrode and exit the system as part of the waste stream. BV-TAG labeled FIELD USE Ranking
species on the microparticles are detected by introducing tripropylamine M Series M1R ranked in the highest third of all evaluated
(TPA) to the flow cell, applying an oxidizing potential at the electrode and products for field use and earned 83% of the utility points
of the best score.
washed with a cleaning solution and prepared for the next sample. For
the electrochemiluminescent reaction, the system uses two bulk reagent ALTERNATIVE UTILITY
solutions that enter the flow cell via bulk solution containers attached Best Score 0.943
directly to the instrument system. The first bulk reagent, known as BV Assay BioVeris M1R 0.778
Buffer contains TPA that is used in the electrochemiluminescent reaction Lowest Score 0.343
process. The second bulk reagent is BV Cell Cleaner that is used by the
system to remove the previous reaction from the flow cell in preparation for Logistics Operations Effectiveness Biological Agents
receipt of the next sample. Preference Set: Field Use
II:174
Emanuel and Fruchey

source
BEST FIT WORST FIT • Less than 100 ul volume • One additional piece of
automated system
be deactivated
CONTACT INFORMATION
BioVeris Corporation
16020 Industrial Drive • 0-2 manual steps required for • Operated from 15°C to 37°C
Gaithersburg, MD 20877 detection • Components can be stored at
www.bioveris.com room temperature
Re-use: • Performance of the device or
Point of Contact: • Device or system is intended for system is not influenced by
Jill White multiple use relative humidity
(240) 632-2206 fax • 1 component Sensitivity:
jwhite@bioveris.com • A decontamination protocol is • 100-1,000 CFU per ml
required for use one time per
week
Maturity gauge:
• $5.63/sample Maintenance: t
• $<50,000.00/system or device • 0-1 consumable or expendable
needed
• Expected life is 5-10 years MOST MATURE LEAST MATURE
procedures
II:175
M SERIES M384
by BioVeris Corp.

DETECTING THE M Series M384 ranked in the highest third of all
Bacillus anthracis, E. coli 79% of the utility points of the best score.
0157:H7, Botulinum toxins A, ALTERNATIVE UTILITY
B, E, SEB, Ricin (Commercially Best Score 0.901
available as wet/frozen
BioVeris M384 0.715
reagent); Francisella tularensis,
Yersinia pestis, Orthopox virus, Lowest Score 0.217
Smallpox virus (Commercially Effectiveness Biological Agents Logistics Operations
available as a freeze-dried Preference Set: Analytical Laboratory
reagent)

The M384 is an automated analyzer designed for use with BV™ reagents.
This system provides sample handling, detection based upon BioVeris™ M Series M384 ranked in the highest third of all
(BV) Technology, electrochemiluminescence, and analysis in a 96- or 384- evaluated products for diagnostic laboratories and
well microplate format. This system is designed for the detection of multiple earned 90% of the utility points of the best score.
analytes, from small molecules, to proteins, to microorganisms, in a wide ALTERNATIVE UTILITY
variety of matrices. The system processes a single sample in about one Best Score 0.909
minute and an entire plate in approximately 12 minutes. It can also run a
BioVeris M384 0.814
partial or an entire microplate in a single or multi-test mode. The instrument
Lowest Score 0.321
automatically performs a system check to ensure proper system operation
on start-up. The system also checks for reagent type and reagent usage to Effectiveness Operations Biological Agents Logistics
ensure adequate supply and proper system function. An intuitive graphical Preference Set: Diagnostic Laboratory
software interface provides wizards to assist with plate set-up, allows for use
of pre-set protocols or user determined protocols, and real-time updates of
system output and data review.
TECHNOLOGY: M Series M384 ranked in the highest third of all
BV Technology uses a paramagnetic microparticle as the solid support for evaluated products for mobile laboratories and earned
formation of a reaction. Multiple compounds can be labeled with BV-TAG™, 73% of the utility points of the best score.
the product name for ruthenium (II) tris-bipyridine. Using a variety of linking
chemistries, the ruthenium molecule can be directly bound to proteins, ALTERNATIVE UTILITY
thiols, oligonucleotides, carbohydrates, and carboxyl groups using a simple Best Score 0.883
labeling and purification procedure. For BV technology, ruthenium serves BioVeris M384 0.646
as the detector molecule for the system. At the core of the instrument Lowest Score 0.379
system is a flow cell designed to measure the amount of ruthenium bound
to the paramagenetic microparticles through a chemical reaction known as Logistics Biological Agents Effectiveness Operations
electrochemiluminescence. When the reaction mixture enters the flow cell, Preference Set: Mobile Laboratory
a magnet captures the microparticles on the surface of an electrode. Any
microparticles through the assay component interactions continue past the FIELD USE Ranking
electrode and exit the system as part of the waste stream. BV-TAG labeled M Series M384 ranked in the middle third of all evaluated
species on the microparticles are detected by introducing tripropylamine products for field use and earned 70% of the utility points
(TPA) to the flow cell, applying an oxidizing potential at the electrode and of the best score.
washed with a cleaning solution and prepared for the next sample. For ALTERNATIVE UTILITY
the electrochemiluminescent reaction, the system uses two bulk reagent Best Score 0.943
solutions that enter the flow cell via bulk solution containers attached BioVeris M384 0.661
directly to the instrument system. The first bulk reagent, known as BV Assay Lowest Score 0.343
Buffer contains TPA that is used in the electrochemiluminescent reaction
process. The second bulk reagent is BV Cell Cleaner that is used by the Logistics Operations Effectiveness Biological Agents
system to remove the previous reaction from the flow cell in preparation for Preference Set: Field Use
receipt of the next sample.
II:176
Emanuel and Fruchey

source
automated system
be deactivated
• A day of training
CONTACT INFORMATION
BioVeris Corporation
16020 Industrial Drive • 0-2 manual steps required for • Operated from 25°C to 37°C
Gaithersburg, MD 20877 detection • Components can be stored at
www.bioveris.com room temperature
Re-use: • Performance of the device or
Point of Contact: • Device or system is intended for system is not influenced by
Jill White multiple use relative humidity
jwhite@bioveris.com • No cleaning required • 100-1,000 CFU per ml

COST • 0-1 consumable or expendable • Is commercially available
• $4.75/sample wet frozen assay needed
• $<95,000.00/system or device • Every 6 months service required t
II:177
MAGIChip
by Johns Hopkins University Applied Physics Laboratory

DETECTING MAGIChip ranked in the lowest third of all evaluated
Francisella
pestis, E. coli 0157: MAGIChip 0.346
H7, Vibrio cholera, Lowest Score 0.217
Corynebacterium
diptheria, Effectiveness Biological Agents Logistics Operations
Burkholderia
mallei, Burkholderia
pseudomallei,
Coxiella burnetti,
Rickettsia prowazekii, Brucella species (Assays developed)
MAGIChip ranked in the lowest third of all evaluated
DESCRIPTION:
The technology described here is not a PCR system but an alternative approach to products for diagnostic laboratories and earned 35% of
multiplexed bacterial identification. A bacterial biochip prototype has been developed the utility points of the best score.
to address these issues. The prototype consists of a microarray based on ribosomal
sequences. Multiple probes are developed for unique areas of both 16S and 23S ALTERNATIVE UTILITY
ribosomal sequences in order to discriminate bacteria not only at the genus and Best Score 0.909
species level, but using all levels of the phylogenetic tree. This redundancy provides
MAGIChip 0.321
a greater degree of confidence in the identification as the correct pathway to an
identification must be consistent throughout the analysis. For example, if an unknown Lowest Score 0.321
and unculturable microorganism presented to the biochip has a low G/C content or
is not gram positive, it is not possible to be misidentified as Bacillus anthracis even Effectiveness Operations Biological Agents Logistics
though the unknown may have some sequence similarity to specific Bacillus anthracis Preference Set: Diagnostic Laboratory
probes. In addition, the assay described herein is rapid and has a low possibility
of artifactual results due to sample manipulations following extraction. Since
ribosomal RNA is present in many copies per bacterial cell, PCR is not necessary to
amplify the signal output. As all live cells and spores have ribosomal RNA, there is MOBILE Laboratory Ranking
always a detectable signal. This is unlike PCR where identifications are often made MAGIChip ranked in the lowest third of all evaluated
by absence of signal. If the sequence is not present in the genome of the bacteria
undergoing PCR, the signal is negative, leaving the investigator to determine whether products for mobile laboratories and earned 43% of the
matrix effects could have interfered with the reaction or whether the sample is a true utility points of the best score.
negative. Finally, and perhaps most important in any new technology, the biochip
format is extremely amenable to integration with current gold standard methods such ALTERNATIVE UTILITY
as PCR or immunological assays. The current biochip has been developed for the Best Score 0.883
identification of Bacillus species.
MAGIChip 0.379
MAGIChip microarray technology discriminates microorganisms from Kingdom to the
species level based on single polymorphism nucleotide detection using ribosomal Logistics Biological Agents Effectiveness Operations
RNA. An adaptation of this approach also discriminates live versus dead bacterial Preference Set: Mobile Laboratory
and fungal agents. MAGIChip technology encompasses all steps from colony to
signal readout and interpretation. This approach is rapid (under 1-2 hours), robust
(portable, enzyme independent) and reusable (20-50 times, thus lowering costs). The
current portable reader is small, lightweight and relatively inexpensive. Each reader FIELD USE Ranking
is composed of a laser light source for illumination of the target molecules and a MAGIChip ranked in the lowest third of all evaluated
computer-controlled CCD camera for recording signal output. After the initial step,
all the steps in the isolation, purification and labeling of material are performed in
a single column. The preparation of sample is chemically based, not enzymatically of the best score.
based. User confidence measures have been added and additional measures are
under advanced development for individual sample quality control. This technology ALTERNATIVE UTILITY
has been developed for identification of Bacillus anthracis and can be developed for Best Score 0.943
additional microbial targets including viruses (orthopox family completed). MAGIChip MAGIChip 0.395
technology will enhance and harmonize with existing PCR based identification
technology. A centralized secure database and collating tools are under advanced Lowest Score 0.343
development as part of this effort.
II:178
Emanuel and Fruchey

electrical requirement or can toaster
ANALYTICAL use batteries • Between 1 and 5 kg
• The system or device does not • Unknown shelf life
require water
MOBILE FIELD source
• Multiple centrifugation steps
• The system or device does not • No shaking or vortexing steps
DIAGNOSTIC through internal software
Throughput of product: • Assay not available, but capable
• Single sample detection greater of detecting four or more
BEST FIT WORST FIT • 2 samples/batch or higher the same test
• NA volume needed per test for • Two additional pieces of
detection equipment needed
automated system
• Sounds are produced that cannot
be deactivated
CONTACT INFORMATION Training/Speed/Manpower: • Unknown BTUS generated
Johns Hopkins University Applied Physics Laboratory
11100 Johns Hopkins Rd., MS 2-217 for set-up Operational conditions:
Laurel, MD 20723 • Greater than 12 manual steps • Unknown operational conditions
required for detection • Unknown components storage
Joany Jackman Re-use: system is unknown at relative
(443) 778-8501 • Device or system is intended for humidity
(443) 778-6904 fax multiple use
Joany5@aol.com • 4 solutions or buffers used Sensitivity:
• 3 components • Unknown CFU per ml
Maturity gauge:
COST Maintenance: • A few devices or systems exist
• $1.00-1.50/sample based on reuse of chips • 5 or more consumables or (brass board)
• $20,000.00-25,000.00/portable reader expendables needed
• Approx. $50.00/chip in batches of 1000 • Unknown service required t
II:179
MAPP-DS
by Invitrogen

DETECTING MAPP-DS ranked in the highest third of all evaluated
Yersinia pestis, Invitrogen MAPP-DS 0.635
Botulinum toxin
Lowest Score 0.217
A, Botulinum
toxin B, Effectiveness Biological Agents Logistics Operations
Staphylococcal Preference Set: Analytical Laboratory
toxin B, Ricin
toxin (Assay
developed) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: MAPP-DS ranked in the highest third of all
Under contract to the Defense Threat Reduction Agency (DTRA), evaluated products for diagnostic laboratories and
Invitrogen Federal Systems has developed a multiplex array-based earned 81% of the utility points of the best score.
portable detector utilizing novel microfluidics and Resonance ALTERNATIVE UTILITY
Light Scattering (RLS) based detection chemistry. RLS is an
Best Score 0.909
ultra-sensitive signal generation and detection technology based
Invitrogen MAPP-DS 0.738
on nanometer-sized colloidal metal particles (RLS Particles) that
can be used as labels for a wide variety of analytical bioassays. Lowest Score 0.321
This MAPP-DS can multiplex six agents currently with the ability
to increase to 50+ targets, in multiple matrices - clinical and Preference Set: Diagnostic Laboratory
environmental samples. It is fast – currently 20 to 40 minutes,
less than 20 minutes expected in commercial product, blending
high specificity and high sensitivity (based on RLS and antibody
optimization). The MAPP-DS is easy to use, small (< 20lbs MOBILE Laboratory Ranking
– portable) and ruggedized with on board software and minimal MAPP-DS ranked in the highest third of all evaluated
logistics. The workflow is simple and includes the following products for mobile laboratories and earned 77% of
steps: filtration of the sample (note - future development will the utility points of the best score.
include integrated sample preparation); insertion of the array
ALTERNATIVE UTILITY
based microfluidic flow cell into the instrument; insertion of self
Best Score 0.883
contained reagent pack; injection of the sample; read the results
in real time. Ten prototype units have been manufactured and are Invitrogen MAPP-DS 0.678
in the process of being validated. Commercialization of the system Lowest Score 0.379
is planned in 2007/2008.
Resonance Light Scattering (RLS) is an ultra-sensitive signal
generation technology based on nanometer-sized colloidal metal
particles. When illuminated with simple white light, RLS particles FIELD USE Ranking
of uniform dimension generate an intense scattered light signal, MAPP-DS ranked in the highest third of all evaluated
the color and intensity of which are predictable from particle size, products for field use and earned 75% of the utility
shape, and composition. Signal intensity is up to one million times
greater than fluorescent dyes. The advantages of RLS based
assays are (1) Sensitivity (> than fluorescence); (2) Stability (no ALTERNATIVE UTILITY
photobleaching); (3) Archiving (permanent record); (4) Flexibility Best Score 0.943
(conjugation to multiple molecules); (5) Simplicity (simple low Invitrogen MAPP-DS 0.706
cost, low power, white light illumination); (6) Manufacturability Lowest Score 0.343
(established history).
II:180
Emanuel and Fruchey

• System or device uses batteries months and 1 year
ANALYTICAL require water Ease of use/Utility:
MOBILE FIELD require an external vacuum raw data or call a positive
Throughput of product: biological agents or toxins within
DIAGNOSTIC • Single sample detection in 20 the same test
minutes or less • No additional pieces of
• 1 sample/batch equipment needed
BEST FIT WORST FIT • The system or device is • No sounds produced that cannot
currently fully automated be deactivated
training and minimal technical • Operated from 4°C to 45°C
skills • Components must be stored at
CONTACT INFORMATION • Less than 5 minutes set-up 4°C
Invitrogen Federal Systems required • The performance of the device
7335 Executive Way • 3-5 manual steps required for or system is not influenced by
detection relative humidity
Frederick, MD 21704
http://www.invitrogen.com
Re-use: Sensitivity:
• Device or system is intended for • 1,000-10,000 CFU per ml
Point of Contact:
multiple use
Willem Folkerts, Business Director • More than 4 solutions or buffers
(240) 379-4209 used
Maturity gauge:
(240) 379-4750 • 1 component • A few devices or systems exist
willem.folkerts@invitrogen.com • Simple cleaning cycle using (brass board)
a single reagent pack is • Is expected to be ready for
recommended after five assays. commercialization within one
COST calendar year
• $0.50-3.00/sample Maintenance: • Less than $1,000,000 required
• Every 6 months service required to advance device or system to
• Expected life is between 5-10 commercialization
• No daily quality assurance any peer reviewed scientific
procedures publications or independent
evaluations
Transportation: t
toaster
II:181
MAR-Magnetic Assay Reader

by Quantum Design

DETECTING MAR ranked in the highest third of all evaluated products
tularensis, E. MAR-Magnetic Assay Reader 0.755
coli 0157:H7, Lowest Score 0.217
Orthopox virus,
SEB (assays Effectiveness Biological Agents Logistics Operations
developed) Preference Set: Analytical Laboratory
DESCRIPTION:
The Magnetic DIAGNOSTIC Laboratory Ranking
Assay Reader
MAR ranked in the highest third of all evaluated products
(MAR) is an
innovative, for diagnostic laboratories and earned 90% of the utility
patented platform capable of performing a wide range of points of the best score.
biochemical assays in the fields of medical diagnostics, chemical ALTERNATIVE UTILITY
and biological warfare agents, and research. The MAR provides Best Score 0.909
quantitative results via the detection of superparamagnetic MAR-Magnetic Assay Reader 0.818
particles (used as labels) which are bound to the analyte. Used
Lowest Score 0.321
in this manner, magnetic particle detection offers the benefits of
sensitivity, speed and low cost. Additionally, its’ portability opens Effectiveness Operations Biological Agents Logistics
the avenues to convenient field and point of care testing. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
The MAR measures the amount of magnetic material bound to
the analyte and localized in the analytical region. Three basic MOBILE Laboratory Ranking
subsystems are employed in this detection system. A ferrite MAR ranked in the highest third of all evaluated products
core electromagnet drives the oscillating magnetic field used to for mobile laboratories and earned 81% of the utility
excite the paramagnetic particles to saturation, thereby ensuring points of the best score.
maximum signal. Detection is performed by way of a mutual
ALTERNATIVE UTILITY
induction technique. The detector measures the local magnetic
Best Score 0.883
field expressed by the total mass of iron (as Fe3O4) in the sample.
Then by way of an empirically established calibration curve, this MAR-Magnetic Assay Reader 0.711
value may be corrected to the number of molecules of analyte. Lowest Score 0.379
Consisting of electronics, hardware and software, this subsystem
provides a user-friendly interface and digital readout of data in
standard ASCII files. The MAR is uniquely suited to a wide range
of point-of-care applications in the fields of medical diagnostics,
food and environmental monitoring, and battlefield detection of
chemical and biological agents. The flexibility of the instrument FIELD USE Ranking
built around the fundamental MAR detection principle, gives rise MAR ranked in the highest third of all evaluated products
to many instrument configurations as may be required by the for field use and earned 80% of the utility points of the
application. best score.
ALTERNATIVE UTILITY
Best Score 0.943
MAR-Magnetic Assay Reader 0.757
Lowest Score 0.343

II:182
Emanuel and Fruchey

• Can not view results “in real
time”
DIAGNOSTIC • Single sample detection 20 raw data or call a positive
• 1 samples/batch or higher, • Assay available and capable of
adaptable for more samples/ detecting two or more biological
BEST FIT WORST FIT batch agents or toxins within the same
• Less than 50 ul volume needed test
Quantum Design
6325 Lusk Boulevard for set-up
San Diego,CA 92121 • 0-2 manual steps required for Operational conditions:
www.qdusa.com detection • Operated from 4°C to 37°C
room temperature
Ron Laborde • Device or system is intended for • Performance of the device or
(858) 481-4400 multiple use system is not influenced by
(858) 481-7410 fax • 0-1 solution or buffer used relative humidity
laborde@qdusa.com • 2 components
COST Maintenance:
• $5.00/sample • 0-1 consumable or expendable Maturity gauge:
• Less than $2000.00/system or device needed • A few devices or systems exist
• No service required (brass board)
years
t
II:183
MatriCycler Thermocycler
by Quantum Design

DETECTING MatriCycler ranked in the lowest third of all evaluated
Able to amplify ALTERNATIVE UTILITY
toxins DNA MatriCycler 0.334
Lowest Score 0.217
DESCRIPTION:
The MatriCycler Effectiveness Biological Agents Logistics Operations
is a high speed Preference Set: Analytical Laboratory
high throughput
thermal cycler for
use in amplifying DIAGNOSTIC Laboratory Ranking
DNA, DNA sequencing, and other applications requiring rapid
MatriCycler ranked in the lowest third of all evaluated
changes in temperature. The system is based on a new patented
technology that allows for both high speed thermal cycling and products for diagnostic laboratories and earned 47% of
high density work. The system is the only thermal cycler currently the utility points of the best score.
available that will work with both 384 well plates and 1536 well ALTERNATIVE UTILITY
plates with sample volumes as low as one microliter. Best Score 0.909
TECHNOLOGY: MatriCycler 0.428
The MatriCycler is not a detector. It is a high throughput Lowest Score 0.321
thermocycler for amplifying DNA samples.

MatriCycler ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.883
MatriCycler 0.486
Lowest Score 0.379

FIELD USE Ranking

MatriCycler ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
MatriCycler 0.651
Lowest Score 0.343

II:184
Emanuel and Fruchey

require water • NA shelf life
source
• NA centrifugation steps
require an external vacuum • NA vortexing steps
source • NA to interpret raw data or call a
positive through internal software
DIAGNOSTIC Throughput of product: • NA detecting multiple biological
• Single sample detection agents or toxins within the same
between 30 and 40 minutes test
• 384 samples/batch or higher • NA additional pieces of
BEST FIT WORST FIT • Less than 10 ul volume needed equipment needed
• The system or device could Signature:
automated system
be deactivated
CONTACT INFORMATION Operational conditions:
MatriCal, Inc. • Operated from 4°C to 45°C
for set-up
665 N. Riverpoint Blvd. • NA steps required for detection • NA components storage
Spokane, WA 99202 • Performance of the device or
www.matrical.com system is not influenced by
Re-use:
• Device or system is intended for relative humidity
Point of Contact: single use
Kevin R. Oldenburg • NA solution or buffer used Sensitivity:
(509) 343-6222 • NA components • 100-1000 CFU per ml
(509) 343-6220 fax • NA cleaning
Kevin.Oldenburg@matrical.com Maturity gauge:
Maintenance: • A few devices or systems exist
• 0-1 consumable or expendable (brass board)
COST needed
• $0.50/sample plus cost of Taq enzyme • Once a year service required t
• $34,000.00/system or device • Expected life is 3-5 years
II:185
MatriXarray

DETECTING THE MatriXarray ranked in the highest third of all evaluated
Able to detect any the utility points of the best score.
organisms for which assay ALTERNATIVE UTILITY
are developed. Best Score 0.901
MatriXarray 0.690
DESCRIPTION:
Lowest Score 0.217
MatriXarray is an
integrated system for Effectiveness Biological Agents Logistics Operations
making Microarrays of Preference Set: Analytical Laboratory
oligonucleotides that
includes software for
designing Microarrays,
a semi-conductor chip
on which the microarray of oligonucleotides is made by in situ MatriXarray ranked in the highest third of all evaluated
synthesis, a microarray synthesizer that can fit on a benchtop, products for diagnostic laboratories and earned 79% of
and software for data acquisition and recording. With this system the utility points of the best score.
custom oligonucleotides microarrays can be produced within 48 ALTERNATIVE UTILITY
hours, and users can customize the content of the chip, optimize Best Score 0.909
microarray performance, and make immediate changes to
MatriXarray 0.715
microarray designs as revisions or new data appear in genomic
databases. CombiMatrix oligonucleotides microarrays can be used Lowest Score 0.321
for both gene expression and DNA sequence identification for Effectiveness Operations Biological Agents Logistics
pathogen detection and for SNP analysis. This system allows for a Preference Set: Diagnostic Laboratory
large number of DNA sequences to be detected with a very small
amount of sample.

DNA sequence Detection for Pathogen Analysis starts with design MatriXarray ranked in the middle third of all evaluated
of oligonucleotides arrays. Roche has a client-server based products for mobile laboratories and earned 64% of the
software system to manage the entire process. The microarray utility points of the best score.
starts with the design of an appropriate set of capture probes.
The user begins by using a target specifier software module ALTERNATIVE UTILITY
which checks genomic databases for cross hybridization. After Best Score 0.883
probes are designed the user then uses software for arranging the MatriXarray 0.561
oligos on a microarray. The layout data is sent to the synthesizer Lowest Score 0.379
hardware to produce the microarrays. Each microarray has
up to 1000 oligo targets. Oligos are synthesized on a silicone Logistics Biological Agents Effectiveness Operations
semiconductor chip using. A highly porous three-dimensional layer Preference Set: Mobile Laboratory
is applied to the surface of the chip that greatly increases the
effective surface area of an assay site. Oligo capture probes are
then synthesized in the porous layer by growing DNA sequences FIELD USE Ranking
off on an initial nucleotide base that is covalently linked to the MatriXarray ranked in the middle third of all evaluated
porous layer. Using this semiconductor technology for synthesis products for field use and earned 67% of the utility points
eliminates the need for moving parts on the chip production of the best score.
instrumentation. The Reader Hybridizer is bench top sized and
can process up to six chips at one time. Fluorescent labels are ALTERNATIVE UTILITY
attached to the sample of interest for detection purposes before Best Score 0.943
hybridization. MatriXarray 0.628
Lowest Score 0.343

II:186
Emanuel and Fruchey

source
time”
• Unknown if system is able to
• Single sample detection positive through internal software
• The system or device could • Two additional pieces of
automated system
Signature:
• Greater than 20 minutes • Unknown BTUS generated
required for set-up
9115 Hague Rd., P.O. Box 50414 • 3-5 manual steps required for
Indianapolis, IN 46250-0141 detection Operational conditions:
www.roche-applied-science.com • Operated from 15°C to 37°C
• Components must be frozen
Re-use:
Mary Pingitore multiple use system is not influenced by
(800) 845-7355 x8015 • Unknown solution or buffer relative humidity
(301) 482-1315 fax used
mary.pingitore@roche.com • 2 components Sensitivity:
• No cleaning required • 1-100 CFU per ml

• Unknown/sample • 2 consumables or expendables • A few devices or systems
• Approx. $95,000.00/system or device needed exist (brass board), will be
• Less than once a year service commercially available spring of
required
2003
• Less than 5 minutes required t
II:187
MCAD
by Northrop Grumman

DETECTING THE MCAD ranked in the middle third of all evaluated
None reported (Generic the utility points of the best score.
Best Score 0.901
DESCRIPTION:
The MCAD is a passive Northrop Grumman MCAD 0.477
infrared standoff Lowest Score 0.217
detector. The MCAD was
designed specifically
for use in the field
for fixed-site and/or
mobile (on-the-move)
applications. The DIAGNOSTIC Laboratory Ranking
MCAD would be used MCAD ranked in the middle third of all evaluated
to provide real-time products for diagnostic laboratories and earned 63% of
warning of the presence the utility points of the best score.
of an airborne biological
ALTERNATIVE UTILITY
agent, and can be used
Best Score 0.909
to monitor the location
of an airborne agent by Northrop Grumman MCAD 0.569
using more than one Lowest Score 0.321
MCAD to triangulate the position of the threat, permitting the user
to track the position of the agent cloud(s) with time. The MCAD
detects materials of interest both at the sensor, and at some
distance from the sensor. It has been used for several years to
detect chemicals in the air at multi-kilometer ranges. It monitors
an area for the presence or absence of specific materials. Over MOBILE Laboratory Ranking
the past few years the infrared spectral features of biological MCAD ranked in the middle third of all evaluated
organisms have been better quantified. Evidence indicates products for mobile laboratories and earned 61% of the
distinct, identifiable infrared characteristics for a number of the utility points of the best score.
biological materials. Preliminary detection algorithms have been
developed and were used in a government field test in 2005, and ALTERNATIVE UTILITY
have been further refined since then. Best Score 0.883
The MCAD operates in the 8-12 µm region of the electromagnetic
spectrum. It uses passive infrared spectroscopy to determine the Logistics Biological Agents Effectiveness Operations
presence or absence of specific materials of interest. The MCAD Preference Set: Mobile Laboratory
contains a Fourier Transform Infrared (FT-IR) spectrometer with a
cryogenically cooled Mercury Cadmium Telluride (MCT) detector.
FIELD USE Ranking
MCAD ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:188
Emanuel and Fruchey

• System or device has 110V or • Can view results “in real time”
220V electrical requirement • No centrifugation steps
require water • System always able to interpret
equipment needed
• Detects airborne material in Signature:
less than 1 second • No sounds produced that cannot
• 32 samples/batch be deactivated
• No liquid detection • Greater than 500 BTUS
BEST FIT WORST FIT • The system or device is generated
Training/Speed/Manpower: • Operated from -32°C to 49°C
• A day of training and technical • The peak performance of the
skills are required device or system is at low relative
• 5-10 minutes set-up required humidity
Northrup Grumman detection
7055 Troy Hill Drive, Suite 500 Sensitivity:
• 10,000 ACPLA (Agent Containing
Elkridge, MD 21075
Re-use: Particles per Liter Air)
Point of Contact: multiple use
Keith Uithoven Maturity gauge:
(410) 471-6513 • Hardware is commercially
• 0 components
(410) 865-5484 • No cleaning required available. Biological Detection
keith.uithoven@ngc.com algorithms are in the brass board
state.
Maintenance: • Is expected to be ready for
calendar years
COST years
• $350,000.00/device or system • No daily quality assurance
for advancement of device or
procedures
system to commercialization
Transportation: reviewed scientific publications
• Larger than a home dishwasher or independent evaluations
• More than 50 kg
• Reagent shelf life greater than t
3 years
II:189
Microfluidic FRET Reader


DETECTING Microfluidic FRET Reader ranked in the middle third of all
any organisms for Best Score 0.901
which assay are Microfluidic FRET Reader 0.594
developed.
Lowest Score 0.217

This instrument Preference Set: Analytical Laboratory
is a compact
fluorescence
resonance energy DIAGNOSTIC Laboratory Ranking
transfer (FRET) reader, capable of rapid one-step immunoassays
Microfluidic FRET Reader ranked in the highest third of
(without wash steps). Immuno FRET assays were developed for
Bacillus cereus spores and E. coli bacteria (see Bruno et al., all evaluated products for diagnostic laboratories and
Biochem. Biophys. Res. Comm. Vol. 287:875-880, 2001). Assays earned 80% of the utility points of the best score.
are currently performed in 50 uL plastic or silicon cartridges, ALTERNATIVE UTILITY
OmniSite is developing microfluidic cartridges that will contain Best Score 0.909
freeze-dried immuno-FRET reagents that can be rehydrated by the
sample and assayed within minutes.
Lowest Score 0.321
FRET is popular technique in the research and clinical diagnostic
arenas for such popular assays as the TaqMan PCR assays,
because it enables a high sensitivity “lights on” or “lights off”
effect due to quenching or liberation of fluorescence with an
absorbing molecule (quencher). In OmniSite’s FRET format, MOBILE Laboratory Ranking
Oregon Green dyes are quenched by QSY-7. The reader has a Microfluidic FRET Reader ranked in the middle third of all
slider capable of holding eight or more single assay cartridges. evaluated products for mobile laboratories and earned
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Microfluidic FRET Reader ranked in the highest third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:190
Emanuel and Fruchey

battery requirement toaster
require water • Shelf life greater than 3 years
source
• Single sample detection 20 • Not capable of detecting multiple
automated system
be deactivated
CONTACT INFORMATION
• No set-up required
OmniSite BioDiagnostics, Inc.
• 0-2 manual steps required for Operational conditions:
101 West 6th Street, Suite 200 detection • Operated from 15°C to 37°C
Austin, TX 78701 • Components must be stored at
4°C
Re-use:
Point of Contact: • Device or system is intended for • Performance of the device or
John G. Bruno multiple use system is not influenced by
(512) 479-7732 x2202 • 3 solutions or buffers used relative humidity
(512) 494-0756 fax • 1 component
bruno@spec.com • No cleaning required Sensitivity:
• 100-1,000 CFU per ml
Maintenance:
COST needed • A few devices or systems exist
• $0.10/sample plus cost of immunoassay • Less than once a year service (brass board)
• $2,000.00/system or device required
years
• 10-20 minutes daily assurance
procedures
II:191
Mini-PCR Fluorescence Reader


DETECTING THE Mini-PCR Fluorescence Reader ranked in the middle third
FOLLOWING: of all evaluated products for analytical laboratories and
Able to detect any earned 67% of the utility points of the best score.
organisms/toxins ALTERNATIVE UTILITY
for which assays Best Score 0.901
are developed.

This instrument Effectiveness Biological Agents Logistics Operations
combines a Preference Set: Analytical Laboratory
compact thermal
cycler for PCR with
an epifluorescence
head to detect and measure fluorescence intensity optically
through a window on a microfluidic chip. The device reads TaqMan Mini-PCR Fluorescence Reader ranked in the highest third
PCR FRET assays very rapidly and detects amplification within of all evaluated products for diagnostic laboratories and
5–10 cycles of PCR, faster than comparable PCR readers. earned 79% of the utility points of the best score.
ALTERNATIVE UTILITY
TECHNOLOGY:
The mini-PCR FRET reader, originally funded by NASA SBIR, is Best Score 0.909
designed to detect PCR amplification of TaqMan assays in shuttle Mini-PCR Fluor. Reader 0.719
craft/space station workplace where microgravity environment Lowest Score 0.321
precludes normal liquid handling methods for innovative use of
microfluidic interconnections to prevent liquid spillage. OmniSite Effectiveness Operations Biological Agents Logistics
received high ratings from NASA for this Phase II SBIR funded
device and is in the process of filing two patents for the innovative
microfluidic chip design and the fluid interconnects that allow
rapid and facile snapping of the chip into place in microgravity MOBILE Laboratory Ranking
environment without liquid spillage. Mini-PCR Fluorescence Reader ranked in the middle third
of all evaluated products for mobile laboratories and
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Mini-PCR Fluorescence Reader ranked in the highest third
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:192
Emanuel and Fruchey

battery electrical requirements toaster
source
• Single sample detection 20 • Not capable of detecting multiple
automated system
be deactivated
CONTACT INFORMATION
OmniSite BioDiagnostics, Inc.
for set-up Operational conditions:
101 West 6th Street, Suite 200 • 3-5 manual steps required for • Operated from 4°C to 45°C
Austin, TX 78701 detection • Components must be frozen
• Performance of the device or
Point of Contact: Re-use: system is not influenced by
John G. Bruno • Device or system is intended for relative humidity
(512) 479-7732 x2202 multiple use
(512) 494-0756 fax • More than 4 solutions or buffers Sensitivity:
bruno@spec.com used • 1-100 CFU per ml
• 1 component
Maturity gauge:
• A few devices or system exist
COST Maintenance: (brass board)
• $0.50/sample plus cost of Taq enzyme • 2 consumables or expendables
• $3,000.00/system or device needed t
required
years
II:193
Mobile Molecular Laboratory

by MJ Research

DETECTING THE Mobile Molecular Laboratory ranked in the highest third
E. coli 0157: ALTERNATIVE UTILITY
H7, Orthopox Best Score 0.901
virus (Assays Mobile Molecular Lab. 0.627
developed)
Lowest Score 0.217
The Mobile Preference Set: Analytical Laboratory
Molecular
Laboratory is
a professional-
quality DNA laboratory in a suitcase. It is appropriate for field
investigation, education, or as a quick and inexpensive way Mobile Molecular Laboratory ranked in the middle third
to equip a lab just beginning DNA research. It features a of all evaluated products for diagnostic laboratories and
MiniCycler thermal cycler, microcentrifuge, mini gel box, compact earned 60% of the utility points of the best score.
power supply, compact UV transilluminator, transilluminator ALTERNATIVE UTILITY
photodocumentation system, insulating-foam cooler, benchtop Best Score 0.909
enzyme chiller, 500ml polypropylene bottles, and rugged foam-
lined plastic case. All instruments feature universal power
adapters and detachable cord sets and are resistant to power Lowest Score 0.321
surges. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The system would use PCR-based assays, which would require
running out the amplification products on pre-cast gels complete
with ethidium bromide; results would require interpretation by MOBILE Laboratory Ranking
user by observing gel on transilluminator or from a Polaroid photo Mobile Molecular Laboratory ranked in the middle third of
of gel. all evaluated products for mobile laboratories and earned
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Mobile Molecular Laboratory ranked in the lowest third of
all evaluated products for field use and earned 49% of the
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:194
Emanuel and Fruchey

require water • Shelf life greater than 3 years if
• The system or device does not lyophilized
source
require an external vacuum time”
DIAGNOSTIC Throughput of product: • System never able to interpret
• Single sample detection greater raw data or call a positive
than 60 minutes through internal software
BEST FIT WORST FIT • Less than 50 ul volume needed of detecting four or more
• The system or approach is not the same test
amendable to automation • No additional pieces of
equipment needed
• Greater than 20 minutes • No sounds produced that cannot
CONTACT INFORMATION
required for set-up be deactivated
MJ Research, Inc.
• Greater than 12 manual steps • Greater than 500 BTUS
590 Lincoln St. required for detection
Waltham, MA 02451 generated
www.mjr.com
multiple use
John Hansen • Components must be stored at
(617) 972-8157 x8157 • 5 or more components 4°C
(617) 923-8080 fax • No cleaning required • Performance of the device or
johnh@mjr.com system is not influenced by
relative humidity
Maintenance:
COST expendables needed Sensitivity:
• Unknown/sample • More often than every 6 months • 100-1,000 CFU per ml
• $6071.00 GSA price/system or device service required
• Expected life is 5-10 years Maturity gauge:
• 5-10 minutes required for daily • Is commercially available
t
II:195

by Morphix Technologies

DETECTING THE Morphix Chem Bio Detector ranked in the lowest third
Detects gram earned 38% of the utility points of the best score.
positive and gram ALTERNATIVE UTILITY
negative bacteria Best Score 0.901
DESCRIPTION: Morphix Chem Bio Detector 0.344

In January Lowest Score 0.217
2005, Morphix
Technologies was Preference Set: Analytical Laboratory
awarded a contract
by the Defense Threat Reduction Agency (DTRA) to develop a
hand-held chemical / biological detection unit for use by the
military and first responders. After completion of this two-year DIAGNOSTIC Laboratory Ranking
program, three prototypes have been developed. The wireless, Morphix Chem Bio Detector ranked in the middle third
electronic, chemical biological agent detector is very small (35mm of all evaluated products for diagnostic laboratories
x 85mm x 105mm) and weighs less than 400 grams. The Morphix and earned 55% of the utility points of the best score.
chem/bio detector is easy to use. Simply insert the colorimetric
ALTERNATIVE UTILITY
coupon coated with chemical formulations specific for classes
Best Score 0.909
of chemical and biological agents, into the Morphix chem/bio
detector and turn the unit on. Optoelectronic sensing of the Morphix Chem Bio Detector 0.499
coupon occurs at a predetermined rate. Upon detection of a color Lowest Score 0.321
change on the coupon, the results are communicated wirelessly.
The modular net-centric wireless communication technology is
adaptable to multiple communication protocols. The modularity of
this device makes it adaptable to many applications including as a
personal detection badge, perimeter detection, standoff detection
and mounted on an unmanned aerial vehicle or unmanned MOBILE Laboratory Ranking
ground vehicle. Given it is the only known device capable of Morphix Chem Bio Detector ranked in the middle third
detecting both chemical and biological threats in such a compact of all evaluated products for mobile laboratories and
package, the Morphix chem/bio detector is an excellent screening earned 56% of the utility points of the best score.
tool. This device has broad applicability within the military and
first responder communities. The wireless, electronic, chemical, ALTERNATIVE UTILITY
biological agent detection module provides broad chemical and Best Score 0.883
biological agent class detection with significantly smaller size, Morphix Chem Bio Detector 0.492
weight, cost, training requirements and power requirements than Lowest Score 0.379
current technologies.
Generic biological agent class detection (e.g. bacterial vegetative
cells or bacterial endospores) is achieved through the use of
colorimetric, labeled antibodies, and fluorescence-on chemistries FIELD USE Ranking
coupled with optical spectroscopy. Chemistries are contained in Morphix Chem Bio Detector ranked in the middle third
stable, proprietary formulations which have been hardened to
of all evaluated products for field use and earned 62%
perform under mil-spec environmental conditions.
of the utility points of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Morphix Chem Bio Detector 0.585
Lowest Score 0.343

II:196
Emanuel and Fruchey

or 110V electrical requirement
source
• Real time bioaerosol detection • No additional pieces of
• 2 samples/batch equipment needed
• Depends on the agent
concentration in the aerosol
BEST FIT WORST FIT • The system or device is
Signature:
be deactivated

skills
CONTACT INFORMATION 25°C to 45°C
• The effect of relative humidity on
Morphix Technologies required
the device or system is unknown
2557 Production Road • 0-2 manual steps required for
Virginia Beach, VA 23454 detection
www.morphtec.com Sensitivity:
• 100-1,000 CFU per ml
Re-use:
Kim Chapman multiple use Maturity gauge:
(757) 431-2260 x222 • 0-1 solution or buffer used • A few devices or systems exist
(757) 431-2255 • 2 components (brass board)
kchapman@morphtec.com • No cleaning required • Is expected to be ready for
Maintenance: calendar years
COST • Weekly change the sensor • $1,000,000 - $2,000,000
• <$25.00/sample cartridge and charge the battery required to advance the device or
• <$1,500.00/device or system • Expected life is between 1-3 system to commercialization
• Less than 5 minutes daily any peer reviewed scientific
quality assurance procedures publications or independent
evaluations
Transportation: t
• Approximately the size of a soda
can
• Less than 1 kg MOST MATURE LEAST MATURE
II:197

by Meso-Scale Discoveries

MSD Cartridge Reader ranked in the highest third of all
DETECTING THE
FOLLOWING:
E. coli O157:H7, ALTERNATIVE UTILITY
Yersinia pestis, VEE MSD Cartridge Reader 0.765
virus, Botulinum toxin
Lowest Score 0.217
A, SEB, Ricin (Assays
developed) Effectiveness Biological Agents Logistics Operations
DESCRIPTION:
The Cartridge Reader
is an electrochemiluminescence (ECL) based, portable system with all
assay reagents contained in a stand-alone cartridge. Just add sample to DIAGNOSTIC Laboratory Ranking
the cartridge and the system will do the rest. Cartridges are capable of MSD Cartridge Reader ranked in the highest third of
performing up to 20 tests per sample. The instrument is capable of rapid, all evaluated products for diagnostic laboratories and
highly sensitive measurements and detecting multiple analytes (up to 20 earned 93% of the utility points of the best score.
tests per sample) in a single cartridge. The system is being designed for use
ALTERNATIVE UTILITY
in the clinical diagnostics market. On top of superior detection capabilities
Best Score 0.909
across the spectrum of potential bioagents (viruses, bacteria and toxins,)
the MSD instrument is easy to use and capable of providing results in 15 MSD Cartridge Reader 0.846
minutes without any user intervention. The Cartridge Reader is perfectly Lowest Score 0.321
suited for the needs the first responder or a soldier out in the field.
Electrochemiluminescence (ECL) is a well-developed, commercial
technology for the detection and study of biomolecular interactions
and function. ECL-based assays employ labels that emit light when MOBILE Laboratory Ranking
electrochemically oxidized or reduced under appropriate chemical MSD Cartridge Reader ranked in the highest third of all
conditions. The existence of small, stable and highly efficient ECL labels evaluated products for mobile laboratories and earned
makes the technique robust, sensitive and easy to implement. ECL detection 90% of the utility points of the best score.
is already widely used in the military for detection of biological agents.
We have adapted the technology to allow ECL assays to be carried out ALTERNATIVE UTILITY
on inexpensive disposable electrodes in a format that is compatible with Best Score 0.883
multiplexed array-based measurements. Our systems are currently being MSD Cartridge Reader 0.794
evaluated at the Edgewood Chemical and Biological Center and USAMRIID. Lowest Score 0.379
Assays are carried out on proprietary cartridges that have integrated
electrodes that act as both a capture surface and an energy source for Logistics Biological Agents Effectiveness Operations
electrochemiluminescence excitation. The spatial control inherent in Preference Set: Mobile Laboratory
ECL induction and imaging detection allows for multiplexed array based
measurement employing patterned arrays of binding reagents on an
electrode surface. In addition, the cartridges contain all the necessary wet FIELD USE Ranking
reagents to perform a measurement. Cartridges are capable of detecting MSD Cartridge Reader ranked in the highest third of all
up to 20 analytes per sample. The cartridges will be manufactured using evaluated products for field use and earned 85% of the
well-established scalable techniques such as screen-printing that allow for
high volume manufacturing at low cost. These assays are capable of highly
sensitive detection with broad dynamic ranges. A cartridge can be read in ALTERNATIVE UTILITY
under 15 minutes. Best Score 0.943
Lowest Score 0.343

II:198
Emanuel and Fruchey

• System or device has a 110V • Approximately the size of a
DIAGNOSTIC • System sometimes able to
Throughput of product: interpret raw data or call a
• Single sample detection 20 positive through internal software
BEST FIT WORST FIT • 2 samples/batch or higher of detecting two or more
• Less than 250ul needed per biological agents or toxins within
test for detection the same test
Signature:
CONTACT INFORMATION Training/Speed/Manpower: • No sounds produced that cannot
ChemSensing, Inc. • Very brief training be deactivated
60 Hazelwood Drive • 5-10 min set-up required • Less than 200 BTUS generated
Champaign, IL 61820 • 3-5 manual steps required for
www.chemsensing.com detection Operational conditions:
Joel Dryer • Device or system is intended for 25°C to 45°C
(847) 412-0010 multiple use • Performance of the device or
joel@chemsensing.com • 3 components relative humidity
• Cleaning involves purging the
system with air or nitrogen Sensitivity:
COST • 1-100 CFU per ml
• Estimated $5000.00/system or device • 2 consumables or expendables Maturity gauge:
needed • Is expected to be ready for
• Unknown service required commercialization within one
• Expected life measure is 1-3 calendar year
years • A few devices or systems exist
• Less than 5 minutes required (brass board)
II:199
MSD Sector Imager 6000


THE FOLLOWING: MSD Sector Imager 6000 ranked in the highest third
Bacillus anthracis, E. coli O157: of all evaluated products for analytical laboratories and
H7, Francisella tularensis, Yersinia earned 88% of the utility points of the best score.
pestis, VEE virus, Botulinum toxin ALTERNATIVE UTILITY
A, SEB, Ricin (Assay developed) Best Score 0.901
DESCRIPTION: MSD Sector Imager 6000 0.792

The Sector Imager 6000 (SI6000) Lowest Score 0.217
is an electrochemiluminesence Effectiveness Biological Agents Logistics Operations
(ECL) based system using assay Preference Set: Analytical Laboratory
reagents that are directly immobilized on the electrode used to induce ECL.
The carbon-based electrodes are in the form of standard microtiter plates
with 96, 384 and 1,536 wells per plate. The centerpiece of this system
is the cooled-CCD camera and telecentric lens which enable rapid, highly DIAGNOSTIC Laboratory Ranking
sensitive measurements. In addition, the use of screen-printed electrodes MSD Sector Imager 6000 ranked in the highest third of
has enabled MSD to produce a machine capable of detecting of multiple all evaluated products for diagnostic laboratories and
analytes in one well (multiplexing.) The system was originally designed earned 95% of the utility points of the best score.
for use by the pharmaceutical industry in support of their high throughput
ALTERNATIVE UTILITY
screening efforts. On top of superior detection capabilities across the
Best Score 0.909
spectrum of potential bioagents (viruses, bacteria and toxins,) the MSD
instruments are easy to use and capable of providing results in 30 minutes MSD Sector Imager 6000 0.866
for over one thousand tests. The SI 6000 is perfectly suited for the needs of Lowest Score 0.321
central lab demanding highly sensitive measurements in a rapid pace for a
large volume of sample Preference Set: Diagnostic Laboratory
TECHNOLOGY:
Electrochemiluminescence (ECL) is a well-developed, commercial
technology for the detection and study of biomolecular interactions MOBILE Laboratory Ranking
and function. ECL-based assays employ labels that emit light when MSD Sector Imager 6000 ranked in the highest third of
electrochemically oxidized or reduced under appropriate chemical all evaluated products for mobile laboratories and earned
conditions. The existence of small, stable and highly efficient ECL labels 77% of the utility points of the best score.
makes the technique robust, sensitive and easy to implement. ECL
detection is already widely used in the military for detection of biological ALTERNATIVE UTILITY
agents. We have adapted the technology to allow ECL assays to be carried Best Score 0.883
out on inexpensive disposable electrodes in a format that is compatible MSD Sector Imager 6000 0.681
with multiplexed array-based measurements. Our systems are currently Lowest Score 0.379
being evaluated at the Edgewood Chemical and Biological Center and
USAMRIID. Assays are carried out on proprietary Multi-Array plates having Logistics Biological Agents Effectiveness Operations
integrated electrodes that act as both a capture surface and an energy Preference Set: Mobile Laboratory
source for electrochemiluminescence excitation. The spatial control inherent
in ECL induction and imaging detection allows for multiplexed array based
measurement employing patterned arrays of binding reagents on an FIELD USE Ranking
electrode surface. A variety of plate formats have been designed to suit the MSD Sector Imager 6000 ranked in the highest third of
broad range of needs of drug discovery and biological research – from the all evaluated products for field use and earned 83% of
standard 96, 384 and 1536-well formats to custom Multi-Spot plates for
performing multiple measurements in each well of specially designed 96
and 24-well plates. The 96-well plates are capable of detecting 4, 7 or 10 ALTERNATIVE UTILITY
analytes per well. The 24-well plates are capable of detecting 25, 64 or Best Score 0.943
100 analytes per well. The plates are manufactured using well-established MSD Sector Imager 6000 0.778
scalable techniques such as screen-printing that allow for high volume
Lowest Score 0.343
manufacturing at low cost. These assays are capable of highly sensitive
detection with broad dynamic ranges. The SI600 is can perform over 1,000 Logistics Operations Effectiveness Biological Agents
determinations per minute. Preference Set: Field Use
II:200
Emanuel and Fruchey

electrical requirements dishwasher
require water aliquots • Shelf life between 6 months and
source
source • A single shaking or vortexing step
• Single sample detection in less software
than 20 min • Assays available, and capable of
• 384 samples/batch or higher detecting four or more agents or
BEST FIT WORST FIT • Less than 100 ul volume toxins within the same well
needed per test for detection • Three additional pieces of
• An afternoon of training • Between 200-500 BTUS
CONTACT INFORMATION
• No set-up required generated
Meso-Scale Discoveries
9238 Gaither
www.meso-scale.com
• Device or system is intended for room temperature
Point of Contact: multiple detections • The influence of relative humidity
Vit Vasista • 0-1 solution or buffer used on the performance of the device
(240) 631-2522 x4622 • 1 component or system is unknown
vvasista@meso-scale.com Sensitivity:
• 100-1,000 CFU per ml
Maintenance:
• $4.00/assay • Needs service less than once • Is commercially available
• $250,000/device or system a year
t
years
procedures necessary MOST MATURE LEAST MATURE
II:201
MSD Sector PR 2

DETECTING THE MSD Sector PR 2 ranked in the highest third of all
Brucella species,
Yersinia pestis,
Orthopox virus, Lowest Score 0.217
E.coli O157:H7,
Influenza virus,
Botulinum toxin A,
Staphylococcal toxin B,
Ricin toxin Botulinum toxin B, Abrin toxin (Assay developed); Vibrio MSD Sector PR 2 ranked in the highest third of all
cholera (Assay validated) evaluated products for diagnostic laboratories and
The PR2 system is a compact automated detection system Best Score 0.909
for carrying out multiplexed electrochemiluminescence (ECL)
assays in an array format. Assays are carried out in proprietary
disposable multi-well plates having integrated carbon ink Lowest Score 0.321
electrodes. These electrodes act as solid phase supports for Effectiveness Operations Biological Agents Logistics
arrays of biological reagents (for example, antibodies or nucleic Preference Set: Diagnostic Laboratory
acids) and also provide the source of electrical energy for
generating ECL signals. The use of array-based multiplexing allows
for the detection of multiple analytes in each well of a multi-well
plate (up to 25 per well of a 96-well plate). The PR2 uses a cooled MOBILE Laboratory Ranking
CCD camera and molded lens to image ECL generated from MSD Sector PR 2 ranked in the highest third of all
arrays in MSD’s plates. The inventive PR2 design allows the PR2 evaluated products for mobile laboratories and earned
to maintain the sensitivity and multiplexing capability of MSD’s 96% of the utility points of the best score.
high-throughput Sector Imager instruments but in a much smaller
and portable foot-print. The PR2 has integrated pipetting, shaking ALTERNATIVE UTILITY
and seal removal capabilities that provide the ability to carry out Best Score 0.883
fully automated sample analysis using sealed plates that hold all MSD Sector PR 2 0.846
the required biological reagents in a dry form. The system can Lowest Score 0.379
unseal and use one well of a plate at a time so that individual
samples can be measured without compromising the ability to use Logistics Biological Agents Effectiveness Operations
the remaining well at a later time. For higher throughput batch Preference Set: Mobile Laboratory
processing, the PR2 can also be used as a dedicated plate reader
to analyze plates that have been processed off-line.
FIELD USE Ranking
TECHNOLOGY: MSD Sector PR 2 ranked in the highest third of all
The PR2 employs electrochemiluminescence (ECL) detection.
ECL assays employ labels that emit light when electrochemically
stimulated at an electrode. We attach these labels to biological
binding reagents and use these in sold phase binding assays such ALTERNATIVE UTILITY
as nucleic acid hybridization assays of sandwich immunoassays. Best Score 0.943
The existence of small, stable and highly efficient ECL labels MSD Sector PR 2 0.902
makes the technique robust, sensitive and easy to implement. We Lowest Score 0.343
have adapted the technology to allow ECL assays to be carried
out using biological arrays patterned on inexpensive disposable Logistics Operations Effectiveness Biological Agents
electrodes in a format that is compatible with multiplexed array- Preference Set: Field Use
based measurements.
II:202
Emanuel and Fruchey

Signature:
• An afternoon of training and be deactivated
some technical skills required • Less than 200 BTUS generated
CONTACT INFORMATION • Less than 5 minutes set-up
Meso-Scale Discoveries required
9238 Gaither • 0-2 manual steps required for Operational conditions:
www.meso-scale.com room temperature
Re-use: • The performance of the device
Point of Contact: • Device or system is intended for or system is not influenced by
Vit Vasista multiple use relative humidity
(240) 631-2522 x4622 • 0-1 solution or buffer used
vvasista@meso-scale.com • No cleaning required • 100-1,000 CFU per ml

COST • Less than once a year service • Is commercially available
• $4.00/sample required • Has been featured in peer
• $80,000.00/device or system • Expected life is between 5-10 reviewed scientific publications
procedures t
II:203
MSD Sector™ PR Plate Reader


DETECTING THE MSD Sector PR ranked in the highest third of all
Brucella species,
MSD Sector PR 0.868
Yersinia pestis,
Orthopox virus, Lowest Score 0.217
Botulinum toxin A, Staphylococcal toxin B, Ricin toxin, E.coli
O157:H7, Influenza virus, Botulinum toxin B, Abrin toxin (Assays
developed); Vibrio cholera (Assay validated)
DESCRIPTION: MSD Sector PR ranked in the highest third of all
The Sector PR plate readers are compact readers for carrying out evaluated products for diagnostic laboratories and
electrochemiluminescence (ECL) assays. Assays are carried out in earned 100% of the utility points of the best score.
proprietary disposable multi-well plates having integrated carbon
ALTERNATIVE UTILITY
ink electrodes. These electrodes act as solid phase supports
Best Score 0.909
for immobilized biological reagents (for example, antibodies or
nucleic acids) and also provide the source of electrical energy MSD Sector PR 0.909
for generating ECL signals. The centerpiece of this system is Lowest Score 0.321
an array of photodiodes which enable rapid, highly sensitive
measurements. The photodiode array is used to simultaneously
measure ECL from one row of wells. The array is scanned across
the columns of the plate allowing a full plate to be read in roughly
two minutes.
The Sector PR 100 and PR 400 readers are useful in a wide MSD Sector PR ranked in the highest third of all
variety of applications ranging from life science research, evaluated products for diagnostic laboratories and
pharmaceutical quality control and biowarfare agent detection. earned 100% of the utility points of the best score.
Biodefense applications have been driven by the systems superior
detection capabilities across the spectrum of potential bioagents ALTERNATIVE UTILITY
(viruses, bacteria and toxins). The MSD instruments are easy Best Score 0.883
to use and extremely fast. The Sector PR 100 is a singleplex MSD Sector PR 0.834
instrument while the Sector PR 400 allows for limited multiplexing Lowest Score 0.379
(up to four measurements per well). The combination of a small
light-weight form factor and sensitive rapid analysis makes the Logistics Biological Agents Effectiveness Operations
Sector PRs well suited for testing in a wide variety of settings from Preference Set: Mobile Laboratory
the central lab to the field.

The Sector PR readers employ electrochemiluminescence
MSD Sector PR ranked in the highest third of all evaluated
(ECL) detection. ECL assays employ labels that emit light when
electrochemically stimulated at an electrode. We attach these
labels to biological binding reagents and use these in solid phase of the best score.
binding assays such as nucleic acid hybridization assays or ALTERNATIVE UTILITY
sandwich immunoassays. The existence of small, stable and highly Best Score 0.943
efficient ECL labels makes the technique robust, sensitive and
MSD Sector PR 0.893
easy to implement. We have adapted the technology to allow ECL
assays to be carried out using biological reagents patterned on Lowest Score 0.343
inexpensive disposable electrodes in a multi-well plate format. Logistics Operations Effectiveness Biological Agents
II:204
Emanuel and Fruchey

• System or device uses • Approximately the size of a
batteries or has 110V electrical toaster
• The system or device does not • Reagent shelf life between 1 to
require water 3 years
MOBILE FIELD source
require an external vacuum • There is a single shaking or
source vortexing step
DIAGNOSTIC • System always able to interpret
• An afternoon of training and • Less than 200 BTUS generated
Meso-Scale Discoveries
some technical skills required
9238 Gaither
• No set-up required Operational conditions:
www.meso-scale.com detection • Components must be stored at
room temperature
Vit Vasista • Device or system is intended for or system is not influenced by
(240) 631-2522 x4622 multiple use relative humidity
(240) 632-2219 fax • 0-1 solution or buffer used
vvasista@meso-scale.com • 1 component Sensitivity:
• No cleaning required • 100-1,000 CFU per ml

• $4.00/sample • Less than once a year service • Is commercially available
• $25,000.00/PR100; $50,000/PR400 required • Has been featured in peer
• Expected life is between 5-10 reviewed scientific publications
procedures t
II:205
Multi-Photon Detection (MPD) Portable

by BioTraces, Inc.

DETECTING THE MPD Portable ranked in the highest third of all evaluated
Yersinia pestis, Best Score 0.901
Brucella species, MultiPhoton Detection Portable 0.759
E. coli 0157:H7,
Lowest Score 0.217
Vibrio cholera,
Corynebacterium Effectiveness Biological Agents Logistics Operations
diptheria, Preference Set: Analytical Laboratory
Burkholderia pseudomallei, Coxiella burnetti, Rickettsia prowazeki,
Rift Valley fever virus, Orthopox virus, VEE virus, Hanta virus,
Yellow fever virus, Dengue fever virus, MS-2 bacteriophage,
Botulinum toxins A, B, E, SEB, T-2 toxin, Ricin, Saxitoxin, MPD Portable ranked in the highest third of all evaluated
Shigatoxin, Conotoxins, Palytoxin (Assays developed) products for diagnostic laboratories and earned 91% of
Multi-Photon Detection (MPD) provides the new standard of Best Score 0.909
sensitivity for immunological detection, quantification and
identification of pathogens. MPD technology applies to the full
spectrum of BW agents: viruses, bacteria and biotoxins. Lowest Score 0.321
TECHNOLOGY: Effectiveness Operations Biological Agents

Logistics
MPD technology utilizes unique photons detection methods. This
system maps photon properties and rejects all non-specific events.
Coincidence is used to diminish the background by a factor
of more than thousand. The “introduced” tags are specifically MOBILE Laboratory Ranking
recognized and counted. This unique technology provides the MPD Portable ranked in the highest third of all evaluated
best possible sensitivity for both the nucleic-acid based and products for mobile laboratories and earned 76% of the
immunological detection, including accurate identification of utility points of the best score.
pathogens. This method is compatible with the development
of automated air and water safety monitoring that is fast and ALTERNATIVE UTILITY
accurate. We developed the MPD enhanced immunoassays with Best Score 0.883
about 1 fg/ml sensitivity for about 10 targets. We are currently MultiPhoton Detection Portable 0.667
extending this technology to P-chips with MPD read-out. The Lowest Score 0.379
proposed BW agents detection system will consist of three parts:
air intake/filtration sub-system, “biochemical wet chamber”, and Logistics Biological Agents Effectiveness Operations
the MPD based immunodetection module. Preference Set: Mobile Laboratory
FIELD USE Ranking

MPD Portable ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:206
Emanuel and Fruchey

• The system or device does • Shelf life between 6 months and
require an external air source 1 year
MOBILE FIELD source
Throughput of product: • No shaking or vortexing steps
• Single sample detection 20 • System always able to interpret
DIAGNOSTIC minutes or less raw data or call a positive
• Less than 100 ul volume • Assay available and capable of
needed per test for detection detecting four or more biological
BEST FIT WORST FIT • The system or device could agents or toxins within the same
easily be adapted into a fully test
automated system • No additional pieces of
equipment needed
• An afternoon of training Signature:
• Less than 5 minutes required • Sounds are produced that cannot
for set-up
• 0-2 manual steps required for • Less than 200 BTUS generated
BioTraces, Inc.
detection
13455 Sunrise Valley Drive, Suite 200
Herndon, VA 20171 Operational conditions:
www.biotraces.com Re-use: • Operated from 15°C to 37°C
multiple use
Point of Contact: room temperature or 4°C
A.K. Drukier • 2 components • Performance of the device or
(703) 793-1550 x108 • Daily extensive wash required system is not influenced by
(703) 793-1564 fax relative humidity
AKD@biotraces.com Maintenance:
• 2 consumables or expendables Sensitivity:
needed • 1-100 CFU per ml
COST • Every 6 months service required
• $1.00/sample • Expected life is 3-5 years Maturity gauge:
• $30,000.00/system or device • 5-10 minutes required for daily • A few devices or systems exist
assurance procedures (brass board)
II:207
Multi-Photon Detection (MPD) Tabletop

by BioTraces, Inc.

DETECTING MPD Tabletop ranked in the highest third of all evaluated
Francisella MultiPhoton Detection Tabletop 0.762
tularensis,
Lowest Score 0.217
Yersinia pestis,
species, E. Preference Set: Analytical Laboratory
coli 0157:H7,
Vibrio cholera,
Corynebacterium diptheria, Burkholderia mallei, Burkholderia DIAGNOSTIC Laboratory Ranking
pseudomallei, Coxiella burnetti, Rickettsia prowazeki, Rift Valley
MPD Tabletop ranked in the highest third of all evaluated
fever virus, Orthopox virus, VEE virus, Hanta virus, Yellow fever
virus, Dengue fever virus, MS-2 bacteriophage, Botulinum toxins products for diagnostic laboratories and earned 91% of
A, B, E, SEB, T-2 toxin, Ricin, Saxitoxin, Shigatoxin, Conotoxins, the utility points of the best score.
Palytoxin (Assays developed) ALTERNATIVE UTILITY
Best Score 0.909
DESCRIPTION: MultiPhoton Detection Tabletop 0.827
Multi-Photon Detection (MPD) provides the new standard of
Lowest Score 0.321
sensitivity for immunological detection, quantification and
identification of pathogens. MPD technology applies to the full Effectiveness Operations Biological Agents Logistics
spectrum of BW agents: viruses, bacteria and biotoxins. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
MPD technology utilizes unique photons detection methods. This
system maps photon properties and rejects all non-specific events. MOBILE Laboratory Ranking
Coincidence is used to diminish the background by a factor MPD Tabletop ranked in the highest third of all evaluated
of more than thousand. The “introduced” tags are specifically products for mobile laboratories and earned 74% of the
recognized and counted. This unique technology provides the utility points of the best score.
best possible sensitivity for both the nucleic-acid based and
ALTERNATIVE UTILITY
immunological detection, including accurate identification of
Best Score 0.883
pathogens. This method is compatible with the development
of automated air and water safety monitoring that is fast and MultiPhoton Detection Tabletop 0.657
accurate. We developed the MPD enhanced immunoassays with Lowest Score 0.379
about 1 fg/ml sensitivity for about 10 targets. We are currently
extending this technology to P-chips with MPD read-out. The
proposed BW agents detection system will consist of three parts:
air intake/filtration sub-system, “biochemical wet chamber”, and
MPD based immunodetection module.
FIELD USE Ranking
MPD Tabletop ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:208
Emanuel and Fruchey

• System or device has 110/220V • Approximately the size of a carry-
(switch able) electrical on luggage suitcase
• The system or device does • Shelf life between 6 months and
require water aliquots 1 year
• The system or device does
require an external air source
minutes or less • Assay available and capable of
BEST FIT WORST FIT • Less than 100 ul volume agents or toxins within the same
automated system
Signature:
• Less than 5 minutes required • Less than 200 BTUS generated
BioTraces, Inc.
for set-up
13455 Sunrise Valley Drive, Suite 200 • 0-2 manual steps required for
Herndon, VA 20171 detection Operational conditions:
www.biotraces.com • Operated from 15°C to 37°C
Re-use:
Point of Contact: room temperature or 4°C
A.K. Drukier multiple use • Performance of the device or
(703) 793-1550 x108 • 2 solutions or buffers used system is not influenced by
AKD@biotraces.com • Daily extensive wash required
Sensitivity:
• $1.00/sample needed Maturity gauge:
• $30,000.00/system or device • Every 6 months service required • A few devices or systems exist
• Expected life is 3-5 years (brass board)
assurance procedures t
II:209
Mx3000P Real Time PCR System

by Stratagene Inc.

DETECTING THE Mx3000P Real Time PCR System ranked in the highest
Bacillus anthracis, and earned 74% of the utility points of the best score.
Yersinia pestis, Brucella Best Score 0.901
species, Orthopox virus
(Assays developed)
Lowest Score 0.217
The Mx3000P is a system Preference Set: Analytical Laboratory
for performing real-time
quantitative PCR (QPCR).
This technique allows
researchers to quickly
and easily quantify nucleic acids for studying gene expression, mutational Mx3000P Real Time PCR System ranked in the middle
analysis, disease state, gene dosage, and pathogen detection. QPCR third of all evaluated products for diagnostic laboratories
measures PCR product accumulation during the exponential phase of the and earned 66% of the utility points of the best score.
reaction and before amplification becomes vulnerable to limiting reagents ALTERNATIVE UTILITY
and cycling variability. Fluorescent QPCR data provides accurate information Best Score 0.909
on initial starting copy number. Using QPCR, amplification and detection are
combined in a single step and in a single closed tube. This eliminates the
Lowest Score 0.321
need for numerous post-PCR manual steps, and reduces the possibility of
introducing variability or laboratory contamination. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The Mx3000P can be used to detect and quantify the amount of a
specific sequence DNA or RNA present as starting template prior to a
PCR amplification reaction. This is done using a technique known as MOBILE Laboratory Ranking
real-time quantitative PCR. This technology is based on the measurement Mx3000P Real Time PCR System ranked in the middle
of the fluorescence of either a double stranded DNA binding dye such as third of all evaluated products for mobile laboratories and
SYBR Green or a fluorescent dye-bound probe based system like Taqman, earned 59% of the utility points of the best score.
Molecular Beacons, or Scorpions Probes. For any of these systems, the
amount of fluorescence will increase as the amount of amplified PCR ALTERNATIVE UTILITY
product increases. Based on the cycle number in the PCR reaction where Best Score 0.883
your fluorescence rises above a threshold of background fluorescence (the Stratagene Mx3000P 0.524
threshold cycle, or Ct) you can calculate how much starting template you Lowest Score 0.379
had in your amplification reaction. The more starting material you have,
the earlier the cycle number at which the fluorescence will rise above Logistics Biological Agents Effectiveness Operations
the threshold. The Mx3000P combines the capabilities of a microplate Preference Set: Mobile Laboratory
fluorescence reader with a PCR thermocycler so fluorescence levels can
be read as the PCR reaction progresses. It uses a tungsten halogen white
light bulb to provide the excitation light, and the range of excitation is FIELD USE Ranking
350-750nm. There is a single optical channels in the instrument, but Mx3000P Real Time PCR System ranked in the middle
along this optical channel there are two filter wheels, one with a set of four third of all evaluated products for field use and earned
excitation filters and one with a set of four emission filters. This allows you to 67% of the utility points of the best score.
specifically excite and measure the fluorescent signal for up to four different
dyes in one tube. ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:210
Emanuel and Fruchey

requires water aliquots • Shelf life between 1-3 years
source
• A single centrifugation step
source steps
• Single sample detection in software
greater than 60 min • Assay not available, but capable
• The system or approach is not • Three additional pieces of
amenable to automation equipment needed
• More than a day of training • No sounds produced that cannot
• 6-8 manual steps required for • Between 200-500 BTUS
Stratagene Inc.
detection generated
11011 North Torrey Pines Rd.
La Jolla, CA 92037
www.Mx3000P.com Re-use: Operational conditions:
multiple detections • Components must be frozen
Point of Contact: • More than 4 solutions or buffers • Device or system has peak
Mike Metzler, Al Grafsky, or Owen Hardy used
performance at normal relative
(800) 894-1304 x2 • 5 or more components
• No cleaning required humidity conditions only
(858) 535-0034 fax
qpcrsystemssupport@stratagene.com
• 5 or more consumables or • 1-100 CFU per ml
COST expendables needed
• Variable/sample • Never needs service Maturity gauge:
• $24,995.00/device or system • Expected life measure of 5-10 • Is commercially available
years
procedures necessary
II:211
Mx3005P Real Time QPCR System


The Mx3005P will work with any published or commercially Mx3005P Real Time QPCR System ranked in the
available primer and probe sets for detecting these targets. highest third of all evaluated products for analytical
DESCRIPTION: best score.
The Mx3005P is a system for performing real-time quantitative
PCR (QPCR). This technique allows researchers to quickly and ALTERNATIVE UTILITY
easily quantify nucleic acids for studying gene expression, Best Score 0.901
mutational analysis, disease state, gene dosage, and pathogen Stratagene Mx3005P 0.673
detection. QPCR measures PCR product accumulation during Lowest Score 0.217
the exponential phase of the reaction and before amplification
becomes vulnerable to limiting reagents and cycling variability. Effectiveness Biological Agents Logistics Operations
Fluorescent QPCR data provides accurate information on initial Preference Set: Analytical Laboratory
starting copy number. Using QPCR, amplification and detection
are combined in a single step and in a single closed tube. This DIAGNOSTIC Laboratory Ranking
eliminates the need for numerous post-PCR manual steps, and Mx3005P Real Time QPCR System ranked in the
reduces the possibility of introducing variability or laboratory middle third of all evaluated products for diagnostic
contamination. laboratories and earned 66% of the utility points of the
TECHNOLOGY: best score.
The Mx3005P can be used to detect and quantify the amount of a ALTERNATIVE UTILITY
specific sequence DNA or RNA present as starting template prior Best Score 0.909
to a PCR amplification reaction. This is done using a technique Stratagene Mx3005P 0.604
known as real-time quantitative PCR. This technology is based
Lowest Score 0.321
on the measurement of the fluorescence of either a double
stranded DNA binding dye such as SYBR Green or a fluorescent Effectiveness Operations Biological Agents Logistics
dye-bound probe based system like Taqman, Molecular Beacons, Preference Set: Diagnostic Laboratory
or Scorpions Probes. For any of these systems, the amount
of fluorescence will increase as the amount of amplified PCR MOBILE Laboratory Ranking
product increases. Based on the cycle number in the PCR reaction
Mx3005P Real Time QPCR System ranked in the lowest
where your fluorescence rises above a threshold of background
fluorescence (the threshold cycle, or Ct) you can calculate how
third of all evaluated products for mobile laboratories
much starting template you had in your amplification reaction. and earned 52% of the utility points of the best score.
The more starting material you have, the earlier the cycle number ALTERNATIVE UTILITY
at which the fluorescence will rise above the threshold. The Best Score 0.883
Mx3005P combines the capabilities of a microplate fluorescence Stratagene Mx3005P 0.459
reader with a PCR thermocycler so fluorescence levels can be
Lowest Score 0.379
read as the PCR reaction progresses. It uses a tungsten halogen
white light bulb to provide the excitation light, and the range Logistics Biological Agents Effectiveness Operations
of excitation is 350-750nm. There is a single optical channel, Preference Set: Mobile Laboratory
but along this optical channel there are two filter wheels. In the
Mx3005P one filter wheel contains a set of four excitation filters
and one a set of four emission filters. The motion of these filter
wheels are controlled independently to allow any one of the
FIELD USE Ranking
excitation filters to be aligned with any one of the emission filters.
Mx3005P Real Time QPCR System ranked in the middle
This independent filter wheel control allows additional flexibility third of all evaluated products for field use and earned
in the optical system to allow for applications such as FRET 60% of the utility points of the best score.
detection. The five filter positions allow you to specifically excite ALTERNATIVE UTILITY
and measure the fluorescent signal for up to five different dyes in Best Score 0.943
one tube in the Mx3005P.
Lowest Score 0.343

II:212
Emanuel and Fruchey

• System or device has 110V or • Approximately the size of a carry-
require an external vacuum • There is a single centrifugation
source step
DIAGNOSTIC Throughput of product: vortexing step
• Single sample detection greater • System always able to interpret
• Less than 10 ul volume needed • Capable of detecting multiple
BEST FIT WORST FIT per test for detection biological agents or toxins within
• The system or device is not the same test
amenable to automation • Three additional pieces of
equipment needed
and significant technical skills • No sounds produced that cannot
CONTACT INFORMATION required be deactivated
Meso-Scale Discoveries • 10-20 minutes set-up required • Between 200-500 BTUS
9238 Gaither • 6-8 manual steps required for generated
Gaithersburg, MD 20878 detection
www.meso-scale.com Operational conditions:
Point of Contact: • Device or system is intended for • Components must be frozen
Vit Vasista multiple use • The performance of the device or
(240) 631-2522 x4622 • More than 4 solutions or buffers system is influenced by relative
(240) 632-2219 fax used humidity
vvasista@meso-scale.com • 5 or more components
• 100-1,000 CFU per ml
COST Maintenance:
• $0.50/sample plus cost of Taq enzyme • No service required Maturity gauge:
• $29,995.00/device or system • Expected life is between 5-10 • Is commercially available
years • Has been featured in peer
II:213
Mx4000 Multiplex Quantitative PCR System

by Stratagene Inc.

DETECTING THE Mx4000 Multiplex Quantitative PCR System ranked in
FOLLOWING: the highest third of all evaluated products for analytical
Yersinia pestis, Brucella ALTERNATIVE UTILITY
species, Orthopox virus
Best Score 0.901
(Commercially available as Stratagene Mx 4000
a freeze-dried reagent) 0.715
Multiplex PCR Sys.
Lowest Score 0.217
DESCRIPTION:
The Mx4000 is a system Effectiveness Biological Agents Logistics Operations
for performing real-time Preference Set: Analytical Laboratory
quantitative PCR (QPCR).
This technique allows researchers to quickly and easily quantify
nucleic acids for studying gene expression, mutational analysis, Mx4000 Multiplex Quantitative PCR System ranked in
disease state, gene dosage, and pathogen detection. QPCR the highest third of all evaluated products for diagnostic
measures PCR product accumulation during the exponential laboratories and earned 73% of the utility points of the
phase of the reaction and before amplification becomes best score.
vulnerable to limiting reagents and cycling variability. Fluorescent ALTERNATIVE UTILITY
QPCR data provides accurate information on initial starting copy
Best Score 0.909
number. Using QPCR, amplification and detection are combined in Stratagene Mx 4000 0.668
a single step and in a single closed tube. This eliminates the need Multiplex PCR Sys.
for numerous post-PCR manual steps, and reduces the possibility Lowest Score 0.321
of introducing variability or laboratory contamination.
The Mx4000 can be used to detect and quantify the amount of a
specific sequence DNA or RNA present as starting template prior MOBILE Laboratory Ranking
to a PCR amplification reaction. This is done using a technique Mx4000 Multiplex Quantitative PCR System ranked in
known as real-time quantitative PCR. This technology is based the middle third of all evaluated products for mobile
on the measurement of the fluorescence of either a double laboratories and earned 62% of the utility points of the
stranded DNA binding dye such as SYBR Green or a fluorescent best score.
dye-bound probe based system like Taqman, Molecular Beacons,
or Scorpions Probes. For any of these systems, the amount ALTERNATIVE UTILITY
of fluorescence will increase as the amount of amplified PCR Best Score 0.883
product increases. Based on the cycle number in the PCR reaction Stratagene Mx 4000
Multiplex PCR Sys. 0.551
where your fluorescence rises above a threshold of background Lowest Score 0.379
fluorescence (the threshold cycle, or Ct) you can calculate how
much starting template you had in your amplification reaction. Logistics Biological Agents Effectiveness Operations
The more starting material you have, the earlier the cycle number Preference Set: Mobile Laboratory
at which the fluorescence will rise above the threshold. The
Mx4000 combines the capabilities of a microplate fluorescence FIELD USE Ranking
reader with a PCR thermocycler so fluorescence levels can be Mx4000 Multiplex Quantitative PCR System ranked in the
read as the PCR reaction progresses. It uses a tungsten halogen middle third of all evaluated products for field use and
white light bulb to provide the excitation light, and the range of earned 67% of the utility points of the best score.
excitation is 350-750nm. There are four optical channels in the
instrument, each with its own set of excitation and emission filters ALTERNATIVE UTILITY
to specifically excite and measure the fluorescent signal for up to Best Score 0.943
four different dyes in one tube. Stratagene Mx 4000 Multiplex 0.628
PCR Sys.
Lowest Score 0.343

II:214
Emanuel and Fruchey

source
• Single centrifugation step
• Single sample detection greater • Assay not available, but capable
• More than a day of training
CONTACT INFORMATION • Between 200-500 BTUS
Stratagene Inc.
11011 North Torrey Pines Rd. detection
La Jolla, CA 92037 Operational conditions:
www.Mx3000P.com • Operated from 15°C to 37°C
Re-use: • Components must be frozen
Mike Metzler system has a peak performance
• More than 4 solutions or buffers
(800) 894-1304 x15434 used at normal relative humidity
(858) 535-0034 fax • 5 or more components conditions only
tech_services@stratagene.com • No cleaning required
Sensitivity:
COST • 5 or more consumables or
• Variable/sample expendables needed Maturity gauge:
• $59,995.00/system or device • No service required • Is commercially available
procedures
II:215
NanoChip Molecular Biology Workstation

by Nanogen, Inc.

DETECTING NanoChip Molecular Biology Workstation ranked in the
THE highest third of all evaluated products for analytical
FOLLOWING: laboratories and earned 72% of the utility points of the
Bacillus best score.
anthracis, E. ALTERNATIVE UTILITY
coli 0157:H7, Best Score 0.901
Yersinia pestis,
NanoChip Workstation 0.648
Orthopox
virus (Assays Lowest Score 0.217
DESCRIPTION:
The NanoChip Molecular Biology Workstation is an automated DIAGNOSTIC Laboratory Ranking
multi-purpose instrument that facilitates detection of known
NanoChip Molecular Biology Workstation ranked in the
sequences, such as in the analysis of Single Nucleotide
Polymorphisms (SNPs) and Short Tandem Repeats (STRs), using highest third of all evaluated products for diagnostic
the NanoChip Electronic Microarray. The unique, open-architecture laboratories and earned 72% of the utility points of the
design permits researchers to define, select, and build their own best score.
test panels or select from predefined panels. ALTERNATIVE UTILITY
Our fully integrated NanoChip System consists of three major NanoChip Workstation 0.652
subsystems: (1) the NanoChip Loader for loading samples on Lowest Score 0.321
one to four NanoChip Cartridges, (2) the NanoChip Reader, a
highly sensitive, laser-based fluorescence scanner for detection
of assay results, and (3) computer hardware and software which
automates import, analysis and export of sample information
making data analysis simple. The NanoChip System is based on MOBILE Laboratory Ranking
electronic addressing which involves placing charged molecules at NanoChip Molecular Biology Workstation ranked in
specific test sites on a NanoChip microarray. Electronic addressing the middle third of all evaluated products for mobile
allows on-chip hybridization to occur within seconds compared laboratories and earned 59% of the utility points of the
to several hours in passive hybridization. In addition, DNA target best score.
molecules are electronically concentrated at the array sites,
exceeding ca 1000 times the concentration in the bulk of solution. ALTERNATIVE UTILITY
When a biotinylated sample solution is introduced onto the array, Best Score 0.883
the negatively charged sample rapidly moves to the selected NanoChip Workstation 0.521
positively charged sites, where it is concentrated and bound to Lowest Score 0.379
the streptavidin in the permeation layer. The array is then washed
and another sample can be added. Site by site, row by row, an Logistics Biological Agents Effectiveness Operations
array of samples are assembled on the array. Such user-definable Preference Set: Mobile Laboratory
microchip arrays allow the customer to respond quickly to the
ever evolving list of genes to be tested. The customer may analyze FIELD USE Ranking
multiple genes from a single test site (representing one sample) NanoChip Molecular Biology Workstation ranked in the
or from multiple test sites (representing different samples). The lowest third of all evaluated products for field use and
customer also has the ability to electronically address multiplexed earned 53% of the utility points of the best score.
amplicons to a single test site. To date, we have developed two
Analyte Specific Reagents (ASRs) - Factor V (Leiden) and Cystic ALTERNATIVE UTILITY
Fibrosis and we offer research application notes for determining Best Score 0.943
the following genes: Factor (II) prothrombin (coronary disease), NanoChip Workstation 0.498
Factor V/II multiplex (cardiovascular disease); MTHFR (cardiac Lowest Score 0.343
function); hereditary hemochromatosis (venous thrombotic
disease). This same platform has been used for development and Logistics Operations Effectiveness Biological Agents
testing of amplified DNA samples of biological warfare agents. Preference Set: Field Use
II:216
Emanuel and Fruchey

ANALYTICAL • The system or device does • More than 50 kg
source
automated system
Signature:
• 10-20 minutes required for • Less than 200 BTUS generated
Nanogen, Inc
set-up
10398 Pacific Center Court • 3-5 manual steps required for
San Diego, CA 92121 Operational conditions:
detection
www.nanogen.com • Operated from 15°C to 37°C
Re-use: 4°C
system is not influenced by
Sales Department • More than 4 solutions or buffers
(877) NANOGEN
• 1,000-10,000 CFU per ml
COST Maintenance:
• Unknown/sample • 5 or more consumables or Maturity gauge:
• $165,000.00/system or device expendables needed • Is commercially available
• More often than every 6 months
service required t
years
• 10-20 minutes required for daily MOST MATURE LEAST MATURE
II:217
NIDS® Detection System

by ANP Technologies, Inc.

DETECTING NIDS Detection System ranked in the highest third of all
Francisella ANP NIDS 0.797
tularensis,
Lowest Score 0.217
Coxiella
burnetti, Effectiveness Biological Agents Logistics Operations
species, E.coli
O157:H7,
Yersinia pestis,
NIDS Detection System ranked in the highest third of
Smallpox virus,
Orthopox virus, all evaluated products for diagnostic laboratories and
Rift valley earned 96% of the utility points of the best score.
fever virus, Venezuelan equine encephalitis virus, Botulinum toxin ALTERNATIVE UTILITY
A, Staphylococcal toxin B, Ricin toxin, Dengue fever virus, MS-2 Best Score 0.909
bacteriophage, Botulinum toxin B (Assays developed); Influenza ANP NIDS 0.874
virus (Assay validated)
Lowest Score 0.321
DESCRIPTION: Effectiveness Operations Biological Agents Logistics
The NIDS® Detection System combines handheld immunoassays Preference Set: Diagnostic Laboratory
with a semi-automated reader to provide for the rapid and
accurate detection of biothreat agents in aqueous samples. The
biothreats comprise both BWA and non-BWA pathogens. The
target must be water-borne, but the sample can be generated
from surface swabs, aerosol collection, or natural water samples. NIDS Detection System ranked in the highest third of all
The detection system provides an easy tool to be used either in evaluated products for mobile laboratories and earned
the field or a laboratory setting and eliminates inter-personnel 98% of the utility points of the best score.
differences in interpreting assay results. The system can be used
ALTERNATIVE UTILITY
for both qualitative and quantitative analysis of samples. The user
Best Score 0.883
applies 100 µL of sample (3-4 drops) to the assay and allows the
assay to develop for 10 - 15 minutes before inserting it into the ANP NIDS 0.869
reader. A simple push button operation provides a simple display Lowest Score 0.379
of the assay results, with data being archived for subsequent
transfer to a PDA or PC. The platform system can also be used
as a diagnostic device in a point-of-care setting but does require
specialized assays for use with medical samples.

The assay is a lateral flow immunoassay that incorporates ANP NIDS Detection System ranked in the highest third of all
Technologies’ nanomanipulation technology to increase the assay evaluated products for field use and earned 96% of the
sensitivity while reducing the false positive result rate. This is utility points of the best score.
accomplished through the use of polymeric scaffolds that orient
the detection antibodies so that their configuration is optimal for ALTERNATIVE UTILITY
sensing the desired target pathogens. An image of the developed Best Score 0.943
assay is automatically analyzed for positive results using ANP NIDS 0.903
proprietary algorithms that are more sensitive than the human Lowest Score 0.343
eye.
II:218
Emanuel and Fruchey

• System or device uses • Approximately the size of a soda
rechargeable batteries can
require water • Reagent shelf life 1 to 3 years
source
• Single sample detection less • Capable of detecting multiple
automated system with some
effort
be deactivated
CONTACT INFORMATION Training/Speed/Manpower:
ANP Technologies, Inc. Operational conditions:
824 Interchange Blvd. • Operated from 15°C to 37°C
skills
Newark, DE 19711 • No set-up required • Components must be stored at
www.anptinc.com • 0-2 manual steps required for room temperature
Robert Daniel Re-use: relative humidity
(302) 283-1733 fax multiple use Sensitivity:
robert@anptinc.com • 0-1 solution or buffer used • 1,000-10,000 CFU per ml
• 1 component
• Cleaned with alcohol or bleach Maturity gauge:
• To be determined Maintenance: • Has been featured in peer
• Less than once a year service reviewed scientific publications
required or independent evaluations
years
t
procedures
II:219
NRL Array Biosensor

by Naval Research Laboratory

DETECTING THE NRL Array Biosensor ranked in the highest third of all
E. coli O157:H7, ALTERNATIVE UTILITY
Vibrio cholera, Yersinia
pestis, Brucella
Lowest Score 0.217
species, Botulinum
toxin A &B, SEB, Ricin, Effectiveness Biological Agents Logistics Operations
Aflatoxin (Assays Preference Set: Analytical Laboratory
developed)

The array biosensor is an automated, portable detection device
for simultaneous analysis of multiple samples for multiple NRL Array Biosensor ranked in the highest third of all
analytes. It has progressed through a series of prototypes to evaluated products for diagnostic laboratories and
obtain a reliable, small system to which a user can add six earned 94% of the utility points of the best score.
samples, with minimal, if any, sample preparation, and test for a ALTERNATIVE UTILITY
variable number of targets. The current system weighs less than Best Score 0.909
6 kg and is operated using a laptop computer. The user places
two reservoir modules in the system, one containing up to six
samples and the other containing up to six cocktails of tracer Lowest Score 0.321
reagents, and starts the assay. The fluidic system automatically Effectiveness Operations Biological Agents Logistics
runs the samples over the waveguide, exposes the waveguide to Preference Set: Diagnostic Laboratory
tracer, and washes out excess tracer. Image acquisition and data
analysis are still performed offline, but the program to determine
the boundaries of the spots and background controls and to
calculate mean increase in fluorescence over the background is MOBILE Laboratory Ranking
semi-automated. Applications explored to date include detection NRL Array Biosensor ranked in the highest third of all
of infectious diseases and toxins in clinical fluids, food (liquids evaluated products for mobile laboratories and earned
and homogenates), drinking water and environmental samples. In 92% of the utility points of the best score.
most cases, toxins can be detected at 0.1-1 ng/mL and bacteria
ALTERNATIVE UTILITY
at ~1000 cfu/mL without any target preconcentration. Assays for
Best Score 0.883
multiple targets are generally performed in 12 minutes; extending
the time increases the sensitivity. NRL Array Biosensor 0.812
Lowest Score 0.379
TECHNOLOGY:
The biochemical component of the multi-analyte biosensor Logistics Biological Agents Effectiveness Operations
consists of a patterned array of biological recognition elements Preference Set: Mobile Laboratory
(“capture” antibodies, oligosaccharides, antibiotics, other generic
or specific receptors) immobilized on the surface of a planar
waveguide. A fluorescence assay is performed on the patterned FIELD USE Ranking
surface, yielding an array of fluorescent spots, the loci of which NRL Array Biosensor ranked in the highest third of all
are used to identify what target is present. Signal transduction evaluated products for field use and earned 84% of the
is accomplished by means of a diode laser for fluorescence utility points of the best score.
excitation and a CCD camera for image capture. Data analysis
software has been developed to quantify the fluorescent signals ALTERNATIVE UTILITY
in each spot. The assays are fast, sensitive, and specific; up to Best Score 0.943
32 immunoassays have been conducted simultaneously on six NRL Array Biosensor 0.790
independent samples. NRL has demonstrated the ability to detect Lowest Score 0.343
proteins, toxins, bacteria, and viruses in a variety of physiological,
food, and environmental matrices. Logistics Operations Effectiveness Biological Agents
II:220
Emanuel and Fruchey

requires water aliquots • Shelf life between 6 months and
source
• Ability to view results “in real
require an external vacuum time” depends upon application
DIAGNOSTIC Throughput of product: • System may be able to interpret
min or less through internal software in the
• 2 samples/batch or higher future
BEST FIT WORST FIT • Greater than 250 ul volume • Assay available, and capable of
needed per test for detection detecting four or more biological
• The system or device is agents or toxins within the same
currently fully automated test
Training/Speed/Manpower: equipment needed
CONTACT INFORMATION • Less than 5 min required for Signature:
set-up • Sounds produced that cannot be
Naval Research Laboratory
• 3-5 manual steps required for deactivated
Center for Bio/Molecular Science & Engineering, detection • Less than 200 BTUS generated
Code 6900
Washington, DC 20375-5348
cbmse.nrl.navy.mil
multiple detections • Components can be stored at
Point of Contact: • 2 solutions or buffers used room temperature
Frances Ligler • 5 or more components • Performance of the device or
(202) 404-6002 • No cleaning required
system is not influenced by
(202) 404-8897 fax relative humidity
fligler@cbmse.nrl.navy.mil Maintenance:
• 0-1 consumable or expendable Sensitivity:
COST needed • 100-1,000 CFU per ml
• Unknown/sample • Never needs service
• $10,000/device or system • Expected life measure not
applicable Maturity gauge:
• Less than 5 minutes required • Expected to be ready for
for daily quality assurance commercialization within three or
procedures more calendar years
(brass board)
t
II:221

by bioMerieux

DETECTING NucliSens EasyQ System ranked in the highest third of all
VEE virus (Assay ALTERNATIVE UTILITY
developed); Best Score 0.901
Dengue fever NucliSens EasyQ System 0.752
virus (Assay
Lowest Score 0.217
validated)
The NucliSens EasyQ System combines isothermal (41C) nucleic
acid sequence-based amplification (NASBA) and molecular
beacon detection for Real-Time RNA assays using the NucliSens DIAGNOSTIC Laboratory Ranking
Basic Kit. RNA amplification assays are developed by the user
NucliSens EasyQ System ranked in the highest third of
with bioMerieux support. The system is designed for ease
of use in low or large volume molecular testing laboratories. all evaluated products for diagnostic laboratories and
Amplification time is generally 60 minutes, with total time to result earned 80% of the utility points of the best score.
for amplification and detection of less than two hours for 48 ALTERNATIVE UTILITY
samples. Commercially have done studies to link with automated Best Score 0.909
and manual sample prep.
NucliSens EasyQ System 0.726
The NucliSens EasyQ System combines nucleic acid sequenced-
based amplification (NASBA) and real-time molecular beacon Preference Set: Diagnostic Laboratory
detection. The system is designed for ease of use and is equally
suited to large or small volume molecular testing. Real-time
NASBA amplification with molecular beacon detection equals
rapid reaction time and often total time to result for amplification MOBILE Laboratory Ranking
and detection in less than two hours and in some cases less than NucliSens EasyQ System ranked in the highest third of all
15 minutes for 48 samples. NASBA technology is an isothermal evaluated products for mobile laboratories and earned
process that uses three enzymes (AMV-RT, RNase H and T7 RNA 72% of the utility points of the best score.
polymerase) and target specific oligonucleotides. The reaction
ALTERNATIVE UTILITY
run at 41C, generating single stranded RNA as an end product.
Best Score 0.883
Windows based open software generates results, melting curve
data and run performance information. The system is compact NucliSens EasyQ System 0.638
with a footprint of 16.5 x 16.5 in. combined with a small incubator Lowest Score 0.379
and dedicated computer and centrifuge.
FIELD USE Ranking

NucliSens EasyQ System ranked in the highest third of all
ALTERNATIVE UTILITY
Best Score 0.943
NucliSens EasyQ System 0.772
Lowest Score 0.343

II:222
Emanuel and Fruchey

source
require an external vacuum • Single centrifugation step
automated system
Signature:
CONTACT INFORMATION
• No set-up required • Less than 200 BTUS generated
bioMerieux
100 Rodolphe St.
Durham, NC 27712
www.biomerieux-usa.com
Point of Contact: multiple use • Device or system has peak
Lynell Grosso • 0-1 solution or buffer used performance at normal relative
(919) 620-2094 • 5 or more components humidity conditions only
(919) 620-7019 fax • Monthly maintenance required
lynell.grosso@na.biomerieux.com Sensitivity:
COST needed
• Approx. $10.00/sample • Less than once a year service
Maturity gauge:
required • Is commercially available
years
procedures necessary
II:223
Optical Immuno-assay
by Thermobiostar

DETECTING THE Optical Immuno-assay ranked in the middle third of all
Botulinum toxin ALTERNATIVE UTILITY
A, Ricin (Assays Best Score 0.901
developed)

Thermobiostar currently produces a small, rapid (15-minute), Effectiveness Biological Agents Logistics Operations
easy to operate immuno-based detection assay. These assays are Preference Set: Analytical Laboratory
based on the change in refractive index of a small silicon based
wafer due to deposition of enzymatic product following binding
of a secondary, detection antibody to the target organism which
has been captured by specific detection antibody adhered to
the wafer. This technology, which currently exists for detection Optical Immuno-assay ranked in the highest third of
of clinically relevant infectious agents, such as streptococcus all evaluated products for diagnostic laboratories and
and influenza, is being adapted through a CRADA with the Naval earned 73% of the utility points of the best score.
Research Laboratory and modified for the rapid detection of ALTERNATIVE UTILITY
environmental and potential bioterrorism agents. The assay is Best Score 0.909
rapid, extremely sensitive (equivalent or better than ELISA) and
is capable of quantitative detection. A further advantage of the
assay is the capability to incorporate detection of multiple agents Lowest Score 0.321
(10 or more) onto a single chip, greatly increasing the speed Effectiveness Operations Biological Agents Logistics
of agent detection. The assay, in its current configuration for Preference Set: Diagnostic Laboratory
clinically relevant infectious agents, is being used in many clinical
laboratories and physicians’ offices around the country.

The assay is predicated on the change in refractive index Optical Immuno-assay ranked in the highest third of all
associated with the formation of a thin–film created by deposition evaluated products for mobile laboratories and earned
of enzymatic product resulting from reaction of enzyme, attached 75% of the utility points of the best score.
to detection antibody with its substrate. The operation of the
assay is summarized by reacting the target antigen to the silicon ALTERNATIVE UTILITY
wafer which has been derivatized with specific capture antibody. Best Score 0.883
The antigen bound wafer is then further reacted with secondary, Optical Immuno-assay 0.660
detection antibody conjugated with enzymatic probe. Visualization Lowest Score 0.379
is conducted by further reaction of the wafer with substrate to
form a thin-film, yielding a change in color of the chip which is Logistics Biological Agents Effectiveness Operations
readily detected by eye. The color changes from its normal red Preference Set: Mobile Laboratory
color to various shades of blue and ultimately white, depending
on the concentration of antigen in the sample.
FIELD USE Ranking
Optical Immuno-assay ranked in the highest third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:224
Emanuel and Fruchey

• The system or device does can
source
DIAGNOSTIC • Single sample detection raw data or call a positive
• Less than 10 ul volume needed of detecting four or more
BEST FIT WORST FIT per test for detection biological agents or toxins within
easily be adapted into a fully • No additional pieces of
• Very brief training • No sounds produced that cannot
• No set-up required be deactivated
CONTACT INFORMATION
Thermobiostar
detection
6655 Lookout Road
Boulder, CO 80301
www.thermobiostar.com Re-use: • Operated from 25°C to 37°C
• Device or system is designed for • Components must be stored at
single use 4°C
Point of Contact: • 2 solutions or buffers used • Performance of the device or
John Dorson • 4 components system is not influenced by
(800) 637-3717 • No cleaning required relative humidity
(303) 581-6405 fax
j_Dorson@thermobiostar.com Maintenance: Sensitivity:
• 2 consumables or expendables • 10,000-100,000 CFU per ml
needed
• Approx. $10.00/sample • NA expected life
Maturity gauge:
• Approx. $10.00 /system or device
procedures required
t
II:225
P-CAN Sensor™
by IBI

DETECTING THE P-CAN ranked in the highest third of all evaluated
tularensis, Brucella Best Score 0.901
species, E.coli
IBI P-CAN 0.843
O157:H7, Vibrio
cholera, Yersinia Lowest Score 0.217
pestis, Orthopox Effectiveness Biological Agents Logistics Operations
virus, Venezuelan Preference Set: Analytical Laboratory
equine encephalitis
virus, Botulinum
toxin A, Smallpox
virus, Ricin toxin
(Assay developed); P-CAN ranked in the highest third of all evaluated
Dengue fever products for diagnostic laboratories and earned 96% of
virus, Rift valley the utility points of the best score.
fever virus (Assay ALTERNATIVE UTILITY
validated) Best Score 0.909
DESCRIPTION: IBI P-CAN 0.871
The basis for this platform is CANARY™ technology, which Lowest Score 0.321
provides a unique combination of speed, sensitivity, and flexibility
for pathogen detection. CANARY™ provides the capability for
detection of bacteria, viruses, and toxins in liquid or aerosol
samples, and delivers a result within minutes of sample isolation.
Use of CANARY™ with environmental samples is performed using
an completely automated system called the PANTHER, described MOBILE Laboratory Ranking
elsewhere in this survey. The sensor described here facilitates P-CAN ranked in the highest third of all evaluated
detection in liquid samples with a time to result of less than five products for mobile laboratories and earned 89% of the
minutes and a sensitivity of as few as 50 target organisms. This utility points of the best score.
sensor system consists of a 16-channel centrifugal rotor that
is positioned adjacent to a photomultiplier tube in a light-tight ALTERNATIVE UTILITY
enclosure. A brief centrifugation step facilitates the interaction Best Score 0.883
of the target with the detection reagent, resulting immediately in IBI P-CAN 0.789
a luminescent output that is recorded in real time as the sample Lowest Score 0.379
passes by the photomultiplier tube. The position of each tube in
the rotor is monitored in tandem with the light output, enabling a Logistics Biological Agents Effectiveness Operations
determination of the presence or absence of pathogen in all tubes Preference Set: Mobile Laboratory
within one minute.

The CANARY™ technology consists of B cell lines engineered to P-CAN ranked in the highest third of all evaluated
express a bioluminescent protein along with an antibody localized
to the cell surface that recognizes a molecular target of interest.
Binding of target to the surface-bound antibodies initiates a
luminescent response within seconds, allowing for real-time ALTERNATIVE UTILITY
detection of target. CANARY™ has a demonstrated sensitivity for Best Score 0.943
most targets of as few as 50 organisms, achieved by virtue of the IBI P-CAN 0.752
fact that interaction between target and B cell reagent can be
Lowest Score 0.343
efficiently facilitated by a short centrifugation step. Time to result
in liquid samples is less than five minutes. Logistics Operations Effectiveness Biological Agents
II:226
Emanuel and Fruchey

electrical requirement • There are multiple centrifugation
ANALYTICAL • The system or device does not steps
require water • No shaking or vortexing steps
require an external air or gas raw data or call a positive
MOBILE FIELD • The system or device does not • Capable of detecting multiple
• One additional piece of
DIAGNOSTIC • Single sample detection in 20
equipment needed

• 2 samples/batch or higher • There are sounds produced that
• Greater than 250 ul volume cannot be deactivated
BEST FIT WORST FIT needed per test for detection • Less than 200 BTUS generated
adapted into a fully automated Operational conditions:
system
Training/Speed/Manpower: 4°C
relative humidity
IBI skills
387 Technology Drive • Less than 5 minutes set-up Sensitivity:
College Park, MD 20742 required • 50-100 CFU per ml
innovativebiosensors.com • 3-5 manual steps required for
detection Maturity gauge:
Point of Contact:
Re-use: (brass board)
Thomas Hazel • Device or system is intended for • Is expected to be ready for
(301) 405-8466 multiple use commercialization within one
(301) 314-7436 • 2 solutions or buffers used calendar year
tom.hazel@innovativebiosensors.com • 1 component
for device or system to advance
COST Maintenance: to commercialization

• Once a year service required • Has not been featured in
• $28.00/sample any peer reviewed scientific
• $15,000.00/device or system publications or independent
years
procedures t
Transportation:
toaster MOST MATURE LEAST MATURE
• Reagent shelf life between 1 to
6 months
II:227
Palm-Cycler Thermocycler
by Corbett Research

DETECTING THE Palm-Cycler ranked in the highest third of all evaluated
Able to detect the utility points of the best score.
any organisms for ALTERNATIVE UTILITY
which assays are Best Score 0.901
developed. Palm-Cycler PCR 0.659

The Palm-Cycler is Effectiveness Biological Agents Logistics Operations
designed to regulate Preference Set: Analytical Laboratory
temperatures
in a small metal
block based on
user programs for
temperature and Palm-Cycler ranked in the highest third of all evaluated
cycling times. The products for diagnostic laboratories and earned 74% of
Palm-Cycler is used to facilitate the enzymatic reactions necessary the utility points of the best score.
for many detection methods. It does not directly detect anything ALTERNATIVE UTILITY
itself. There are a wide array of sequencing , DNA amplification, Best Score 0.909
Real-Time and isothermal reaction assays that can be used on the
Palm-Cycler.
Lowest Score 0.321
TECHNOLOGY:
Overall, the Palm-Cycler is a very simple system to operate. The
temperature can be regulated from 4°C-99°C in a 96 x 0.2ml,
384 x 0.1ml or 60 x 0.5ml block. The system utilizes a heated lid
to prevent condensation and is controlled by an HP Journada, a
pocket PC device. MOBILE Laboratory Ranking
Palm-Cycler ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Palm-Cycler ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:228
Emanuel and Fruchey

source
source • System is never able to interpret
• Detection performed in greater • System cannot detect multiple
than 60 minutes biological agents or toxins
• 96 samples/batch or higher detection within the same test
BEST FIT WORST FIT • Less than 10 ul volume needed • Three additional pieces of
• The system could be adapted
into a fully automated system Signature:
with some effort • No sounds produced that cannot
be deactivated
Training/Speed/Manpower: • Between 200-500 BTUS
• Very brief training generated
CONTACT INFORMATION
Corbett Research
1/14 Hilly Street
Mortlake, NSW 2137 Australia
• Components must be stored
www.corbettresearch.com
Re-use: at 4°C, and stored at room
• Device or system is intended for temperature
John Corbett • 2 solutions or buffers used system is not influenced by
011-612-973-613-20 • 1 component relative humidity
011-612-973-613-64 fax • No cleaning required
john@corbettesearch.com Sensitivity:
COST needed
• Unknown/sample • Less than once a year service Maturity gauge:
required • Is commercially available
• Expected life is 5-10 years t
procedures
II:229
PANTHER Autonomous Sensor

by MIT

DETECTING THE PANTHER Autonomous Sensor ranked in the
FOLLOWING: highest third of all evaluated products for analytical
Bacillus anthracis, Francisella laboratories and earned 91% of the utility points of the
tularensis, Brucella species, best score.
E.coli O157:H7, Vibrio cholera, ALTERNATIVE UTILITY
Yersinia pestis, Orthopox virus,
Best Score 0.901
Botulinum toxin A (Commercially
MIT Panther 0.821
available as a wet/frozen reagent); Smallpox virus, Ricin toxin (Assay
developed); Dengue fever virus, Rift valley fever virus, Venezuelan equine Lowest Score 0.217
encephalitis virus (Assay validated)
We have incorporated the pathogen identification technology with the best-
known combination of speed and sensitivity into a flexible bioaerosol sensor DIAGNOSTIC Laboratory Ranking
platform called PANTHER (Pathogen Alarm and Notification of Threatening PANTHER Autonomous Sensor ranked in the
Environmental Releases). A fully autonomous aerosol identification sensor highest third of all evaluated products for diagnostic
based on PANTHER has been designed that would be capable of automatically laboratories and earned 95% of the utility points of the
collecting, processing, and identifying pathogen aerosols in response to
as many as 30 independent triggered or timed aerosol collections. High-
best score.
confidence collection and identification of bioaerosols in two minutes has ALTERNATIVE UTILITY
been demonstrated using the core PANTHER sensor technology (see PANTHER Best Score 0.909
CUB questionnaire for more details). This sensor was designed to provide
MIT Panther 0.865
bioaerosol identification performance that is as much as 10 times faster
and 10 times more sensitive than that provided by existing sensors while Lowest Score 0.321
increasing the number of analyses per test and reducing false positive rates,
power requirements, and overall size and weight. The autonomous PANTHER
sensor design eliminates the need for all liquid collection consumables and
their associated fluid handling mechanisms. This enables it to be smaller,
faster, and simpler than existing autonomous bioaerosol sensors while still MOBILE Laboratory Ranking
including onboard environmental control for the PANTHER disks and transport PANTHER Autonomous Sensor ranked in the highest
mechanisms to allow it to automatically collect and analyze up to 30 aerosol third of all evaluated products for mobile laboratories
samples. The autonomous PANTHER sensor design has a volume of less than 6 and earned 87% of the utility points of the best score.
ft3 and an estimated weight of 140 lbs (64 kg). This sensor design represents
the full-capability automated aerosol identification sensor in the PANTHER family ALTERNATIVE UTILITY
of mission-specific automated bioaerosol identification sensors useful as stand- Best Score 0.883
alone bioaerosol sensors for site/building protection, portable sensors for field MIT Panther 0.772
use by emergency responders, and rapid processing of environmental samples
Lowest Score 0.379
in the field or in the laboratory. NOTE: Because the revolutionary design of the
PANTHER bioaerosol sensor conducts direct analyses of dry-collected samples, Logistics Biological Agents Effectiveness Operations
the questions in the survey that assume liquid samples are not directly relevant Preference Set: Mobile Laboratory
to this sensor. Questions related to throughput and processing requirements
have been answered assuming a dry sample as collected by the PANTHER and
additional comments have been added where necessary.
FIELD USE Ranking
TECHNOLOGY: PANTHER Autonomous Sensor ranked in the middle
PANTHER employs reagentless inertial impaction for aerosol collection third of all evaluated products for field use and earned
coupled directly with CANARY B-cell pathogen identification technology 72% of the utility points of the best score.
in a configuration that eliminates the need for fluid transfer mechanisms
and liquid collection consumables. All of the features required for aerosol ALTERNATIVE UTILITY
collection, reagent storage, reagent delivery, and optical signal monitoring Best Score 0.943
have been built into a simple, disposable, injection-molded disk that is MIT Panther 0.677
automatically processed by the CUB sensor. A single PANTHER disk with a Lowest Score 0.343
diameter the same as a standard CD or DVD is capable of collecting aerosol
samples at up to 520 L/min (32 L/min/channel) and completing 16 Logistics Operations Effectiveness Biological Agents
independent assays on the collected sample simultaneously. Preference Set: Field Use
II:230
Emanuel and Fruchey

equipment needed
• Single sample detection in 20 Signature:
minutes or less • There are sounds produced that
• 32 samples/batch or higher cannot be deactivated
• Less than 10 ul volume needed
• The system or device is Operational conditions:
currently fully automated • Operated from 4°C to 45°C
4°C or room temperature
• A day of training or system is not influenced by
• 5-10 minutes set-up required relative humidity
MIT Lincoln Laboratory detection
244 Wood St. Sensitivity:
• 100-1,000 CFU per ml
Lexington, MA 02420
Re-use:
• Device or system is intended for Maturity gauge:
multiple use
Point of Contact: • Only one incomplete device or
James Harper • 1 component system exists (bread board)
(781) 981-0794 • No cleaning required • Is expected to be ready for
(781) 981-3867 commercialization within one
harper@LL.mit.edu calendar year
Maintenance: • Less than $1,000,000 required
• Every 6 months service required
to advance device or system to
COST commercialization
years
• $0.63/sample • Has not been featured in
• $100,000.00/device or system any peer reviewed scientific
procedures
evaluations
Transportation: t
• More than 50 kg
• Reagent shelf life between 1 to MOST MATURE LEAST MATURE
6 months
II:231
PANTHER CUB
by MIT

DETECTING PANTHER CUB ranked in the highest third of all
tularensis, MIT Panther Cub 0.848
Brucella species,
Lowest Score 0.217
E.coli O157:H7,
Vibrio cholera, Effectiveness Biological Agents Logistics Operations
Yersinia pestis, Orthopox virus, Botulinum toxin A (Commercially available Preference Set: Analytical Laboratory
as a wet/frozen reagent); Smallpox virus, Ricin toxin (Assay developed);
Dengue fever virus, Rift valley fever virus, Venezuelan equine encephalitis
virus (Assay validated) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: PANTHER CUB ranked in the highest third of all
We have incorporated the pathogen identification technology with the best- evaluated products for diagnostic laboratories and
known combination of speed and sensitivity into a flexible bioaerosol sensor earned 98% of the utility points of the best score.
platform called PANTHER (Pathogen Alarm and Notification of Threatening
Environmental Releases). The first PANTHER sensor, the CUB, is a compact ALTERNATIVE UTILITY
portable sensor capable of automatically collecting, processing and identifying Best Score 0.909
pathogen aerosols. High-confidence collection and identification of bioaerosols MIT Panther Cub 0.894
in two minutes has been demonstrated using PANTHER CUB sensors that Lowest Score 0.321
can ultimately be made for less than $20K in volume. CUB sensors currently
weigh 37 lb. (17 kg) and fit in a volume of ~1 ft3, and further size and weight Effectiveness Operations Biological Agents Logistics
reductions are possible. The CUB design is simple and reliable: It has no Preference Set: Diagnostic Laboratory
fluidics, no liquid consumables, minimal moving parts, loads like a CD player,
and automatically collects and analyzes aerosol samples. This sensor has been
designed with modular upgrades in mind and can form the core of a family of
mission-specific automated bioaerosol identification sensors useful as stand-
alone bioaerosol sensors for site/building protection, portable sensors for field PANTHER CUB ranked in the highest third of all
use by emergency responders, and rapid processing of environmental samples evaluated products for mobile laboratories and earned
in the field or in the laboratory. NOTE: Because the revolutionary design of the 95% of the utility points of the best score.
CUB bioaerosol sensor conducts direct analyses of dry-collected samples, the
questions in the survey that assume liquid samples are not directly relevant to ALTERNATIVE UTILITY
this sensor. Questions related to throughput and processing requirements have Best Score 0.883
been answered assuming a dry sample as collected by the PANTHER CUB and MIT Panther Cub 0.839
additional comments have been added where necessary. Lowest Score 0.379

PANTHER employs reagentless inertial impaction for aerosol collection Preference Set: Mobile Laboratory
coupled directly with CANARY B-cell pathogen identification technology
in a configuration that eliminates the need for fluid transfer mechanisms
and liquid collection consumables. All of the features required for aerosol FIELD USE Ranking
collection, reagent storage, reagent delivery, and optical signal monitoring
PANTHER CUB ranked in the highest third of all
have been built into a simple, disposable, injection-molded disk that is
automatically processed by the CUB sensor. A single PANTHER disk with a
diameter the same as a standard CD or DVD is capable of collecting aerosol utility points of the best score.
samples at up to 520 L/min (32 L/min/channel) and completing 16 ALTERNATIVE UTILITY
independent assays on the collected sample simultaneously. Best Score 0.943
Lowest Score 0.343

II:232
Emanuel and Fruchey

require water • Reagent shelf life between 1 to 6
• The system or device does not months
Signature:
Training/Speed/Manpower: • There are sounds produced that
• Very brief (minutes-hours) cannot be deactivated
training and minimal technical • Less than 200 BTUS generated
MIT Lincoln Laboratory • Less than 5 minutes set-up
244 Wood St. required Operational conditions:
Lexington, MA 02420
Point of Contact: Re-use: or system is not influenced by
James Harper • Device or system is intended for relative humidity
(781) 981-3867 • 0-1 solution or buffer used Sensitivity:
harper@LL.mit.edu • 1 component • 100-1,000 CFU per ml
Maturity gauge:
COST Maintenance: • Is commercially available
• $0.63/sample • Once a year service required
• Has not been featured in
• Unknown/system • Expected life is greater than 10
years
evaluations
procedures
t
II:233
PathAlert™
by Invitrogen

DETECTING THE PathAlert ranked in the highest third of all evaluated
Yersinia pestis, Smallpox Best Score 0.901
virus, Orthopox virus,
Invitrogen PathAlert 0.841
(Commercially available
Lowest Score 0.217
as a freeze-dried
reagent); Brucella Effectiveness Biological Agents Logistics Operations
species, E.coli O157:H7, Preference Set: Analytical Laboratory
Ebola virus, Botulinum
toxin A, Botulinum toxin B
(Assay developed)
DESCRIPTION: PathAlert ranked in the highest third of all evaluated
The PathAlert™ detection kit is a multiplex PCR system capable products for diagnostic laboratories and earned 85% of
of detecting Bacillus anthracis (Anthrax), Yersinia pestis (Plague), the utility points of the best score.
Francisella tularensis (Tularemia), or Smallpox (Orthopox) in
ALTERNATIVE UTILITY
individual assays. The system is intended for use in stationary
or mobile laboratory settings. The workflow is simple – following Best Score 0.909
nucleic acid extraction of the sample (which may be performed Invitrogen PathAlert 0.770
by any commercial method including Invitrogen’s ChargeSwitch™ Lowest Score 0.321
product offering), PathAlert™ reagents are used to perform end-
point PCR analysis and the amplification product is analyzed using Effectiveness Operations Biological Agents Logistics
the microfluidics based Agilent 2100 Bioanalyzer. PathAlert™ Preference Set: Diagnostic Laboratory
is specific due to multiple loci and the use of both amplification
and size for detection; sensitive given proprietary PCR based
technology; and flexible given future capabilities for multi-agent
detection in single assays. The PathAlert™ kits and Agilent 2100 MOBILE Laboratory Ranking
Bioanalyzer are COTS. The key advantage of the 2100 Bioanalyzer PathAlert ranked in the highest third of all evaluated
is the ability to perform multiplex detection, simultaneously products for mobile laboratories and earned 86% of the
interrogating collected samples (20 or more) for multiple bacteria utility points of the best score.
and viruses. This results in dramatically reduced operating costs
and a more efficient workflow. Using the electropherogram traces ALTERNATIVE UTILITY
from the Bioanalyzer output, the operator is provided with a clear Best Score 0.883
“yes/no” answer as to the presence of the pathogen specific Invitrogen PathAlert 0.759
amplification products. The PathAlert™ System has recently been
included in the mobile laboratory developed for the Air Force by Lowest Score 0.379
Battelle at Kirtland Air Force Base in Utah; used to ensure the Logistics Biological Agents Effectiveness Operations
safety of athletes in the recent Olympic games in Italy and in the Preference Set: Mobile Laboratory
Commonwealth Games in Australia; and in a number of other
government and commercial settings.

PathAlert™ kits include an optimized PCR supermix specific PathAlert ranked in the highest third of all evaluated
to the pathogen of interest and an external positive control for products for field use and earned 80% of the utility points
system validation. Critical kit components are: Taq polymerase, of the best score.
pre-complexed with antibodies for “hot start” PCR (for specificity
and sensitivity); Uracil DNA Glycosylase (UDG) and dUTP (for the ALTERNATIVE UTILITY
elimination of post-PCR cross-contamination); and an internal Best Score 0.943
positive control, to identify potential PCR inhibition. The external Invitrogen PathAlert 0.758
positive control has been engineered to produce a unique Lowest Score 0.343
amplicon size, thereby eliminating any concerns associated
with false positives related to external control contamination. Logistics Operations Effectiveness Biological Agents
The microfluidics based Agilent 2100 Bioanalyzer uses capillary Preference Set: Field Use
electrophoresis to provide amplicon sizing information.
II:234
Emanuel and Fruchey

source
vortexing step
• Single sample detection greater raw data or call a positive
than 60 minutes through internal software
• 96 samples/batch or higher • Capable of detecting multiple
Signature:
• An afternoon of training and be deactivated
CONTACT INFORMATION
some technical skills required • Greater than 500 BTUS
Invitrogen
7335 Executive Way • 6-8 manual steps required for
Frederick, MD 21704 detection Operational conditions:
www.invitrogen.com/pathogenresearch • Operated from 4°C to 37°C
Re-use: • Components must be frozen
Bill Folkerts multiple use or system is not influenced by
(240) 379-4209 • More than 4 solutions or buffers relative humidity
Willem.Folkerts@invitrogen.com used
• Cleaning of the Bioanalyzer • 1-100 CFU per ml
requires the use of a multiple
COST use water containing Maturity gauge:
microfluidic chip
• $2.50-5.00/sample • Is commercially available
• $25,000.00/device or system • Has been featured in peer
Maintenance: reviewed scientific publications
• No service required or independent evaluations
years t
procedures
II:235
Portable NanoChip Molecular Biology Workstation

by Nanogen, Inc.

DETECTING THE Portable NanoChip Molecular Biology Workstation ranked
FOLLOWING: in the highest third of all evaluated products for analytical
Bacillus anthracis, E. coli laboratories and earned 70% of the utility points of the
0157:H7, Yersinia pestis, best score.
Orthopox virus, SEB (Assays ALTERNATIVE UTILITY
developed)
Best Score 0.901
DESCRIPTION: Port. NanoChip Workstation 0.627

The Portable NanoChip Lowest Score 0.217
Molecular Biology Workstation Effectiveness Biological Agents Logistics Operations
is a miniaturized automated Preference Set: Analytical Laboratory
instrument that facilitates
detection of known DNA
sequences, primarily
developed for the detection Portable NanoChip Molecular Biology Workstation
of biological warfare agents ranked in the highest third of all evaluated products for
using the 400-site NanoChip diagnostic laboratories and earned 72% of the utility
Electronic Microarray. The unique, open-architecture design permits users to points of the best score.
easily develop new assays for bacterial or viral identification as well as other
ALTERNATIVE UTILITY
genetic analysis applications. The Portable NanoChip System uses CMOS
Best Score 0.909
400-site microarray embedded into a cartridge for electronic addressing
of the DNA samples or probes onto the array. The fluorescent reporters Port. NanoChip Workstation 0.650
are attached passively or actively and an optical system with CCD camera Lowest Score 0.321
measures fluorescence at each array site. The samples are simply pipetted
through a sample cup as well as some of the reagents needed in the tests
and automatically pumped onto the microarray chip. Buffer and waste
bottles are housed in the instrument. The software provides fully automated
fluidic control, electronic addressing on the array as well as fluorescent MOBILE Laboratory Ranking
image data display and interpretation. Portable NanoChip Molecular Biology Workstation ranked
in the middle third of all evaluated products for mobile
TECHNOLOGY: laboratories and earned 67% of the utility points of the
Nanogen’s NanoChip technology is used in the instrument which is based best score.
on electronic addressing of charged molecules at specific test sites on the
NanoChip microarray. Electronic addressing allows on-chip hybridization to ALTERNATIVE UTILITY
occur within seconds compared to several hours in passive hybridization. Best Score 0.883
In addition, DNA target molecules are electronically concentrated at the Port. NanoChip Workstation 0.588
array sites, exceeding ca 1000 times the concentration in the bulk of Lowest Score 0.379
solution. When a biotinylated sample or probe is introduced onto the array,
the negatively charged molecules rapidly move to the selected positively Logistics Biological Agents Effectiveness Operations
charged sites, where it is concentrated and bound to the streptavidin in Preference Set: Mobile Laboratory
the permeation layer. The array is then washed and another sample can be
added. Site by site, row by row, an array of samples are assembled on the FIELD USE Ranking
array and fluorescence detected. The platform allows both electronic and Portable NanoChip Molecular Biology Workstation ranked
thermal stringency assays to be developed which assure single base pair in the middle third of all evaluated products for field use
recognition. The customer may analyze multiple genes from a single test site and earned 56% of the utility points of the best score.
(representing one sample) or from multiple test sites (representing different
samples). The customer also has the ability to electronically address ALTERNATIVE UTILITY
multiplexed amplicons to a single test site. DNA samples amplified by PCR, Best Score 0.943
or strand displacement amplification (SDA) can be used in the analysis. In Port. NanoChip Workstation 0.531
addition, Nanogen developed an on-chip SDA DNA amplification method for Lowest Score 0.343
the detection of geological warfare agents. This method allows multiplexed
amplification on the chip as well as detection of amplified products. Logistics Operations Effectiveness Biological Agents
II:236
Emanuel and Fruchey

or 110V requirement on luggage suitcase
ANALYTICAL • The system or device does • Between 5 and 25 kg
source
• The system or device could • Two additional pieces of
automated system
Signature:
CONTACT INFORMATION
• 5-10 minutes required for set-up • Less than 200 BTUS generated
Nanogen, Inc.
10398 Pacific Center Court
San Diego, CA 92121
www.nanogen.com
Sales Department • 4 solutions or buffers used system is not influenced by
(877) NANOGEN • 5 or more components relative humidity
Sensitivity:
• 1,000-10,000 CFU per ml
Maintenance:
• Unknown/sample • More often than every 6 months • A few devices or systems exist
• Unknown/system or device service required (brass board)
years t
II:237
Pro Strips™ Rapid Screening System

by Advnt

DETECTING Pro Strips ranked in the highest third of all evaluated
Yersinia pestis, Advnt Pro Strips 0.663
Botulinum toxin
Lowest Score 0.217
A, Botulinum
toxin B, Effectiveness Biological Agents Logistics Operations
Staphylococcal Preference Set: Analytical Laboratory
toxin B,
Ricin toxin
(Commercially available as wet/frozen reagent) DIAGNOSTIC Laboratory Ranking
DESCRIPTION: Pro Strips ranked in the highest third of all evaluated
One Device - One Sample, Multiple threat recognition capabilities. products for diagnostic laboratories and earned 85% of
Inspired by HAZMAT professionals, Pro Strips™ is the first and only the utility points of the best score.
Hand-Held Assay designed to detect and identify multiple threats ALTERNATIVE UTILITY
using one small sample and one, simple to use device. Pro Strips Best Score 0.909
advanced design revolutionizes speed, efficiency, and ease-of-use,
Advnt Pro Strips 0.770
while providing the highest degree of accuracy needed to correctly
mitigate the risk associated with a biological threat. Each Hand- Lowest Score 0.321
Held Assay is individually packaged and comes complete with Effectiveness Operations Biological Agents Logistics
everything needed to perform the test. No reader or additional Preference Set: Diagnostic Laboratory
collection kits required.
TECHNOLOGY:
Pro Strips™ biowarfare detection kits are a hand-held MOBILE Laboratory Ranking
immunochromatographic assay which employs the use of Pro Strips ranked in the highest third of all evaluated
labeled antibodies for detection. products for mobile laboratories and earned 90% of the
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Pro Strips ranked in the highest third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:238
Emanuel and Fruchey

• There is no electrical • Approximately the size of a soda
requirement can
require water • Reagent shelf life between 1 and
source • 1 shaking or vortexing step
• System cannot interpret raw data
DIAGNOSTIC Throughput of product: or call a positive through internal
• Single sample detection less software
than 20 minutes • Capable of detecting two or more
needed per test for detection • No additional equipment
• The system or device is not required
amenable to automation
Signature:
Training/Speed/Manpower: • There are no sounds that cannot
Advnt skills Operational conditions:
2102 West Quail Avenue, Suite 3 • No set-up required • Operated from 4°C to 45°C
Phoenix, AZ 85027 • 3-5 manual steps required for • Components must be stored at
www.advnt.org detection room temperature
• The performance of the device or
system is influenced by relative
Point of Contact: Re-use: humidity
Dan Faubion • Device or system is intended for
(888) 223-3269 single use Sensitivity:
(623) 879-9697 • 0-1 solution or buffer used • 1000-10,000 CFU per ml
danf@advnt.org • 1 component
Maturity gauge:
Maintenance: • Is commercially available
• $13.99/Pro Strips 5 and $16.65/Pro Strips 3 • The expected life is unknown
• $69.95/Pro Strips 5 and $49.95/Pro Strips 3
II:239
PROFILE-1 ATP Luminescence System

by New Horizons Diagnostics Corp.

DETECTING THE Profile-1 ATP ranked in the highest third of all evaluated
Generic Bacterial/spore the utility points of the best score.
(Commercially available ALTERNATIVE UTILITY
as wet/frozen reagent) Best Score 0.901
DESCRIPTION:
Lowest Score 0.217
New Horizon Diagnostics
Corporation (NHD) Effectiveness Biological Agents Logistics Operations
manufactures a hand- Preference Set: Analytical Laboratory
held, generic detector for ATP in living systems with a no specificity, battery
operated (AC-DC), luminometer that is capable of determining the presence
of viable low levels of bacteria and spores. The protocol incorporates
a method for the removal of non-bacterial cells as well as potential
interferents. The System provides Real-Time results; 5 minutes for bacterial Profile-1 ATP ranked in the highest third of all evaluated
detection and 20 minutes for spore detection. The PROFILE System detects products for diagnostic laboratories and earned 87% of
only viable organisms and has the capability to quantitate bacterial levels. the utility points of the best score.
PROFILE has received FDA 510(k) for human use (bacteria in urine), field ALTERNATIVE UTILITY
validated by USDA for bacterial detection on meat carcasses, field tested Best Score 0.909
by WHO labs for water samples, and tested by DOD for detection of spores.
More recently, DARPA funded studies have demonstrated the utility of the
Lowest Score 0.321
System to detect and identify as low as 100 Bacillus anthracis spores in
less than 30 minutes. Identification can be made via utilization of specific Effectiveness Operations Biological Agents Logistics
bacteriophage lytic enzymes or antibodies. The PROFILE is a field instrument Preference Set: Diagnostic Laboratory
that was incorporated in the original BIDS for air samples. There is also
application for other environmental samples (powders, surfaces, etc.) water,
food, as well as fuel oils. Detection limits are normally between 1000
and 100,000 cells, depending on the debris in the sample area, but the MOBILE Laboratory Ranking
system can be adjusted to detect 100 or less cells. The System has been Profile-1 ATP ranked in the highest third of all evaluated
incorporated in a Bio-Screen “Triage” system for First Responders. As part of products for mobile laboratories and earned 90% of the
a “Layered” approach system, PROFILE received highest score for general utility points of the best score.
detection in DOD study (ECBC-TR-171).
ALTERNATIVE UTILITY
Luminescence is the emission of light that does not derive energy from the PROFILE-1 ATP Lumin. Sys. 0.801
temperature of the emitting body. It is caused by chemical, biochemical, Lowest Score 0.379
or physical changes of a material in a sample. Luminescence techniques
utilize this phenomenon to measure the presence of an analyte in a sample Logistics Biological Agents Effectiveness Operations
that exhibits this characteristic. This typically is achieved by the reaction of Preference Set: Mobile Laboratory
the analyte with a substrate that produces light. Luciferin-Luciferase (L/L)
luminescence techniques are used to measure the adenosine triphosphate
(ATP) content (pg/ml) in samples containing either vegetative bacterial cells FIELD USE Ranking
or spores. Evaluation for the presence of total bio-mass from both bacterial Profile-1 ATP ranked in the highest third of all evaluated
and non-bacterial sources of ATP is achieved by suspending the collected products for field use and earned 94% of the utility points
samples in phosphate buffered saline (PBS), transferring an aliquot of the of the best score.
PBS suspension into a Filtravette, adding bacterial releasing agent (BRA),
then adding L/L. The sample then reacts with the L/L, and the resulting ALTERNATIVE UTILITY
Relative Light Units (RLU) indicative of the total ATP content, are measured. Best Score 0.943
Identical techniques are used to prepare the bacterial cells for analysis with PROFILE-1 ATP Lumin. Sys. 0.890
one additional step: a wash of the sample with somatic cell releasing agent Lowest Score 0.343
(SRA) before adding BRA. The SRA wash is added to the Filtravette along
with the sample and lyses all non-microbial (somatic and quenching) cells. Logistics Operations Effectiveness Biological Agents
These lysed cells are removed from the Filtravette via positive pressure, Preference Set: Field Use
leaving the bacterial cells whole on the surface of the Filtravette.
II:240
Emanuel and Fruchey

• System could be able to interpret
DIAGNOSTIC • Single sample detection 20 through internal software in the
minutes or less future
• 32 samples/batch or higher • Assay available and capable of
• Less than 50 ul volume needed detecting four or more biological
BEST FIT WORST FIT per test for detection agents or toxins within the same
• The system or device could be test
adapted into a semi automated • No additional pieces of
• Less than 5 min required for be deactivated
CONTACT INFORMATION
set-up • Less than 200 BTUS generated
New Horizons Diagnostic Corp.
9110 Red Branch Rd.
Columbia, MD 21045
www.NHDiag.com
• Device or system is designed for room temperature
Point of Contact: single use • Performance of the device or
David Trudil • 3 solutions or buffers used system is not influenced by
(410) 992-9357 x222 • 3 components relative humidity
NHDiag@aol.com Sensitivity:
• 1,000-10,000 CFU per ml
Maintenance:
• $4.00-8.00/sample • No service required • Is commercially available and
• $4,000.00/system or device • Expected life is 5-10 years meets military specifications
II:241
PROFILE-II
by MEDTOX

DETECTING THE Profile-II ranked in the lowest third of all evaluated
Yersinia pestis, Botulinum ALTERNATIVE UTILITY
toxins A, B, T-2 toxin, Ricin Best Score 0.901
(Assays developed)
PROFILE-II 0.380

The device is a hand held Effectiveness Biological Agents Logistics Operations
manual system that is Preference Set: Analytical Laboratory
approximately 2 and 3/8
by 1 and ½ and ¼ inches.
The device is contained
in a poly foil aluminum
package. The device Profile-II ranked in the middle third of all evaluated
was designed to perform products for diagnostic laboratories and earned 63% of
immunoassays for the the utility points of the best score.
detection of drugs of ALTERNATIVE UTILITY
abuse (currently over 40 configurations) but was also used for the Best Score 0.909
detection of biological agents and toxins in liquid environmental
PROFILE-II 0.572
samples. Many of the current users of our drug tests are state
agencies where police, probation and parole officers have used Lowest Score 0.321
hundreds of thousands of devices to run on-site drug tests. Effectiveness Operations Biological Agents Logistics
Environmental air and surface samples that are impinged or Preference Set: Diagnostic Laboratory
swabbed into a liquid sample buffer can also be tested on this
device. The user-friendly device only requires the addition of two
drops of liquid sample and can be read in 5 to 10 minutes.
TECHNOLOGY: Profile-II ranked in the highest third of all evaluated
The MEDTOX ‘s test device utilizes a one step lateral flow products for mobile laboratories and earned 82% of the
immunochromatographic technology. When sample solution is utility points of the best score.
applied to the device, a mobile particle (gold or latex) coated with
antibody is hydrated and migrates on a nitrocellulose membrane. ALTERNATIVE UTILITY
At select positions on the membrane a complementary binding Best Score 0.883
pair member is immobilized. In the case of a competitive assay PROFILE-II 0.724
(drug test) positive drug samples will inhibit the formation of a Lowest Score 0.379
visible line while drug free samples will permit the formation of a
line at the binding pair member site. In the detection of bio-agents Logistics Biological Agents Effectiveness Operations
a positive sample will generate a visible line at the immobilized Preference Set: Mobile Laboratory
complementary antibody site. A bio-agent negative sample will
generate no line at the immobilized binding site. Also present on
the test device is an internal control that indicates that the proper FIELD USE Ranking
sample volume was applied and that the reagents migrated to Profile-II ranked in the highest third of all evaluated
the end of the device. A visible control line must appear on each products for field use and earned 82% of the utility points
device to ensure that the proper test procedures were performed. of the best score.
The device can test environmental air and surface samples that
are impinged or swabbed into a liquid sample buffer .The user- ALTERNATIVE UTILITY
friendly device only requires the addition of two drops (100μl) Best Score 0.943
of liquid sample and can be read in 5 to 10 minutes. Spores, PROFILE-II 0.772
vegetative bacteria and toxins have been detected in liquid Lowest Score 0.343
samples with the MEDTOX device.
II:242
Emanuel and Fruchey

• No electrical requirements • Approximately the size of a soda
• The system or device does not • Shelf life between 1 to 3 years
• NA interpret raw data or call a
Throughput of product: positive through internal software
DIAGNOSTIC • Single sample detection in 20 • Assay not available, but capable
minutes or less of detecting four or more
• NA samples/batch biological agents or toxins within
• Sample volume less than 250 ul the same test
BEST FIT WORST FIT • The system or approach is not • No additional equipment needed
amendable to automation
Signature:
• No set-up time required • NA BTUS
CONTACT INFORMATION detection Operational conditions:
Medtox Diagnostics, Inc. • Operated from 4°C to 45°C
1238 Anthony Road Re-use: • Components can be stored at
Burlington, NC 27215
single use • Unknown if performance of the
www.medtox.com device or system is influenced by
Point of Contact: • NA cleaning required
Michael Turanchik Sensitivity:
(336) 226-6311 x273 • Greater than 100,000 CFU per
(336) 229-4471 fax
Maintenance:
ml
mturanchik@medtox.com needed
• Never requires service Maturity gauge:
• Expected life is NA • A few devices or systems exist
COST • No daily quality assurance (brass board)
• $20.00 - 75.00 depending on test configuration/ procedures necessary
sample t
• $20.00 - 75.00 depending on test configuration/
system or device
II:243
RAMP
by Response Biomedical Corp.

THE FOLLOWING: RAMP ranked in the highest third of all evaluated
Francisella tularensis, Yersinia products for analytical laboratories and earned 78% of
pestis (Assays developed); the utility points of the best score.
Bacillus anthracis, Smallpox ALTERNATIVE UTILITY
virus, Orthopox virus, Best Score 0.901
Botulinum toxin A, B, E, Ricin
(Commercially available as
wet/frozen reagent) Lowest Score 0.217

RAMP is a rapid qualitative
immunochromatographic system for the screening of
environmental samples such as for the presence of B. anthracis
spores, ricin, botulinum toxin and orthopox viruses. The Reader DIAGNOSTIC Laboratory Ranking
is a scanning fluorometer and data analysis system used for RAMP ranked in the highest third of all evaluated
the measurement of fluorescence in RAMP immunoassay products for diagnostic laboratories and earned 86% of
applications. The Reader can be operated on battery power or the utility points of the best score.
powered via an AC Adapter. The RAMP Test Cartridge is a single-
ALTERNATIVE UTILITY
use disposable, analyte specific cartridge that is used to detect
Best Score 0.909
the level of an analyte in an aqueous sample. The operator
prepares the appropriate sample according to the package Response Biomedical RAMP 0.778
insert and then places an aliquot into the sample well of the Lowest Score 0.321
Test Cartridge. The Test Cartridge is then inserted into the RAMP
Reader, which analyzes the sample and provides a result. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
RAMP assays are processed in disposable, single-use Test
Cartridges. Each Cartridge houses an analyte-specific, mylar- MOBILE Laboratory Ranking
backed nitrocellulose immunochromatographic strip on which RAMP ranked in the highest third of all evaluated
the assay runs. The strip simultaneously runs a test reaction and products for mobile laboratories and earned 80% of the
an independent internal control reaction. The internal control utility points of the best score.
has been incorporated into the RAMP System to provide reliable
results by compensating for test-to-test variations. To perform ALTERNATIVE UTILITY
an assay, the operator transfers a sample into the sample well Best Score 0.883
of a Test Cartridge and inserts the Cartridge into the Reader. Response Biomedical RAMP 0.707
The sample is drawn by capillary action along the membrane. Lowest Score 0.379
For example, in the Anthrax Test, BA spores present in the
sample interact and bind with the mobile, fluorescently labeled Logistics Biological Agents Effectiveness Operations
anti-BA antibodies, forming an antibody-antigen complex. The Preference Set: Mobile Laboratory
complexes and labeled antibodies are subsequently captured at
the detection and internal control zones. When the reaction in the
Cartridge is complete, the Reader scans the test strip and detects FIELD USE Ranking
fluorescence in the detection and the internal control zones and RAMP ranked in the highest third of all evaluated
determines the concentration of BA spores. To accomplish this products for field use and earned 88% of the utility points
task, the Reader calculates the ratio between the concentrations
of the best score.
of fluorescing particles in the detection and internal control zones.
By calculating the final assay result as a ratio between the two ALTERNATIVE UTILITY
measurements, the RAMP System automatically accounts for Best Score 0.943
variations in sample and membrane properties. A “POSITIVE“ or Response Biomedical RAMP 0.837
“NEGATIVE “ test result is determined by the Reader. An assay Lowest Score 0.343
result appears on the Reader’s display within 15 minutes of
inserting the Cartridge. The result can also be stored, printed, or Logistics Operations Effectiveness Biological Agents
uploaded to a laboratory, hospital or other information system. Preference Set: Field Use
II:244
Emanuel and Fruchey

• 1 sample/batch biological agents or toxins within
BEST FIT WORST FIT needed per test for detection • No additional pieces of
Signature:
Training/Speed/Manpower: • Sounds produced that cannot be
• An afternoon of training deactivated
• No required set-up • Less than 200 BTUS generated
CONTACT INFORMATION
Response Biomedical Corp.
8081 Lougheed Highway
Burnaby, BC V5A 1W9 Canada Re-use: • Components can be stored at
www.responsebio.com • Performance of the device or
multiple use
• 0-1 solution or buffer used system is not influenced by
Point of Contact: • 2 components relative humidity
David Trotter • No cleaning required
(604) 681-4101 x210 Sensitivity:
(604) 412-9830 fax • 1,000-10,000 CFU per ml
Maintenance:
dtrotter@responsebio.com • 0-1 consumable or expendable
needed Maturity gauge:
• No service required • Is commercially available and
COST • Expected life is greater than 10 meets military specifications
• $25.00/sample years
• $9,750.00/system or device • No daily quality assurance t
procedures required
II:245
RAPID (Ruggedized Advanced Pathogen Identification Device)

by Idaho Technology

DETECTING RAPID ranked in the highest third of all evaluated
coli 0157:H7, Idaho Tech RAPID 0.737
Francisella
Lowest Score 0.217
tularensis,
species (Commercially available as a freeze-dried reagent);
Smallpox virus, Orthopox virus, VEE virus (Assay validated);
Bacillus anthracis, Ricin E. coli 0157:H7, Vibrio cholera, DIAGNOSTIC Laboratory Ranking
Francisella tularensis, Yersinia pestis, MS-2 bacteriophage,
RAPID ranked in the highest third of all evaluated
Botulinum toxin A, SEB (Assays developed); Brucella species
RAPID is a fluorescent monitoring thermal cycler that is man- ALTERNATIVE UTILITY
portable, impact resistant, and requires minimal training for Best Score 0.909
operational use in military field hospitals and other austere
environments. The system can be made operational within 30
minutes of arrival on site (includes setup and warm-up time) Lowest Score 0.321
and is designed to prevent operator exposure to the samples Effectiveness Operations Biological Agents Logistics
being processed while preserving sample integrity. The system Preference Set: Diagnostic Laboratory
has a feature for clinical identification of pathogenic agents. The
identification feature applies a specific identification technology
to allow for pinpointing the presence of specific pathogens. The
RAPID is used extensively by all branches of the U.S. DoD for
biowarfare pathogen identification and well as food borne illness RAPID ranked in the highest third of all evaluated
identification. It is rugged and field portable with simple push products for mobile laboratories and earned 89% of the
button software for field use while maintaining an advanced user utility points of the best score.
interface for laboratory research applications. ALTERNATIVE UTILITY
The RAPID is a high speed real-time air thermal-cycler that relies Idaho Tech RAPID 0.785
on specific DNA amplification for pathogen identification. We Lowest Score 0.379
couple this with optimized freeze-dried reagents alleviating the
need for any refrigeration or freezing of chemistry components
for six months. We have validated freeze-dried assays for Anthrax,
Brucella spp., Y. pestis, Tularemia, Salmonella, C.botulinum,
Campylobacter, E.coli 0157, and L. monocytogenes.
FIELD USE Ranking
RAPID ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:246
Emanuel and Fruchey

source
source required
• Single shaking or vortexing step
DIAGNOSTIC Throughput of product: • System able to interpret raw data
• Single sample detection or call a positive through internal
• 32 samples/batch or higher • Not capable of detecting multiple
Signature:
• More than a day of training be deactivated
CONTACT INFORMATION
• Less than 5 minutes required • Between 200-500 BTUS
Idaho Technology
for set-up generated
390 Wakara Way • 9-12 manual steps required for
Salt Lake City, UT 84108 detection Operational conditions:
www.idahotech.com • Operated from 4°C to 45°C
Matt Scullion multiple use • Performance of the device or
(801) 736-6354 x327 • 0-1 solution or buffer used system is not influenced by
(801) 588-0507 fax • 5 or more components relative humidity
matts@idahotech.com • No cleaning required
Sensitivity:
Maintenance:
• $16.00/sample (duplicate reactions) expendables needed Maturity gauge:
• $48,400.00 GSA/$60,000.00 non-GSA price/ • Needs service every 6 months • Is commercially available and
system or device • Expected life is greater than 10 meets military specifications
years
procedures required
II:247
Rapid Flu Test

by Cellex

DETECTING THE Rapid Flu Test ranked in the highest third of all evaluated
Influenza virus (Assay the utility points of the best score.
Best Score 0.901
DESCRIPTION:
Pandemic influenza
could have devastating Lowest Score 0.217
impact on our military Effectiveness Biological Agents Logistics Operations
capability. An important Preference Set: Analytical Laboratory
part of influenza
pandemic preparedness
is the availability of
rapid and sensitive
influenza diagnostic Rapid Flu Test ranked in the highest third of all evaluated
tests, which can be products for diagnostic laboratories and earned 87% of
used for surveillance, the utility points of the best score.
early pandemic period ALTERNATIVE UTILITY
monitoring, patient admission, and treatment decision. Current Best Score 0.909
rapid flu tests are not sensitive (about 70% or lower) and labor
intensive; the latter also increases the risk of occupational
Lowest Score 0.321
infection.
Our system is designed to be simple, sensitive, inexpensive and
rapid for influenza diagnosis. This semi-automatic system uses
only simple devices, including a handheld luminometer, a magnet
and pasture pipet. The entire assay process takes less than 30
minutes with analytical sensitivity of less than 100 TCID50/mL MOBILE Laboratory Ranking
or CEID50/mL for all viral stains tested. The device can store Rapid Flu Test ranked in the highest third of all evaluated
up to 100 test data, which can be transferred to a computer for products for mobile laboratories and earned 73% of the
further analysis if necessary. In addition, the device has a printing utility points of the best score.
option with automated interpretation of the test results (positive
or negative). We expect a substantially improved clinical sensitivity ALTERNATIVE UTILITY
as well. Best Score 0.883
The handheld detection device is essentially a luminometer.
Detection technology is chemiluminescence that detects the Logistics Biological Agents Effectiveness Operations
neuraminidase activity of the influenza virus. The reagents Preference Set: Mobile Laboratory
consists of two proprietary components, an influenza virus
capture reagent that can rapidly capture and concentrate the
virus from a large sample volume and a chemical that generates FIELD USE Ranking
light signal through the action of an exogenously added enzyme
Rapid Flu Test ranked in the highest third of all evaluated
in a neuraminidase dependent manner. These two reagents work
together for rapid and sensitive detection of influenza virus.
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:248
Emanuel and Fruchey

can
• Less than 1 kg
require water
• The system or device does not • Reagent shelf life between 6
months and 1 year
source
require an external vacuum • Cannot view results “in real time”
between 20 and 30 minutes • Capable of detecting multiple
• 20 samples/batch biological agents or toxins within
BEST FIT WORST FIT • Greater than 250 ul volume the same test
needed per test for detection • One additional piece of
adapted easily be adapted into
a fully automated system
Signature:
• Very brief (minutes-hours) • Less than 200 BTUS generated
Cellex skills
9700 Great Seneca Highway Operational conditions:
• Less than 5 minutes set-up • Operated from 15°C to 37°C
Rockville, MD 20850 required • Components must be stored at
www.cellexinc.com • 3-5 manual steps required for 25°C to 37°C
X. James Li Re-use: relative humidity
(240) 269-4843 multiple use Sensitivity:
lix@cellexinc.com • 3 solutions or buffers used • 1-100 TCID50 per ml of Influenza
• 3 components virus
• $1000.00/system or device • Once a year service required • Had not been featured in
• Less than 5 minutes required evaluations
procedures t
II:249
Rapid Flu Test (Automated)

by Cellex

DETECTING THE Rapid Flu Test (Automated) ranked in the highest third
Influenza virus (Assay earned 82% of the utility points of the best score.
Best Score 0.901
DESCRIPTION: Cellex Rapid Flu Test - Automated 0.743
Pandemic influenza
Lowest Score 0.217
could have a
devastating impact on Effectiveness Biological Agents Logistics Operations
our military capability. Preference Set: Analytical Laboratory
An important part of
influenza pandemic
preparedness is
the availability of
rapid and sensitive Rapid Flu Test (Automated) ranked in the highest third
influenza diagnostic of all evaluated products for diagnostic laboratories and
tests, which can be earned 87% of the utility points of the best score.
used for surveillance, ALTERNATIVE UTILITY
early pandemic period Best Score 0.909
monitoring, patient admission, and treatment decision. Current
Cellex Rapid Flu Test - Automated 0.792
rapid flu tests are not sensitive (about 70% or lower) and labor
intensive; the latter also increases the risk of occupational Lowest Score 0.321
infection. In addition, there is no automatic system that allows Effectiveness Operations Biological Agents Logistics
simultaneous rapid detection, nucleic acid recovery for PCR based Preference Set: Diagnostic Laboratory
genotyping, and live virus isolation for culture, all of which would
be important tools for countering an influenza pandemic. This
system uses a novel reagent for rapid viral capturing, cleaning and
concentration, a novel chemiluminescence based system for rapid MOBILE Laboratory Ranking
detection of influenza viral neuraminidase, and a fully developed Rapid Flu Test (Automated) ranked in the highest third of
instrument, which is compact and suitable for use in point-of-care all evaluated products for mobile laboratories and earned
or pandemic situations. This system will simultaneously isolate 73% of the utility points of the best score.
viral nucleic acids and live viruses. Therefore, this system will
ALTERNATIVE UTILITY
be able to perform three functions: rapid and sensitive influenza
Best Score 0.883
virus detection (based on neuraminidase activity), recovery of viral
nucleic acids for genotyping, and live virus isolation for culture. Cellex Rapid Flu Test - Automated 0.641
All necessary reagents will be preloaded onto a cartridge that Lowest Score 0.379
is compatible with the automatic instrument. This system can
be easily adapted for rapid and sensitive detection of botulinum
toxins, Bacillus anthracis lethal factor, ricin and many other toxins.
TECHNOLOGY:
The technology used in the instrument is called Magtration, which FIELD USE Ranking
was developed by Precision Science Systems. It uses magnetic Rapid Flu Test (Automated) ranked in the highest third of
particles to transfer analytes from one well to another, which all evaluated products for field use and earned 85% of
avoids the conventional liquid handling method. All necessary the utility points of the best score.
reagents and solutions are pre-filled into a cartridge, which
completely eliminates any manual operation. All that an operator ALTERNATIVE UTILITY
has to do is to place a sample vial inside the instrument, insert Best Score 0.943
the cartridge and press the start button. The instrument performs Cellex Rapid Flu Test - Automated 0.802
influenza virus capture. The captured virus is split into three Lowest Score 0.343
portions: one for rapid and sensitive flu virus detection based on
neuraminidase-dependent chemiluminescent reaction, one for Logistics Operations Effectiveness Biological Agents
nucleic acid extraction to provide RT-PCR ready nucleic acids, and Preference Set: Field Use
one for virus culture which involves mixing of culture cells with the
virus bound to the capture reagent.
II:250
Emanuel and Fruchey

System Requirements: • Between 25 and 50 kg
• System or device has 110V • Reagent shelf life between 6
months and 1 year
MOBILE FIELD source • No shaking or vortexing steps
• Single sample detection • No additional pieces of
between 20 and 30 minutes equipment needed
BEST FIT WORST FIT • 6-12 samples/batch
• The system or device is fully be deactivated
automated • Less than 200 BTUS generated

Cellex skills 25°C to 45°C
9700 Great Seneca Highway • Greater than 20 minutes set-up • The performance of the device
Rockville, MD 20850 required or system is not influenced by
www.cellexinc.com • 0-2 manual steps required for relative humidity
detection
X. James Li Re-use: • 1-100 TCID50 of Influenza virus
(301) 947-0202 • Device or system is intended for per mls
lix@cellexinc.com • More than 4 solutions or buffers Maturity gauge:
used • Is commercially available with
• 0 components pending fee payments
COST • Less than $1,000,000 required
• $20.00/sample to advance the system or device
• $10,000.00/system or device Maintenance: to commercialization
evaluations
procedures t
Transportation:
• Approximately the size of a MOST MATURE LEAST MATURE
II:251
RAPTOR
by Research International & BAE Systems

THE FOLLOWING: RAPTOR ranked in the highest third of all evaluated
Bacillus anthracis, Ricin products for analytical laboratories and earned 73% of
(Commercially available as a freeze- the utility points of the best score.
dried reagent); E. coli 0157:H7, ALTERNATIVE UTILITY
Vibrio cholera, Francisella tularensis, Best Score 0.901
Yersinia pestis, MS-2 bacteriophage,
Botulinum toxin A, SEB (Assays
developed); Brucella species (Assay Lowest Score 0.217
validated) Effectiveness Biological Agents Logistics Operations
DESCRIPTION:
The RAPTOR is a portable (14 lbs) MILSPEC-qualified bioassay system
that was initially designed by Research International to U.S. Special Forces
specifications and which is now being sold worldwide for evaluation DIAGNOSTIC Laboratory Ranking
as a biowarfare detection system. The battery-powered system can RAPTOR ranked in the highest third of all evaluated
simultaneously detect the presence of up to four biological agents or toxins products for diagnostic laboratories and earned 85% of
in a liquid sample at parts-per-billion concentration levels. It represents the utility points of the best score.
a novel integration of optics, fluidics, electronics, and software into one
compact system that can automatically perform a user-defined, multistep, ALTERNATIVE UTILITY
assay protocol using plastic optical waveguide biosensors mounted in a Best Score 0.909
disposable assay coupon. The RAPTOR may be used in any context when Research International RAPTOR 0.774
an assay for a biological agent must be conducted in a short period of
time with little or no sample preparation. The system is designed to be Lowest Score 0.321
carried to a site and operated by non-technical personnel. Uses under Effectiveness Operations Biological Agents Logistics
active evaluation include both covert and overt operations by warfighters,
homeland security applications such as first response, infrastructure
protection and medical triage, and food and drinking water protection.

The RAPTOR is a self-contained, 4-channel system for conducting these RAPTOR ranked in the highest third of all evaluated
evanescent wave fluorometric assays to monitor biological agents, toxins,
explosives, and chemical contaminants. It can automatically perform a
multi-step assay protocol based on the fluorescent detection of reactions utility points of the best score.
occurring at the surface of four individual optical waveguide sensors ALTERNATIVE UTILITY
mounted in a disposable coupon. The sensors function independently Best Score 0.883
allowing four different assays to be performed on a single sample.
The form factor of the waveguide sensor and the overall design of Lowest Score 0.379
the RAPTOR make the system particularly well suited to performing
fluoroimmunoassays conducted in the ‘sandwich’ format. Typically, a Logistics Biological Agents Effectiveness Operations
capture antibody is immobilized on the waveguide surface by physical Preference Set: Mobile Laboratory
adsorption. A sample is introduced and incubated for 1.5–7 minutes. The
sample is then flushed and fluorophore-labeled secondary antibody is
introduced to the waveguide. Following a second 1.5 minute incubation,
the secondary antibody solution is recovered, the waveguide is rinsed, and FIELD USE Ranking
the fluorescence signal is measured. This assay format makes it possible RAPTOR ranked in the highest third of all evaluated
to detect a wide range of biomolecules, viruses, and bacteria with high products for field use and earned 88% of the utility points
specificity at ‘ppb’ concentrations. These miniature waveguide-based of the best score.
biosensors exhibit the sensitivity and specificity of an ELISA but tolerate
very crude samples, exhibit extremely rapid assay times, consume minimal ALTERNATIVE UTILITY
reagents, and are reusable. The sandwich assay format, as implemented Best Score 0.943
with the RAPTOR, provides an assay protocol that is extremely resistant Research International RAPTOR 0.831
to sample contamination. First, essentially only fluorophore bound to the
Lowest Score 0.343
waveguide through a specific antibody-antigen-antibody reaction can be
seen due to the evanescent wave excitation approach. Second, neither Logistics Operations Effectiveness Biological Agents
particulates nor soluble, fluorescent impurities will effect assay results since Preference Set: Field Use
the fluorescent signal is detected after the waveguide has been rinsed.
II:252
Emanuel and Fruchey

ANALYTICAL water aliquots • Between 5 and 25 kg
source
Throughput of product: • System able to interpret raw data
DIAGNOSTIC • Single sample detection 20 or call a positive through internal
minutes or less software
• Greater than 250 ul volume detecting four or more biological
BEST FIT WORST FIT needed per test for detection agents or toxins within the same
• The system or device is test
currently fully automated • No additional pieces of
equipment needed
• A day of training Signature:
• 10-20 minutes required for • No sounds produced that cannot
CONTACT INFORMATION
Research International, Inc.
detection
In partnership with BAE Systems, Inc
17161 Beaton Road SE
Monroe, WA 98272 Re-use: • Operated from 4°C to 45°C
• Device or system is intended for • Components can be stored at
www.resrchintl.com 25°C to 45°C
multiple use
• 0-1 solution or buffer used • Performance of the device or
Point of Contact: • 2 components system is not influenced by
David McCrae • Water and/or bleach cleaning relative humidity
(360) 805-4930 required
(360) 863-0439 fax Sensitivity:
davidmccrae@resrchintl.com • 10,000-100,000 CFU per ml
Maintenance:
• $1.00/sample • Once a year service required • Is commercially available and
• $49,000.00/system or device • Expected life is 3-5 years meets military specifications
procedures required t
II:253
RAZOR
by Idaho Technology

DETECTING RAZOR ranked in the highest third of all evaluated
coli 0157:H7, Idaho Tech RAZOR 0.674
Francisella
Lowest Score 0.217
tularensis,
Brucella species Preference Set: Analytical Laboratory
(Commercially
available as a
freeze-dried DIAGNOSTIC Laboratory Ranking
reagent);
RAZOR ranked in the highest third of all evaluated
Smallpox virus,
Orthopox virus, products for diagnostic laboratories and earned 86% of
VEE virus (Assay validated) the utility points of the best score.
ALTERNATIVE UTILITY
Idaho Technology continues to set the standard in pathogen Idaho Tech RAZOR 0.782
detection. RAZOR is a handheld, battery powered biological
Lowest Score 0.321
identification system. RAZOR uses IT’s proven freeze dried
reagents contained in pre-packaged pouches. RAZOR’s Effectiveness Operations Biological Agents Logistics
dimensions are 4 x 8 x 12” (10 x 20 x 30 cm) and it weighs Preference Set: Diagnostic Laboratory
10 lbs (4.5 kg).
TECHNOLOGY:
The basis of RAZOR’s technology is polymerase chain reaction MOBILE Laboratory Ranking
(PCR), a method of DNA amplification. RAZOR’s accuracy, RAZOR ranked in the highest third of all evaluated
portability and ease of use make it the ideal device for field and products for mobile laboratories and earned 85% of the
onsite detection. RAZOR also has a fluorometer to measure DNA utility points of the best score.
product and provide real-time detection. In a single RAZOR run,
ALTERNATIVE UTILITY
up to 12 samples can be analyzed (under 30 minutes) including
positive controls, negative controls, and unknown samples. Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

RAZOR ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:254
Emanuel and Fruchey

source
DIAGNOSTIC • Single sample detection or call a positive through internal
• Less than 100 ul volume detecting four or more biological
• The system or device could be test
adapted into a semi automated • No additional pieces of
• A day of training • No sounds produced that cannot
CONTACT INFORMATION
for set-up • Less than 200 BTUS generated
Idaho Technology
390 Wakara Way
Salt Lake City, UT 84108
www.idahotech.com
Point of Contact: multiple use • Performance not influenced by
David McCrae • 0-1 solution or buffer used relative humidity
(360) 805-4930 • 3 components
(360) 863-0439 fax • No cleaning required Sensitivity:
davidmccrae@resrchintl.com • 1-100 CFU per ml
Maintenance:
COST needed • Is commercially available
• >$30.00/sample • Less than once a year service
required
t
• Approx. $37,000/system or device
• No daily assurance procedures
required MOST MATURE LEAST MATURE
II:255
RBI Robot
by ChemImage

DETECTING THE RBI Robot ranked in the highest third of all evaluated
Best Score 0.901
DESCRIPTION: ChemImage RBI Robot 0.777
The Raman Bio
Lowest Score 0.217
Identification
(RBI) Detector Effectiveness Biological Agents Logistics Operations
is a reagentless Preference Set: Analytical Laboratory
chemical,
biological and
explosives (CBE)
threat detection
and identification RBI Robot ranked in the highest third of all evaluated
system that can be products for diagnostic laboratories and earned 87% of
completely mounted onto an unmanned ground vehicle (UGV). The the utility points of the best score.
RBI Detector has been designed to remotely detect and identify a ALTERNATIVE UTILITY
broad range of CBE threats on environmental surfaces in a single Best Score 0.909
measurement cycle. When the RBI Detector is configured on the
ChemImage RBI Robot 0.791
UGV, an operator located in a safe or protected area can remotely
drive it to the measurement site and assess the threat level. Lowest Score 0.321
Being able to bring the sensor to the sample minimizes problems Effectiveness Operations Biological Agents Logistics
associated with sampling, such as cross contamination and Preference Set: Diagnostic Laboratory
pre-analysis decontamination, as well as the problems of sample
disposal after analysis.

The RBI Detector System is based on the Raman spectroscopic RBI Robot ranked in the highest third of all evaluated
detection technology developed by ChemImage Corporation and products for mobile laboratories and earned 81% of the
validated in several U.S. Government-sponsored test programs. utility points of the best score.
Raman detection offers clear advantages over immunoassay
and DNA-based biological detection strategies, especially when ALTERNATIVE UTILITY
configured for use on UGV systems. Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

RBI Robot ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:256
Emanuel and Fruchey

System Requirements: Ease of use/Utility:
• There is a single centrifugation
step
require water
• The system or device does not • There is a single shaking or
vortexing step
source
MOBILE FIELD • The system or device does not through internal software
the same test
DIAGNOSTIC Throughput of product: • Two additional pieces of
• Single sample detection in 20 equipment needed
minutes or less
BEST FIT WORST FIT • Less than 10 ul volume needed • No sounds produced that cannot
per test for detection be deactivated
• The system or device could be • Between 200-500 BTUS
adapted into a semi-automated generated
• A day of training and technical • Components must be stored at
CONTACT INFORMATION skills are required 25°C to 45°C
ChemImage • 10-20 minutes of set-up • The performance of the device
7301 Penn Ave required or system is not influenced by
Pittsburgh, PA 15208 • 3-5 manual steps required for relative humidity
www.chemimage.com detection
Sensitivity:
Point of Contact: Re-use: • 100-1000 CFU per ml
Charles W. Gardner. PhD • Device or system is intended for
(412) 241-7335 x212 multiple use Maturity gauge:
(412) 241-7311 • 0-1 solution or buffer used • A few devices or systems exist
gardner@chemimage.com • 2 components (brass board)
• Cleaning with 5% bleach wipe • Is expected to be ready for
COST Maintenance: calendar year
• $0.54/sample • Every 6 months service required • Less than $1,000,000 required
• Expected life is greater than 10 to advance the system to
• 10-20 minutes of daily quality • Has not been featured in
toaster t
• Reagent shelf life greater than
3 years MOST MATURE LEAST MATURE
II:257
RIDASCREEN ELISA Test Kit

by Idaho Technology

DETECTING RIDASCREEN ELISA ranked in the lowest third of all
SEB, T-2 toxin, ALTERNATIVE UTILITY
Saxitoxin, Best Score 0.901
Shigatoxin RIDASCREEN ELISA 0.326
(Assay
Lowest Score 0.217
developed)
DESCRIPTION:
RIDASCREEN test kits are all microwell ELISA based test kits.
TECHNOLOGY: DIAGNOSTIC Laboratory Ranking

The basis of the test is an antigen-antibody reaction. The wells in RIDASCREEN ELISA ranked in the lowest third of all
the microtiter strips are coated with specific antibodies to mouse evaluated products for diagnostic laboratories and
antibodies. By adding standards or the sample solutions, enzyme earned 45% of the utility points of the best score.
labeled toxin (enzyme conjugate), and anti-toxin antibodies,
ALTERNATIVE UTILITY
free and enzyme labeled toxin compete for the antibody binding
Best Score 0.909
sites of the anti-toxin antibodies, which themselves are bound
simultaneously by the capture antibodies on the microtiter RIDASCREEN ELISA 0.410
plate. Any unbound enzyme conjugate is then removed in a Lowest Score 0.321
washing step. Enzyme substrate (urea peroxide) and chromogen
(tetramethylbenzidine) are added to the wells and incubated.
Bound enzyme conjugate converts the colorless chromogen
into a blue product. The addition of the stop reagent leads to
a color change from blue to yellow. The measurement is made
photometrically at 450 nm (optional reference wavelength ³ MOBILE Laboratory Ranking
600 nm). The absorption is inversely proportional to the toxin RIDASCREEN ELISA ranked in the middle third of all
concentration in the sample. evaluated products for mobile laboratories and earned
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

RIDASCREEN ELISA ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

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Emanuel and Fruchey

ANALYTICAL • The system or device does • Between 1 and 5 kg
require water aliquots • Shelf life between 6 months and
source
than 60 minutes • Not capable of detecting multiple
needed per test for detection • Four or more additional pieces of
• An afternoon of training • Less than 200 BTUS generated
CONTACT INFORMATION
• 5-10 minutes required for set-up
R-Biopharm, Inc.
7950 Old US 27 South
Marshall, MI 49068
www.r-biopharm.com
Re-use: 4°C
• Device or system is intended for • Peak performance of the device
Point of Contact: multiple use or system is at normal relative
Sean Tinkey • More than 4 solutions or buffers humidity only
(269) 789-3033 used
(269) 789-3070 fax • 5 or more components Sensitivity:
s.tinkey@r-biopharm.com • No cleaning required • NA CFU per ml

COST • 3 consumables or expendables • Is commercially available
• $450.00/system or device • Once a year service required t
procedures
II:259
Rotor-Gene 3000 Real Time DNA Amplification System

by Corbett Research

DETECTING Rotor-Gene 3000 ranked in the highest third of all
Francisella Rotor-Gene DNA Amp. Sys. 0.775
tularensis,
Lowest Score 0.217
Yersinia pestis,
species (Assay developed) Preference Set: Analytical Laboratory
DESCRIPTION:
The Rotor-Gene is designed to measure an increase of amplified DIAGNOSTIC Laboratory Ranking
DNA fragments for quantitative and qualitative analysis. It uses
Rotor-Gene 3000 ranked in the highest third of all
chemistry platforms to detect any nucleic acid sequence from
multiple sources (i.e. bacteria, viruses and spores from blood, evaluated products for diagnostic laboratories and
tissue, soil and environmental samples.) earned 85% of the utility points of the best score.
ALTERNATIVE UTILITY
Real-time detection system using various DNA amplification
methods comprised of a thermal cycler to control the temperature Rotor-Gene DNA Amp. Sys. 0.773
of samples/reagents and a fluorometer to take fluorescent Lowest Score 0.321
measurements at any time point. The machine measures DNA
amplification via fluorescence to determine quantities of starting
templates of genetic markers. The Rotor-Gene is an open
chemistry platform capable of running isothermal assays (Invader,
Roling Circle, NASBA, TMA) and temperature cycling assays such
as PCR with all the current chemistry platforms (sybr, dual-labeled MOBILE Laboratory Ranking
probes, molecular beacons, scorpions, hybridization probes). The Rotor-Gene 3000 ranked in the highest third of all
flexible and user friendly software of the Rotor-Gene allows for evaluated products for mobile laboratories and earned
data acquisition at any point during the cycling with multiple filter 77% of the utility points of the best score.
combinations. Using multiple LED’s for excitation and a PMT for
detection, the unit can multiplex up to four dyes in a single tube. ALTERNATIVE UTILITY
The 6six emission filters on the standard system allow for a wide Best Score 0.883
range of fluors to be detected (510, 555, 610, 585hp, 610hp Rotor-Gene DNA Amp. Sys. 0.680
660hp). Lowest Score 0.379

FIELD USE Ranking

Rotor-Gene 3000 ranked in the highest third of all
ALTERNATIVE UTILITY
Best Score 0.943
Rotor-Gene DNA Amp. Sys. 0.741
Lowest Score 0.343

II:260
Emanuel and Fruchey

• The system or device requires
an external air source Ease of use/Utility:
• System able to interpret raw data
Throughput of product: or call a positive through internal
DIAGNOSTIC • Single sample detection software
• The system could be adapted • One additional pieces of
into a semi-automated system equipment needed
with some effort
Signature:
• Less than 5 minutes required • Between 200-500 BTUS
CONTACT INFORMATION
Corbett Research
1/14 Hilly Street
Mortlake, NSW 2137 Australia
www.corbettresearch.com
John Corbett • 2 solutions or buffers used system is not influenced by
011-612-973-613-20 • 2 components relative humidity
011-612-973-613-64 fax • No cleaning required
john@corbettresearch.com Sensitivity:
Maintenance:
• $0.50/sample plus cost of Taq enzyme • Once a year service required • Is commercially available
• $34,990.00/system or device • Expected life is greater than 10 t
years
procedures
II:261
RuggID Biological Detection System

by Nanosphere, Inc.

DETECTING RuggID ranked in the highest third of all evaluated
Francisella Nanosphere RuggID 0.631
tularensis,
Lowest Score 0.217
Yersinia pestis, Smallpox virus (Assay developed, Assay validated,
Commercially available as a wet/frozen reagent); Influenza Effectiveness Biological Agents Logistics Operations
virus, Botulinum toxin A, Botulinum toxin B, Ricin toxin (Assay Preference Set: Analytical Laboratory
developed)
DESCRIPTION:
Nanosphere Inc.’s RuggID System is a universal molecular testing DIAGNOSTIC Laboratory Ranking
system that transcends limitations of existing technologies. The RuggID ranked in the middle third of all evaluated
RuggID platform’s superior performance is based on proprietary products for diagnostic laboratories and earned 69% of
and patented gold nanoparticle probes to identify DNA, RNA the utility points of the best score.
and protein targets. The platform is comprised of self-contained, ALTERNATIVE UTILITY
single-use, disposable test cartridges, the RuggID autoprocessing Best Score 0.909
system (RuggID APS) that performs the assay, and the RuggID
Nanosphere RuggID 0.630
reader that controls the APS, performs image analysis, and
provides results. The operator adds the sample to the disposable Lowest Score 0.321
test cartridge, which is inserted into the RuggID APS. The APS, Effectiveness Operations Biological Agents Logistics
which is controlled via the user interface on the RuggID reader, Preference Set: Diagnostic Laboratory
performs all microfluidic manipulations and temperature
adjustments required for the assay. Once the assay is completed,
the cartridge is removed and placed into the RuggID reader for
analysis. The test is automatically analyzed and a definitive result MOBILE Laboratory Ranking
is displayed as to the specific identification of bioagent or toxin. RuggID ranked in the highest third of all evaluated
Key features of the RuggID system include: (1) Overall Simplicity. products for mobile laboratories and earned 75% of the
All assay steps after sample addition are automated. The intuitive utility points of the best score.
user-interface on the RuggID requires minimal training. Objective
ALTERNATIVE UTILITY
data is provided eliminating user interpretation. (2) Field-Ready
Device- it has been ruggedized to withstand various environmental Best Score 0.883
and physical assaults. Together, with the stability of the assay Nanosphere RuggID 0.666 0.666
components the RuggID system offers high reliability testing for Lowest Score 0.379
battlefield personnel and/or first responders. (3) Single Platform
for Detecting Nucleic Acids and Proteins. Multiplex assays have
been developed for the detection of bio-warfare agent DNA (or
RNA) as well as for the multiplex detection of protein-based
markers and bio-toxins.
FIELD USE Ranking
TECHNOLOGY: RuggID ranked in the middle third of all evaluated
Detection is based on the high scatter efficiency associated products for field use and earned 64% of the utility
with gold nanoparticle probes. Bio-warfare agent DNA is directly
detected by ‘sandwiching’ the target between DNA capture
molecules attached to a solid substrate and DNA-functionalized ALTERNATIVE UTILITY
gold nanoparticle probes. The gold probes impart exquisite Best Score 0.943
specificity and sensitivity allowing direct detection of targets Nanosphere RuggID 0.608
without amplification, eliminating variability associated with Lowest Score 0.343
amplification processes such as PCR. Protein-based targets are
detected by using antibodies as capture molecules and antibody- Logistics Operations Effectiveness Biological Agents
coated gold nanoparticles as labels. All assays are accomplished Preference Set: Field Use
automatically in a single use microfluidic cartridge which is
automatically processed by the RuggID System.
II:262
Emanuel and Fruchey

or 110V electrical requirement
require water • Cannot view results “in real time”
require an external air or gas • There are multiple shaking or
source vortexing steps
MOBILE FIELD • The system or device does not • System always able to interpret
DIAGNOSTIC Throughput of product: biological agents or toxins within
• Single sample detection greater the same test
than 60 minutes • One additional piece of
BEST FIT WORST FIT needed per test for detection Signature:
• The system or device could be • No sounds produced that cannot
adapted to a fully automated be deactivated
system with some effort • Less than 200 BTUS generated

Nanosphere, Inc. skills room temperature
4088 Commercial Ave • Less than 5 minutes set-up • The performance of the device
required or system is not influenced by
Northbrook, IL 60062
• 9-12 manual steps required for relative humidity
www.nanosphere.us
detection
Re-use: • 1,000-10,000 CFU per ml
William Cork • Device or system is intended for
Maturity gauge:
wcork@nanosphere.us • 1 component • A few devices or systems exist
• No cleaning required (brass board)
COST Maintenance: commercialization within one
• $50.00/sample • Less than once a year service calendar year
• $85,000.00/device or system required • Less than $1,000,000 required
• Expected life is greater than 10 to advance the device or system
years to commercialization
• Less than 5 minutes daily • Has not been featured in
quality assurance procedures any peer reviewed scientific
t
II:263
SAIC BAND
by SAIC

DETECTING THE SAIC BAND ranked in the highest third of all evaluated
Burkholderia Best Score 0.901
SAIC BAND 0.812
burnetti, Brucella
species, E.coli O157: Lowest Score 0.217
H7, Burkholderia mallei, Effectiveness Biological Agents Logistics Operations
Yersinia pestis, Rickettsia Preference Set: Analytical Laboratory
prowazekii, Marburg virus,
Smallpox virus, Orthopox virus, Venezuelan equine encephalitis virus, Ebola
virus, MS-2 bacteriophage, Botulinum toxin A, Staphylococcal toxin B, Ricin
toxin (Assay developed)
SAIC BAND ranked in the highest third of all evaluated
The SAIC BAND prototype sensor has been developed by a team including the utility points of the best score.
SAIC, GHC Technologies, Ibis Biosciences, QTL BioSystems, MesoSystems,
ALTERNATIVE UTILITY
and Delphi Medical Systems under sponsorship from the DHS Homeland
Best Score 0.909
Security Advanced Research Projects Agency (HSARPA). The SAIC BAND
prototype sensor is a fully-automated robotic system for collecting and SAIC BAND 0.751
analyzing urban air samples to detect airborne biological threats. It is a Lowest Score 0.321
prototype for a sensor to be deployed nationwide as a BioWatch system
upgrade. In its baseline configuration, our fieldable BAND system will
detect 20 CDC Category A and B microbial pathogens and toxins with high
sensitivity (bacteria and DNA genome viruses: 0.005 orgs/liter air, RNA
genome viruses: 0.05 orgs/ liter air, toxins: 0.5 pg/liter air). The fieldable
system will run continuously 24/7 providing detection assessments every MOBILE Laboratory Ranking
three hours. It will run autonomously requiring only reagent reloading SAIC BAND ranked in the highest third of all evaluated
and minimal maintenance once every month. The SAIC BAND system products for mobile laboratories and earned 77% of the
will provide a robust method for rapid, specific detection of all relevant utility points of the best score.
biothreat types: spore-forming and vegetative bacteria, DNA/RNA viruses,
and toxins. It accomplishes threat DNA and RNA detection in a common ALTERNATIVE UTILITY
process flow, based on highly-multiplexed PCR amplification and microarray Best Score 0.883
readout. It performs toxin detection in a separate process flow using an SAIC BAND 0.680
antibody-based sandwich assay. The prototype system includes all the Lowest Score 0.379
basic subsystems that will be in the fielded system with the exception of
the environmental control, wireless communications, and long term reagent Logistics Biological Agents Effectiveness Operations
storage subsystems. The SAIC team has built three laboratory prototype Preference Set: Mobile Laboratory
systems, one of which has been tested at ECBC.

Our sensor collects airborne particulates onto filter tape. Separate portions SAIC BAND ranked in the lowest third of all evaluated
are used for DNA/RNA and toxin detection. The DNA/RNA portion is
punched into a vial containing lysis buffer and glass beads and shaken.
Lysate passes through a filter binding DNA and RNA. After rinsing, the
nucelic acid elutes into three wells: two for multiplex-PCR, a third for RT-PCR. ALTERNATIVE UTILITY
After amplification, products transfer onto a microarray for hybridization. The Best Score 0.943
laser-excited microarray is imaged with a CCD. Image analysis quantifies SAIC BAND 0.343
threat presence. Multiple PCR primers per threat coupled with multiple Lowest Score 0.343
microarray probes per PCR product yield high detection performance. A
parallel immunoassay detects toxins. Logistics Operations Effectiveness Biological Agents
II:264
Emanuel and Fruchey

• System or device has 110V months and 1 year
electrical requirement
ANALYTICAL • The system or device requires Ease of use/Utility:
water aliquots • Cannot view results “in real time”
• The system or device does not • There is a single centrifugation
require an external air or gas step
MOBILE FIELD • The system or device does not vortexing step
Throughput of product: • Capable of detecting multiple
DIAGNOSTIC • Single sample detection greater biological agents or toxins within
• 1 sample/batch • One additional piece of
be deactivated
Training/Speed/Manpower: • Greater than 500 BTUS
• Very brief (minutes-hours) generated
skills Operational conditions:
CONTACT INFORMATION • Greater than 20 minutes set-up • Operated from 15°C to 37°C
SAIC required • Components must be stored at
• 0-2 manual steps required for 4°C
10260 Campus Point Drive
San Diego, CA 92121 or system is not influenced by
www.saic.com Re-use: relative humidity
Point of Contact: multiple use Sensitivity:
David W. Robbin • More than 4 solutions or buffers • 100-1,000 CFU per ml
(858) 826-6904 used
• 5 or more components Maturity gauge:
(858) 775-6904 cell
• Monthly cleaning is required. • A few devices or systems exist
robbinsd@saic.com
Also, decontamination after (brass board)
running positive samples is • Is expected to be ready for
recommended commercialization within two
COST calendar years
• <$3.00/sample Maintenance: • More than $2,000,000 required
• $25,000.00/for a lot of 1000 • More often than every 6 months for device or system to advance
service required to commercialization
• Expected life is between 3-5 • Has been featured in peer
years reviewed scientific publications
• No daily quality assurance or independent evaluations
procedures
t
Transportation:
home dishwasher
• More than 50 kg
II:265
Sherlock® Microbial Identification System

by MIDI, Inc.

DETECTING THE MDI Sherlock ranked in the highest third of all
Corynebacterium MIDI Sherlock 0.681
diphtheria,
Lowest Score 0.217
Burkholderia
E.coli O157:H7,
Vibrio cholera,
Burkholderia
mallei, Yersinia
pestis (Assay MDI Sherlock ranked in the highest third of all
developed) evaluated products for diagnostic laboratories and
MIDI, Inc has been developing automated microbial identification
Best Score 0.909
solutions for bio/pharma quality control, biodefense, research and
clinical labs since 1985. The Sherlock® Microbial Identification MIDI Sherlock 0.684
System is used to identify over 1,500 bacterial species, Lowest Score 0.321
including six bioterrorism agents using gas chromatography.
The Sherlock® Microbial Identification System has both U.S.
Department of Homeland Security and U.S. FDA 510(k) clearance
for confirmation of the anthrax pathogen. Sherlock® DNA is an
optional add-on to the Sherlock® Microbial Identification System
that can identify bacteria using any DNA Sequencer. For over 20 MOBILE Laboratory Ranking
years, MIDI, Inc. has been a Premier Channel Partner of Agilent MDI Sherlock ranked in the highest third of all
Technologies. MIDI & MIDI Authorized distributors are the sole evaluated products for mobile laboratories and earned
source for the Sherlock® Systems. 73% of the utility points of the best score.
The Sherlock® Microbial Identification System is based on gas Best Score 0.883
chromatographic analysis of fatty acid methyl esters (GC-FAME). MIDI Sherlock 0.645
Each bacterial species has a unique set of fatty acids in their Lowest Score 0.379
cell membrane. The MIDI sample procedure uses qualitative and
quantitative information from the GC-FAME analysis to identify Logistics Biological Agents Effectiveness Operations
each bacteria. Sherlock pattern recognition algorithms are used Preference Set: Mobile Laboratory
to compare the unknown GC-FAME profile to stored libraries
of known bacteria for the closest match. The Sherlock® DNA
option uses analysis of the 16S rRNA to identify each bacteria. FIELD USE Ranking
Sample preparation prepares the 16S rRNA for DNA Analysis MDI Sherlock ranked in the highest third of all evaluated
and 500 base pairs are used for identification. The Sherlock
software uses comparative DNA analysis for the closest match of
the unknown bacteria to stored libraries of known bacteria. For
definitive identification, with the Sherlock software, results of the ALTERNATIVE UTILITY
GC-FAME analysis and DNA Sequence analysis can be combined Best Score 0.943
into a polyphasic report, the only one of it’s kind in the microbial MIDI Sherlock 0.726
identification marketplace. Lowest Score 0.343

II:266
Emanuel and Fruchey

• The system or device requires 3 years
both an external air or gas
source • There are multiple shaking or
vortexing steps
• 384 samples/batch or higher • Capable of detecting four or more
• 2 mg pure bacterial culture biological agents or toxins within
• The system or device is • Four or more additional pieces of
• Two days of training and • No sounds produced that cannot
significant technical skills are be deactivated
CONTACT INFORMATION required • Greater than 500 BTUS
MIDI, Inc. • Greater than 20 minutes set-up generated
125 Sandy Drive required
Newark, DE 19713 • 3-5 manual steps required for
www.midi-inc.com • Operated from 15°C to 37°C
Point of Contact: Re-use: room temperature
Craig Kunitsky • Device or system is intended for • The performance of the device
(302) 737-4297 multiple use or system is not influenced by
(302) 737-7781 • 3 solutions or buffers used relative humidity
sales@midi-inc.com • 5 or more components
• 10,000-100,000 CFU per ml
COST Maintenance:
• $5.00/sample • Once a year service required Maturity gauge:
• $95,000.00/device or system • Expected life is greater than 10 • Is commercially available
years • Has been featured in peer
• 10-20 minutes daily quality reviewed scientific publications
assurance procedures or independent evaluations
II:267
SMART (flowthrough)
by New Horizons Diagnostics Corp.

THE FOLLOWING: SMART Tickets ranked in the highest third of all evaluated
Bacillus anthracis, E.coli products for analytical laboratories and earned 69% of
0157:H7, Francisella the utility points of the best score.
tularensis, Vibrio cholera, ALTERNATIVE UTILITY
Yersinia pestis, Brucella Best Score 0.901
species, Botulinum toxins
SMART Tickets 0.618
A, B, SEB, Ricin (Assay
validated); Burkholderia Lowest Score 0.217
pseudomallei, Coxiella Preference Set: Analytical Laboratory
burnetti, Rift Valley fever virus,
Smallpox virus, VEE virus,
Botulinum toxin E (Assay
developed) DIAGNOSTIC Laboratory Ranking
SMART Tickets ranked in the highest third of all evaluated
New Horizons Diagnostics (NHD) Corporation’s SMART-II (lateral the utility points of the best score.
flow) screening assay includes a plastic cassette, which contains ALTERNATIVE UTILITY
all the active ingredients, a bottle of Chase Buffer, and a plastic Best Score 0.909
dropper. The assay is designed to act as a screen for the presence
SMART Tickets 0.766
of a target organism. It is designed for environmental samples,
not for human samples or for the diagnosis of disease. No known Lowest Score 0.321
rapid screening assay is 100% sensitive or 100% specific; results Effectiveness Operations Biological Agents Logistics
should be confirmed by another method. The SMART assay must Preference Set: Diagnostic Laboratory
be utilized with the SWIPE collection system or similar validated
collection system.

In the Lateral Flow format, which is similar to an OTC pregnancy SMART Tickets ranked in the highest third of all evaluated
test, antibody coated colloidal gold particles are applied to a products for mobile laboratories and earned 100% of the
membrane surface and dried. When a test sample is applied, utility points of the best score.
the gold conjugate reacts with the antigen that is present as
it migrates across the length of the membrane to where it ALTERNATIVE UTILITY
encounters a zone of capture antibody. Those antibody-gold Best Score 0.883
conjugates, which have bound to antigen in the test sample, are SMART Tickets 0.883
then bound in the capture antibody zone, presenting a visually Lowest Score 0.379
detectable line of color and indicating a positive test result.
Sufficient antibody will be available to permit passage through the Logistics Biological Agents Effectiveness Operations
capture zone. These particles will then contact an area coated Preference Set: Mobile Laboratory
with an appropriate IgG fraction, where they will bind, producing
a visible line of color. This line is the Control or Positive Reading
Guide Line. The intent is to indicate that the reagents and test FIELD USE Ranking
sample have successfully migrated the length of the membrane. SMART Tickets ranked in the highest third of all evaluated
Additionally, the “C” (Control) line provides the user/operator an products for field use and earned 96% of the utility points
example of what a positive should look like.
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
SMART Tickets 0.906
Lowest Score 0.343

II:268
Emanuel and Fruchey

• No electrical requirements • Approximately the size of a soda
• System never able to interpret
• 1 samples/batch biological agents or toxins within
CONTACT INFORMATION
New Horizons Diagnostic Corp.
9110 Red Branch Rd.
• Components can be stored at
Columbia, MD 21045
www.NHDiag.com Re-use: room temperature
• Device or system is designed for • Performance of the device or
single use system is not influenced by
Point of Contact: • 0-1 solution or buffer used relative humidity
David Trudil • 2 components
(410) 992-9357 x222 • NA cleaning required Sensitivity:
(410) 992-0328 fax • 10,000 - 100,000 CFU per ml
NHDiag@aol.com Maintenance:
needed • Is commercially available and
COST • No service required meets military specifications
• $15.00-32.00/sample • NA expected life t
• $15.00-32.00/system or device • No daily quality assurance
procedures
II:269
Smart Bio Sensor (SBS)

by Smiths Detection

DETECTING THE SBS ranked in the lowest third of all evaluated products
Designed to detect points of the best score.
biological particles and ALTERNATIVE UTILITY
classify as vegetative or Best Score 0.901
sporulated bacterium or
Smiths SBS 0.385
virus. (Generic Detector)
Lowest Score 0.217
The Smiths Detection Preference Set: Analytical Laboratory
Smart Bio Sensor (SBS)
detects aerosolized
biological warfare
agents directly from the DIAGNOSTIC Laboratory Ranking
ambient air. It does so by SBS ranked in the middle third of all evaluated products
continuously sampling for diagnostic laboratories and earned 55% of the utility
the environment for the points of the best score.
presence of passing
ALTERNATIVE UTILITY
clouds. The SBS uses a
Best Score 0.909
sophisticated algorithm
to determine whether a Smiths SBS 0.504
detected cloud contains Lowest Score 0.321
biological particles or
background clutter. Preference Set: Diagnostic Laboratory
Its semi-selective biochemical sensors allow the SBS to further
classify a detected bioagent as bacterium, spore, virus or toxin.
This technology is much less susceptible to false alarms than
conventional bioparticle triggers and can be used to enhance the MOBILE Laboratory Ranking
utility of more complex identification technologies. The SBS is SBS ranked in the middle third of all evaluated
designed for soldiers in the field, and can be deployed as a single products for mobile laboratories and earned 62% of the
point detector or a networked array of multiple systems. The SBS utility points of the best score.
is one man-portable, fully autonomous during operation, and
ALTERNATIVE UTILITY
requires only a rapid change of its sensors when indicated by the
system. Several SBS systems have been rigorously tested with a Best Score 0.883
variety of bioagents, simulants and interferents at various venues Smiths SBS 0.518
over the last few years. Lowest Score 0.379

The Smart Bio Sensor uses a multi-channel optical system to Preference Set: Mobile Laboratory
detect particles that are sampled from the air and trapped onto
an array of semi-selective chemical sensors. The fluorescence
output from the array is processed by an on-board computer to FIELD USE Ranking
produce signal patterns that are characteristic of bioagents. Semi- SBS ranked in the middle third of all evaluated
quantitative information related to the number of particles on the products for field use and earned 61% of the utility
sensors can also be derived. The bioagents are retained on the
sensor substrates for confirmatory analysis or forensic archiving.
ALTERNATIVE UTILITY
Best Score 0.943
Smiths SBS 0.579
Lowest Score 0.343

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Emanuel and Fruchey

or has a 110V or 220V electrical • System always able to interpret
ANALYTICAL requirement raw data or call a positive
• The system or device does not through internal software
require water • Capable of detecting multiple
require an external air or gas the same test
MOBILE FIELD source • No additional pieces of
• The system or device does not equipment needed
source Signature:
DIAGNOSTIC • No sounds produced that cannot
Throughput of product: be deactivated
• Airborne bioagent detector • Less than 200 BTUS generated
with detection time less than 2
minutes
BEST FIT WORST FIT • Real-time detection of bioagents Operational conditions:
• The system or device is • Operated from 4°C to 45°C
currently fully automated • Components must be stored at
• The performance of the device or
Training/Speed/Manpower: system is influenced by relative
• Very brief (minutes-hours) humidity
Smiths Detection • 5-10 minutes set-up required Sensitivity:
451 D Street • 10,000-100,000 CFU per ml
Boston, MA 02210
Re-use: Maturity gauge:
www.smithsdetection.com • Device or system is intended for
multiple use
Point of Contact: • 0-1 solution or buffer used (brass board)
Mary Beth Tabacco, Ph.D. • 2 components • Is expected to be ready for
(617) 443-0066 • Occasional cleaning of commercialization within one
(617) 204-3080 particulate residue calendar year
marybeth.tabacco@smithsdetection.com • No money is required for
Maintenance: device or system to advance to
• Once a year service required commercialization
COST • Expected life is unknown • Has been featured in peer
• $75.00/sample • No daily quality assurance reviewed scientific publications
• $80,000.00/device or system procedures or independent evaluations
t
Transportation:
toaster MOST MATURE LEAST MATURE
• Reagents shelf life between 6
months and 1 year
II:271
Smart Cycler
by Cepheid

THE FOLLOWING: Smart Cycler ranked in the highest third of all evaluated
Bacillus anthracis, E. coli products for analytical laboratories and earned 96% of
0157:H7, Vibrio cholera, the utility points of the best score.
Burkholderia mallei, Yersinia Best Score 0.901
Rickettsia prowazekii, Brucella
species, Smallpox virus, VEE Lowest Score 0.217
virus, Hanta virus, Dengue Effectiveness Biological Agents Logistics Operations
fever virus, Orthopox virus, Preference Set: Analytical Laboratory
Ricin (Assay developed)
DESCRIPTION:
The Smart Cycler is a real-time, integrated DNA/RNA amplification, DIAGNOSTIC Laboratory Ranking
detection, and analysis system. Quantitation of the amplified Smart Cycler ranked in the highest third of all evaluated
product is achieved by measuring the increase in fluorescence products for diagnostic laboratories and earned 82% of
during the PCR reaction. This is accomplished by incorporating the utility points of the best score.
an intercalating dye, such as SYBR Green, a fluorogenic probe,
ALTERNATIVE UTILITY
such as a TaqMan hybridization probe or a molecular beacon,
Best Score 0.909
or fluorogenic primers, such as Amplifluor or Scorpion primers.
Features of the instrument include: Random Access- Up to sixteen Smart Cycler PCR 0.749
different cycling protocols can be performed simultaneously Lowest Score 0.321
in one processing block. Multiple experimental runs can be
started at different times, allowing several operators to use Preference Set: Diagnostic Laboratory
the instrument concurrently. Fast turnaround time- Rapid
thermal cycling is possible due to efficient heating and cooling
of the sample using the specially designed tubes to achieve a
high surface-to-volume ratio. Accuracy- Reduce the number of MOBILE Laboratory Ranking
replicates with reliable quantification of target DNA by identifying Smart Cycler ranked in the highest third of all evaluated
the earliest PCR cycle in which the fluorescence signal is above products for mobile laboratories and earned 84% of the
background. Irreproducible results from endpoint analysis are utility points of the best score.
eliminated.
ALTERNATIVE UTILITY
The Smart Cycler is a real-time, integrated DNA/RNA amplification, Smart Cycler PCR 0.742
detection, and analysis system. Quantitation of the amplified Lowest Score 0.379
product is achieved by measuring the increase in fluorescence
during the PCR reaction. Logistics Biological Agents Effectiveness Operations
FIELD USE Ranking

Smart Cycler ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

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Emanuel and Fruchey

electrical requirement on luggage
source
require an external vacuum • A single centrifugation step
• System is able to interpret raw
DIAGNOSTIC Throughput of product: data or call a positive through
• Single sample detection in internal software
greater than 60 minutes • Assay available and capable of
BEST FIT WORST FIT • Greater than 250 ul volume agents or toxins within the same
• The system or device could be • Three additional pieces of
Signature:
CONTACT INFORMATION
• 5-10 minutes required for set-up • Less than 200 BTUS generated
Cepheid
904 Caribbean Drive
Sunnyvale, CA 94089
www.smartcycler.com
Point of Contact: multiple use • Peak performance of the device
Jeffrey Ryan • 2 solution or buffer used or system is at normal humidity
(888) 838-3222 • 3 components conditions only
ryan@cepheid.com Sensitivity:
Maintenance:
• $2.50/sample • Once a year service required • Is commercially available and
• $31,000.00-34,000.00/system or device • Expected life is greater than 10 meets military specifications
years
t
procedures required
II:273
Staphylococcal Enterotoxin (SET) Visual Immunoassay (VIA)


DETECTING SET VIA ranked in the middle third of all evaluated
Staphylococcal ALTERNATIVE UTILITY
entertoxins A, Best Score 0.901
B, C1, C2, C3, D TECRA Staph. Entero. VIA 0.445
and E
Lowest Score 0.217


A rapid and simple screening test for detection of Staphylococcal SET VIA ranked in the lowest third of all evaluated
enterotoxins A, B, C1, C2, C3, D and E in food, food related products for diagnostic laboratories and earned 45% of
samples and enrichment cultures. The kit is designed for the the utility points of the best score.
direct screening of foods for the presence of any of the seven
ALTERNATIVE UTILITY
toxins, which may be detected at concentrations as low as 1 ng
Best Score 0.909
per mL within four hours. However, the kit cannot be used for the
identification of a specific toxin type. For this purpose, the TECRA TECRA Staph. Entero. VIA 0.408
SET ID kit may be used. The ELISA can be used manually and the Lowest Score 0.321
results read by eye. However, it can also be semi-automated with
the use of microtitre plate readers and washers or fully automated
for large scale testing. The kit is available in a 48 and 96 well
formats.

The TECRA SET VIA is an Enzyme-linked Immunoassay (ELISA) SET VIA ranked in the middle third of all evaluated
performed in a sandwich configuration. products for mobile laboratories and earned 64% of the
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

SET VIA ranked in the middle third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

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Emanuel and Fruchey

ANALYTICAL water aliquots • Less than 1 kg
source
source • Single centrifugation step
Throughput of product: • System not able to interpret raw
DIAGNOSTIC • Single sample detection greater data or call a positive through
than 60 minutes internal software
• 384 samples/batch or higher • Assay available and capable
• Less than 250 ul volume of detecting multiple biological
• The system or device could test
easily be adapted into a fully • Two additional pieces of
CONTACT INFORMATION
TECRA International Pty Ltd
13 Rodborough Rd.
Frenchs Forest, NSW 2086 Australia
www.tecra.net
• Device or system is designed for 4°C
Nick Vale • More than 4 solutions or buffers system is not influenced by
+61 2 8977011 used relative humidity
+61 2 9453 3422 fax • 5 or more components
nick.vale@tecra.net • NA cleaning required Sensitivity:
• NA CFU per ml
Maintenance:
COST • 5 or more consumables or Maturity gauge:
• $7.00/sample expendables needed • Is commercially available
• $306.00 for 48 wells • No service required t
• $556.00 for 96 wells/system or device • Expected life NA
II:275
Stations of Robotic Monitoring (STORM)

by Edgewood Chemical Biological Center

DETECTING STORM ranked in the highest third of all evaluated
Francisella ECBC STORM 0.784
tularensis,
Lowest Score 0.217
Yersinia pestis,
Orthopox virus,
Smallpox virus,
VEE virus, Botulinum toxin A, SEB, Ricin DIAGNOSTIC Laboratory Ranking
STORM ranked in the highest third of all evaluated
DESCRIPTION:
The STORM (STations Of Robotic Monitoring) was designed at products for diagnostic laboratories and earned 72% of
ECBC to provide a reliable, high-throughput means of sample the utility points of the best score.
screening for biological warfare agents. Both the mobile and ALTERNATIVE UTILITY
stationary analytical labs employ the STORM concept. STORM Best Score 0.909
utilizes the “lessons learned” from a previous DoD effort, the ECBC STORM 0.654
Automated Biological Agent Testing System (ABATS). STORM
Lowest Score 0.321
utilizes the DNA extraction method from ABATS, but eliminates
the full-system integration feature. This modification allows Effectiveness Operations Biological Agents Logistics
greater flexibility when dealing with an inconsistent number of Preference Set: Diagnostic Laboratory
samples. The STORM mobile laboratory, designed in conjunction
with and manufactured by ENG Mobile Systems Inc. (Concord,
CA), is a 24-foot, 5th wheel trailer with custom modifications
for the accommodation of the Biomek FX automated liquid
handling system (Beckman Coulter, Inc.), M1R analyzer (BioVeris STORM ranked in the middle third of all evaluated
Corporation), and ABI 7900 (Applied Biosystems, Inc.). It is products for mobile laboratories and earned 70% of the
equipped with a 6-foot Class II/B2 biological safety cabinet and utility points of the best score.
a Class III glove box with outside access port to a pass-through ALTERNATIVE UTILITY
chamber. The Biomek is contained within a HEPA-filtered chamber Best Score 0.883
in order to protect the environment and operators from aerosols
ECBC STORM 0.583
generated by the Biomek during the liquid handling process.
Lowest Score 0.379
TECHNOLOGY:
Samples are analyzed by complimentary testing using
both real time polymerase chain reaction (PCR) and
electrochemiluminescent (ECL) technologies concurrently. The
majority of the PCR assays were developed at ECBC and part
of the JPEO-CBD Critical Reagent Repository (CRP). ECL assays FIELD USE Ranking
are manufactured by BioVeris Corporation using CRP antibodies. STORM ranked in the lowest third of all evaluated
Targets analyzed are determined by customer requirements, and products for field use and earned 51% of the utility points
targets can be changed or increased. Sample processing of 1-64 of the best score.
samples for all seven targets is completed within an eight hour
work day. ALTERNATIVE UTILITY
Best Score 0.943
ECBC STORM 0.438
Lowest Score 0.343

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Emanuel and Fruchey

ANALYTICAL • The system or device requires • Shelf life between 6 months and
water aliquots 1 year
source
• There are multiple centrifugation
require an external vacuum steps
source • There are multiple shaking or
vortexing steps
DIAGNOSTIC Throughput of product: • System can interpret raw data or
• Single sample detection in call a positive through internal
greater than 60 min software
• 96 samples/batch or higher • Assay available, and capable of
BEST FIT WORST FIT • Greater than 250 ul volume detecting four or more biological
needed per test for detection agents or toxins within the same
• The system or device could test
easily be adapted into a fully • No additional pieces of
• More than a day of training • No sounds produced that cannot
CONTACT INFORMATION
• 10-20 min required for set-up be deactivated
Edgewood Chemical Biological Center
• 9-12 manual steps required for • Greater than 500 BTUS
AMSRD-ECB-CB, Building E3330 detection generated
Aberdeen Proving Ground, MD 21010
www.ecbc.army.mil Operational conditions:
Re-use:
Point of Contact: multiple detections • Components must be stored at
Ray Mastnjak • More than 4 solution or buffer 4°C
(410) 436-4735 used • Performance of the device or
raymond.mastnjak@us.army.mil • 5 or more components system is not influenced by
• General decontamination with relative humidity
bleach is the only cleaning
requirement Sensitivity:
COST • 100-1,000 CFU per ml
• $300.00/sample for true unknown Maintenance:
• Approximately $900,000.00/device or system • 5 or more consumable or Maturity gauge:
expendable needed • Expected to be ready for
• Needs service once a year commercialization within three or
• Expected life measure of greater more calendar years
than 10 years • A few systems or devices exist
• 10-20 minutes required for daily (brass board)
t
II:277
T5000 Biosensor
by Ibis

DETECTING THE T5000 Biosensor ranked in the highest third of all
diphtheria, IBIS T5000 0.815
Burkholderia
Lowest Score 0.217
pseudomallei,
E.coli O157:H7,
Vibrio cholera, Burkholderia mallei, Yersinia pestis, Rickettsia prowazekii,
Marburg virus, Smallpox virus, Influenza virus, Orthopox virus, Venezuelan
equine encephalitis virus, Ebola virus
T5000 Biosensor ranked in the highest third of all
DESCRIPTION: evaluated products for diagnostic laboratories and
SAIC and Ibis Biosciences developed T5000 biosensor technology under earned 77% of the utility points of the best score.
DARPA sponsorship. Ibis Biosciences manufactures the T5000, designed
ALTERNATIVE UTILITY
for automated laboratory-based detection of bacterial/viral biological
Best Score 0.909
threats as well as other key human and agricultural pathogens. The T5000
detects pathogens using broad range PCR amplification of genomic IBIS T5000 0.701
DNA coupled with mass spectrometry interrogation of PCR products and Lowest Score 0.321
sophisticated maximum likelihood signal processing of the resulting mass
spectra to determine identities and abundances of the various microbes
whose predicted spectra best fit the observed spectra. The system analyzes
liquid samples derived from environmental (air samples or surface swabs),
clinical (throat swabs or blood) and other matrices. Standard laboratory
equipment performs sample preparation: a plate-based bead beater to MOBILE Laboratory Ranking
lyse microbes, a robot to isolate genomic threat DNA and RNA, a robot to T5000 Biosensor ranked in the middle third of all
format microtiter plates for PCR, and thermocyclers to amplify. The T5000 evaluated products for mobile laboratories and earned
processes PCR products on 96-well plates with two to 16 wells per sample; 68% of the utility points of the best score.
an assay covering a viral genus requires two-four wells while a broad assay
detecting most bacterial pathogens requires 16; six to 48 samples are ALTERNATIVE UTILITY
processed per plate. The T5000 desalts input PCR products removing salts Best Score 0.883
that would otherwise interfere with mass spectrometry. These products are IBIS T5000 0.604
flown through a mass spectrometer and analyzed to determine product Lowest Score 0.379
base compositions and the identities and abundances of microbes in the
input samples. Assays are available for broad detection of bacteria and Logistics Biological Agents Effectiveness Operations
viruses and for microbial strain-typing. Systems are deployed to the CDC, Preference Set: Mobile Laboratory
USAMRIID, NHRC, NBFAC, NIAID, and FBI.

The T5000 uses broad range PCR primers that bind to conserved sites T5000 Biosensor ranked in the lowest third of all
spanning hypervariable regions within genes required for microbial life.
These regions are amplified until detectable by mass spectrometry.
Hypervariable regions have base composition variations among different
microbial species and strains. MS analysis determines the PCR products’ ALTERNATIVE UTILITY
base compositions which act as fingerprint-like signatures indicating Best Score 0.943
organism identity. This allows a single assay to detect many different IBIS T5000 0.415
biological agents. Further, because this analysis yields detections for all
Lowest Score 0.343
species primed by our broad range primers, even ones with unknown
sequence information, it detects unknown organisms including novel, Logistics Operations Effectiveness Biological Agents
emerging, and engineered organisms. Preference Set: Field Use
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Emanuel and Fruchey

ANALYTICAL • The system or device requires • Reagent shelf life 1 to 6 months
water aliquots
• The system or device requires Ease of use/Utility:
an external gas source • Can view results “in real time”
source vortexing step
DIAGNOSTIC • Single sample detection greater through internal software
than 60 minutes • Capable of detecting multiple
per test for detection • Four or more additional pieces of
BEST FIT WORST FIT • The system or device is equipment needed
Signature:
• More than a day of training be deactivated
and significant technical skill • Greater than 500 BTUS
required
CONTACT INFORMATION • Greater than 20 minutes set-up
generated
SAIC
required
10260 Campus Point Drive Operational conditions:
San Diego, CA 92121 • Operated from 4°C to 45°C
www.saic.com
4°C
• Device or system is intended for or system is not influenced by
David W. Robbins
multiple use relative humidity
(858) 826-6904
(858) 775-6904 (cell) • More than 4 solution or buffer
(858) 826-2225
used Sensitivity:
• 5 or more components • 1-100 CFU per ml
robbinsd@saic.com • Occasional decontamination
required
• $50.00/sample • Is commercially available
Maintenance: • Has been featured in peer
• $400,000.00/device or system • More often than every 6 months reviewed scientific publications
service required or independent evaluations
years t
• 10-20 minutes of daily quality
II:279
TAC-BIO
by Edgewood Chemical Biological Center

DETECTING THE TAC-BIO ranked in the lowest third of all evaluated
ALTERNATIVE UTILITY
The TAC-BIO is a
ECBC TAC-BIO 0.380
small, solid-state,
low cost, low power Lowest Score 0.217
aerosol biological Effectiveness Biological Agents Logistics Operations
agent detector. It Preference Set: Analytical Laboratory
provides a generic
detection capability. It
does not require any
consumables. The DIAGNOSTIC Laboratory Ranking
detector is capable of TAC-BIO ranked in the middle third of all evaluated
autonomous operation products for diagnostic laboratories and earned 55% of
and will provide an the utility points of the best score.
alarm when threshold
ALTERNATIVE UTILITY
concentrations
Best Score 0.909
biological agents
are present. When ECBC TAC-BIO 0.502
compared to currently Lowest Score 0.321
available detectors,
this detector will not
only provide for a
cost effect detection capability with reduced physical attributes,
but also, offer novel opportunities to better protect the war
fighter. This would include remote detection applications such as MOBILE Laboratory Ranking
Unmanned Aerial Vehicle (UAV), Unmanned Ground Vehicle (UGV), TAC-BIO ranked in the middle third of all evaluated
and drop off sensing. products for mobile laboratories and earned 60% of the
TECHNOLOGY:
The TAC-BIO detector is based on the established capability to ALTERNATIVE UTILITY
detect biological aerosols using ultra-violet (UV) fluorescence. In Best Score 0.883
the TAC-BIO, aerosolized particles are pulled through the detector ECBC TAC-BIO 0.528
via an air pump and exposed to UV radiation. The UV excites Lowest Score 0.379
the fluorophores within the bio-agent particle, to include flavins,
NADH, and tryptophan, and results in a fluorescent emission that Logistics Biological Agents Effectiveness Operations
is detected using photomultiplier tubes. The relative fluorescent Preference Set: Mobile Laboratory
and scattering signals produced by biological particles when
subjected to these excitation sources is used to determine the
presence of a biological agent threat. FIELD USE Ranking
TAC-BIO ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
ECBC TAC-BIO 0.586
Lowest Score 0.343

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Emanuel and Fruchey

ANALYTICAL require water • No shaking or vortexing steps
• The system or device does not • System may be able to interpret
• The system or device does not future
MOBILE FIELD require an external vacuum • Capable of detecting multiple
the same test
Throughput of product: • No additional pieces of
DIAGNOSTIC • Single sample detection in 20 equipment needed
minutes or less
BEST FIT WORST FIT currently fully automated be deactivated
training and minimal technical • Operated from 0°C to 50°C
skills • Unknown influence from relative
• 5-10 minutes set-up required humidity
Edgewood Chemical Biological Center detection Sensitivity:
AMSRD-ECB-CB, Building E3330 • 100-150 ACPLA (Agent
Aberdeen Proving Ground, MD 21010 Containing Particles per Liter of
Re-use:
www.ecbc.army.mil • Device or system is intended for
Air)
multiple use
Point of Contact: • 0-1 solution or buffer used Maturity gauge:
Ray Mastnjak • No cleaning required • A few devices or systems exist
(410) 436-4735 (brass board)
raymond.mastnjak@us.army.mil Maintenance: • Is expected to ready for
• Expected life is between 1-3 commercialization within one
years calendar year
• No daily quality assurance • Less than $1,000,000
COST procedures required for advancement of
• $0.00/sample device or system to ready for
• $1,000.00/system or device commercialization
Transportation:
• Approximately the size of a soda • Has not been featured in
can any peer reviewed scientific
• Between 1 and 5 kg publications or independent
• Reagent shelf life greater than evaluations
3 years
t
II:281
TECRA UNIQUE™ Staphylococcal Enterotoxins


DETECTING TECRA UNIQUE ranked in the middle third of all
Staphylococcal ALTERNATIVE UTILITY
toxin B (Assay Best Score 0.901
developed and TECRA UNIQUE 0.440
validated)
Lowest Score 0.217

DESCRIPTION:
For the detection of pre-formed Staphylococcal enterotoxins (SET) DIAGNOSTIC Laboratory Ranking
in food and food-related samples within four hours; or to detect TECRA UNIQUE ranked in the lowest third of all
the production of SET after overnight enrichment of samples evaluated products for diagnostic laboratories and
containing enterotoxigenic Staphylococcus spp. There are seven earned 44% of the utility points of the best score.
serologically distinct Staphylococcal enterotoxins: A, B, C1, C2, C3,
ALTERNATIVE UTILITY
D and E. UNIQUE SET is designed for the direct screening of foods
Best Score 0.909
for the presence of any of the seven toxins which may be detected
at concentrations as low as 0.25ng /mL of sample. However, the TECRA UNIQUE 0.400
kit cannot be used for the identification of a specific toxin type. For Lowest Score 0.321
this purpose, the TECRA SET ID kit may be used. The ELISA can be
used manually and the results read by eye. However, it can also be
automated with the use of the TECRA UNIQUE PLUS instrument.
There are 20 tests per pack.

TECRA UNIQUE SET is essentially an Enzyme-Linked TECRA UNIQUE ranked in the middle third of all
Immunosorbent Assay (ELISA) performed in a “sandwich” evaluated products for mobile laboratories and earned
configuration. Rather than being carried out in a microtitre well
plate, all reagents are provided in a single-test module and a
UNIQUE stick performs both the capture and detection steps. ALTERNATIVE UTILITY
Best Score 0.883
TECRA UNIQUE 0.605
Lowest Score 0.379

FIELD USE Ranking

TECRA UNIQUE ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
TECRA UNIQUE 0.674
Lowest Score 0.343

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Emanuel and Fruchey

• There is no electrical • Approximately the size of a
requirement toaster
require water • Reagents shelf life between 1 to
• Greater than 250 ul volume the same test
BEST FIT WORST FIT needed per test for detection • Two additional pieces of
Signature:
• An afternoon of training and • Less than 200 BTUS generated
CONTACT INFORMATION some technical skills required
TECRA International Pty Ltd • 10-20 minutes set-up required
PO Box 6127 Frenchs Forest DC • 9-12 manual steps required for Operational conditions:
Sydney, NSW 2086
Australia 4°C
www.tecra.net Re-use: • The effects of relative humidity
• Device or system is intended for are unknown
Point of Contact: single use
Laura Gleeson • More than 4 solutions or buffers Sensitivity:
+61 2 8977 3035 used • 0.25 ng SET per ml
+61 2 9453 3422 • 1 components
laura.gleeson@tecra.net • No cleaning required
Maturity gauge:
• Is commercially available
COST Maintenance:
• Has not been featured in peer
• $12.00/sample • No service required
• $237.00/for 20 tests • Expected life is between 1-3
years
procedures
II:283

DETECTING THE Tetracore Bio Threat Alert ELISA ranked in the
diphtheria, E.coli
Best Score 0.901
O157:H7, Yersinia
pestis, Orthopox virus,
MS-2 bacteriophage, Lowest Score 0.217
Staphylococcal toxin B, Effectiveness Biological Agents Logistics Operations
Ricin toxin, Abrin toxin Preference Set: Analytical Laboratory
DESCRIPTION:
The BioThreat Alert ELISA Kits were designed to detect biological DIAGNOSTIC Laboratory Ranking
agents in solution. While they are able to be used in the field Tetracore Bio Threat Alert ELISA ranked in the
by advanced teams, they are used more often in a laboratory middle third of all evaluated products for diagnostic
setting. These kits were not intended for use on clinical samples. laboratories and earned 65% of the utility points of the
The BioThreat Alert ELISA Kits have better sensitivity than the best score.
BioThreat Alert Test Strips, and the ELISA format is friendly to
samples from complex matrices such as food, surface swipes, ALTERNATIVE UTILITY
unknown powders, air collected samples, air filters, etc. The Best Score 0.909
optional “Positive/Negative” capture format helps to reduce Tetracore Bio Threat Alert ELISA 0.587
matrix effects. The kits are available in either pre-coated with Lowest Score 0.321
capture antibody format or non-coated format to allow for user
flexibility. The BioThreat Alert ELISA Kits are often utilized by USDA Effectiveness Operations Biological Agents Logistics
and FDA laboratories. Preference Set: Diagnostic Laboratory

The BioThreat Alert ELISA Kit is a pre-packaged capture ELISA. Tetracore Bio Threat Alert ELISA ranked in the highest
The kit itself comes with a positive capture antibody, a negative third of all evaluated products for mobile laboratories
capture antibody (if positive/negative format is purchased), a
and earned 89% of the utility points of the best score.
detector antibody, a conjugate, substrate, and protein blocking
buffer, as well as one or two 96-well ELISA plates. The capture ALTERNATIVE UTILITY
antibodies (target specific) are placed in the wells first, followed Best Score 0.883
by the sample and detector antibodies ( target specific), creating Tetracore Bio Threat Alert ELISA 0.790
a very sensitive and very specific antibody “sandwich” that helps Lowest Score 0.379
to eliminate false results. When the target substance is present in
the well, the conjugate and the substrate produce a blue-colored Logistics Biological Agents Effectiveness Operations
product. This color change indicates a positive result and can be Preference Set: Mobile Laboratory
detected by any ELISA plate reader, as well as the naked eye.
FIELD USE Ranking

Tetracore Bio Threat Alert ELISA ranked in the highest
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:284
Emanuel and Fruchey

• There is no electrical • Approximately the size of a soda
requirement can
ANALYTICAL • The system or device requires • Less than 1 kg
water aliquots • Reagent shelf life measure is
• The system or device does not between 6 months and 1 year
MOBILE FIELD • The system or device does not • Can not view results “in real
require an external vacuum time”
DIAGNOSTIC Throughput of product: vortexing steps
• Single sample detection greater • System may be able to interpret
• 96 samples/batch or higher through internal software in the
• Less than 10 ul volume needed future
BEST FIT WORST FIT per test for detection • Assay not capable of detecting
• The system or device could multiple biological agents or
easily be adapted into a fully toxins within the same test
automated system • Four or more additional pieces of
equipment needed
• A day of training and technical Signature:
CONTACT INFORMATION skills required • No sounds produced that cannot
TetraCore • No set-up required be deactivated
9901 Belward Campus Dr, Suite 300 • Greater than 12 manual steps • Less than 200 BTUS generated
Rockville, MD 20850 required for detection
www.tetracore.com Operational conditions:
Point of Contact: single use 4°C
Tom O’Brien • More than 4 solutions or buffers • The performance of the device
(240) 268-5400 x5401 used or system is not influenced by
(240) 268-1107 • 5 or more components relative humidity
tobrien@tetracore.com • No cleaning required
Sensitivity:
COST Maintenance: • 10,000-100,000 CFU per mL
• Unknown/sample • No service required
• $450.00/device or system • Expected life is N/A Maturity gauge:
procedures • Has been features in peer
t
II:285
Threshold System
by Molecular Devices

DETECTING Threshold System ranked in the lowest third of all
toxins for which Threshold System 0.217
antibodies are developed.
Lowest Score 0.217
The Threshold system is used to detect and quantitate Preference Set: Analytical Laboratory
contaminants in biopharmaceuticals and sequence-specific DNA.
Contaminants commonly analyzed with the Threshold system
include total DNA, host cell proteins, bovine contaminants (BSA, DIAGNOSTIC Laboratory Ranking
IgG, insulin, transferrin), Proteins A and G, Bio-warfare agents, and
Threshold System ranked in the lowest third of all
any unique protein that can be bound by antibodies. The military
uses Threshold for its Biological Integrated Detection System evaluated products for diagnostic laboratories and
(BIDS). The technology is also used in ETG’s BioDetector. The earned 43% of the utility points of the best score.
Threshold system’s contaminant assays’ proven advantages of ALTERNATIVE UTILITY
speed, reproducibility, and reliability are incorporated into these Best Score 0.909
new applications.
The sample containing the analyte of interest is incubated with
the appropriate binding proteins or oligonucleotide probes. The Preference Set: Diagnostic Laboratory
analyte will be bound by the binding proteins or hybridized to the
probes to form a complex. The sample mixture is then filtered
through a membrane where the analyte complex is captured and
separated from the sample. The captured analyte complex will MOBILE Laboratory Ranking
contain enzyme proportional to the amount of complexed analyte. Threshold System ranked in the lowest third of all
The membrane is inserted into the Threshold reader which evaluated products for mobile laboratories and earned
contains the silicon sensor. A kinetic measurement of the enzyme 47% of the utility points of the best score.
activity is completed in 90 seconds. This data is then processed
by the Threshold software and quantitation is provided. ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Threshold System ranked in the highest third of all
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:286
Emanuel and Fruchey

• System or device has 110V and • Approximately the size of a carry-
source
require an external vacuum • Single centrifugation steps may
source be required
• Multiple shaking or vortexing
DIAGNOSTIC Throughput of product: steps
• Single sample detection 20 • System sometimes able to
minutes or less interpret raw data or call a
• 32 samples/batch or higher positive through internal software
BEST FIT WORST FIT • Less than 250 ul volume • Not capable of detecting multiple
needed per test for detection biological agents or toxins within
• The system or approach is not the same test
amendable to automation • Four or more additional pieces of
equipment needed
• Less than 5 minutes required • No sounds produced that cannot
CONTACT INFORMATION
for set-up be deactivated
Molecular Devices
• Greater than 12 manual steps • Unknown BTUS generated
1311 Orleans Dr. required for detection
Sunnyvale, CA 95128
www.moleculardevices.com
Point of Contact: multiple use 4°C and frozen
Emil Beitsayad • More than 4 solutions or buffers • Performance of the device or
(408) 548-6326 used system is not influenced by
(408) 747-3601 fax • 5 or more components relative humidity
Beitsayad@moldev.com • No cleaning required
Sensitivity:
• Unknown CFU per ml
Maintenance:
• $3.25/sample expendables needed Maturity gauge:
• $50,000.00/system or device • Once a year service required • Is commercially available and
• Expected life is greater than 10 meets military specifications
years
• Less than 5 minutes required t
II:287
Transgenomic WAVE System

by Transgenomic

DETECTING Transgenomic WAVE System ranked in the middle third
Yersinia pestis, Transgenomic WAVE Sys. 0.473
Shigatoxin
Lowest Score 0.217
(Assays
DESCRIPTION:
The WAVE System is a mutation discovery system. It identifies
SNPs, insertions, and deletions, and is one of the most sensitive DIAGNOSTIC Laboratory Ranking
mutation discovery methods known. The WAVEMAKER software
Transgenomic WAVE System ranked in the middle third
provides a melting curve, a melt profile, and the prediction of the
temperature to begin screening for mutation detection by entering of all evaluated products for diagnostic laboratories and
the DNA sequence. WAVE Systems are fully automated, robust, earned 57% of the utility points of the best score.
versatile and cost effective, meeting the critical requirements of ALTERNATIVE UTILITY
leading academic and biopharmaceutical laboratories worldwide. Best Score 0.909
TECHNOLOGY: Transgenomic WAVE Sys. 0.518

The Transgenomic WAVE System is a DHPLC (Denaturing-High Lowest Score 0.321
Performance Liquid Chromatography) system. The system directly Effectiveness Operations Biological Agents Logistics
analyzes post-PCR product and is also used for oligonucleotide Preference Set: Diagnostic Laboratory
purification and analysis. It can also be used for total RNA
purification and quantitation.

Transgenomic WAVE System ranked in the lowest third of
all evaluated products for mobile laboratories and earned
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Transgenomic WAVE System ranked in the middle third
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:288
Emanuel and Fruchey

• System or device has 110V and • Approximately the size of a home
220V electrical requirement dishwasher
water aliquots • Shelf life between 1 and 3 years
source
source • System sometimes able to
interpret raw data or call a
DIAGNOSTIC Throughput of product: positive through internal software
• Single sample detection 20 • Assay available and capable of
minutes or less after performing detecting two or more biological
PCR on the sample agents or toxins within the same
BEST FIT WORST FIT • 384 samples/batch or higher test
• Less than 10 ul volume needed • Three additional pieces of
• More than a day of training • Less than 200 BTUS generated
CONTACT INFORMATION
Transgenomic
12325 Emmet St.
required for set-up Operational conditions:
• 3-5 manual steps required for • Operated at 25°C only
Omaha, NE 68164 detection • Components must be stored at
www.transgenomic.com 4°C and room temperature
Re-use: • Device or system has peak
Point of Contact: • Device or system is intended for performance at normal relative
Will Jeffers multiple use humidity conditions only
(410) 598-7885 cell • 1 components Sensitivity:
(410) 992-3861 fax • No cleaning required • Unknown CFU per ml
wjeffers@transgenomic.com
COST • 3 consumables or expendables • Is commercially available
• $0.45-0.57/sample (post PCR) needed
• Every six months service
t
• $49,950.00-90,000.00/system or device
(excluding reagents) required
years MOST MATURE LEAST MATURE
• 10 -20 minutes required
procedures
II:289
Triage Meter
by Biosite Inc.

DETECTING THE Triage Meter ranked in the middle third of all evaluated
Bacillus Anthracis the utility points of the best score.
(Commercially ALTERNATIVE UTILITY
available as a Best Score 0.901
freeze-dried
reagent)
Lowest Score 0.217
The Triage Preference Set: Analytical Laboratory
meter consists
of a microfluidic
immunoassay
protein chip (ticket)
and a portable Triage Meter ranked in the highest third of all evaluated
fluorometer to read the ticket. Triage measures multiple analytes products for diagnostic laboratories and earned 81% of
simultaneously in any biological fluid using a single ticket, which the utility points of the best score.
makes it possible to simultaneously identifying all BW threat ALTERNATIVE UTILITY
agents on one ticket. Biosite has also developed a highly specific Best Score 0.909
(low false alarm rate) and sensitive immunoassay on Triage for the
detection of Bacillus anthracis.
Lowest Score 0.321
TECHNOLOGY:
The triage meter is a microfluidic immunoassay on a protein chip
or ticket which is read by a portable fluorometer.

Triage Meter ranked in the highest third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

Triage Meter ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:290
Emanuel and Fruchey

source
DIAGNOSTIC • Single sample detection 20 or call a positive through internal
minutes or less software
• Less than 250 ul volume of detecting two or more
adapted into a fully automated • No additional pieces of
CONTACT INFORMATION
Biosite Inc.
11030 Roselle St.
San Diego, CA 92121
www.biosite.com
Ferran Prat • 0-1 solution or buffer used system is not influenced by
(858) 597-4815 x3181 • 1 component relative humidity
discovery@biosite.com • No cleaning required
Sensitivity:
• 100-1,000 CFU per ml
Maintenance:
• $25.00/sample • Less than once a year service • Is commercially available
• $25.00/system or device, Approx. $4500.00 for required
t
reader
II:291
Upconverting Phosphor Technology (UPT) Handheld Sensor

by SRI International

DETECTING THE UPT Handheld Sensor ranked in the middle third of all
Orthopox virus, MS-2 ALTERNATIVE UTILITY
bacteriophage, Ricin Best Score 0.901
(Assays developed)

The fieldable handheld Effectiveness Biological Agents Logistics Operations
biosensor is designed Preference Set: Analytical Laboratory
to sensitively detect the
presence of low-levels
of biological warfare agents in a variety of military operational environments.
The system consists of several subsystems and disposable items. The
system uses a lateral flow immunoassay test strip with upconverting UPT Handheld Sensor ranked in the highest third of
phosphor technology (UPT) reporters. Sample collection is performed using all evaluated products for diagnostic laboratories and
the included surface sampling kit. Alternatively, if the unknown sample earned 80% of the utility points of the best score.
is already in liquid form, it may be directly applied to the test strip. Each ALTERNATIVE UTILITY
lateral flow test strip is capable of screening the liquid sample for one to Best Score 0.909
three different biological targets (e.g. toxins, viruses, and bacteria).
Following an incubation period of at least 15 minutes, the sensor analyzes Lowest Score 0.321
the assay test strip. This is accomplished by sliding the reader cover door
open, inserting the test strip into the slot, and initiating the scan using the Effectiveness Operations Biological Agents Logistics
Palm touch screen display. The strip is analyzed in about 45 seconds and Preference Set: Diagnostic Laboratory
the results are displayed on the reader screen and stored in the appropriate
data file.
TECHNOLOGY: UPT Handheld Sensor ranked in the middle third of all
The fieldable handheld biosensor is based on a new technology for
sensitive detection of biological materials, known as the Upconverting
Phosphor Technology (UPT). Upconverting phosphors are rare-earth doped
ceramic materials with the unique property of emitting visible light upon ALTERNATIVE UTILITY
excitation with near-infrared light. Known since 1966, SRI (under DARPA Best Score 0.883
funding) has developed UPT for the sensitive detection of biological targets UPT Handheld Sensor 0.620
(e.g., bacteria, viruses, and toxins) in solution. The ability to perform highly
Lowest Score 0.379
multiplexed (i.e., multiple target) assays on a single sample is the first
key advantage of UPTTM over conventional reporters such as molecular Logistics Biological Agents Effectiveness Operations
fluorescent dyes, colloidal gold and fluorescent microspheres. The second Preference Set: Mobile Laboratory
major advantage is that, due to the unique nature of the upconversion
process itself—no other materials in nature upconvert—there is no optical
background. Consequently, these materials can be detected in dirty FIELD USE Ranking
environmental samples. Third, because single phosphor particles are
UPT Handheld Sensor ranked in the highest third of all
detected using diode laser excitation sources and conventional optical
systems, compact biosensors are possible that offer exquisite sensitivity.
Finally, since their emission properties are a characteristic of the bulk utility points of the best score.
ceramic material, the upconverting phosphors are photochemically ALTERNATIVE UTILITY
stable with long lifetimes (years). Hence, the upconverting phosphors are Best Score 0.943
ideal reporters for use in the field for sensitive, real-time detection and UPT Handheld Sensor 0.739
identification of pathogens with minimum false alarms. Furthermore, their
Lowest Score 0.343
stability means that UPT-based assays can be archived (and stored in a dry
condition) for later analysis. Logistics Operations Effectiveness Biological Agents
II:292
Emanuel and Fruchey

source • There are no shaking or vortexing
steps
DIAGNOSTIC • Single sample detection 20 raw data or call a positive
• Less than 250 ul volume of detecting four or more
adapted into a fully automated • One additional piece of
• No set-up required be deactivated
CONTACT INFORMATION
SRI International
detection
333 Ravenswood Ave., Room 30626
Menlo Park, CA 94025
www.sri.com Re-use: • Operated from 15°C to 37°C
multiple use 4°C
Point of Contact: • 0-1 solution or buffer used • Performance of the device or
David E. Cooper • 2 components system is not influenced by
(650) 859-3742 • No cleaning required relative humidity
(650) 859-5036 fax
david.cooper@sri.com Maintenance: Sensitivity:
• 1,000-10,000 CFU per ml
needed
COST • Once a year service required Maturity gauge:
• $10.00/sample • Expected life is 3-5 years • A few devices or systems exist
• $25,000.00/system or device • No required daily quality (brass board)
t
II:293
Verigene ID Assay System

by Nanosphere, Inc.

DETECTING THE Verigene ID Assay System ranked in the lowest third of all
None reported 34% of the utility points of the best score.
ALTERNATIVE UTILITY
The Verigene Verigene ID 0.313
platform is a
Lowest Score 0.217
universal molecular
testing system Effectiveness Biological Agents Logistics Operations
that transcends Preference Set: Analytical Laboratory
the limitations of existing technologies. Verigene’s superior
performance is based on ClearRead™ technology that uses
proprietary and patented nanoparticle probes to identify DNA,
RNA and protein targets. This technology directly detects a target
without amplification of nucleic acid, eliminating the variability Verigene ID Assay System ranked in the lowest third of
associated with the amplification process (PCR). ClearRead™ all evaluated products for diagnostic laboratories and
also permits the simultaneous identification of multiple targets earned 40% of the utility points of the best score.
from a single sample. Nanosphere’s Verigene™ ID is a stand- ALTERNATIVE UTILITY
alone instrument designed to read light scatter from the gold Best Score 0.909
nanoparticles. The device illuminates the test slide and uses
Verigene ID 0.364
inexpensive optics to deliver scattered light from the test sites
to a photosensor. This detector is interfaced to an embedded Lowest Score 0.321
microprocessor that allows automatic spot detection and data Effectiveness Operations Biological Agents Logistics
processing. Preference Set: Diagnostic Laboratory
TECHNOLOGY:
For the detection of specific BWAs with gold probes, target-specific
oligonucleotides are conjugated to gold nanoparticles at a very MOBILE Laboratory Ranking
high density by using proprietary methods. The high density of Verigene ID Assay System ranked in the lowest third of all
oligonucleotides attached to the probe confers stability toward salt evaluated products for mobile laboratories and earned
and temperature fluctuations, provides low non-specific binding 53% of the utility points of the best score.
to surfaces and has a significant impact on assay sensitivity
and specificity. The chip-based detection assay is primarily a ALTERNATIVE UTILITY
sandwich hybridization where the target is captured between Best Score 0.883
surface-immobilized capture strands and the nanoparticle probe. Verigene ID 0.472
The assay design requires that for detection to occur, both the Lowest Score 0.379
capture and the probe bind the target. Therefore, assay specificity
is derived from both the capture strand and the probe. Detection Logistics Biological Agents Effectiveness Operations
is achieved by a signal enhancement procedure that involves Preference Set: Mobile Laboratory
depositing a signal enhancement reagent at the test site in a
strictly gold-dependent manner and measuring light scatter from
the resulting enhanced gold nanoparticles. The enhancement FIELD USE Ranking
step provides greater than 10^5-fold signal enhancement. Verigene ID Assay System ranked in the middle third of all
ALTERNATIVE UTILITY
Best Score 0.943
Verigene ID 0.591
Lowest Score 0.343

II:294
Emanuel and Fruchey

requires water aliquots • Shelf life between 6 months and
source
source • Number of shaking or vortexing
steps is unknown
DIAGNOSTIC Throughput of product: • System can interpret raw data or
• Single sample detection in 50- call a positive through internal
60 min software
BEST FIT WORST FIT • Less than 50 ul volume needed of detecting two or more
adapted into a fully automated • Unknown number of additional
CONTACT INFORMATION
• Less than 5 min required for be deactivated
Nanosphere, Inc.
set-up • Less than 200 BTUS generated
4088 Commercial Ave • 9-12 manual steps required for
Northbrook, IL 60062 detection Operational conditions:
www.nanosphere.us • Operated from 15°C to 37°C
William Cork multiple detections • Performance of the device or
(847) 400-9112 • More than 4 solution or buffer system is not influenced by
(847) 400-9199 fax used relative humidity
wcork@nanosphere.us • 1 component
• CFU per ml unknown
COST Maintenance:
• To Be Determined/sample • 5 or more consumables or Maturity gauge:
• To Be Determined/device or system expendables needed • Expected to be ready for
• Needs service less than once commercialization within one
a year calendar year
• Expected life measure of greater • A few systems or devices exist
than 10 years (brass board)
procedures required t
II:295
Veritide Bacterial Spore Detector

by Veritide

DETECTING THE Veritide Bacterial Spore Detector ranked in the
Bacillus anthracis laboratories and earned 75% of the utility points of the
(Assay developed) best score.

The Veritide Bacterial Best Score 0.901
Spore Detector Veritide Bacterial Spore Detector 0.675
is designed for Lowest Score 0.217
non-invasive, rapid,
reliable detection Effectiveness Biological Agents Logistics Operations
of bacterial spores
in the field by first
responders. It is DIAGNOSTIC Laboratory Ranking
intended to be Veritide Bacterial Spore Detector ranked in the
used as an anthrax highest third of all evaluated products for diagnostic
screening tool by laboratories and earned 84% of the utility points of the
fire departments, best score.
HazMat teams, police departments, airports, port security, postal
services, building/facilities owners/managers, and any other ALTERNATIVE UTILITY
first responder unit. Applications include biohazard detection, Best Score 0.909
suspicious powder analysis, and decontamination validation. The Veritide Bacterial Spore Detector 0.763
detector is intended to be used with surface powder samples, Lowest Score 0.321
but may also be used with liquid samples. The Veritide Bacterial
Spore Detector is as easy to use as a flashlight, and is robust, Effectiveness Operations Biological Agents Logistics
lightweight and handheld. It uses optical detection technology Preference Set: Diagnostic Laboratory
and is therefore inherently non-invasive, ensuring that the sample
being tested is not contaminated, consumed or destroyed. MOBILE Laboratory Ranking
Results are returned within minutes, enabling multiple samples Veritide Bacterial Spore Detector ranked in the middle
to be analyzed consecutively without extensive preparation and third of all evaluated products for mobile laboratories
waiting time. No chemical reagents or wet chemistry are used, and earned 71% of the utility points of the best score.
eliminating time-consuming and difficult sample preparation. No
consumables are required for analysis. The detector is waterproof ALTERNATIVE UTILITY
and designed for decontamination. Best Score 0.883
The Veritide Bacterial Spore Detector is based on non-invasive
optical detection technology. Optical recognition protocols are Logistics Biological Agents Effectiveness Operations
employed to detect the presence or absence of bacterial spores Preference Set: Mobile Laboratory
without physically contacting, contaminating, consuming or
heating the sample. No reagents, antibodies, or wet chemistry are
employed. FIELD USE Ranking
Veritide Bacterial Spore Detector ranked in the highest
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:296
Emanuel and Fruchey

• System or device uses batteries • Cannot view results “in real time”
ANALYTICAL require water • No shaking or vortexing steps
• The system or device does not • Not capable of detecting multiple
MOBILE FIELD require an external vacuum biological agents or toxins within
Throughput of product: equipment needed
DIAGNOSTIC • Single sample detection in 20
• 1 sample/batch • No sounds produced that cannot
BEST FIT WORST FIT
training and minimal technical • The effect of relative humidity is
skills unknown
required
CONTACT INFORMATION • 0-2 manual steps required for Sensitivity:
Veritide detection • 1-100 CFU per ml
P.O. Box 13-761
Christchurch 8001 Maturity gauge:
Re-use: • A few devices or systems exist
New Zealand • Device or system is intended for
www.veritide.com multiple use (brass board)
• 0-1 solution or buffer used • Is expected to be ready for
Point of Contact: • The device must be wiped commercialization within one
Andrew Rudge down with bleach solution if it calendar year
+64 3 3795 975 becomes contaminated • Less than $1,000,000 required
+64 3 364 2511 to advance the device or system
a.rudge@veritide.com Maintenance: to commercialization
COST • Expected life is between 5-10 any peer reviewed scientific
• $20,000.00/device or system years publications or independent
• Less than 5 minutes daily evaluations
t
Transportation:
toaster
• Less than 1 kg
II:297
Vero Tect
by Biral

DETECTING VeroTect ranked in the lowest third of all evaluated
Detects biological ALTERNATIVE UTILITY
vs. non-biological Best Score 0.901
particles Vero Tect 0.318
VeroTect is an Effectiveness Biological Agents Logistics Operations
aerosol analyzer Preference Set: Analytical Laboratory
that can be
used to detect
the presence of
biological warfare DIAGNOSTIC Laboratory Ranking
agents in the VeroTect ranked in the lowest third of all evaluated
atmosphere. It products for diagnostic laboratories and earned 38% of
is a biosensor of the utility points of the best score.
ruggedized design ALTERNATIVE UTILITY
suitable for field Best Score 0.909
deployment.
Vero Tect 0.345
It works by
measuring the size and shape of individual particles and Lowest Score 0.321
measuring the fluorescence response of an aerosol sample. Effectiveness Operations Biological Agents Logistics
This information is combined using powerful analytical tools to Preference Set: Diagnostic Laboratory
interpret with a high degree of confidence whether an aerosol is
biological or non biological. Its response is real time providing field
commanders and first responders with an early warning capability
to enable evasive action or appropriate protection measures to be MOBILE Laboratory Ranking
undertaken. VeroTect ranked in the middle third of all evaluated
TECHNOLOGY: utility points of the best score.
VeroTect uses real time optical (reagentless) technology to
provide its biodetection capability. ASAS (Aerosol Size And Shape) ALTERNATIVE UTILITY
technology was developed in conjunction with the University of Best Score 0.883
Herfordshire and the UK MOD, Dstl Research Establishment at Vero Tect 0.486
Porton Down in the UK. ASAS uses elastic scattering of laser light Lowest Score 0.379
and biological characterization is performed using light induced
fluorescence responses from the target aerosols. Logistics Biological Agents Effectiveness Operations
FIELD USE Ranking

VeroTect ranked in the middle third of all evaluated
ALTERNATIVE UTILITY
Best Score 0.943
Vero Tect 0.606
Lowest Score 0.343

II:298
Emanuel and Fruchey

• System is either mains operated • Can view results “in real time”
or low voltage (24V) DC • No centrifugation steps
source • Not capable of detecting multiple
equipment needed
• Real time aerosol detector Signature:
BEST FIT WORST FIT • Very brief (minutes-hours) • Greater than 500 BTUS
training and minimal technical generated
skills
• 5-10 minutes set-up required Operational conditions:
• Operated from -33°C to 55°C
Re-use: • Components must be stored
• Device or system is intended for from 25°C to 45°C or room
temperature
CONTACT INFORMATION continual use
BIRAL • System must be
decontaminated if exposed to a or system is not influenced by
PO Box 2, Portishead relative humidity
threat agent. Decontamination
Bristol, BS207JB
procedures are continually
UK under review. Sensitivity:
www.biral.com • 1-100 CFU per ml
Point of Contact:
Maintenance:
• Once a year service required Maturity gauge:
Steve Evans • Expected life is greater than 10 • Is commercially available and
+44 (0) 1275 847787 years meets military specifications
+44 (0) 1275 847303 • No daily quality assurance • Has been featured in peer
sevans@biral.com procedures reviewed scientific publications
COST Transportation:
• £72,000.00 GB Pounds sterling /device or system • Approximately the size of a
t
• Reagent shelf life greater than MOST MATURE LEAST MATURE
3 years
II:299
VIP for EHEC

by BioControl Systems, Inc.

DETECTING THE VIP for EHEC ranked in the highest third of all evaluated
E. coli 0157:H7, the utility points of the best score.
Salmonella, Listeria ALTERNATIVE UTILITY
(Assay validated) Best Score 0.901
VIP for EHEC 0.612
DESCRIPTION:
Lowest Score 0.217
VIP family of rapid
tests are patented, Effectiveness Biological Agents Logistics Operations
lateral flow Preference Set: Analytical Laboratory
immunoprecipitate
assays for the
detection of food
pathogens. Each
VIP test is totally self-contained. All the reagents have been VIP for EHEC ranked in the highest third of all evaluated
systematically incorporated into the test device. After sample products for diagnostic laboratories and earned 83% of
enrichment simply inoculate the VIP test. Results can be read the utility points of the best score.
after 10-20 minutes of room temperature incubation. ALTERNATIVE UTILITY
Proprietary antibodies, with high specificity to E. coli O157:H7 VIP for EHEC 0.758
antigens, are bound to chromogenic carrier and, separately, to Lowest Score 0.321
solid support matrix. Reagents are incorporated in test units and
produce visually discernible reaction product in presence of E.
coli O157:H7. During initial hydration of test unit, E. coli O157:H7
reacts with antibody-chromogen complex to form antigen-antibody
chromogen complex, which flows across lateral flow membrane
and is bound by antibody immobilized on membrane. Positive MOBILE Laboratory Ranking
reaction is indicated by presence of detection line positioned VIP for EHEC ranked in the highest third of all evaluated
across the solid support in test sample window. Proper test products for mobile laboratories and earned 77% of the
completion is indicated by another line formed in test verification utility points of the best score.
window. Absence of line in test verification window invalidates the
test. ALTERNATIVE UTILITY
Best Score 0.883
VIP for EHEC 0.683
Lowest Score 0.379

FIELD USE Ranking

VIP for EHEC ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
VIP for EHEC 0.882
Lowest Score 0.343

II:300
Emanuel and Fruchey

• System not able to interpret raw
Throughput of product: data or call a positive through
DIAGNOSTIC • Single sample detection 20 internal software
• 1 sample/batch biological agents or toxins within
• The system or device is not equipment needed
amendable to automation
Signature:
• No set-up required • Less than 200 BTUS generated
CONTACT INFORMATION
BioControl Systems, Inc.
12822 SE 32nd St.
Bellevue, WA 98055 Re-use: • Components can be stored at
• Device or system is designed for room temperature
www.biocontrolsys.com • Performance of the device or
single use
• 0-1 solution or buffer used system is not influenced by
Point of Contact: • 1 component relative humidity
Maritta Ko • No cleaning required
(425) 603-1123 x105 Sensitivity:
(425) 603-0070 fax • 1-100 CFU per ml
Maintenance:
mko@biocontrolsys.com • 0-1 consumable or expendable
needed Maturity gauge:
• No service required • Is commercially available
COST • NA expected life t
• $7.00-10.00/sample • No daily quality assurance
• $6.00-8.00/system or device procedures required
II:301
xMAP
by Luminex Inc.

DETECTING THE xMAP ranked in the highest third of all evaluated products
Burkholderia Best Score 0.901
pseudomallei, Coxiella Luminex xMAP 0.825
burnetti, Brucella
Lowest Score 0.217
species, E.coli O157:H7, Vibrio cholera, Burkholderia mallei,
Yersinia pestis, Smallpox virus, Influenza virus, Dengue fever Effectiveness Biological Agents Logistics Operations
virus, Orthopox virus, Venezuelan equine encephalitis virus, Preference Set: Analytical Laboratory
MS-2 bacteriophage, Botulinum toxin A, Botulinum toxin B,
Staphylococcal toxin B, Ricin toxin, Abrin toxin (Assay validated)

The Luminex System is a flexible analyzer based on the xMAP ranked in the highest third of all evaluated products
principles of flow cytometry that is designed to meet the needs for diagnostic laboratories and earned 78% of the utility
of laboratory medicine and the care of patients, as well being points of the best score.
used in the research environment. The system enables you to ALTERNATIVE UTILITY
multiplex (simultaneously measure) up to 100 analytes in a single Best Score 0.909
microplate well, using very small sample volumes. The system
Luminex xMAP 0.708
delivers fast and cost-effective bioassay results on many assay
formats including nucleic acid assays, receptor-ligand assays, Lowest Score 0.321
immunoassays and enzymatic assays. Effectiveness Operations Biological Agents Logistics
TECHNOLOGY:
The Luminex System is the combination of three core xMAP
technologies. The first is xMAP microspheres, a family of 100
fluorescently dyed 5.6 micron-sized polystyrene microspheres that MOBILE Laboratory Ranking
act as both the identifier and the solid surface to build the assay. xMAP ranked in the highest third of all evaluated products
The second is a flow cytometry-based instrument, the Luminex for mobile laboratories and earned 77% of the utility
analyzer, which integrates key xMAP detection components such points of the best score.
as lasers, optics, advanced fluidics and high-speed digital signal
processors. The third component is the IS 2.3 software, which is ALTERNATIVE UTILITY
designed for template-based data acquisition with robust data Best Score 0.883
regression analysis - ideal for the clinical laboratory setting. Luminex xMAP 0.680
Lowest Score 0.379

FIELD USE Ranking

xMAP ranked in the middle third of all evaluated products
best score.
ALTERNATIVE UTILITY
Best Score 0.943
Luminex xMAP 0.579
Lowest Score 0.343

II:302
Emanuel and Fruchey

• System or device has 110V • Reagent shelf life between 6
electrical requirement months and 1 year
source
require an external vacuum vortexing steps
source • System may be able to interpret
DIAGNOSTIC Throughput of product: through internal software in the
future
per test for detection • Four or more additional pieces of
Signature:
Training/Speed/Manpower: • There are sounds produced that
• More than a day of training cannot be deactivated
and significant technical skills
CONTACT INFORMATION • Greater than 500 BTUS
required generated
Luminex Inc.
12212 Technology Blvd. required
Austin, TX 78727-6115 • Greater than 12 manual steps Operational conditions:
www.Luminexcorp.com required for detection • Operated from 15°C to 37°C
Point of Contact: Re-use: 4°C
Sales Department • Device or system is intended for • The peak performance of the
(888) 219-8020 multiple use device or system is at normal
(512) 219-5195 fax • 3 solutions or buffers used relative humidity
• 100-1,000 CFU per ml
COST Maintenance:
• $2.00-3.00/sample • Less than once a year service Maturity gauge:
• $63,950.00/device or system required • Is commercially available
• Expected life is greater than 10 • Has been featured in peer
years reviewed scientific publications
• 5-10 minutes daily quality or independent evaluations
t
Transportation:
home dishwasher MOST MATURE LEAST MATURE
II:303
XMX/2L-MIL
by Dycor

None reported XMX/2L-MIL ranked in the lowest third of all evaluated
The XMX/2L-MIL is an aerosol separator, sample preparation,
ALTERNATIVE UTILITY
and high mass flow concentrator system, designed to operate
Best Score 0.901
under harsh field conditions. This system was designed to process
and collect large concentrations of aerosols in the respirable Dycor XMX 0.385
range (1 to 10 microns in diameter) in relatively short periods Lowest Score 0.217
of time. This system collects 530 (+/- 25) standard liters of air
per minute, strips away all of the large dust particles (greater
than 10 microns), and all of the very small micro debris (less
than 1 micron), and concentrates the aerosols between 1
and 10 microns. The particles are then impinged into a liquid
sample contained within a collection vial (normally sterile water DIAGNOSTIC Laboratory Ranking
or phosphate buffered saline). Once the sample is collected, XMX/2L-MIL ranked in the middle third of all evaluated
the user removes the centrifuge tube for subsequent analysis products for diagnostic laboratories and earned 59% of
(immunoassay, PCR, culturing). One of the primary issues in the utility points of the best score.
bioaerosol detection is the fact that one cannot obtain enough
ALTERNATIVE UTILITY
sample of interest to detect an airborne threat concentration
Best Score 0.909
that is lethal to humans. Our system concentrates approximately
530 liters of air per minute, cleans it up, and prepares a Dycor XMX 0.537
small aqueous aliquot to minimize dilution for detection, all Lowest Score 0.321
simultaneously. Additionally, our XMX system is designed for use
while wearing MOPP gear. There is superior system reliability
and having only one moving part—the blower motor—reduces
maintenance requirements and ensures a low MTBF. The XMX
system is quick and easy to setup and tear down to minimize
training and improper or incorrect usage. MOBILE Laboratory Ranking
XMX/2L-MIL ranked in the middle third of all evaluated
The XMX/2L-MIL sampler operates using principles of virtual
impaction. Particles are accelerated through nozzle/gap
combinations and are subjected to large aerodynamic forces ALTERNATIVE UTILITY
generated by a perpendicular airflows moving at a high flow Best Score 0.883
rate. Above a certain threshold, larger particles have sufficient Dycor XMX 0.611
momentum to cross the gap where smaller particles are deflected Lowest Score 0.379
by the larger airflow and separated from the initial particle stream.
The threshold sizes are determined by physical device and airflow Logistics Biological Agents Effectiveness Operations
design. In effect, this air sampler acts as an amplifier for particles Preference Set: Mobile Laboratory
within the size range 1-10µm and as a filter for particles outside
of this range.
FIELD USE Ranking
XMX/2L-MIL ranked in the highest third of all evaluated
of the best score.
ALTERNATIVE UTILITY
Best Score 0.943
Dycor XMX 0.843
Lowest Score 0.343

II:304
Emanuel and Fruchey

or has 110V or 220V electrical on luggage suitcase
• The system or device requires • Reagent shelf life greater than 3
water aliquots years
MOBILE FIELD source
source
DIAGNOSTIC
Signature:
Throughput of product: • No sounds produced that cannot
• Single sample detection in 20 be deactivated
minutes or less • Between 200-500 BTUS
BEST FIT WORST FIT • 96 samples/batch or higher generated
Training/Speed/Manpower: 25°C to 45°C
CONTACT INFORMATION or system is not influenced by
skills relative humidity
Dycor Technologies Ltd.
1851 - 94 Street required
Edmonton, Alberta T6N 1E6 Sensitivity:
• 0-2 manual steps required for • 10,000-100,000 CFU per ml
Canada detection
www.dycor.com
Maturity gauge:
Re-use: • Is commercially available and
Point of Contact: • Device or system is intended for meets military specifications
Antony Roth single use • Has been featured in peer
(780) 486-0091 x2326 • 0-1 solution or buffer used
reviewed publications or
(780) 486-3535 • 2 component
independent evaluations
apr@dycor.com • No cleaning require
t
COST Maintenance:
• $1.00/sample • Less than once a year service
required MOST MATURE LEAST MATURE
years
• Less than 5 minutes daily
II:305
ZeptoMARK and SensiChip Product Line

by Zeptosens AG

DETECTING THE ZeptoMARK and SensiChip Product Line ranked in the
Corynebacterium laboratories and earned 74% of the utility points of the
diptheria (Assay best score.
Best Score 0.901
DESCRIPTION:
High sensitivity
DNA and protein Lowest Score 0.217
microarray system Effectiveness Biological Agents Logistics Operations
comprehending sample isolation and workup, assay performance, Preference Set: Analytical Laboratory
readout of results, data collection and data presentation.
Applicability has been shown for determination of gene expression
as a consequence of infection, medical treatment, cancer
progression, stress, ageing. Applicability has been shown as well ZeptoMARK and SensiChip Product Line ranked in the
for the determination of protein expression and protein activation middle third of all evaluated products for diagnostic
in drug development. System has been successfully applied for laboratories and earned 69% of the utility points of the
the high sensitivity determination and characterization of clinically best score.
relevant pathogenic bacteria with minimal sample preparation
ALTERNATIVE UTILITY
requirements.
Best Score 0.909
TECHNOLOGY: ZeptoMARK and SensiChip 0.623
In contrast to competing microarray readout systems based on Lowest Score 0.321
epifluorescence, Zeptosens is using planar waveguide detection.
This results in facilitated sample workup requirements (more Effectiveness Operations Biological Agents Logistics
tolerant towards contamination) and about 50 fold increase of Preference Set: Diagnostic Laboratory
sensitivity. Lowest limit of detection: 1 attomol labeled DNA.
ZeptoMARK and SensiChip Product Line ranked in
the lowest third of all evaluated products for mobile
best score.
ALTERNATIVE UTILITY
Best Score 0.883
Lowest Score 0.379

FIELD USE Ranking

ZeptoMARK and SensiChip Product Line ranked in the
lowest third of all evaluated products for field use and
ALTERNATIVE UTILITY
Best Score 0.943
Lowest Score 0.343

II:306
Emanuel and Fruchey

requires water aliquots • Shelf life between 1-6 months
source
source steps
min or more • Assay not available, but capable
automated system
Signature:
CONTACT INFORMATION
• Greater than 20 min required • Greater than 500 BTUS
Zeptosens AG
Benkenstrasse 254 • 6-8 manual steps required for
Witterswil, CH-4108, Switzerland detection Operational conditions:
www.zeptosens.com • Operated from 15°C to 37°C
Gerhard Kresbach multiple detections • Performance of the device or
+41617268183 • 4 solution or buffer used system is not influenced by
+41617268171 fax • 5 or more components relative humidity
gerhard.kresbach@zeptosens.com • No cleaning required, uses
disposable cartridges Sensitivity:
COST Maintenance:
• $800.00/sample • 4 consumable or expendable Maturity gauge:
• $130,000.00/device or system needed • Is commercially available
• Needs service every 6 months t
years
for daily quality assurance MOST MATURE LEAST MATURE
procedures
II:307
II:308

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Biological Detectors

Isaac R. Fruchey, M.S. Peter A. Emanuel, Ph.D.

Instructions for the Use of This Guide

The use of either trade or manufacturers’ names in this report

Market Survey: Biological Detectors

1. Introduction 2. Four Different Scenarios Where Detection

3. Overview of PCR Techniques 4. Overview of Immunoassay Techniques

Figure 1. Hierarchical representation of criteria for detection

FIELD MOBILE DIAGNOSTIC ANALYTICAL 6. Selection Factors

4.2 Viral Measure. Number of assays that have been

4.3 Multiplex Measure. Ability to detect multiple biodefense

4.4 Toxins Measure. Number of assays that have been

4.5 Total Agents Measure. Total number of biological warfare

FIELD USE SMART Tickets

or system, time for set up, detection speed, maintainability,

maturity, and total agents detectable were considered as

the most important criteria. An ideal field use device would

immunoassay technologies and represent the best fit for this

technologies. This PCR device ranges in size from 1 kg to 5 kg Ambion Ag-Path ID

centrifuges, shaker, vortex) for use, which decreased the ease

of use and increased the number of manual steps. Figure 2

highlights the criteria specific to the evaluation of products

and technologies for field use. ABI PRISM 7500 PCR

Detection Systems DNA Engine Thermal Cycler

Effectiveness Logistics Operations Biological

0.025 0.135 0.045 0.010 TECRA Staph. Entero. VIA

Utility Consumables Set Up Time Viral DTX 800 Multimode Detector

0.02 0.045 0.090 0.010 Northrop Grumman MCAD

Conditions 0.045 0.01 AD 200 Absorb. Det.

Maintainability Total Agents ABI StepOne

Re-use 0.135 0.01 Vero Tect

0.045 Invader Assay

Requirements Smiths SBS

0.023 HKDNA LOAC

Figure 2. Hierarchical representation of criteria for Evaluation of

Detection Products for Field Use Mail Sentry

Logistics Operations Effectiveness

Preference Set = Field Use

MOBILE LABORATORY Ranking for Detection Goal

laboratories, factors pertaining to the bacterial, total agents,

and toxins detectable; transportation; operational conditions;

and re-use ability were considered as the most important

equipment; and would have increased throughput, speed, and BioMAPP

potential for automation. BioVeris M1R

Easy transportation and the ability of a device to detect many

agents topped the evaluation for mobile laboratory detection

products. The ABI PRISM 7900 Sequence Detection System

required several manual steps for detection, which increased

the process time and manpower requirements and reduced

the ease of use. Figure 3 highlights the criteria specific to the

evaluation of products and technologies for mobile laboratory Optical Immuno-assay

1.00 NucliSens EasyQ System

Effectiveness Logistics Operations Biological UPT Handheld Sensor

Utility Consumables Set Up Time Viral Sapidyne KinExA In-Line

0.05 0.05 0.004 0.045 Clear Lake Medical CD-M

Volume Signature Speed Multiplex MesoSystems AirSentinel

Operational Manpower Toxins

Maintainability Total Agents Northrop Grumman MCAD

0.08 Compact, Quantum Dots Biosens.

Ease of Use Mobile Molecular Lab.

Requirements HKDNA LOAC

Maturity ABI 9800

Figure 3. Hierarchical representation of criteria for Evaluation of AD 340 Absorb. Det.