ULTRA HDL

3K33-20
30-4129/R5

ULTRA HDL
This package insert contains information to run the Ultra HDL assay on the ARCHITECT c Systems™ and the
AEROSET System.

NOTE: Changes Highlighted

NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.

Customer Support
United States: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative

Symbols in Product Labeling

Calibrator Catalog number/List number

Concentration Serial number

Authorized Representative in the
Consult instructions for use
European Community
Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

Reagent 1

Reagent 2

ABBOTT LABORATORIES ABBOTT

Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
May 2008
©2005, 2008 Abbott Laboratories

1
NAME
ULTRA HDL
INTENDED USE
The Ultra HDL (UHDL) assay is used for the quantitation of high density
lipoprotein (HDL) cholesterol in human serum or plasma.
SUMMARY AND EXPLANATION OF TEST
Plasma lipoproteins are spherical particles containing varying amounts
of cholesterol, triglycerides, phospholipids, and proteins. Phospholipids,
free cholesterol, and proteins constitute the outer surface of the
lipoprotein particle, while the inner core contains mostly esterified
cholesterol and triglyceride. These particles serve to solubilize and
transport cholesterol and triglyceride in the bloodstream.
The relative proportions of protein and lipid determine the density
of these lipoproteins and provide a basis on which to begin their
classification.1 The classes are: chylomicron, very-low-density
lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density
lipoprotein (HDL). Numerous clinical studies have shown that the
different lipoprotein classes have very distinct and varied effects on
coronary heart disease risk.2
The principle role of HDL cholesterol in lipid metabolism is the uptake
and transport of cholesterol from peripheral tissues to the liver
through a process known as reverse cholesterol transport (a proposed
cardioprotective mechanism).3 Low HDL cholesterol levels are strongly
associated with an increased risk of coronary heart disease.4-7
Hence, the determination of serum HDL cholesterol is a useful tool in
identifying high-risk patients. The Adult Treatment Panel of the National
Cholesterol Education Program (NCEP) recommends that in all adults
20 years of age and over, a fasting lipoprotein profile (total cholesterol,
LDL cholesterol, HDL cholesterol, and triglyceride) should be obtained
once every five years to screen for coronary heart disease risk.8
PRINCIPLES OF PROCEDURE
The Ultra HDL assay is a homogeneous method for directly measuring
HDL cholesterol concentrations in serum or plasma without the need for
off-line pretreatment or centrifugation steps.
The method uses a two-reagent format and depends on the properties
of a unique detergent. This method is based on accelerating the
reaction of cholesterol oxidase (CO) with non-HDL unesterified
cholesterol and dissolving HDL cholesterol selectively using a specific
detergent. In the first reagent, non-HDL unesterified cholesterol is
subject to an enzyme reaction and the peroxide generated is consumed
by a peroxidase reaction with DSBmT yielding a colorless product. The
second reagent consists of a detergent (capable of solubilizing HDL
cholesterol), cholesterol esterase (CE), and chromagenic coupler to
develop color for the quantitative determination of HDL cholesterol.
Methodology: Accelerator Selective Detergent
REAGENTS
Reagent Kit
3K33 Ultra HDL is supplied as a liquid, ready-to-use, two-reagent
kit which contains:
4 x 84 mL
4 x 32 mL
Estimated tests per kit: 1,440
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients Concentration
Cholesterol oxidase (E. coli) < 1,000 U/L
Peroxidase (Horseradish) < 1,300 ppg U/L
N, N-bis (4-sulphobutyl)-m-toluidine-disodium < 1.0 mmol/L
(DSBmT)
Accelerator < 1.0 mmol/L
Ascorbic oxidase (Curcubita sp.) < 3,000 U/L
Cholesterol esterase (Pseudomonas sp.) < 1,500 U/L
4-Aminoantipyrine < 0.1%
Detergent < 2.0%
The Ultra HDL reagent is certified as traceable to the HDL cholesterol
designated comparison method, covering the NCEP medical decision
points, by the CDC-Certified Cholesterol Reference Method Laboratory
Network (CRMLN).
2
REAGENT HANDLING AND STORAGE
Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
Reagent Storage
• Unopened reagents are stable until the expiration date when stored
at 2 to 8°C.
• DO NOT FREEZE.
• Protect reagents from direct sunlight.
• Reagent stability is 28 days if the reagent is uncapped and onboard.
Indications of Deterioration
• Quality control results outside of the acceptance criteria defined by
your laboratory.
• Presence of turbidity.
WARNINGS AND PRECAUTIONS
Precautions for Users
1. For in vitro diagnostic use.
2. Do not use components beyond the expiration date.
3. Do not mix materials from different kit lot numbers.
4. CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.8 Biosafety Level 29 or other
appropriate biosafety practices10,11 should be used for materials that
contain or are suspected of containing infectious agents.
5. and contain a mixture of 5-chloro-2-methyl-4-isothiazolin-
3-one and 2-methyl-4-isothiazolin-3-one (3:1), which is a
component of ProClin, and are classified per applicable European
Community (EC) Directives as: Irritant (Xi). The following are the
appropriate Risk (R) and Safety (S) phrases:
R43 May cause sensitization by skin contact.
S24 Avoid contact with skin.
S35 This material and its container must be disposed
of in a safe way.
S37 Wear suitable gloves.
S46 If swallowed, seek medical advice immediately
and show this container or label.
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum and plasma are acceptable specimens. The National Cholesterol
Education Program (NCEP) recommends using fasting specimens for
a lipoprotein profile. If the specimen is nonfasting, only the values for
total cholesterol and HDL cholesterol are usable.12
• Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
When processing samples, separate serum from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
• Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are sodium
heparin, lithium heparin (with or without gel barrier), and spray-dried
EDTA.* Ensure centrifugation is adequate to remove platelets.
When processing samples, separate plasma from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
*NOTE: Lower HDL cholesterol results obtained from EDTA plasma
have been attributed to an osmotic dilution effect. The NCEP has
suggested multiplying EDTA plasma results by a factor of 1.03 to
correct the EDTA result to a serum equivalent value.13
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
SPECIMEN COLLECTION AND HANDLING (Continued)
Specimen Storage
Serum and Plasma
Temperature Maximum Bibliographic
Storage Reference
20 to 25°C 2 days 14
2 to 8°C 7 days 14, 15
-20°C 3 months 14
Guder et al.14
suggest storage of frozen specimens at -20°C for
no longer than the time interval cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
laboratories to establish a range around -20°C for specimen storage.
This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
PROCEDURE
Materials Provided
3K33 Ultra HDL Reagent Kit
Materials Required but not Provided
• 1E68 HDL Calibrator, 6 x 1 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Specimen Dilution Procedures
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Serum and plasma: Specimens with HDL cholesterol values exceeding
180 mg/dL (4.66 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure.
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a dilution
of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To set up the
automatic dilution feature, refer to Section 2 of the instrument-specific
operations manual for additional information.
Manual Dilution Procedure
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered
factor.
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate dilution factor before reporting the result.
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual.
CALIBRATION
Calibration is stable for approximately 28 days (672 hours) and is
required with each change in reagent lot number. Verify calibration with
at least two levels of controls according to the established quality control
requirements for your laboratory. If control results fall outside acceptable
ranges, recalibration may be necessary.
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the HDL Calibrator
package insert.
3
QUALITY CONTROL
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.
RESULTS
Refer to the instrument-specific operations manual for information on
results calculations.
• ARCHITECT System Operations Manual—Appendix C
• AEROSET System Operations Manual—Appendix A
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
LIMITATIONS OF THE PROCEDURE
Using three homogenous HDL assays, Camps, et al. have reported
artificially low HDL results in patients with liver cirrhosis.16 Published
studies are not available that define the severity of liver disease
necessary to affect lipoprotein and HDL metabolism, or establish other
possible patterns of interference with HDL results. When an HDL result
is diagnostically critical with concomitant clinically relevant liver disease,
use a recognized precipitation or ultracentrifugation HDL-reference
method for confirmation. Artificially decreased or increased HDL values
in the presence of dyslipidemias have been reported.17,18
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
For the AEROSET System only: Ultra HDL must be run on a separate
line from 7D60-02 Total Bilirubin (TBil) and 7D74-20
Triglyceride (Trig).
EXPECTED VALUES
Reference Range
Serum/Plasma12
Range Range
(mg/dL) (mmol/L)
Major risk factor for heart disease < 40 < 1.04
Negative risk factor for heart disease ≥ 60 ≥ 1.55
To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0259.
The National Cholesterol Education Program (NCEP) Adult Treatment
Panel III Report recommends the classification shown above.
Laboratories should follow recommendations for lipid ranges effective in
their locale if they differ from those of the NCEP.
SPECIFIC PERFORMANCE CHARACTERISTICS
Linearity
Ultra HDL is linear up to 180 mg/dL (4.66 mmol/L), with recovery within
10% of the predicted value with 95% confidence.
Linearity was verified using a modified Clinical and Laboratory
Standards Institute (CLSI) protocol NCCLS EP6-A.19 An internal
verification study produced linear results up to 221 mg/dL
(5.72 mmol/L).
Limit of Detection and Quantitation
The limit of quantitation (LOQ) for Ultra HDL is 5.0 mg/dL (0.13 mmol/L),
and the limit of detection (LOD) is 2.5 mg/dL (0.06 mmol/L).
The LOD testing for Ultra HDL was performed using a study design
based on CLSI protocol NCCLS EP17-A.20 An internal verification
study produced an LOD for Ultra HDL of 0.3 mg/dL (0.01 mmol/L).
The proportions of false positives (α) and false negatives (β) were less
than 5% and the limit of blank (LOB) was 0.2 mg/dL (0.01 mmol/L).
The LOQ is the analyte concentration at which the CV = 20%.
An internal verification study produced a CV of 9.1% at an HDL
cholesterol concentration of 4.4 mg/dL (0.11 mmol/L).
SPECIFIC PERFORMANCE CHARACTERISTICS Accuracy
(Continued) Accuracy data for Ultra HDL were collected using the HDL Cholesterol
Certification Protocol for Manufacturers.23 The data were analyzed
Interfering Substances using CLSI protocol NCCLS EP21-A.24
Interference studies were conducted using an acceptance criteria of Serum results from the Ultra HDL assay on an ARCHITECT c System
5% of the target value. Interference effects were assessed by Dose and an AEROSET System were compared with the designated
Response method, at the medical decision levels of the analyte. comparison method (DCM) for HDL cholesterol.
Lower Decision Level
ARCHITECT AEROSET
Interfering Target Observed
Substance Interferent Concentration N Mean %Bias -1.6 -1.8
(mg/dL) (% of Target)
Ascorbic Acid 2.9 mg/dL (165 μmol/L) 3 35 99 %Total Error 10.9 10.2
3.9 mg/dL (221 μmol/L) 3 35 99 Method Comparison
Conjugated 32.6 mg/dL (557 μmol/L) 3 34 104 Correlation studies were performed using CLSI protocol NCCLS
Bilirubin EP9-A2.25
63.3 mg/dL (1,082 μmol/L) 3 34 77
Serum results from the Ultra HDL assay on the AEROSET System
Unconjugated 32.4 mg/dL (554 μmol/L) 3 33 105 were compared with those from a commercially available accelerator
Bilirubin 65.5 mg/dL (1,120 μmol/L) 3 33 107 selective detergent methodology.
Hemoglobin 1,000 mg/dL (10 g/L) 3 31 102 Serum results from the Ultra HDL assay on an ARCHITECT c System
were compared with those from the Ultra HDL assay on an AEROSET
2,000 mg/dL (20 g/L) 3 31 104 System.
Intralipid 1,000 mg/dL (10 g/L) 3 32 102 AEROSET vs. ARCHITECT vs.
2,000 mg/dL (20 g/L) 3 32 115 Comparative Method AEROSET
N 111 110
Upper Decision Level Y - Intercept 0.46 0.61
Interfering Target Observed Correlation Coefficient 0.999 0.999
Substance Interferent Concentration N
(mg/dL) (% of Target) Slope 0.97 1.00
Ascorbic Acid 2.9 mg/dL (165 μmol/L) 3 69 101 %Bias at 35 mg/dL -2 1
3.9 mg/dL (221 μmol/L) 3 69 101 %Bias at 60 mg/dL -2 1
Conjugated 32.0 mg/dL (547 μmol/L) 3 68 102 Range (mg/dL) 12 to 188 12 to 179
Bilirubin 63.5 mg/dL (1,086 μmol/L) 3 68 95
Unconjugated 33.9 mg/dL (580 μmol/L) 3 67 102
Bilirubin 67.1 mg/dL (1,147 μmol/L) 3 67 102
Hemoglobin 1,000 mg/dL (10 g/L) 3 62 99
2,000 mg/dL (20 g/L) 3 62 100
Intralipid 1,000 mg/dL (10 g/L) 3 75 99
2,000 mg/dL (20 g/L) 3 75 101
Ascorbic acid solutions at the above concentrations were prepared by
addition of L-ascorbic acid to human serum pools. Conjugated bilirubin
solutions at the above concentrations were prepared by addition of a
ditaurobilirubin stock to human serum pools. Unconjugated bilirubin
solutions at the above concentrations were prepared by addition of
a NIST SRM 916a bilirubin stock to human serum pools. Hemoglobin
solutions at the above concentrations were prepared by addition of
hemolysate to human serum pools. Intralipid solutions at the above
concentrations were prepared by addition of Intralipid to human serum
pools.
Interferences from medications or endogenous substances may affect
results.21
Precision
The imprecision of the Ultra HDL assay is total SD ≤ 1.7 mg/dL or
total CV ≤ 4%, whichever is greater. Internal verification studies were
performed using CLSI protocol NCCLS EP5-A.22 Representative data
are summarized below.
Control Level 1 Level 2
N 80 80
Mean (mg/dL) 20.9 78.9
SD 0.36 0.76
Within Run
%CV 1.7 1.0
SD 0.23 0.36
Between Run
%CV 1.1 0.5
SD 1.07 0.73
Between Day
%CV 5.1 0.9
SD 1.15 1.11
Total
%CV 5.5 1.4

4
BIBLIOGRAPHY TRADEMARKS
1. Gotto AM. Lipoprotein metabolism and the etiology of AEROSET and ARCHITECT are registered trademarks of Abbott
hyperlipidemia. Hosp Pract 1988;23(Suppl 1):4–13. Laboratories.
2. Third Report of the National Cholesterol Education Program (NCEP) c System is a trademark of Abbott Laboratories.
Expert Panel on Detection, Evaluation, and Treatment of High Blood All other trademarks, brands, product names, and trade names are the
Cholesterol in Adults (Adult Treatment Panel III)—Final Report.
National Institutes of Health. National Heart, Lung, and Blood property of their respective companies.
Institute. NIH Publication No. 02-5215. September 2002; I-1–II-22. Licensed under PCT/JP00/03860 and PCT/JP97/04442.
3. Badimon JJ, Badimon L, Fuster V. Regression of atherosclerotic
lesions by high density lipoprotein plasma fraction in the
cholesterol-fed rabbit. J Clin Invest 1990;85(4):1234–41.
4. Castelli WP, Doyle JT, Gordon T, et al. HDL Cholesterol and
other lipids in coronary heart disease. The cooperative lipoprotein
phenotyping study. Circulation 1977;55(5):767–72.
5. Gordon T, Castelli WP, Hjortland MC, et al. High density lipoprotein
as a protective factor against coronary heart disease. Am J Med
1977;62(5):707.
6. Williams P, Robinson D, Bailey A. High density lipoprotein and
coronary risk factors in normal men. Lancet 1979;1(8107):72–5.
7. Kannel WB, Castelli WP, Gordon T. Cholesterol in the prediction
of atherosclerotic disease; New perspectives based on the
Framingham study. Ann Intern Med 1979;90(1):85–91.
8. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Occupational Exposure to
Bloodborne Pathogens.
9. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office; January 2007.
10. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization; 2004.
11. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline―Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
12. Executive summary of the third report of the National Cholesterol
Education Program (NCEP) Expert Panel on detection, evaluation,
and treatment of high blood cholesterol in adults (Adult Treatment
Panel III). JAMA 2001;285(19):2486–97.
13. National Cholesterol Education Program. Recommendations on
Lipoprotein Measurement, from the Working Group on Lipoprotein
Measurement. National Institutes of Health. National Heart, Lung,
and Blood Institute. NIH Publication No. 95-3044. September 1995.
14. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:22–3.
15. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
16. Camps J, Simo JM, Guaita S, et al. Altered Composition of
Lipoproteins in Liver Cirrhosis Compromises Three Homogenous
Methods for HDL-Cholesterol. Clin Chem 1999;45(5):685–88.
17. Roberts WL, Leary ET, Lambert TL, et al. Falsely low direct
HDL-cholesterol results in a patient with dysbetalipoproteinemia.
Clin Chem 2000;46:560–2.
18. Lackner, KJ, Schmitz G. Beta-VLDL of patients with type III
hyperlipoproteinemia interferes with homogenous determination of
HDL-cholesterol based on polyethylene glycol-modified enzymes.
Clin Chem 1998;44:2546–8.
19. Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity
of Quantitative Measurement Procedures: A Statistical Approach;
Approved Guideline (EP6-A). Wayne, PA: The National Committee
for Clinical Laboratory Standards, 2003.
20. Tholen DW, Linnet K, Kondratovich M, et al. Protocols for
Determination of Limits of Detection and Limits of Quantitation;
Approved Guideline (EP17-A). Wayne, PA: The National Committee
for Clinical Laboratory Standards, 2004.
21. Young DS, Effects of Drugs on Clinical Laboratory Tests, 5th ed.
Washington, DC: AACC Press, 2000:3-399–3-414.
22. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1999.
23. Cholesterol Reference Method Laboratory Network. HDL Cholesterol
Certification Protocol for Manufacturers. November 2002. Accessed
July 11, 2005 from: http://www.cdc.gov/labstandards/pdf/crmln/
MFRHDLNov2002final.pdf.
24. Krouwer JS, Astles JR, Cooper WG, et al. Estimation of Total
Analytical Error for Clinical Laboratory Methods; Approved Guideline
(EP21-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 2003.
25. Krouwer JS, Tholen DW, Garber CC, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline—Second
Edition (EP9-A2). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 2002.

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Ultra HDL Serum/Plasma—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — c 8000 SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: UHDL Type: Photometric Version: † Assay: UHDL
Number: 1093 COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 TRIG0 10% Detergent B*** 345 1
Reaction mode: End up Cuvette Trig 10% Detergent B 345
Primary Secondary Read times
Wavelength: 604 / 700 Main: 31 – 33 *** Select “Detergent B” for software prior to version 2.2.
Last required read: 33
Absorbance range: ___ – ___ Color correction: ___ – ___ Configure assay parameters — c 16000 SmartWash
Sample blank type: Self Blank: 14 – 16
о General о Calibration ● SmartWash о Results о Interpretation
Assay: UHDL
о Reaction definition ● Reagent / Sample о Validity checks COMPONENT REAGENT / ASSAY WASH Volume Replicates
R1 R2 R1 AlbG0 Detergent A 345 1
Reagent: UHDL0 Reagent volume: 200 67 R1 AlbP0 Water 345 1
Diluent: Saline Water volume: ___ ___ R1 TRIG0 10% Detergent B 345 1
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Cuvette Trig 10% Detergent B 345
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution
STANDARD : 2.0 ___ ___ ___ = 1:1.00 ● Ultra HDL Serum/Plasma—Conventional Units
_________ : ___ ___ ___ ___ = о
_________ : ___ ___ ___ ___ = о
Configure assay parameters — Results
о Reaction definition о Reagent / Sample ● Validity checks о General о Calibration о SmartWash ● Results о Interpretation
Assay: UHDL Assay number: 1093
Reaction check: None
Dilution default range: Result units: mg/dL
Low-Linearity: 5
High-Linearity: 180
Gender and age specific ranges:*
Maximum absorbance variation: ___ GENDER AGE (UNITS) NORMAL EXTREME
Either 0 – 130 (Y) 40 – 60

Configure assay parameters — Calibration

о General ● Calibration о SmartWash о Results о Interpretation Configure result units
Assay: UHDL Calibration method: Linear Assay: UHDL
Version: †
● Calibrators о Volumes о Intervals о Validity checks Result units: mg/dL
Calibrator set: Calibrator level: Concentration: Decimal places: 0 [Range 0 – 4]
UHDL Blank: Water 0‡ Correlation factor: 1.0000
Cal 1: UHDL1 †† Intercept: 0.0000
Replicates: 3 [Range 1 – 3]

о Calibrators ● Volumes о Intervals о Validity checks Ultra HDL Serum/Plasma—SI Units

Calibrator: UHDL Diluted
Calibrator level Sample sample Diluent Water Configure assay parameters — Results
Blank: Water 2.0 ___ ___ ___ о General о Calibration о SmartWash ● Results о Interpretation
Cal 1: UHDL1 2.0 ___ ___ ___ Assay: UHDL Assay number: 1093
Dilution default range: Result units: mmol/L
Low-Linearity: 0.13
о Calibrators о Volumes ● Intervals о Validity checks High-Linearity: 4.66
Calibration intervals: Gender and age specific ranges:*
Full interval: 672 (hours) GENDER AGE (UNITS) NORMAL EXTREME
Calibration type: Either 0 – 130 (Y) 1.04 – 1.55
Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks

Blank absorbance range: _____ – _____ Configure result units
Span: Blank – Blank
Assay: UHDL
Span absorbance range: _____ – _____ Version: †
Expected cal factor: 0.00
Result units: mmol/L
Expected cal factor tolerance %: 0
Decimal places: 2 [Range 0 – 4]
Correlation factor: 1.0000
Intercept: 0.0000

* User defined.
† Due to differences in instrument systems and unit configurations, version numbers may vary.
‡ Displays the number of decimal places defined in the decimal places parameter field.
†† Refer to concentration specified on calibrator labeling.

6
AEROSET SYSTEM ASSAY PARAMETERS

Ultra HDL Serum/Plasma—Conventional Units Ultra HDL Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
UHDL 93 A-Line** UHDL 93 A-Line**
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 40 60 0.0 0.0* * * 0.0* 0.0 1.04 1.55 0.0 0.0* *
5 L-Linear Range-H 180 0.13 L-Linear Range-H 4.66
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 604 / 700 31 – 33 / 0 – 0 0.0 END UP 604 / 700 31 – 33 / 0 – 0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
UHDL ( 93 ) 14 – 16 0–0 0.0 – 0.0 UHDL ( 93 ) 14 – 16 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 2.0 0.0 0 0 Rgt Name/Pos Standard 2.0 0.0 0 0 Rgt Name/Pos
Dil 1 2.0 0.0 0 0 Diluent: _______ – __* Dil 1 2.0 0.0 0 0 Diluent: _______ – __*
Dil 2 2.0 0.0 0 0 Type# 0 Dil 2 2.0 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 UHDL061 – ___* 200 0 0 Reagent 1 UHDL061 – ___* 200 0 0
Reagent 2 UHDL052 – ___* 67 0 0 Reagent 2 UHDL052 – ___* 67 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
___________ 1–1/1–1 0.0 – 0.0 0.0 ___________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 0 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 672 Linear 672
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 0 BLK – 1 0.0 – 0.0 3/3 0 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range
BLK Water 2.0 0.0 0 0 0.0 – 0.0 BLK Water 2.0 0.0 0 0 0.0 – 0.0
C1 UHDL 1 2.0 0.0 0 0 Cal Deviation C1 UHDL 1 2.0 0.0 0 0 Cal Deviation
0.0 0.0
FAC Limit (%) FAC Limit (%)
10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
ALBG061 AlkW 345 ALBG061 AlkW 345
ALBP061 AlkW 345 ALBP061 AlkW 345
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** Ultra HDL must be run on a separate line from 7D60-02 Total Bilirubin (TBil) and 7D74-20 Triglyceride (Trig).

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