Beruflich Dokumente
Kultur Dokumente
Indira Soundiram
2012
A Better Way to Platform Design
GeneXpert
Infinity-48
GX-XVI
GeneXpert
Module
GX-I GX-II GX-IV
2 2010 Cepheid
Defining Molecular Diagnostics
3 2010 Cepheid
Delivering A Better Way
4 2010 Cepheid
GeneXpert Dx System Components
Modules
Thermal and optical system
Cartridge
Self-Contained
Disposable
Computer System
Software
Barcode scanner
Optional Accessories
Printer
UPS
5 2010 Cepheid
GeneXpert Technology
Instrument platform
Cartridges
Protocols and Controls
6 2010 Cepheid
GeneXpert Technology
Employ random access fluidic systems that bridge microfluidics with macro
fluidics
Smart fluidics
Encoded software driven motors for valve movement and integral hydraulic drives
Advanced micro fluidics technologies to enable complex sample prep processing protocols
(many milliliters down to 10 micro liters)
8 2010 Cepheid
Cepheid Technology
GeneXpert
DNA/RNA DNA or RAN
Washing extraction purification
Patient Sample
MasterMix
SmartCycler
Positive
Analysis Detection Amplification
Ngative
9 2010 Cepheid
Automated Xpert MTB/RIF Protocol
in less than 2h
7. View/print
results about
50 minutes later!
10 2010 Cepheid
Platforms
SmartCycler Instrument
I-CORE module
GeneXpert Instrument
GX module
BDS
11 2010 Cepheid
The I-Core Module
12 2010 Cepheid
GeneXpert I-Core module Excitation & Detection
13 2010 Cepheid
A micro lab: GeneXpert module + the cartridge
Syringe Motor
Processing
Motherboard Chambers
Reaction
tube
I-CORE +
Module Door Valve
Body
Valve Drive Motor
14 2010 Cepheid
Cepheid Technology
GeneXpert SmartCycler
15 2010 Cepheid
Cepheid Cartridge
Syringe drive
I-CORE
Valve drive Ultrasonic horn
16 2010 Cepheid
GeneXpert Module
Syringe Motor
Motherboard
Uniframe
I-CORE
Ultrasonic
Horn
17 2010 Cepheid
Inside Chamber
Ultrasonic horn
18 2010 Cepheid
GeneXpert Cartridge
19 2010 Cepheid
Cartridge Side View
20 2010 Cepheid
Cartridge Exploded View
Cartridge Body
Ports for (11 Fluid Chambers and
PCR tube overmolded gasket)
PCR
Tube
Cap/Ultrasonic Interface
Cartridge Foot
21 2010 Cepheid
Cartridge Valve Body Types
Cartridge A Cartridge C
22 2010 Cepheid
Cepheid Assay Control Strategy
The use of external controls will have limited use in assuring proper
assay performance
Cepheid designed specific molecular methods to include internal
controls that enable the system to detect specific failure modes
Three elements of the molecular design were created to address all the
23 2010 Cepheid
Probe Check
What is it?
Just prior to starting thermal cycling, multiple fluorescence readings at different
temperatures are made.
The results are automatically compared to pre-established factory settings in the
software.
24 2010 Cepheid
Sample Processing Control (SPC)
What is it?
Intact organisms, DNA or RNA
Detection probe: A fluorescently-labeled hybridization probe with different color
reporter dye than that of the target probe(s) or the internal control (IC); present in
primer-probe bead
Primers: Can be the same as those for the target or IC or can be unique; present in
primer-probe bead
What does it do?
Co-processed with target organism through entire sample prep process
Co-amplified with targets
- The SPC assesses the effectiveness of the sample processing steps, including and up
to reaction tube filling
- Detects degradation of enzyme(s) or other components of system
- Detects sample inhibition
25 2010 Cepheid
Regular Real-Time PCR Assay
26 2010 Cepheid
GeneXpert Real-Time PCR Assay
27 2010 Cepheid
SPC does not compete with target DNA
28 2010 Cepheid
SPC does not compete with target DNA
29 2010 Cepheid
Interpretation of Results
Probe Check
Test No Value
Pass Fail Stopped
Target Error
Pos No Value
Positive SPC IC
Pos No Value
Negative Invalid
30 2010 Cepheid