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© Cepheid – Proprietary and Confidential
GeneXpert® Technology
2013
© Cepheid – Proprietary and Confidential 2
A Better Way to Platform Design
GX-I
GX-XVI
GeneXpert® Infinity-4880
GeneXpert® Module
GX-II GX-IV
© Cepheid – Proprietary and Confidential 3
Defining Molecular Diagnostics
The GeneXpert®
Family of Systems
GeneXpert®
Module
GeneXpert®
Cartridge SmartCycler®
Tube SmartCycler®
System
ICORE®
Module
Any Test
Any Time
Any Sample
Any Place
© Cepheid – Proprietary and Confidential 4
Delivering A Better Way
EASY
To Use
FAST
Answers
ACCURATE
Results
Delivering a Better Way to Realize the Benefits of Molecular Diagnostics
© Cepheid – Proprietary and Confidential 5
Platforms
I-CORE module
GeneXpert®
module
SmartCycler® Instrument
GeneXpert® Instrument
BDS
© Cepheid – Proprietary and Confidential 6
Cepheid Technology
SmartCycler®
GeneXpert®
© Cepheid – Proprietary and Confidential 7
GeneXpert® System Components
GeneXpert System includes:
• Modules Thermal and optical system
• Cartridge Self-Contained
Disposable
• Computer System Software
Barcode scanner
• Optional Accessories
Printer
UPS
© Cepheid – Proprietary and Confidential 8
GeneXpert® Technology
This technology includes:
• Instrument platform
• Test cartridges
• Dedicated protocols and Controls
© Cepheid – Proprietary and Confidential 9
GeneXpert® Technology
• Exploits proven SmartCycler® technology (Incorporated same “solid-state” thermal
cycler/fluorometer module)
•Employs an integrated and closed fluid transfer system
• Uses multiplex, rapid real-time PCR technique (6-colors)
• Based on microfluidics-based reconstitution, and simplification of automated
filling
Utilizes families of cartridges to address wide range of applications
and specimen types
© Cepheid – Proprietary and Confidential 10
No wet interface between instrument and cartridge to eliminate carry-over
Integrated ultrasonic horn for rapid lysis of spores
Total internal control of reagent system –
• No separate external positive or negative controls required
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)
Automated data reduction and results interpretation
GeneXpert® Design Approach
© Cepheid – Proprietary and Confidential 11
Cepheid Technology
MasterMix
Other real-time instrument
Amplification Detection Analysis Positive
Negative
Patient
Sample
Washing
DNA
extraction DNA
purification
GeneXpert®
© Cepheid – Proprietary and Confidential 12
Automated Xpert® MTB/RIF Protocol
in less than 2h
© Cepheid – Proprietary and Confidential 13
The I-Core Module
Building Block of the Smart Cycler® and GeneXpert®
© Cepheid – Proprietary and Confidential 15
Reaction
tube
Plunger Motor
Motherboard
I-CORE
Valve Drive Motor
Cartridge inserter
A micro lab: GeneXpert® module + cartridge
+
Valve
Body
Processing
Chambers
Ultrasonic Horn
© Cepheid – Proprietary and Confidential 16
Inside Chamber
ICORE tube
insertion
Valve drive (wedge) Ultrasonic horn
Plunger drive shaft
© Cepheid – Proprietary and Confidential 17
GeneXpert® Cartridge
This is a self-contained system
Amplification tube Amplification tube
Valve Body Valve Body
Chambers contain
reagents, primers and
probes , buffers and
extracted sample
Chambers contain
reagents, primers and
probes , buffers and
extracted sample
By turning, it directs the
fluids into the different
chambers and the PCR
tube.
By turning, it directs the
fluids into the different
chambers and the PCR
tube.
Allows you to perform
a rapid thermal
cycling and optical
excitation/detection
Allows you to perform
a rapid thermal
cycling and optical
excitation/detection Processing Chambers Processing Chambers
© Cepheid – Proprietary and Confidential 18
PCR Tube Cartridge Body
Syringe Barrel
Cap/Ultrasonic Interface
Rotary Valve/Filter and
Ultrasonic Lysis region
Cartridge Foot
. .
Cartridge Exploded View
Syringe drive
Valve body Ports
© Cepheid – Proprietary and Confidential 19
GeneXpert® Cartridge
• GX cartridge has 11 chambers
• Lower numbered chambers are used for sample
processing
• Higher numbered chamber are used for reagents
• Two types of cartridges
– Cartridge A
– Cartridge C
• Both cartridge A and C has identical body
construction. Only difference is the bottom part
Pre-filter or
Funnel
Cartridge A
only
© Cepheid – Proprietary and Confidential 20
Difference between cartridge A and cartridge C
Cartridge A Cartridge C
Xpert®
MTB/RIF
© Cepheid – Proprietary and Confidential 21
Cartridge Side View
Target-specific reagent bead:
primers; probe; controls; Mg2+;
excipients
Enzyme reagent bead:
Taq polymerase; dNTPs; … Buffer, Mg
2+; salts; excipients…
Sample Preparation bead:
Controls, excipients
+ Liquid Reagents
Retaining balls
© Cepheid – Proprietary and Confidential 22
Video
Please load the training documents and the training video on the above FTP
link:
Please copy and paste this link in EXPLORER, not INTERNET
EXPLORER
ftp link * ftp://hbdc:Crasa7Uc@ftp.caplaser.net
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