GENE XPERT

(Cepheid)
CONTENTS

• INTRODUCTION
• PRINCIPLE
• COMPONENTS
• TECHNOLOGY OF GENEXPERT
• SAFETY PRECAUTION
• INSTALLATION
• PREVENTIVE MAINTENANCE
• SOFTWARE KEY MESSAGE
• TROUBLESHOOTING
• DO AND DON’T
INTRODUCTION
GeneXpert

 New test for tuberculosis

 Can find out

-Person infected with TB
-TB bacterium resistance: Rifampicin
 EVOLUTION
Homebrew PCR OF PCR Xpert Tests

Patient Sample(s) Patient Sample(s)

Washing Sample Preparation

Nucleic acid extraction

Purification

Master Mix

Amplification and Detection

Result Interpretation by Lab Technician Automatic Result Interpretation

Advantage of GENE XPERT

 Reliable test results with compared to sputum microscopy

 Reliable test results when compared with culture

Identification of rifampicin resistance with in 2 hrs.

 Disadvantage of GENE XPERT

Shelf life of the cartridges : 18 months

 Cost of the test

 Temperature ceiling is critical

PRINCIPLE
 Works on molecular level
Procedural Steps
 Automated Xpert Protocol
1. Sample is
added to the
6. Results are cartridge
ready to view 2. The cartridge is
loaded into the
5. instrument
Simultaneo
us
amplificati 3. Nucleic acids are
on and purified
detection 4. Purified
occurs Nucleic acids
mix with PCR
reagents
GeneXpert

 Gene Xpert MTB/RIF assay

- Nucleic acid amplification (NAA )test

which is simultaneously detects DNA
of Mycobacterium tuberculosis complex
(MTBC) and resistance to rifampin (RIF)
in <2 hrs.
• Standard cultures-2-6 weeks for MTBC to grow

• >3 weeks-conventional drug resistance tests

• The system integrates and automates

-Sample processing
-Nucleic acid amplification
-Detection of the target sequences
COMPONENTS
Major parts of GeneXpert

1.Thermal and optical module(s)

2.Computer System and GeneXpert Dx Software

3. Barcode scanner
GeneXpert® Module
4.Cartridge

 Self-Contained
 Disposable
 Assay Definition
Protocol (ADF)
Xpert® Cartridge
 Cartridge Bottom View

Rotary valve is pre-aligned to fit with the valve in the module

• Do not rotate the rotary valve
• Alignment required to lock the module door and start the process
Internal View of the Cartridge
Cartridge Bay
The I-CORE® Module
Recommended Accessories
-UPS
-Surge protector

Optional Accessories
-Batteries/Power generator
-Printer
 Technology of GeneXpert

Integrated and closed system

 No direct contact between instrument and sample to

eliminate carry-over

 The sample is enclosed in the cartridge

 Integrated ultrasonic horn for cell lysis (when applicable)

 Fluid transfer: Micro fluidics based reconstitution, and
automated filling

 Software driven motors for valve movement and integral hydraulic drives

 Multiple integrated controls to validate every step

 Automated protocol, data reduction and results interpretation

PCR Reaction Chamber

Fluid transfer in the PCR Reaction Tube

• Do not touch the PCR reaction
• Wear gloves whenever you prepare a cartridge
ROUTINE OPERATION
VIEW YOUR RESULTS
 GENERATE A REPORT
• You can generate a report in PDF format and print it
 Power Consumption Requirements

• Power Supply: Auto Rating

• GeneXpert Energy Consumption information
 Cont…..
 Computer Energy Consumption information
-Laptop 350 kW
- Desktop 350 kW
Safety Precautions
 Injury may result if the instrument is not lifted properly.

 It is possible for you or the system to be exposed to biological

hazards.

 The GeneXpert instrument’s enclosure is designed to protect

operators from electrical shock hazards.
 Disposal
 Biological specimens, transfer devices, and used cartridges should
be considered capable of transmitting infectious agents requiring
standard precautions

 Follow your institution’s environmental waste procedures for

proper disposal

 These materials may exhibit characteristics of chemical hazardous

waste requiring specific national or regional disposal procedures
Installation
What to check before installation

• Well ventilated room Controlled laboratory temperature (150 -300C)

• A stable work bench with no centrifuge close to the system

• Away from an air conditioning vent or window (away from direct sunlight)

• 10-15 cm of clearance surrounding the instrument

• Near a power source (at least one required if connected to UPS/surge protector
INSTALLATION OF A SYSTEM WITH A
DESKTOP COMPUTER
Preventive Maintenance
• Required Materials

-1:10 dilution of household chlorine bleac

- 70% ethanol solution

- Lint-free wipes
:-brushes; gloves; clean water; eye protection
• Daily Maintenance

• Weekly Maintenance
• Monthly Maintenance

• Yearly Maintenance
Check the module performance with Xpert®Check once a year
Software Key Messages
• It is crucial to understand the key messages delivered by the software. The most
frequent messages are:

• INVALID
• NO RESULT
• ERRORS
• 5005, 5006, 5007
• 2008
• 212(X)
• 5011
TROUBLESHOOTING
Troubleshooting

-INVALID
Troubleshooting

-NO RESULT
 ERRORS

• ERROR results could be due to sample quality, cartridge preparation,

module, cartridge integrity.

• Always refer to the Troubleshooting section of the latest GeneXpert

Operator Manual.

• You may contact Cepheid Technical Support to help you diagnose and
solve your issue
 ERROR 5007/5006

• Probe Check Control failed and test was stopped before amplification
 ERROR 2008

• Pressure exceeds the maximum accepted level

 ERROR 212(X)

• Loss of communication between module(s) and software, while test is

running Possible errors: 2120; 2121; 2122; 2123; 2124; 2126; 2127
 ERROR 5011

• Signal loss detected in the amplification curve

Do’s And Don’ts
• COMPUTER
• GENEXPERT SYSTEM
• CARTRIDGE