Cepheid Xpert MTB/XDR

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Product Details:

Display Type Digital (Instrument Interface)
Frequency 5060 Hz
Instruments Type Molecular Diagnostic Assay Cartridge
Usage Type Clinical, Laboratory diagnostic
Accuracy High (Factory-validated with controls included per run)
Measurement Range Qualitative detection of MTB and resistance mutations
Storage Instructions 228C (Cartridge); avoid freezing
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Cepheid Xpert MTB/XDR Price And Quantity

Throughput Depends on number of modules (scalable, e.g., 180 tests simultaneously)
Assay Run Time Approximately 90 minutes
Compatible Instruments GeneXpert Systems (I/II/IV/XVI/Infinity)
Results Output Qualitative Report (Detected/Not Detected/Resistance/MDR/XDR mutations)
Sample Types Sputum, other respiratory specimens
Software Compatibility GeneXpert Dx or Infinity Software
Internal Controls Integrated sample processing and PCR controls
Environmental Requirements 1530C operation, 2080% humidity, non-condensing
Data Export USB, Ethernet, LIS compatible
Regulatory Certification CE-IVD, WHO endorsed
Sample Preparation Minimal, direct addition to cartridge
Intended Use Rapid detection of MTB and resistance to isoniazid, fluoroquinolones, ethionamide, and injectables
Assay Target Genes rpoB, katG, inhA, gyrA, gyrB, eis, rrs, and others
Disposability Single-use diagnostic cartridge

Cepheid Xpert MTB/XDR Product Specifications

Operating Type Automatic
Power Source Electric
Condition New
Real-Time Operation Yes
Measurement Range Qualitative detection of MTB and resistance mutations
Power Consumption <100 VA (System, Module dependent)
Portable Yes, with certain instrument configurations
Instruments Type Molecular Diagnostic Assay Cartridge
Display Type Digital (Instrument Interface)
Frequency 5060 Hz
Color White/Blue (Cartridge color: Translucent/White)
Voltage 100240 V AC, 5060 Hz
Usage Type Clinical, Laboratory diagnostic
Accuracy High (Factory-validated with controls included per run)
Function Detection of MTB, Multi-Drug Resistance (MDR), XDR markers
Shelf Life 12 months (Cartridge)
Dimension (L*W*H) Varies by instrument platform; e.g., 32.5 cm x 35 cm x 28 cm (GeneXpert instrument module)
Features Automated nucleic acid extraction, Amplification, Detection, Sample-to-result platform, Minimal hands-on time
Weight Varies with instrument module; e.g., 13 kg (GeneXpert System)
Noise Level Low
Storage Instructions 228C (Cartridge); avoid freezing
Equipment Type Real Time PCR System Cartridge
Technology Molecular Diagnostic (PCR) Technology
Use Detection of MTB (Mycobacterium tuberculosis) and drug resistance (INH, FQ, ETH, AMK, KAN, CAP)
Wall Mounted No
Material Plastic Cartridge, Electronic Module

Throughput Depends on number of modules (scalable, e.g., 180 tests simultaneously)
Assay Run Time Approximately 90 minutes
Compatible Instruments GeneXpert Systems (I/II/IV/XVI/Infinity)
Results Output Qualitative Report (Detected/Not Detected/Resistance/MDR/XDR mutations)
Sample Types Sputum, other respiratory specimens
Software Compatibility GeneXpert Dx or Infinity Software
Internal Controls Integrated sample processing and PCR controls
Environmental Requirements 1530C operation, 2080% humidity, non-condensing
Data Export USB, Ethernet, LIS compatible
Regulatory Certification CE-IVD, WHO endorsed
Sample Preparation Minimal, direct addition to cartridge
Intended Use Rapid detection of MTB and resistance to isoniazid, fluoroquinolones, ethionamide, and injectables
Assay Target Genes rpoB, katG, inhA, gyrA, gyrB, eis, rrs, and others
Disposability Single-use diagnostic cartridge

Product Description

Brand Cepheid

Product Type PCR Kit

Pack Size 10T

CAT No GXMTB/XDR-10

Application Molecular Biology

The Xpert MTB/XDR test enables rapid molecular DST. When combined with the frontline Xpert MTB/RIF Ultra test, it sets new standards by detecting mutations associated with resistance to isoniazid (INH), fluoroquinolones (FLQ), second-line injectable drugs (SLIDs), and ethionamide (ETH) in a single test.

Fast time to result for molecular DST
Results in <90 minutes
Same easy-to-use process as the Xpert MTB/RIF Ultra test
Run on existing GeneXpert platforms equipped with 10-color modules

Rapid and Reliable TB Detection

With a brief assay run time of about 90 minutes, the Xpert MTB/XDR provides fast and accurate identification of both Mycobacterium tuberculosis and mutations linked to multidrug resistance (MDR) and extensively drug-resistant (XDR) strains. This enables timely clinical decision-making, supporting optimal patient management.

User-Friendly, Automated Platform

The system's minimal sample preparation and fully automated workflow streamline diagnostic processes. Users can directly add the specimen to the cartridge, reduce hands-on time, and experience seamless operation via the digital interface using GeneXpert Dx or Infinity software. Its scalable format allows for simultaneous testing with multiple modules.

Versatile and Scalable for Laboratories

Compatible with various GeneXpert System modules (I/II/IV/XVI/Infinity), Xpert MTB/XDR can serve settings from small clinics to high-throughput laboratories. Its portability, low noise level, low power consumption, and straightforward data export capability (USB, Ethernet, LIS) facilitate easy integration and adaptability.

FAQ's of Cepheid Xpert MTB/XDR:

Q: How does the Cepheid Xpert MTB/XDR assay detect drug-resistant TB?

A: The Xpert MTB/XDR uses real-time PCR technology to identify Mycobacterium tuberculosis and mutations in genes (e.g., rpoB, katG, inhA, gyrA, gyrB, eis, rrs) associated with resistance to isoniazid, fluoroquinolones, ethionamide, and injectable drugs. Results indicate whether MTB or resistance mutations are detected.

Q: What types of samples are compatible with the Xpert MTB/XDR test?

A: The assay is validated for sputum and a range of other respiratory specimens. Minimal preparation is required; samples are added directly to the disposable cartridge for processing.

Q: When can results be expected after starting the test?

A: Results are typically available in about 90 minutes after sample analysis begins, allowing for rapid clinical response and treatment planning.

Q: Where can the Xpert MTB/XDR system be used?

A: The system is suitable for clinical and laboratory diagnostic environments, including settings that require scalable throughput. It is designed to operate across a broad range of temperatures (15-30C) and relative humidity (20-80% non-condensing).

Q: What is the process for running a test with Xpert MTB/XDR?

A: Users minimally prepare the specimen, directly load it into the cartridge, and then insert the cartridge into the GeneXpert instrument. The system automates nucleic acid extraction, amplification, and detection, delivering results via the instrument's digital display.

Q: What are the primary benefits of using the Xpert MTB/XDR assay?

A: Benefits include high diagnostic accuracy, rapid turnaround, detailed detection of MTB and relevant resistance mutations, minimal hands-on time, and suitability for both low and high-throughput labs. The system is CE-IVD certified and endorsed by WHO.

Q: How are the test results accessed and managed?

A: Results are provided as a qualitative report (Detected/Not Detected/Resistance/MDR/XDR mutations) on the GeneXpert's digital interface. They can be exported or integrated with laboratory information systems via USB, Ethernet, or LIS connectivity.

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