Introduction
Xpert® MTB/RIF is an in vitro diagnostic medical device designed for the rapid detection of Mycobacterium tuberculosis (MTB) and resistance to rifampicin, a marker for multidrug-resistant strains. This test provides results in two hours, significantly reducing the time required for diagnosis compared to traditional methods.

The Need
Current testing methodologies for MTB are slow, often taking weeks to deliver results, which can delay treatment and increase the spread of the disease. The emergence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains further complicates treatment, as current drug resistance testing can take over four weeks.

The Solution
The Xpert® MTB/RIF test offers simultaneous detection of MTB and rifampicin resistance with high sensitivity and specificity. It requires no additional instrumentation beyond the GeneXpert® System and provides on-demand results, enabling rapid and effective treatment decisions.

Performance Characteristics
The assay uses hemi-nested PCR and targets the rpoB gene to identify rifampicin resistance. It demonstrates high sensitivity and specificity, with overall sensitivity for culture-positive samples at 96.2% and specificity at 99.5% when using three sputum samples per patient.

Benefits
Immediate benefits of the Xpert® MTB/RIF test include improved and earlier diagnosis, early treatment initiation, reduced cross-infection, decreased hospital stay duration, and reduced mortality rates. The test also offers reduced expenses related to antibiotics, isolation, and hospital bed occupancy.

Workflow
The test involves three simple steps with a total hands-on time of two minutes: adding sample reagent to the sample tube, incubating, and then pipetting the sample into the cartridge for testing.

Ordering Information
The Xpert® MTB/RIF test is available in packs of 10 cartridges with sample reagent, catalog number GXMTB/RIF-10.

Contact Information
Corporate Headquarters: 904 Caribbean Drive, Sunnyvale, CA 94089 USA. European Headquarters: Vira Solelh, 81470 Maurens-Scopont, France. For more information, visit www.Cepheidinternational.com.