Xpert® MTB/RIF
Detection of Mycobacterium tuberculosis complex and Rifampin resistance-associated mutations in less than 105 minutes
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The Need

Great challenges face the global community, including the United States, with the worldwide re-emergence of TB and increased number of multi-drug resistant TB (MDR-TB) cases. The need for fast and accurate TB diagnosis with indication for drug resistance is greater than ever.
Current MTB diagnostic methods require weeks to deliver a definitive result. Delayed results reporting can lead to patients placed in respiratory isolation unnecessarily or put on ineffective therapies. AFB smear could provide faster turn-around time, but may be missing the true positive cases and patients may continue to spread MTB to others in the community, increasing the disease burden.

The Solution

Xpert® MTB/RIF, on-demand molecular testing — an ideal solution:
  • On-demand results that empowers physicians to manage patients effectively
  • As few as one negative result can be used in the decision to remove patient from respiratory isolation
  • Simultaneous detection of both MTB and rifampin resistance mutations, which are markers for MDR-TB strain
  • Acceptable samples include raw or concentrated sediments prepared from induced or expectorated sputum

The Impact

Impact on Patient Isolation Pathway
"Test and Release"or "Test and Treat"

* Refer to the Xpert MTB/RIF package insert for details
^ Example with one Xpert® MTB/RIF negative result
# MOTT: Mycobacteria Other Than Tuberculosis; DST: Drug Susceptibly Test
1. FDA. New data shows test can help physicians remove patients with suspected TB from isolation earlier. Press Release. 2015 Feb 12. Accessed Feb 2021. https://wayback.archive-it.org/7993/20180126103209/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434226.htm
2. WHO. WHO endorses new rapid tuberculosis test. Press Release. 2010 Dec 8. Accessed Feb 2021. http://www.who.int/mediacentre/news/releases/2010/tb_test_20101208/en/
3. CDC. A New Tool to Diagnose Tuberculosis: The Xpert MTB/RIF Assay. Accessed Feb 2021. http://www.cdc.gov/tb/publications/factsheets/PDF/XpertMTB-RIFAssayFactSheet_Final.pdf
4. Davis JL, et al. Impact of GeneXpert MTB/RIF on patients and tuberculosis programs in a low-burden setting. a hypothetical trial. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1551-9.
5. Lippincott CK, et al. Xpert MTB/RIF Assay Shortens Airborne Isolation for Hospitalized Patients With Presumptive Tuberculosis in the United States. Clin Infect Dis. 2014 Jul 15;59(2):186-92Workflow:3 Easy StepsUS-IVD. For In Vitro Diagnostic Use.231Pour