Enhanced performance in detecting drug-sensitive and -resistant Tuberculosis cases in less than 80 minutes
Drug-resistant tuberculosis (TB) continues to be a global public health crisis
The End TB Strategy calls for universal access to drug susceptibility testing (DST).1 Yet only 39% of the estimated 448,000 multidrug resistant (MDR) incident cases in 2018 had been notified, and only 32% of those were enrolled in treatment.2 In 2017, among the MDR or rifampicin resistant (RR) TB cases only 50% were tested for resistance to fluoroquinolones and second-line injectable agents.3
At the same time, new evidence and guidance on the treatment of drug-resistant tuberculosis is being issued by WHO, advocating for the use of new oral drug regimens which require DST.4,5 Likewise, the increasing incidence of isoniazid-monoresistance among TB cases calls for reliable molecular diagnostic tests.6
However, so far, the only molecular tests recommended by WHO for molecular DST require a high bacterial load in the sample, specialized laboratory equipment, well-trained personnel2 and have a long time to result.
The world needs rapid molecular DST that can detect resistance to the most common first and second line drugs with an approach that doesn’t require sophisticated skills or laboratory equipment.6
The ideal test would support health care providers with the same quality of test results at the level of a reference lab as well as at decentralized healthcare facilities, to link more patients to appropriate care.
Xpert MTB/XDR allows fast molecular DST. Combined with the frontline test Xpert MTB/RIF Ultra, Xpert MTB/XDR sets new standards by detecting mutations associated with resistance towards isoniazid (INH), fluoroquinolones (FLQ), second-line injectable drug (SLID) (amikacin, kanamycin, capreomycin) and ethionamide (ETH) in a single test.
- Faster time to result for molecular DST
- Results in <90 minutes
- Same easy-to-use process as Xpert MTB/RIF Ultra
- Run on existing GeneXpert® platforms equipped with 10-color modules
The effective management of TB and MDR-TB relies upon early diagnosis including universal DST and effective treatment of resistant TB strains. Fast molecular DST followed by the fast initiation of appropriate treatment regimens has benefits for both the individual, as well as the community where the patient lives. To avoid diagnostic delays, molecular DST should be obtained for fast detection of mutations associated with resistance while waiting for a phenotypic DST result to adjust treatment if necessary.
- Fast and accurate DST results when needed most
- Potential to test and initiate treatment for drug-resistant TB in a single visit
- Adjustment of treatment as early as possible to reduce income loss and improve patient outcome
Potential TB Program Impact
- Accurate and fast test results for drug-resistant TB
- More patients linked to appropriate treatment regimens faster
- Leverage GeneXpert® capacity for further drug-resistance testing
(1) WHO End TB Strategy, https://www.who.int/tb/post2015_strategy/en/ (2) WHO. Global Tuberculosis Report 2019. www.who.int/tb/publications/global_report
(3) WHO. Global Tuberculosis Report 2018. https://apps.who.int/iris/bitstream/handle/10665/274453/9789241565646-eng.pdf
(4) WHO. Rapid Communication: Key changes to treatment of multidrug- and rifampicin-resistant tuberculosis. August 2018. https://www.who.int/tb/publications/2018/WHO_RapidCommunicationMDRTB.pdf
(5) Sulis G et al., Isoniazid-resistant tuberculosis: A problem we can no longer ignore. PLoS Med. 2020 Jan 21;17(1):e1003023.
(6) WHO. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. 2014
(7) WHO, 2019, Rapid Communication: Key changes to the treatment of drug-resistant tuberculosis
(8) Xpert MTB-XDR ENGLISH Package Insert 302-3514 Rev A
Number of Tests: 10Catalog #: GXMTB/XDR-10
Frequently Asked Questions
What does the Xpert® MTB/XDR test do?
What is Cepheid doing to aid in the fast detection of drug-resistant tuberculosis (TB)?
Which GeneXpert® System is required to run the Xpert MTB/XDR test?
Can I run all the existing MTB tests on a GeneXpert System with 10-color technology?
Which specimen types can I use for the Xpert MTB/XDR test?
What materials are needed to run a test?
How can I get more information?
Practical Patient Care Article
The key to rapid diagnostics: the impact of decentralized testing to support MDR TB Treatment
Cepheid interviews Miss South Africa, Tamaryn Green
Miss SA gets behind the @StopTB campaign with the Cepheid SA team. #ItsTime to ensure access to rapid TB diagnostic testing for all #ItsTimetoEndTB #BreaktheStigma@TamarynGreen#BreaktheStigma
Optimized Infection Prevention
Cepheid’s GeneXpert® System can deliver fast and accurate answers enabling clinicians to enhance treatment and infection prevention efforts.