GeneXpert MTB/RIF

The Xpert MTB/RIF is a cartridge-based nucleic acid amplification test (NAAT) for rapid tuberculosis diagnosis and rapid antibiotic sensitivity test. It is an automated diagnostic test that can identify Mycobacterium tuberculosis (MTB) DNA and resistance to rifampicin (RIF). It was co-developed by the laboratory of Professor David Alland at the University of Medicine and Dentistry of New Jersey (UMDNJ),[1] Cepheid Inc. and Foundation for Innovative New Diagnostics, with additional financial support from the US National Institutes of Health (NIH).[2]

In December 2010, the World Health Organization (WHO) endorsed the Xpert MTB/RIF for use in tuberculosis (TB) endemic countries.[3] The announcement followed 18 months of assessing its field effectiveness in tuberculosis, MDR-TB, and TB/HIV co-infection.[4] The test may enable the diagnosis of TB in patients likely to be missed by traditional tests.[4][5]

According to the Centers for Disease Control and Prevention (CDC) in 2015,[6] the Xpert MTB/RIF test was "revolutionizing TB control by contributing to the rapid diagnosis of TB disease and drug resistance. The test simultaneously detects Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) in less than 2 hours. In comparison, standard cultures can take 2 to 6 weeks for MTBC to grow and conventional drug resistance tests can add 3 more weeks."[6]

  1. ^ "Frequently asked questions on Xpert MTB/RIF assay" Archived 2020-08-20 at the Wayback Machine Retrieved on 12 June 2012
  2. ^ Tansey, Bernadette (25 March 2009). Cepheid unveils fast, low cost TB test, San Francisco Chronicle (lists creators, also states "Gene-based test developer Cepheid of Sunnyvale said Tuesday it has devised a rapid, sensitive diagnostic test for tuberculosis and will make it available at reduced cost in developing countries where the life-threatening disease is widespread.")
  3. ^ "WHO endorses new rapid tuberculosis test" 8 December 2010. Retrieved on 12 June 2012
  4. ^ a b Small, Peter M.; Pai, Madhukar (2010). "Tuberculosis Diagnosis — Time for a Game Change". New England Journal of Medicine. 363 (11): 1070–1071. doi:10.1056/NEJMe1008496. PMID 20825320.
  5. ^ Rie, Annelies Van; Page-Shipp, Liesl; Scott, Lesley; Sanne, Ian; Stevens, Wendy (2010). "Xpert®MTB/RIF for point-of-care diagnosis of TB in high-HIV burden, resource-limited countries: Hype or hope?". Expert Review of Molecular Diagnostics. 10 (7): 937–946. doi:10.1586/erm.10.67. PMID 20964612. S2CID 28312109.
  6. ^ a b Centers for Disease Control and Prevention (2015), "A New Tool to Diagnose Tuberculosis: The Xpert MTB/RIF Assay" (PDF), CDC website, archived from the original (PDF) on 2017-12-17, retrieved 2018-05-25.