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|Location||Africa, Asia, North America, South America|
Problem being addressed
Fast, affordable, and accurate diagnosis is key to fighting tuberculosis, which infects around 8 million people every year. In resource-limited settings, access to traditional tests are time consuming, expensive, or non-existent, leading to a need for medical devices that can be used effectively in these places.
Detailed description of the solution
The MTB/RIF device can deliver test results in 2 hours, without making additional demands on laboratory expertise beyond what is generally in most peripheral laboratories that perform direct smear microscopy and cost approximately 10 US dollars per cartridge. It takes sputum (mucus) samples and adds a reagent to liquefy and inactivate the sputum sample. This liquid sputum is transferred into one of Cepheid’s disposable plastic cartridges, where DNA extraction by ultrasonic cell lysis, real-time PCR, and flourometric monitoring all take place automatically to indicate whether or not the patient is infected with TB.
- Designed by: Produced by Cepheid®.
- Manufacturer (if different): n/a
- Manufacturer location: California, USA
When and where it was tested/implemented
The device was tested on 1730 patients in Peru, Azerbaijan, South Africa, and India.
- Miller M, Popowitch E, Backlund M, Ager E. “Performance of Xpert MTB/RIF RUO Assay and IS6110 Real-Time PCR for Mycobacterium tuberculosis Detection in Clinical Samples” (Aug 17, 2011). Retrieved on Jul 26, 2014 from http://jcm.asm.org/content/49/10/3458.full.
Other internally generated reports
- Persing D. “Global Implementation of Xpert MTB/RIF” (Aug 21, 2013). Retrieved from http://www.aphl.org/conferences/proceedings/Documents/2013/2013-National-TB-Conference/ID_2013August21_38_Persing.pdf.
Externally generated reports
- Foundation for Innovative New Diagnostics. “Price for Xpert MTB/RIF and FIND country list” (Oct 2013). Retrieved on Aug 6, 2014 from http://www.finddiagnostics.org/about/what_we_do/successes/find-negotiated-prices/xpert_mtb_rif.html.
- Foundation for Innovative New Diagnostics. “Xpert MTB/RIF” (2011-2013). Retrieved on Jul 26, 2014 from http://www.finddiagnostics.org/programs/tb/find_activities/automated_naat.html.
- “FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin” (Jul 25, 2013). Retrieved on Jul 26, 2014 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm362602.htm.
- “HOW IT WORKS.” Retrieved on Jul 26, 2014 from http://www.cepheidcares.com/tb/cepheid-solution/how-it-works.html.
- World Health Organization. “Automated Real-Time Nucleic Acid Amplification Technology for Rapid and Simultaneous Detection of Tuberculosis and Rifampicin Resistance: Xpert MTB/RIF System” (2011). Retrieved on Jul 26, 2014 from http://whqlibdoc.who.int/publications/2011/9789241501545_eng.pdf.
IP and copyright
Approval by regulatory bodies or standards boards
- Ensdorsed by World Health Organization (2010).
- Approved by FDA (Jul 25, 2013).