MTB/RIF-Cepheid

From Appropedia
About this medical device
Mtbcepheid.jpg
Status Commercialized
Made? No
Replicated? No
Designed in United States
Replicated in Africa, Asia, North America, South America
Health topic Tuberculosis
Health classification Diagnosis
License data
Hardware CC BY-SA 4.0
Documentation data

Problem being addressed[edit | edit source]

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[edit | edit source]

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[edit | edit source]

  • Designed by: Produced by Cepheid®.
  • Manufacturer (if different): n/a
  • Manufacturer location: California, USA

When and where it was tested/implemented[edit | edit source]

The device was tested on 1730 patients in Peru, Azerbaijan, South Africa, and India.

References[edit | edit source]

Peer-reviewed publication[edit | edit source]

  • 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[edit | edit source]

Externally generated reports[edit | edit source]

IP and copyright[edit | edit source]

Approval by regulatory bodies or standards boards[edit | edit source]

  • Ensdorsed by World Health Organization (2010).
  • Approved by FDA (Jul 25, 2013).