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MTB/RIF-Cepheid

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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device


Mtbcepheid.jpg
Health Topic Tuberculosis
Classification Diagnosis
Scope Commercialized
Location Africa, Asia, North America, South America

Problem being addressed[edit]

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]

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]

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

When and where it was tested/implemented[edit]

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

References[edit]

Peer-reviewed publication[edit]

  • 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]

Externally generated reports[edit]

IP and copyright[edit]

Approval by regulatory bodies or standards boards[edit]

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


Facts about "MTB/RIF-Cepheid"
Has imageFile:Mtbcepheid.jpg +
Medical Device ClassificationDiagnosis +
Medical Device LocationAfrica +, Asia +, North America + and South America +
Medical Device ScopeCommercialized +
Medical Device TopicTuberculosis +