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Review
. 2015 Jan;15(1):9-22.
doi: 10.1586/14737159.2015.976556. Epub 2014 Nov 6.

Evaluation of the Cepheid Xpert MTB/RIF assay

Thomas M Shinnick  1 , Angela M Starks, Heather L Alexander, Kenneth G Castro
Affiliations
Review

Evaluation of the Cepheid Xpert MTB/RIF assay

Thomas M Shinnick et al. Expert Rev Mol Diagn. 2015 Jan.

Abstract

The lack of capacity to provide laboratory confirmation of a diagnosis of tuberculosis disease (TB) is contributing to enormous gaps in the ability to find, treat and follow TB patients. WHO estimates that globally only about 57% of the notified new cases of pulmonary TB in 2012 and about 19% of rifampicin-resistant TB cases were laboratory confirmed. The Cepheid Xpert(®) MTB/RIF assay has been credited with revolutionizing laboratory testing to aid in the diagnosis of TB and rifampicin-resistant TB. This semi-automated test can detect both the causative agent of TB and mutations that confer rifampicin resistance from clinical specimens within 2 h after starting the test. In this article, we review the performance of the test, its pathway to regulatory approval and endorsement, guidelines for its use and lessons learned from the implementation of the test in low-burden, high-resource countries and in high-burden, low-resource countries.

Keywords: automated nucleic acid amplification; molecular detection of resistance; rifampicin resistance; tuberculosis.

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Figures

Figure 1
Figure 1. Assay procedure for Xpert MTB/RIF
Diagram supplied by C Boehme, Foundation for Innovative New Diagnostics with permission [22].
Figure 2
Figure 2. Commercial tuberculosis products and development pipeline
Reproduced with permission from UNITAID [98].
See this image and copyright information in PMC

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