Evaluation of the Cepheid Xpert MTB/RIF assay.
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.
Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA 30333.
Thomas M
TM
Shinnick
Angela M
AM
Starks
Heather L
HL
Alexander
Kenneth G
KG
Castro
D000904:Antibiotics, Antitubercular / Q000494:pharmacology; D024881:Drug Resistance, Bacterial; D005069:Evaluation Studies as Topic; D006801:Humans; D025202:Molecular Diagnostic Techniques; D009169:Mycobacterium tuberculosis / Q000235:genetics*; D060888:Real-Time Polymerase Chain Reaction; D012293:Rifampin / Q000494:pharmacology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology
D000904:Antibiotics, Antitubercular; D012293:Rifampin
automated nucleic acid amplification; molecular detection of resistance; rifampicin resistance; tuberculosis