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News From the Centers for Disease Control and Prevention
December 18, 2013

New Assay Detects TB Bacteria and Resistance to Rifampin

Author Affiliations

Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2013;310(23):2498. doi:10.1001/jama.2013.283912

The US Food and Drug Administration (FDA) has added a new tool to clinicians’ tuberculosis (TB) armamentarium. The agency approved the Xpert MTB/RIF assay to detect DNA of the Mycobacterium tuberculosis complex in sputum samples, as well as genetic mutations that confer resistance to the first-line TB drug rifampin.

The assay is a nucleic acid amplification-based (NAA) test with sensitivity and specificity considered comparable with other FDA-approved NAA assays used to detect M tuberculosis complex. In a multicenter study of patients suspected of having TB, the new assay’s sensitivity was 95% and specificity was 99% in detecting rifampin resistance.