Revised device labeling for the Cepheid Xpert MTB/RIF assay for detecting Mycobacterium tuberculosis

MMWR Morb Mortal Wkly Rep. 2015 Feb 27;64(7):193.

Abstract

The Food and Drug Administration (FDA) has cleared the Xpert MTB/RIF Assay (Cepheid; Sunnyvale, California) with an expanded intended use that includes testing of either one or two sputum specimens as an alternative to examination of serial acid-fast stained sputum smears to aid in the decision of whether continued airborne infection isolation (AII) is warranted for patients with suspected pulmonary tuberculosis. This change reflects the outcome of a recent multicenter international study demonstrating that negative Xpert MTB/RIF Assay results from either one or two sputum specimens are highly predictive of the results of two or three negative acid-fast sputum smears.

MeSH terms

  • Bacteriological Techniques
  • Humans
  • Molecular Diagnostic Techniques*
  • Mycobacterium tuberculosis / isolation & purification*
  • Product Labeling*
  • Sensitivity and Specificity
  • Sputum / microbiology*
  • Tuberculosis, Pulmonary / diagnosis*
  • Tuberculosis, Pulmonary / microbiology
  • United States
  • United States Food and Drug Administration