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. 2015 Feb 27;64(7):193.

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

Division of Microbiology Devices, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration; Centers for Disease Control and Prevention (CDC)

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

Division of Microbiology Devices, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration et al. MMWR Morb Mortal Wkly Rep. .

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.

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References

    1. Cepheid. Xpert MTB/RIF assay [package insert] Sunnyvale, CA: Cepheid; 2015. Available at http://www.cepheid.com/mtbrif-pi.
    1. Chaisson LH, Roemer M, Cantu D, et al. Impact of GeneXpert MTB/RIF Assay on triage of respiratory isolation rooms for inpatients with presumed tuberculosis: a hypothetical trial. Clin Infect Dis. 2014;59:1353–60. - PMC - PubMed
    1. Lippincott CK, Miller MB, Popowitch EB, et al. Xpert MTB/RIF Assay shortens airborne isolation for hospitalized patients with presumptive tuberculosis in the United States. Clin Infect Dis. 2014;59:186–92. - PMC - PubMed
    1. CDC. Availability of an assay for detecting Mycobacterium tuberculosis, including rifampin-resistant strains, and considerations for its use—United States, 2013. MMWR Morb Mortal Wkly Rep. 2013;62:821–4. - PMC - PubMed

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