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The Xpert MTB/RIF (Xpert) assay rapidly detects Mycobacterium tuberculosis using automated nucleic acid amplification. In areas of high tuberculosis (TB) prevalence, Xpert is both sensitive and specific. Although approved by the FDA since 2013, published data on the assay's use in the U.S. are limited, and the relatively low prevalence of TB in the U.S. could affect its parameters. To address this issue, researchers conducted a longitudinal, multicenter study at 21 U.S. sites and in Rio de Janeiro, Brazil, and Johannesburg, South Africa, two areas of high TB prevalence. Cepheid, the manufacturer of Xpert, assisted with study design, provided material support and funding, and reviewed the manuscript.
Between May 2012 and November 2013, adult …