17th February 2015 Content supplied by: Cepheid
FDA Clears Expanded Cepheid Tuberculosis Test
Cepheid has received clearance from the FDA for expanded claims on its Xpert® MTB/RIF test. The Xpert MTB/RIF detects Mycobacterium tuberculosis complex (MTB-complex) DNA and in positive specimens, provides simultaneous identification of rifampin-resistance associated mutations of the rpoB gene.
The expanded product claim enables clinicians to use either one or two negative Xpert MTB/RIF test results, in conjunction with other clinical and laboratory data, to remove patients from airborne infection isolation (AII), commonly referred to as respiratory isolation. The test runs on the Cepheid GeneXpert ® System, a molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.
The Xpert MTB/RIF package instruction sheet with the new expanded claims is available on Cepheid's website: www.cepheid.com/us/mtbrif-pi.
Date Published: 17th February 2015
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