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.
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for Research Use Only and not intended for clinical diagnostic procedures unless otherwise stated.
