The FDA has approved Cepheid Xpert C. difficile/Epi assay for the detection of the toxin B gene associated with Clostridium difficile infection. The Cepheid Xpert C. difficile/Epi assay determines if C. difficile is in a patient’s stool and also detects if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the severity and incidence of C. difficile infection (CDI).

The test is intended for use as an aid in the diagnosis of CDI. The detection of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment.

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