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Health Agencies Update
May 25, 2011

C difficile Test Approved

JAMA. 2011;305(20):2056. doi:10.1001/jama.2011.681

The US Food and Drug Administration has approved a new test that can rapidly detect the toxin B gene associated with infection with Clostridium difficile. This bacterium, which can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon, is found in the stool of infected individuals, although spores of this bacterium can live outside the human body.

In addition to detecting the presence of C difficile, the stool test, the Cepheid Xpert C difficile/Epi assay, can identify whether the organism is the epidemic 027/NAP1/BI strain. This strain has been associated with an increase in the severity and incidence of C difficile infection.

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