FDA OKs Rapid Test to Spot Dangerous Intestinal Infection

FRIDAY April 8, 2011 -- A test designed to rapidly detect the genetic fingerprint of Clostridium difficile (C. diff) bacterial infection has been approved by the U.S. Food and Drug Administration.

C. diff is an intestinal infection that's commonly acquired by the elderly, hospital patients, people at group living facilities or nursing homes, and by those taking an antibiotic for another infection. It's easily spread by touching contaminated surfaces.

C. diff infection causes diarrhea and intestinal inflammation, and can lead to complications including colitis, the FDA said in a news release.

The Cepheid Xpert C. difficile/Epi assay detects toxin gene sequences associated with the epidemic 027/NAP1/BI strain of the bacterium in a person's stool. However, the test should not be used to determine or monitor treatment, the agency warned.

The best way to prevent infection is via thorough hand-washing with soap and warm water, the FDA said.

The new test is produced by Cepheid, based in Sunnyvale, Calif.

More information

To learn more about this infection, visit the U.S. Centers for Disease Control and Prevention.

Posted: April 2011


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