Clostridium Difficile Test Cleared

April 18, 2012

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The US Food and Drug Administration has given 510(k) clearance to Quest Diagnostics' Clostridium difficile test. The Simplexa C. difficile Universal Direct Test runs on the 3M Integrated Cycler, using real-time PCR to detect the C. difficile toxin B gene from stool samples. It uses a chemistry that eliminates the need for nucleic acid extraction, and Quest says the testing process takes about an hour. The test is from Quest's wholly owned business Focus Diagnostics. "Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene, a toxin-B producing gene of C. difficile, are essential for identifying and treating this infection as well as containing its spread," says Jay Lieberman, the medical director of infectious disease for Quest Diagnostics and Focus Diagnostics, in a statement.

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