Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler.
The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C difficile, including NAP1.
Simplexa tests, running on the 3M Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria and other analytes.
Quest Diagnostics and Focus Diagnostics infectious disease medical director Jay Lieberman said: "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."
