Quidel Receives CE Mark for Hand-Held C.Diff Molecular Test

Quidel Corporation has announced that it has received CE marking for the AmpliVue C. difficile assay, a non-instrumented molecular test for the detection of toxigenic Clostridium difficile bacterial DNA. Pathogen detection is achieved using a hand-held fully contained detection cassette which utilizes lateral flow technology.

Clostridium difficile (C.Difficile) is a bacterium which causes diarrhea and inflammation of the colon when competing bacteria in the gut flora have been wiped out by antibiotic therapy. Laboratories traditionally use immunoassays or cytotoxicity assays to detect C.difficile. These assays can lack sensitivity or are difficult to perform, requiring several days to yield results.

The AmpliVue C. difficile assay will allow these labs to quickly implement a fast and sensitive molecular method without the purchase of expensive capital equipment. The assay is Quidel’s first to be offered in the hand-held AmpliVue format and is currently available for sale in Europe.

"Clostridium difficile infections can be life-threatening and are therefore critically important to diagnose as soon as possible. Molecular testing offers greater sensitivity and faster turn-around-times compared to many other methods," according to Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel.

"We are delighted to receive CE mark for our AmpliVue C. difficile assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The AmpliVue C. difficile assay will allow those labs that have previously opted for traditional methods to offer a more sensitive molecular test for patients in their care."