Quidel Corp. (QDEL), a provider of rapid diagnostic testing solutions and cellular-based virology assays, announced Monday that it has received 510(k) clearance from the United States Food and Drug Administration or FDA for the sale of Quidel's non-instrumented molecular diagnostic test -- the AmpliVue C. difficile Assay -- for the detection of toxigenic Clostridium difficile bacterial DNA.
Detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification or HDA with its lateral flow detection technology.
C. difficile infection is frequently associated with antibiotic therapy and prolonged hospital stays. Typical symptoms include nausea, fever, watery diarrhea and abdominal pain due to inflammation of the colon.
Clostridium difficile bacterial infections can be life threatening, especially for the elderly, for the immunocompromised, and for patients on a prolonged antibiotic regimen.
The C. difficile assay is Quidel's first assay in the hand-held AmpliVue format, and is now available for sale in the U.S. and Europe.
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