Quidel (QDEL) Gets CE Mark for AmpliVue CDE Assay
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Quidel Corporation (Nasdaq: QDEL), has received CE mark for the AmpliVue C. difficile assay, its non-instrumented molecular test for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held fully contained detection cassette which utilizes lateral flow technology. C. difficile is frequently associated with antibiotic therapy and often causes diarrhea and inflammation of the colon.
A recent study published in the Lancet suggests that a majority of the hospital-based labs in Europe continue to use traditional methods such as immunoassays or cytotoxicity assays. These assays may either lack sufficient sensitivity or are difficult to perform and may require 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.
A recent study published in the Lancet suggests that a majority of the hospital-based labs in Europe continue to use traditional methods such as immunoassays or cytotoxicity assays. These assays may either lack sufficient sensitivity or are difficult to perform and may require 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.
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