The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA.
The AmpliVue C. difficile assay uses a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification, with its lateral flow detection technology, for the detection of pathogen.
Utilizing actual kit components, the assay offers fast and sensitive results compared to cytotoxicity assays and toxigenic culture, which takes 24-48 hours and 3-5 days.
In addition, the assay also requires no upfront nucleic acid extraction step.
Quidel chief scientific officer Timothy Stenzel said according to the Centers for Disease Control and Prevention, C. difficile causes diarrhea linked to 14,000 deaths in the US each year.
"For this reason, accurate and fast diagnosis — like that provided by AmpliVue — is vital to the patient’s proper treatment and recovery," Stenzel added.
Quidel president and chief executive officer Douglas Bryant said, "The AmpliVue C. difficile Assay will allow hospitals currently using traditional detection methods to employ a more sensitive, rapid molecular test, thereby providing laboratory technicians and the physicians they serve with accurate, timely, and reliable diagnosis of C. difficile infections."