Quidel's QuickVue Influenza A+B test receives special 510(k) clearance for H1N1 reactivity update

www.quidel.comSep 17 2009

Quidel Corporation (NASDAQ: QDEL), a global leader in point-of-care (POC) rapid diagnostic tests, received Special 510(k) clearance for an update to the Company's QuickVue® Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus.

Although the QuickVue Influenza A+B test has been shown to detect the 2009 influenza A (H1N1) virus, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The QuickVue Influenza A+B test kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

This clearance supplements the reactivity with 13 other isolates of seasonal H1N1 influenza viruses currently listed in the package insert. In total, 34 different isolates of human Influenza A, 13 different isolates of human Influenza B, and 24 different isolates from birds and mammals have now been shown to be detectable by the QuickVue Influenza A+B test.

Douglas Bryant, president and chief executive officer, stated, “Rapid tests, when used appropriately and correctly, are useful tools in the effort to help diminish the spread of influenza. In one visit, with just one nasal swab, Quidel’s test can provide a result in approximately 10 minutes, aiding the selection and initiation of the appropriate treatment modality.”