Published on September 19, 2009 at 2:23 AM
Quidel Corporation (NASDAQ: QDEL), a global leader in point-of-care (POC) rapid diagnostic tests, issues clarification regarding the Special 510(k) clearance for an update to the Company's QuickVue® Influenza A+B test package insert. A news wire agency released misleading information stating there is a new swine flu version of Quidel’s QuickVue Influenza A+B test and that FDA approved this new version. This statement is incorrect.
Quidel did obtain Special 510(k) clearance for an update to the 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.
Douglas Bryant, president and chief executive officer, clarified, “The Special 510(k) clearance was for an update to the package insert. The QuickVue Influenza A+B test can detect cultured isolates of the 2009 influenza A (H1N1) virus, however, the clinical performance with actual clinical specimens has not been demonstrated.”
http://www.quidel.com/