NEW YORK (360Dx) – Quidel announced late Tuesday that its test to detect and differentiate influenza types A and B has met the US Food and Drug Administration's criteria to be reclassified as a class II rapid influenza diagnostic test and that the test has received 510(k) clearance.
The QuickVue Influenza A+B assay, which was previously CLIA waived, allows for qualitative, 10-minute detection of influenza A and B antigens directly from symptomatic patients' nasal or nasopharyngeal swabs.
The FDA began reclassifying some antigen-based flu tests from class I devices to class II devices last year in order to increase the tests' reliability to detect the influenza virus. Class II devices are considered higher risk than class I devices, and makers must provide information that the products are safe and effective. They must also adhere to special controls including minimum performance standards, checking of results against reference methods, annual monitoring, and provisions for public health emergencies, as previously reported.
The test is now available for sale in the US, where recent figures from the Centers for Disease Control and Prevention "and positivity rates from our Sofia analyzers suggest that this year’s influenza season may be getting worse, not better, and has surpassed the rate of every other year except the unusual pandemic of 2009," Quidel CEO Douglas Bryant noted in a statement.