"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. * The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B. * The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.