Influenza Clinical Trial
Official title:
"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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