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

Status:	Archived
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	February 2011
End Date:	April 2011

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.

We found this trial at

sites

Adriana Castro, MD

Miami, Florida 33173

from

Miami, FL