Influenza

Diagnostic test provider obtains U.S. FDA clearance for influenza A + B test

Published in Medical Letter on the CDC and FDA, January 29th, 2006

Quidel Corporation (QDEL) reported that it has obtained U.S. Food & Drug Administration (FDA) clearance for its claims for the QuickVue Influenza A+B test, which is a 10-minute diagnostic test for influenza.

Among new claims added to the package insert is 94% sensitivity for detecting influenza A when using nasal swab specimens. The package insert for the test is being updated to include clinical study results for nasal swab, nasopharyngeal swab and nasal wash in addition to analytical study results for the detection of cultured avian influenza viruses.

The QuickVue Influenza A+B test has been shown to detect cultured avian influenza viruses,...

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Source: Medical Letter on the CDC and FDA (2006-01-29)

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