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Quidel RSV Immunoassay FDA Cleared, CLIA Waived

NEW YORK (360Dx) – Quidel said on Wednesday that  its Sofia RSV Fluorescent Immunoassay has been cleared by the US Food and Drug Administration and received CLIA waiver for use on the Sofia 2 Immunoassay Analyzer for the rapid detection of respiratory syncytial virus infections.

The assay is FDA cleared and CLIA waived for use in nasopharyngeal swab and nasopharyngeal aspirate/wash speciments taken directly from symptomatic pediatric patients.

The FDA announced the clearance of the assay in March. It employs advanced lateral flow and immunofluorescence technology. The Sofia 2 platform leverages the original Sofia instrument's fluorescent chemistry, but improves upon the graphical user interface and optics system, providing results in as little as three minutes.

Sofia 2 also comes connected to Virena, Quidel's data management system, which provides aggregated, de-identified testing data in near real time.

Quidel President and CEO Douglas Bryant said in a statement that the FDA clearance of the assay, along with the recent clearance of the Sofia Influenza A+ B assay for use on the Sofia 2, allows the firm to diagnose "two of the most common respiratory diseases more quickly, more easily, and at a lower cost."