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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.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.