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.