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US FDA grants clearance, waiver to Quidel's flu-detection test

The U.S. FDA granted a 510(k) clearance and a clinical laboratory improvements amendments waiver to Quidel Corp.'s Sofia Influenza A+B Fluorescent Immunoassay.

The regulator granted the clearance for the immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for quick differential detection of influenza types A and B from direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients.

The Sofia Influenza A+B assay has improved lateral flow and immunofluorescence technologies to provide better clinical sensitivity for influenza A or B infections.