On Dec. 21, 2020, Quidel announced that it had received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to market its Sofia 2 Flu + SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection. The test differentiates the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B.

The QuickVue SARS Antigen test delivers results in just ten minutes and has shown excellent performance for detecting the Covid-19 virus with 96.6% PPA and 99.3% NPA when compared with PCR. It needs no supplemental instrumentation and can be read visually.