On Oct. 2, 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 and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

The new Sofia® 2 Flu + SARS Antigen FIA offers excellent performance for SARS-2 (95.2% PPA versus PCR and 100% NPA versus PCR), as well as for Influenza A (90% sensitivity versus culture and 95% specificity versus culture) and Influenza B (89% sensitivity versus culture and 96% specificity versus culture) in nasal swabs.

Quidel’s new Sofia® test delivers a fast, highly accurate result for all three viruses from one nasal swab (or nasopharyngeal swab) sample in just 15 minutes, providing critical answers to patients and healthcare workers alike.