October 5, 2020 – Quidel Corporation (San Diego, CA), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, has received Emergency Use Authorization (EUA) 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.
The company says the swabs must come 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 test delivers a fast, highly accurate result for all three viruses from one nasal swab (or nasopharyngeal swab) sample in 15 minutes. By enabling three tests to be performed simultaneously on a single cartridge using a single swab sample, the company can scale seasonal production of flu tests without impacting its scheduled ramp of COVID-19 antigen test capacity.
“We believe that our new ABC Test (Sofia 2 Flu + SARS Antigen FIA) will help reduce misdiagnosis, inform proper treatment and improve disease surveillance, significantly enhancing medical effectiveness in fighting COVID-19 and the flu,” said Douglas Bryant, president and CEO of Quidel. “We are proud to put this powerful diagnostic tool in the hands of physicians and public health agencies at this critical time.”
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 says.
Quidel was the first company to develop an EUA cleared rapid point-of-care antigen test for COVID-19. The company also developed the first flu test, the QuickVue Influenza A/B Test, which received FDA approval in September 1999. With the introduction of its ABC Test, Quidel has registered another first-of-its-kind innovation that packs both its flu and SARS diagnostic technologies onto one highly efficient test cartridge that can be manufactured on the same production lines now used for Sofia SARS tests.