NEW YORK – Quidel said late on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for the Sofia 2 Flu + SARS Antigen FIA, a rapid, point-of-care test for the qualitative detection and differentiation of SARS-CoV-2 and influenza A/B.
According to Quidel, the assay is the first rapid antigen test for detecting all three viruses simultaneously to receive EUA.
The test was developed for use with the company's Sofia 2 Fluorescent Immunoassay Analyzer with direct nasopharyngeal and nasal swab specimens from individual suspected of having COVID-19 within the first five days of the onset of symptoms.
San Diego-based Quidel said the Sofia 2 Flu + SARS Antigen FIA has a 95.2 percent positive predictive agreement versus PCR and a 100 percent negative predictive agreement versus PCR for SARS-CoV-2 in nasal swabs, as well as 90 percent sensitivity versus culture and 95 percent specificity versus culture for influenza A, and 89 percent sensitivity versus culture and 96 percent specificity versus culture for influenza B. Results can be achieved for all three viruses in 15 minutes, the firm said.
"We believe that our new [Sofia 2 Flu + SARS Antigen FIA test] will help reduce misdiagnosis, inform proper treatment and improve disease surveillance, significantly enhancing medical effectiveness in fighting COVID-19 and the flu," Quidel CEO Doug Bryant said in a statement.