San Diego–based Quidel describes the Sofia 2 SARS Antigen FIA as a rapid point-of-care test to be used with the Sofia 2 fluorescent immunoassay analyzer. It can produce results in 15 minutes. Cardinal Health, Fisher Healthcare, Henry Schein and McKesson are acting as distribution representatives.
“The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient,” Quidel CEO Douglas Bryant said in a May 8 news release.
FDA expects more antigen test authorizations to follow. FDA commissioner Dr. Stephen M. Hahn and CDRH director Dr. Jeffrey E. Shuren in a statement said antigen tests will play a “critical role in the fight against COVID-19.”
Antigen tests quickly detect fragments of proteins found on or within the virus — with analysis of samples collected from the nasal cavity using swabs. FDA described positive results from the tests as highly accurate, but there’s a higher chance of false negatives than the slower polymerase chain reaction (PCR) tests that look for genetic material from the virus.
Hahn and Shuren said negative results from antigen tests may need to be double-checked with a PCR test. Still, the described the antigen tests as an “important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests.
Once multiple manufacturers enter the antigen tests market, there’s the potential to scale to test millions of Americans per day. The tests, Hahn and Shuren said, boast a simpler design and could help the U.S. better identify infection rates closer to real-time.
FDA has also been authorizing another type of COVID-19 tests: serological tests that look for antibodies to the virus. The tests shouldn’t be used to diagnose an active infection but can tell whether someone has had COVID-19 in the past.
