The test will allow results within minutes but the FDA warned of false negative risk

WASHINGTON — The FDA announced that it has granted an emergency use authorization (EUS) for an antigen test for Covid-19. The Sofia 2 SARS Antigen FIA from Quidel Corporation will help in the rapid detection of SARS-CoV-2, the virus that causes Covid-19.

While the test is quick and can possibly detect the virus within minutes, the FDA explained that antigen testing is not as sensitive as molecular polymerase chain reaction (PCR) tests, but is very specific for a virus. “This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative,” the FDA wrote in a statement about the EUA.

One of the benefits of antigen tests, the agency noted, is that they are generally not as expensive to produce as a PCR test, “and once multiple manufacturers enter the market, [they] can potentially scale to test millions of American per day due to their simpler design…” thus giving more real time rates of infection.

The FDA will be providing an EUA template to help expedite submissions for EUAs; this template will be similar to what has already been provided for other test types.

The Sofie 2 SARAS Antigen FIA is limited for use in laboratories certified by Clinical Laboratory Improvement Amendments (CLIA) and in point-of-care testing facilities operating under a CLIA Certificate of Waiver.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,254,930,791,932,190,926,192,927,151,928,925,934