May 9, 2020 / 3:05 PM / 18 days ago

FDA grants emergency use authorization to Quidel for first antigen test for COVID-19

A Sofia 2 Fluorescent Immunoassay Analyzer used in the coronavirus-antigen tests by the company Quidel Corporation, after the Food and Drug Administration gave emergency-use authorization for its Sofia 2 SARS Antigen FIA, a rapid point-of-care test for detecting SARS-CoV-2 in nasal specimens, is seen in this undated handout image, San Diego, U.S., Quidel Corporation/Handout via Reuters

(Reuters) - The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp (QDEL.O) for the first COVID-19 antigen test.

The emergency use authorization was issued late Friday to Quidel for the Sofia 2 SARS Antigen FIA, the agency said.

The FDA said the authorization is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19.

An antigen test can provide results in minutes but it may not detect all active infections, as they do not work the same way as a PCR test, the agency said.

Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests which 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, it added.

The FDA on Friday also authorized the first diagnostic test for the new coronavirus that allows patients to collect saliva samples at home.

Reporting by Sabahatjahan Contractor in Bengaluru; editing by Diane Craft asnfd Franklin Paul

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