CORONAVIRUS CRISIS | FDA grants emergency use authorization to quidel for first antigen test for COVID-19

NEW YORK – The U.S. Food and Drug Administration on Saturday approved emergency use authorization to Quidel Corp 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 emergency use authorization was issued late Friday to Quidel for the Sofia 2 SARS Antigen FIA, the agency said.

The FDA said thee 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 ways as a PCR test, the agency said.

Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR test which means that positive results from antigen test 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.


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