The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorisation (EUA) to Quidel Corp for the first COVID-19 antigen test.
The emergency use authorisation was issued late Friday to Quidel for the Sofia 2 SARS Antigen FIA, the agency said.
The FDA said the authorisation 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.
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