FDA approves first COVID-19 antigen test

While the test is faster than PCR diagnostic tests, it can give more false negatives.

Updated: May 10, 2020 - 1:01pm

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The U.S. Food and Drug Administration on Friday for the first time authorized a COVID-19 antigen test.

In a press release about the emergency use authorization for Quidel Corporation's Sofia 2 SARS Antigen FIA, the agency explained that the new antigen tests involve nasal swabs to detect the virus that causes COVID-19.

"These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs," the FDA explained.

The antigen test will offer faster results than another form of diagnostic testing known as polymerase chain reaction (PCR) tests. 

While the antigen tests are quicker and their positive test results are accurate, there is a larger possibility of false negative results, according to the FDA. The agency explained that when people test negative in an antigen test they still may need a PCR test.

The FDA said that antigen tests often cost less than PCR tests, and as a result of "simpler design" could possibly be mass produced so that millions of people can be tested daily.