MONDAY, May 11, 2020 (HealthDay News) -- The first emergency use authorization (EUA) for a COVID-19 antigen test has been issued by the U.S. Food and Drug Administration.
Antigen tests are a new category of tests for use in the COVID-19 pandemic and quickly detect fragments of proteins from the virus in samples collected by swabs from people's noses. The approval was issued Friday to the Quidel Corp. for the Sofia SARS Antigen FIA, which is "authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing," according to an FDA news release.
The FDA said it expects to issue more EUAs for antigen tests during the pandemic. The agency has issued EUAs for two other types of tests during the COVID-19 pandemic: polymerase chain reaction (PCR) tests that detect the genetic material from the virus and can help diagnose active COVID-19 infection, often performed using a nasal swab; and serological tests that look for antibodies to the virus, which can help identify people who have had or have an infection and have developed an immune response to the virus. Each type of test has a role to play in combating the COVID-19 pandemic, the FDA noted.
"PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes," the agency explained in the news release. "However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. 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."