The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. 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 EUA was issued late Friday to Quidel Corporation. The laboratories that process these antigen tests will have to have special equipment.
The FDA has already approved several PCR tests (which can help diagnose an active case of COVID-19) and antibody tests (which helps determine if an individual has already had COVID-19).
The FDA says an antigen test is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. 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. The FDA says antigen tests can generally be produced at a lower cost than the PCR test.
Quidel Corporation, headquartered in San Diego, says the antigen tests are available for purchase by healthcare professionals now.
Click here for the FDA release.
