September 25, 2020 — The FDA issued an emergency use authorization for a coronavirus antibody test that can be used at the point of care, the agency announced Wednesday.
The authorization is actually reissue for a test by Assure, which was first deployed in certain labs in July. The new authorization allows doctor’s offices, hospitals, urgent care centers and emergency rooms to use fingerstick blood samples and process them in-house rather than send them to a central lab for results.
“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” Stephen Hahn, MD, the FDA commissioner, said in the statement.
“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test,” Hahn said. “As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”
Antibody tests identify whether someone had a previous or recent COVID-19 infection that allowed them to build an immune response to the virus. Researchers still aren’t sure how long antibodies last after a COVID-19 infection and whether antibodies mean that someone is immune to the virus, according to the statement. Antibody tests can’t indicate whether someone should stop precautionary measures such as self-isolation, social distancing or face masks.
The FDA also noted that antibody tests shouldn’t be used to diagnose an active COVID-19 infection since they can only detect the antibodies formed in response to the virus and not the virus itself. Antibody tests may also produce more false results than standard COVID-19 tests, especially in communities where coronavirus cases are lower.