
The Food and Drug Administration has posted a list of antibody tests that are being removed from the “notification list” of tests being offered under an emergency policy due to the coronavirus pandemic, according to a press release.
Some of the tests have been removed voluntarily by the manufacturer, and others have been removed because they did not submit an Emergency Use Authorization request “within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner,” the FDA said in a statement.
The FDA says it expects that the tests on the removal list will not be marketed or distributed.
“Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests,” said FDA Commissioner Dr. Stephen Hahn. “We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”
Remember: An antibody test can only be administered by gathering blood, either through a finger prick or from a vein. It's designed to detect antibodies, the Y-shaped proteins called immunoglobulins that circulate in our blood to help fight off infections in our bodies.
Even if you've never had any symptoms of Covid-19, the presence of antibodies in your blood would show your body has encountered the virus.
To be clear, antibody tests are not the "swab" tests that are meant to find out if you are currently carrying the virus. Called rt-PCR tests, or molecular diagnostic tests, those typically gather mucus from way up the nose or back of the throat. They take a few days to report results.