The FDA said they’ll be tightening requirements for companies that develop COVID-19 antibody tests to better regulate the frenzy of tests coming to market. The updated policy requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA with performance thresholds for specificity and sensitivity.
Previously, manufacturers of the tests could validate their own tests and bring them to market without FDA review. More than 100 antibody tests have entered the market, fueling a congressional investigation into the accuracy of tests.
FDA posted a list of antibody tests removed from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. FDA announced revised guidance recommending that commercial manufacturers of antibody tests submit an Emergency Use Authorization request within 10 business days from the date they notified FDA of their test validation or the date of publication of the revised policy, whichever was later.
Editorial Note: My advice for folks that believe that they may have recovered from a COVID infection and want to find out for sure is to get a blood draw serology test rather than the simple finger stick rapid test. The results are a lot more reliable. That test costs about $100. Turn around time is about 2 days.