FDA Removes Previously Approved COVID-19 Serology Tests From List

Certain COVID-19 Serology/Antibody Tests Should Not Be Used – Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers.

Although tests on the “removed” test list should no longer be distributed, laboratories and health care providers may still have these tests within their stock, or may have used these tests in the past. The FDA is therefore providing additional information and recommendations to laboratories and health care providers regarding these tests.

Under policies outlined in the Policy for Coronavirus Disease-2019 Tests, some commercial manufacturers’ antibody tests were placed on FDA’s “notification” list and distributed prior to FDA’s review of the manufacturer’s validation data. On May 4, 2020, the FDA updated its policies to include the agency’s expectation that commercial manufacturers of antibody tests submit an EUA 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.

In keeping with the FDA’s commitment to transparency, on May 21, 2020, the agency provided a list of antibody tests from commercial manufacturers that had been removed from the antibody test notification list. This “removed” test list includes tests where significant clinical performance problems were identified that cannot be or were not addressed by the commercial manufacturer in a timely manner, tests for which an EUA request was not submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn from the notification list by the respective commercial manufacturer. FDA will continue to update this “removed” test list.

FDA Actions

The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

Q: What laboratories that had previously provided notification to FDA that they had developed and validated a diagnostic SARS-CoV-2 test under the policy outlined in Section IV.A of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list because FDA has determined the test should no longer be used? (Updated 9/25/20)

Q: What commercial manufacturers of diagnostic tests that had previously provided notification to FDA under the policy outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list and should no longer be offering that test? (Updated 12/18/20)

Q: What commercial manufacturers of serological tests that had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list and should no longer be offering that test? (Updated 12/23/20)