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manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers.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.

Recommendations

The FDA recommends laboratories and health care providers:

• Stop using the antibody tests listed on FDA’s “removed” test list.
• Evaluate, given the patient’s clinical presentation and medical history, whether prior test results generated using these tests may have been incorrect, and whether the patient should be retested using an FDA-authorized test.
• Remove from your stock any remaining tests that are listed on FDA’s “removed” test list. 
• Report any issues with using COVID-19 tests to the FDA.

Source: https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and