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June 19, 2020: FDA Cautions Certain COVID-19 Serology/Antibody Tests Should Not Be Used

COVID-19 Antibody Tests News – The U.S. Food and Drug Administration (FDA) has recommended that clinical laboratories and health care providers stop using COVID-19 antibody tests listed on the FDA’s “removed” test list. On May 15, 2020, the FDA also issued a public alert regarding the accuracy of the Abbott ID NOW point-of-care test for diagnosing COVID-19.

COVID-19 Antibody Tests Information

On June 19, 2020, the FDA issued a letter to clinical labs and health care providers advising that certain COVID-19 antibody tests should not be used. The FDA’s “removed” test list should be used by providers as a guideline for what tests to avoid. This 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 and tests for which an Emergency Use Authorization (EUA) request has not been submitted by a manufacturer of a serology test within a reasonable time period as outlined in FDA’s guidance.

Additional recommendations have been issued for providers and labs that still have these “removed” COVID-19 antibody tests in their inventory. Per the FDA’s announcement:

  • 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.

The FDA will continue to keep health care providers and the public informed of any new or additional information, as it becomes available.

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