FDA has issued a letter recommending that clinical laboratories and healthcare providers stop using covid-19 antibody tests listed on FDA’s ‘removed’ list, which 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.
- Tests voluntarily withdrawn by the respective commercial manufacturers.
Although tests on the ‘removed’ list should no longer be distributed, laboratories and healthcare providers may still have these tests within their stock or may have used these tests in the past. FDA has therefore provided additional information and recommendations to laboratories and healthcare providers regarding these tests.
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