WASHINGTON — U.S. health regulators have pulled their authorization of a COVID-19 blood test after determining it could deliver inaccurate results.
The Food and Drug Administration said late Tuesday that the problems with the test from Chembio Diagnostic System could mislead patients about whether they have had COVID-19.
The move comes as FDA regulators attempt to verify the accuracy of dozens of antibody tests that the agency allowed onto the market earlier this year without evidence that they worked. Critics said that approach created a ‘Wild West’ of unregulated tests. Last month the FDA said testing companies must submit testing data to remain on the market.
Antibody tests are different from the nasal swab tests currently used to diagnose active infections. Instead, the tests look for blood proteins called antibodies, which indicate someone had a previous infection but fought off the virus. Most of the tests use a finger-prick of blood on a test strip.
The Chembio test was one of the first tests that the FDA authorized as meeting federal standards. However, the FDA said follow-up data submitted by the company showed the test delivered an unacceptable number of false results. As a result, the test can no longer be sold.
The FDA has granted emergency authorization to 21 other antibody tests. Meanwhile, roughly 190 antibody tests launched under the agency’s previous policy are awaiting FDA review.