Congress is sounding the alarm after early data from researchers in California showed that 1 in 3 antibody tests they analyzed produced false positives more than 10% of the time.
Researchers from the two University of California schools cautioned that the results are preliminary and haven't yet undergone peer review. But the early results are alarming enough that the House subcommittee is urging the FDA to revise its policy to require antibody test makers to apply for FDA approval and to allow only effective tests to be sold.
Those selling unapproved tests must inform people in the test results that the tests haven't been FDA-reviewed and"should not be used as the sole basis" to determine whether someone has had COVID-19.
FDA Commissioner Stephen Hahn has said"we have and will" take action"such as issuing Warning Letters" telling companies to stop making false claims. But the FDA didn't respond to inquiries about how many letters have been issued or whether the agency has pursued any civil or criminal actions against violators.
"I would clearly tell people not to rely on tests at this point to see if they are immune to future infections with COVID-19," Marson said.
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