The FDA is dealing with a flood of inaccurate coronavirus antibody tests after it allowed more than 120 manufacturers and labs to bring the tests to market
The problem has gotten so bad that the New York City Health Department warned health providers last week against using the tests to determine whether someone is infected with the coronavirus or has developed immunity through previous exposure.
On Friday, the House Oversight Committee released a report on antibody testing that said “numerous companies appear to be marketing fraudulent tests” — and that the FDA had “failed to police the coronavirus serological antibody test market.” The FDA formally warned health care providers April 17 of the concerns surrounding the bulk of the antibody tests available for sale, explaining that it “does not review the validation, or accuracy, data for these tests unless an EUA is submitted.”
Former FDA lawyer Coleen Klasmeier said the agency swung too far the other way. She said FDA needs to set tougher quality standards for specificity — which measures how often a test correctly produces positive results — and sensitivity, which measures how often a test correctly produces negative results.
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