US Targets Fraud in Coronavirus Antibody Test Market With Tighter Rules

US Targets Fraud in Coronavirus Antibody Test Market With Tighter Rules
A health worker in protective gear hands out a self-testing kit in a parking lot of Rose Bowl Stadium during the global outbreak of the coronavirus disease (COVID-19), in Pasadena, Calif. on April 8, 2020. Mario Anzuoni/Reuters
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The United States on May 4 began requiring antibody tests for the new CCP virus to undergo a regulatory agency review, acknowledging that its earlier policy had opened the door to fraud.

The U.S. Food and Drug Administration had previously required only that companies attest their product was valid and labeled as unapproved, attracting 170 companies to the antibody test market including unscrupulous vendors making false claims, Reuters reported last week.