COVID-19 Antibody Tests Being Abused To Falsely Diagnose Coronavirus Cases, FDA Says

Agency revises its 16 March guidance, forwards cases to enforcement branch to stop misuses

 
• By Sue Darcey

A negative COVID-19 antibody or serology test, even when authorized by FDA, is a poor indicator of whether an individual currently has or is completely immune from contracting coronavirus, the agency said on 4 May, issuing an updated guidance to drive the lesson home.

FDA entrance sign 2016
FDA recently warned commercial test manufacturers against inappropriate uses of COVID-19 antibody tests

Some manufacturers are inappropriately marketing their COVID-19 antibody/serology tests for diagnostic use, US Food and Drug Administration officials said at a 4 May press briefing. The realization has prompted the agency to revise its immediately-in-effect guidance of 16 March for both diagnostic and antibody tests.

While high-quality antibody tests can provide information about a population’s exposure to COVID-19, “the antibody tests may not be used as the sole basis for diagnosing cases of

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