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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

Executive Summary

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.

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