Vorys (Ohio/Texas): New NIH Process for Evaluation of Antibody Tests May Offer Increased Confidence, Protection for Providers

On April 18, 2020, the U.S. Food and Drug Administration (FDA) published an official statement confirming that the National Institutes of Health (NIH) will soon begin conducting performance evaluations for serological, or antibody-based, diagnostic tests for COVID-19.  This new evaluation process is not intended to replace FDA’s current guidance, but instead may “complement and inform” FDA’s determination of whether to issue an Emergency Use Authorization (EUA) for a particular test. MORE.