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
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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Public policy group The Pew Charitable Trusts is concerned that the latest iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act prioritizes a faster time to market over patient safety. The group had previously signed onto a letter praising the proposed legislation, which aims to build a new regulatory framework for diagnostics in the US.
While the main role of SARS-CoV-2 antibody testing is currently limited to determining exposure to the virus in populations, the scientific community is working hard to define the neutralizing properties of the antibodies detected, and the duration of the immune response. As a result, antibody testing could be here to stay for the long term for monitoring populations, testing vaccines and selecting patients for trials of a variety of new therapies to treat numerous conditions.
After criticism it was being too lax in overseeing COVID-19 antibody tests coming to market, the US agency issued an updated guidance earlier this month tightening regulations. As a result, it has now pulled more than two dozen tests that don’t meet its standards – and more are expected to follow.