No FDA Review for Most Antibody Tests Draws Rebuke From Lawmaker

The Food and Drug Administration has allowed antibody tests that could show if someone has already been exposed to Covid-19 and developed some immunity to be on the market without its review and has yet to take an enforcement action, according to lawmakers.

President Donald Trump has touted antibody testing as a way to unlock the U.S. economy, and experts say it could be key in doing so safely. However, there have been reports that current tests could be unsafe or inaccurate.

The FDA hasn’t assessed the reliability of most of the antibody tests on the market, according to a ...