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FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block

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.

Simple COVID-19 IgM/IgG Rapid Test. A lot of quick tests of the coronavirus scattered on a red table. The rapid tests have arrived.

The US Food and Drug Administration has yanked more than two dozen COVID-19 antibody tests after criticism they were too inaccurate to be used. The change comes after the agency tightened regulations for such tests earlier this month following a dramatic relaxation of requirements.

The FDA announced on 21 May that it was pulling 28 tests and test kits from a list of about 200 antibody tests used to determine whether a person has antibodies that result from being infected by the SARS-CoV-2 virus

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