5 years ago gotthetest

FDA Tightens Enforcement on COVID-19 Antibody Tests

In March, the FDA relaxed their standards by allowing companies to sell antibody testing without proving that the tests worked. After this resulted in poor quality tests flooding the market, the FDA has reconsidered their options and decided that government scientists must now review the tests before they enter the market. Antibody testing can lead people to think they are immune from Covid-19, so it is crucial that these tests yield accurate results. For this reason, all antibody tests will now undergo scientific approval, in order to obtain correct results and prevent further inaccurate tests from entering the market.

FDA tightens enforcement on Covid-19 antibody tests

After loosening restrictions on antibody tests, the US Food and Drug Administration has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19, according to the CEO of a lab association who was on a call with FDA officials Tuesday morning.

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