FDA: Makers of Coronavirus Antibody Tests Must Now Show Tests Actually Work

upstart writes in with an IRC submission for TurkeyWaddle:

FDA: Makers of coronavirus antibody tests must now show tests actually work:

After a gush of bogus coronavirus blood tests, the US Food and Drug Administration announced Monday that test makers must submit data within 10 days showing that their tests actually work-or risk getting purged from the market.

[...] "In mid-March, it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency... However, flexibility never meant we would allow fraud," the FDA wrote in a policy update Monday. "We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety."

[...] Thus, the presence of antibodies in a person's blood only tells if the immune system has encountered the germ in the past-it's not used to diagnose new cases of COVID-19, the disease caused by SARS-CoV-2. There are separate diagnostic tests for that, which generally work by detecting genetic material from the virus itself.

[...] the market has been flooded with shoddy tests and bogus claims. "Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing," the FDA said. The agency also noted that "a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the [National Institutes of Health]."

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