The FDA lets 'pretty much anyone' sell a COVID-19 antibody test — and a lot of them are shoddy: CNN
Coronavirus AFP : Alberto PIZZOLI

On CNN Tuesday, senior medical correspondent Elizabeth Cohen warned that many of the antibody tests on the market for COVID-19 — the tests that show whether you are immune to the virus — are barely tested under the Food and Drug Administration's new standards, and possibly ineffective.


"So this test tells you, hey, look, you were infected at some point in the past and you have antibodies, which may mean you're immune," Cohen told anchor Brianna Keilar. "That's super helpful on a personal level. On a population level, we would know, this city has a lot of immune people or this city doesn't have a lot of people who are immune."

"The problem is, the FDA lowered the standards last month, and basically pretty much anyone can sell an antibody test," continued Cohen. "They don't even have to show that it works. All they have to do is say, hey, FDA, I want to sell this test and I validated it here in my city where I am. That's all they have to do. They don't have to show their data."

"So the people who know about these things, who run lab associations, say there are a lot of 'crappy' — and that's their word — there are a lot of 'crappy tests,' and the last thing you want to do is tell somebody they have a antibody could make them get COVID," she added. "So a lot of concern about the quality of the tests."

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