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FDA Turns Its Attention To Companies Claiming To Have Legitimate Coronavirus Antibody Tests

NEW YORK (CBSNewYork) -- The Food and Drug Administration is cracking down on companies giving coronavirus antibody tests. It wants them to submit data to prove they are legitimate.

But the agency has given clearance to a company that claims nearly perfect results, CBS2's Dick Brennan reported Monday.

FLASHBACKSen. Schumer Asks FDA To Reveal Which At-Home Coronavirus Test Kits Sold Online Are Legitimate

Aida Vasquez is relieved. She has recovered from coronavirus and tested positive for antibodies.

"I was told that I can't get sick again for I don't know how long, but that's a good sign that I'm on the road to recovery," Vasquez said.


Right now, the FDA says the that companies selling coronavirus antibody tests must apply for authorization. More than 200 have flooded the market, but only 12 have FDA approval. The latest to get a green light is from Roche. It uses a blood test from a vein rather than a pin prick.

"That's the kind of test that we want widely available, because with that level of accuracy we are more likely to be able to identify people who are truly positive with infection and individuals are truly negative and never have the disease," said Erin Kobetz of the University of Miami School of Medicine.

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Antibodies show if you were infected in the past, but with this virus, it's not clear yet just how much protection you get or for how long.

"We have to be a little more careful about it, unfortunately. It's not clear that we are one and done with this virus. We may be subject to repeat infections," said Jeffrey Shaman of the Columbia University Mailman School of Public Health.

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The latest antibody test from Roche claims results that are near perfect.

"The test is said to be more than 99% accurate. Is that possible?" Brennan asked Dr. Max Gomez said.

"I'm not aware of any of these tests that can achieve that kind of accuracy," Gomez said.

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And Gomez said this test is just not as convenient.

"This test drawing requiring drawing blood from a vein makes the accessibility of the test much less," Gomez said. "That's a world different of just drawing a quick finger prick."

Roche said it expects to be producing millions of tests this month and 100 million by the end of the year.

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