DETROIT – The U.S. Food and Drug Administration announced it will begin cracking down on the sale of coronavirus (COVID-19) antibody tests after allowing a flood of unauthorized and potentially inaccurate tests.
The previous regulations created a mess, with some 200 antibody tests on the market that weren’t required to submit any sort of proof to the FDA that they actually worked.
After facing intense criticism, FDA officials are now acting to reign in those unproven and fraudulent tests.
The FDA will now require test makers to seek Emergency Use Authorization and provide their data within 10 business days.
This reverses a policy the FDA instituted in March, which loosened approval standards to the extreme and created widespread confusion and warnings about the inaccuracy of many tests.
So far, 12 test have been granted Emergency Use Authorization by the FDA. The latest includes a test from Swiss drugmaker Roche. The company’s CEO said their test was validated with more than 5,000 blood samples and was incredibly accurate.
“It’s almost near perfect accuracy, with a sensitivity of 100%,” Roche CEO Severin Schwan said. "The specificity of 99.8%, so this is pretty extraordinary.
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Schwan said having antibodies doesn’t guarantee someone is protected.
“I do think it’s valuable information, but we should not fully rely on it,” Schwan said. “In other words, even if you know you have been infected, it is important to keep social distance, to wash your hands, etc.”
With reliable tests, broad antibody testing could provide a better sense of how much of the population has already been infected with the coronavirus, and whether they can get sick again.
“We can now track people who have been infected and have recovered and see whether they get reinfected in the future, which will then be the proof of whether we get immune or not,” Schwan said.
There are still some 200 unauthorized tests out there, so before you even consider getting one, make sure it at least has Emergency Use Authorization from the FDA.
Roche plans to produce millions of test kits this month. It has already started shipping some of them.