The FDA's 'Wild West' COVID-19 antibody test rules did more harm than good, 60 Minutes finds

"Wyatt Earp, the gunslinger who helped tame the American West, once said, 'fast is fine but accuracy is final,'" Sharyn Alfonsi reported on Sunday's 60 Minutes. "The same thing could be said about testing for COVID-19." On March 16, as the new coronavirus was spreading in parts of the U.S. and there were few working diagnostic tests, "the Food and Drug Administration took the unprecedented step of allowing COVID antibody tests to flood the market without review."

"The promise of a new serology, or antibody blood test, that could determine if a person had been exposed to COVID-19 and developed 'protective' antibodies was being heralded as the next best thing" to diagnostic testing, 60 Minutes reported. But federal officials knew pretty quickly that this "'game-changer' that could get Americans back to work" wouldn't work, because many of the tests were seriously flawed, Anfonsi reported, citing a three-month investigation. They "continued to allow them to be sold anyway."

The FDA said it allowed these flawed tests to remain on the market for 50 days after a "careful balancing of risks and benefits." But Rep. Raja Krishnamoorthi (D-Ill.), who is investigating that decision, told 60 Minutes "we've never seen anything like this in terms of a policy which is basically an anything goes, Wild West type of approach to regulating a health care market." In late May, the FDA started pulling tests — 50 so far — "but by then it was too late," 60 Minutes reports. "The flawed antibody tests are still being used and the bad data collected from them is guiding critical decisions about when to reopen communities."

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If you still want to get a serology test, Alfonsi said you should get checked two or three times using different tests to lower the risk of false positives — and even if you do turn out to have antibodies, there's no guarantee you have immunity from the coronavirus. Peter Weber