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."
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.

Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
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
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Peter has worked as a news and culture writer and editor at The Week since the site's launch in 2008. He covers politics, world affairs, religion and cultural currents. His journalism career began as a copy editor at a financial newswire and has included editorial positions at The New York Times Magazine, Facts on File, and Oregon State University.
-
Crossword: June 23, 2025
The Week's daily crossword
-
How far would Russia go for Iran?
Today's Big Question US air strikes represent an 'embarrassment, provocation and opportunity' all rolled into one for Vladimir Putin
-
Anshu Ahuja's golden coconut and butter bean curry recipe
The Week Recommends Plump, creamy beans in a sweet, spicy sauce
-
Economists fear US inflation data less reliable
speed read The Labor Department is collecting less data for its consumer price index due to staffing shortages
-
Crypto firm Coinbase hacked, faces SEC scrutiny
Speed Read The Securities and Exchange Commission has also been investigating whether Coinbase misstated its user numbers in past disclosures
-
Starbucks baristas strike over dress code
speed read The new uniform 'puts the burden on baristas' to buy new clothes, said a Starbucks Workers United union delegate
-
Warren Buffet announces surprise retirement
speed read At the annual meeting of Berkshire Hathaway, the billionaire investor named Vice Chairman Greg Abel his replacement
-
Trump calls Amazon's Bezos over tariff display
Speed Read The president was not happy with reports that Amazon would list the added cost from tariffs alongside product prices
-
Markets notch worst quarter in years as new tariffs loom
Speed Read The S&P 500 is on track for its worst month since 2022 as investors brace for Trump's tariffs
-
Tesla Cybertrucks recalled over dislodging panels
Speed Read Almost every Cybertruck in the US has been recalled over a stainless steel panel that could fall off
-
Crafting emporium Joann is going out of business
Speed Read The 82-year-old fabric and crafts store will be closing all 800 of its stores