US FDA orders companies to submit coronavirus antibody test data

WASHINGTON (NYTIMES) – The United States Food and Drug Administration announced on Monday (May 5) that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market.

The antibody tests are an effort to detect whether a person had been infected with the coronavirus, but results have been widely varied. Since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate.

The FDA's action follows a report which found that only three antibody tests gave consistently reliable results, and even the best had flaws.
The FDA’s action follows a report which found that only three antibody tests gave consistently reliable results, and even the best had flaws.PHOTO: NYTIMES

The FDA’s action follows a report by more than 50 scientists, which found that only three of 14 antibody tests gave consistently reliable results, and even the best had flaws.

An evaluation by the National Institutes of Health, working with other federal health agencies, has also found “a concerning number” of commercial tests that are performing poorly, the FDA said.

The agency has also been under fire from several members of Congress, with numerous lawmakers raising questions about the validity of some of the tests.

So far, little is known about whether those who became ill will develop immunity and, if so, for how long, and that leaves the value of antibody tests still uncertain.

Around the globe, government and health officials have hoped that antibody tests would be a critical tool to help determine when it would be safe to lift stay-at-home restrictions and reopen businesses.

The FDA has blocked imports of some antibody tests at the US border and has ordered some distributors to revise claims about what individuals can learn from them or halt sales.

House Democrats Raja Krishnamoorthi, of Illinois, and Rosa DeLauro, of Connecticut, have criticised the agency for its handling of the matter as has Rep. Lloyd Doggett, D-Texas.

“The administration’s original serology testing policy, which allowed tests on the market with no FDA review, felt like an overreaction to the criticism they faced for their slow rollout of molecular tests,” Krishnamoorthi said. “But FDA went too far, completely abrogating regulatory responsibility.”

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