FDA revises antibody testing policy after ‘concerning number’ of faulty tests flood market

WASHINGTON — The U.S. Food and Drug Administration is tightening rules for approving coronavirus antibody testing following growing concerns about fraudulent and faulty tests.

The coronavirus antibody test determines if someone has had coronavirus and if they may now be immune.

[READ: Antibody tests touted as way to combat coronavirus, but are they accurate?]

The FDA came under fire previously for allowing companies to sell coronavirus antibody tests without proving if they worked.

Since rolling out the initial policy in March, the FDA now said it has become aware of a “concerning number” of faulty and fraudulent tests.


"It seems to have come as a surprise to the FDA that if it does not do its job, fraud arises,” Rep. Lloyd Doggett, D-Texas, said.

The revised policy says that manufacturers have to submit emergency use authorization requests with data showing their tests work within 10 days of the time they notify the FDA about their test.

We looked through records showing dozens of public comments and questions about the FDA’s policy for the testing.

There was confusion about the proper validation process and about the legality of the use of some testing kits by the public commenters.

The FDA said so far, 12 antibody tests have been approved under the latest policy and there are more than 200 under review.

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