US to rein in flood of virus blood tests after lax oversight
FILE - In this April 14, 2020 file photo, a woman holds her hand out to have blood collected for COVID-19 antibodies at a drive-thru site in Hempstead, N.Y. U.S. regulators on Monday, May 4 pulled back a decision that allowed scores of coronavirus blood tests to hit the market without first providing proof that they worked. The Food and Drug Administration said it took the action because some sellers have made false claims about the tests and their accuracy. (AP Photo/Seth Wenig, File)
WASHINGTON (AP) — U.S. regulators are revising a policy that has allowed coronavirus blood tests to reach the U.S. market without first providing proof that they worked.
The move Monday by the Food and Drug Administration follows criticism that the lack of oversight created a Wild West of unregulated tests.
Under the new policy, companies with tests kits for sale will be required to submit information on their test’s accuracy within 10 days.
The blood tests are designed to show who has had a coronavirus infection in the past and may have some immunity.
Most use a finger-prick of blood on a test strip.
