US FDA tightens regulations for Covid-19 antibody tests

The US Food and Drug Administration said on Monday it now expects makers of antibody tests for the new coronavirus to submit requests for emergency use authorization of their tests within 10 days from when the test is validated.

The FDA previously did not expect these submissions if the test maker notified the agency that it was selling these tests, affirmed that the product was valid and labeled as unapproved. 

The FDA said that when it issued its antibody test policy in Mid-March, a high level of flexibility was appropriate since these type of tests were not meant to diagnose a coronavirus infection.

Reuters reported last week that the FDA's approach has provided an entry for questionable vendors and middlemen, with incidents involving an electronics salesman hawking an unauthorized home test kit and a former physician convicted in a fraudulent gold-peddling scheme.

"Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety," the FDA said in a statement.

It said it had become aware that a concerning number of commercial serology tests were being promoted inappropriately, including for diagnostic use, or were performing poorly.