FDA: Makers of coronavirus antibody tests must now show tests actually work

Enlarge / MAY 4, 2020: A health worker handles a blood sample on the first day of a free COVID-19 antibody testing event. (credit: Getty | Barcroft Media)

After a gush of bogus coronavirus blood tests, the US Food and Drug Administration announced Monday that test makers must submit data within 10 days showing that their tests actually work—or risk getting purged from the market.

The new requirement updates a lax policy the FDA announced March 16, which prioritized providing “regulatory flexibility” to allow these blood tests—aka serology tests—to hit the market quickly during the pandemic. That flexibility came at the expense of normal scientific vetting that ensures those tests meet standards for accuracy and reliability.

“In mid-March, it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency... However, flexibility never meant we would allow fraud,” the FDA wrote in a policy update Monday. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”