April 14, 2020 / By Elizabeth Cohen and Devon Sayers, CNN
(CNN) – After loosening restrictions on antibody tests, the US Food and Drug Administration has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19, according to the CEO of a lab association who was on a call with FDA officials Tuesday morning.
On March 16, the FDA loosened its standards and allowed companies to sell antibody tests without submitting any evidence that they worked.
That led to “crappy” tests flooding the market, according to Scott Becker, CEO of the Association of Public Health Laboratories.
Dr. Deborah Birx, the response coordinator for the White House coronavirus task force, has called antibody tests “critical” in the response to the pandemic.
