The FDA's about-face on coronavirus antibody testing
In terms of regulatory flexibility, the FDA's approach to coronavirus antibody testing is a 180-degree turn from its approach to diagnostic testing.
The big picture: The antibody tests, also known as serological tests, essentially detect whether someone's immune system has reacted to the coronavirus, helping determine whether they have had it — regardless of whether they had symptoms.
- The tests will help determine how widespread the coronavirus outbreak has been, something currently unknown because of diagnostic testing failures.
By the numbers: Only one test has received an emergency use authorization from the FDA , but more than 80 test developers have notified the agency that they have non-authorized tests available for use, which is allowed.
- The agency eventually adopted a similarly flexible approach to diagnostic tests.
- But the Trump administration has been widely criticized for its early decisions to rely on tests made by the CDC, and for being slow to allow commercial and academic labs to participate.
Yes, but: The FDA's rationale for keeping a close hold on who was making coronavirus tests was that it was important for the tests to be accurate.
- Scott Becker, executive director of the Association of Public Health Laboratories, has raised concerns about questionable serological tests that have appeared on the market, and has voiced these concerns about the "wild, wild West" environment to the administration, per the Washington Post.