FDA Commissioner Stephen Hahn at a White House briefing on March 19. Photo: Brendan Smialowski/AFP via Getty Images
The FDA blocked 29 manufacturers, many of which are based in China, from selling coronavirus antibody tests in the U.S. on Friday.
Why it matters: Antibody tests help medical workers find out how widespread the coronavirus is in a given community, even if someone is asymptomatic — which New York state has pursued in recent weeks.
- However, the American Medical Association has cautioned that the tests should not be used to determine immunity to the coronavirus.
Details: The FDA did not specify why the tests were barred from distribution in the U.S., but reasons include a test having significant problems or if an emergency authorization request is not submitted in time.
Flashback: The FDA "does not automatically independently verify performance" of antibody tests after granting them emergency authorization, the AMA wrote earlier this month — and tests that are not commercially marketed do not require FDA authorization.