FDA blocks sale of 29 coronavirus antibody tests in the U.S.
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.