May 23, 2020 - Health

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

Orion Rummler

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.

Go deeper: CDC is conflating diagnostic and antibody tests for coronavirus

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

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