Apr 12, 2020 - Health

FDA commissioner warns about accuracy of unapproved antibody tests

Stephen Hahn, the commissioner of the Food and Drug Administration, warned on NBC's "Meet the Press" Sunday that antibody tests for the coronavirus that haven't undergone the FDA's scientific review "may not be as accurate as we'd like them to be."

Why it matters: Developing the antibody tests, which are used to determine whether a person previously had the coronavirus and is therefore immune, will be crucial to understanding the scale of the outbreak. Some U.S. officials consider the development of an effective test to be a key step in being able to reopen the economy.

  • So far, the FDA has authorized only one antibody test under an "Emergency Use Authorization."

What they're saying: "We know that no test is 100% perfect," Hahn said. "But what we don't want are widely inaccurate tests because as I said before, that's going to be much worse having wildly inaccurate tests than having no tests."

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