FDA Boosts Scrutiny of Virus Antibody Tests as Fakes Flood Market

FDA Boosts Scrutiny of Virus Antibody Tests as Fakes Flood Market
A medical staff member is collecting a sample at a middle school as students receive nucleic acid testing for CCP virus in Guangzhou, China, on April 21, 2020. STR/AFP via Getty Images
Katabella Roberts
Updated:

The Food and Drug Administration (FDA) has imposed more stringent oversight of CCP virus antibody tests after previously allowing hundreds of tests to hit the market without adequate evidence that they meet quality and accuracy standards.

Under the updated guidelines, companies that sell the tests are now required to send the FDA an application for “emergency-use authorization” (EUA), along with data showing the tests’ accuracy within 10 business days, the agency said in a statement. Tests will need to be found 90 percent “sensitive,” or able to detect CCP virus antibodies, and 95 percent “specific,” or able to avoid false-positive results.
Katabella Roberts
Katabella Roberts
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Katabella Roberts is a news writer for The Epoch Times, focusing primarily on the United States, world, and business news.
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