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.
