The US Food and Drug Administration revoked its emergency use authorization for one of the first Covid-19 antibody tests granted such approval.
The FDA said it was concerned about the test’s accuracy.
The test was created by Chembio Diagnostic System, Inc. At the time the FDA gave its approval, the agency said it did meet the “may be effective” standard needed for the emergency use authorization.
False results: The federal government continued to evaluate the test's performance and determined that it gave a higher than expected rate of false results.
The risk to public health from false test results make the revocation of this authorization appropriate, the FDA said on its website, adding that the test may not be distributed.
"Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health said in a news release.
"By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test's benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public."