FDA revokes authorization for antibody test

The Food and Drug Administration last week revoked its emergency use authorization for a SARS-CoV-2 antibody test made by Autobio Diagnostics Co. due to concerns with the accuracy of the test when evaluated at the National Institutes of Health’s Frederick National Laboratory for Cancer Research.

“Specifically, the Agency has concluded that it is unlikely that this test is effective in detecting SARS-COV-2 IgM antibodies and that the known and potential benefits of its use do not outweigh the known and potential risks,” the agency said.