Autobio’s Authorization for Antibody Test Revoked
The FDA has withdrawn its Emergency Use Authorization for China-based Autobio Diagnostics’ COVID-19 antibody test.
The agency said it tested the device and found that it was unlikely to be effective in identifying IgM antibodies to the SARS-COV-2 virus. IgM antibodies are usually the first produced by the immune system in response to a viral infection.
“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 FDA said.