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Autobio’s Authorization for Antibody Test Revoked

August 11, 2020

The FDA has withdrawn its Emergency Use Authorization for China-based Autobio Diagnostics’ COVID-19 antibody test.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.

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