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This award-winning blog supplements the articles in Hospital Infection Control & Prevention.

FDA: Do Not Use Antibody Tests to Diagnose COVID-19

By Gary Evans, Medical Writer

While antibody tests are broadly seen as a way forward to determine immunity and exposure to the pandemic coronavirus, the U.S. Food and Drug Administration (FDA) recently warned that the tests should not be used as the “sole basis to diagnose COVID-19.”

“The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection,” the agency said in a letter to healthcare providers. “While the FDA remains open to receiving submissions for these tests for such uses, based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.”

The FDA recommendations for healthcare providers include:

  • Continue to use serological (antibody) tests, as appropriate, and be aware of their limitations.
  • Do not use serological (antibody) tests as the sole basis to diagnose COVID-19 but instead as information about whether a person may have been exposed.
  • Be aware that not all marketed serological tests have been evaluated by the FDA. The FDA’s authorized tests, including serological tests, are listed on the Emergency Use Authorization (EUA) page.

For more on this story, see the upcoming issue of Hospital Infection Control & Prevention.