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FDA Warns Against Using COVID-19 Antibody Testing to Evaluate for Immunity After COVID-19 Vaccination

FDA maze of regulations

New warning from the FDA advises against using COVID-19 antibody test results to infer the efficacy of COVID-19 vaccines

The US Food and Drug Administration (FDA) issued a safety communication for healthcare providers and the public, warning against the use of COVID-19 antibody testing to evaluate for immunity after receiving a COVID-19 vaccine.

The FDA is reminding the public of the limitations of COVID-19 antibody, or serology, testing and providing additional recommendations about the use of antibody tests in people who received a COVID-19 vaccination,” said Tim Stenzel, MD, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, as part of the announcement.

“Antibody tests can play an important role in identifying individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response,” Stenzel continued. “However, antibody tests should not be used at this time to determine immunity or protection against COVID-19 at any time, and especially after a person has received a COVID-19 vaccination.”

The FDA highlights concerns that the antibodies generated by specific COVID-19 vaccines may not be detected through some antibody testing. The FDA also reports that it will monitor the use of COVID-19 antibody tests for “purposes other than identifying people with an adaptive immune response to SARS-CoV-2 from a recent or prior infection.”

There has been considerable and growing interest in offering COVID-19 antibody tests to individuals who have been vaccinated against COVID-19; however, the FDA’s new guidance seems to exclude this use of antibody testing.

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