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FDA: Don’t use antibody testing to evaluate immunity after COVID-19 vaccination

FDA reminded health care professionals and the public that results from currently authorized COVID-19 antibody tests should not be used to assess a person’s level of immunity or protection from COVID-19 at any time, particularly after the person has received a COVID-19 vaccination.

“Currently authorized SARS-CoV-2 antibody tests have not been evaluated to assess the level of protection provided by an immune response to COVID-19 vaccination,” FDA said. “If antibody test results are interpreted incorrectly, there is a potential risk that people may take fewer precautions against SARS-CoV-2 exposure.”

The agency noted that additional research is necessary to better understand the meaning of a positive or negative antibody test, beyond the presence or absence of antibodies, including in people who have been vaccinated against COVID-19, those who have been exposed and have SARS-CoV-2 antibodies, and those who are not fully vaccinated.

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