Wednesday, May 19, 2021

Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination

Read updated information about the use of antibody test results.

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FDA - Center for Devices and Radiological Health

Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination - FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind health care providers and the public that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person's level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.

This safety communication provides:

  • Important recommendations for health care providers and the public.
  • The FDA's actions to address the issue.
  • Instructions to report problems with SARS-CoV-2 antibody tests to the FDA.

Read More

The FDA also updated the Serology/Antibody Tests: FAQs on Testing for SARS-CoV-2  and the Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers web pages to provide updated information on the use of SARS-CoV-2 antibody test results.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).


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