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.
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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