- For Immediate Release:
The following quote is attributed to Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health
“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.
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. 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 will continue to monitor the use of authorized SARS-CoV-2 antibody tests for purposes other than identifying people with an adaptive immune response to SARS-CoV-2 from a recent or prior infection.”
- Today, the U.S. Food and Drug Administration issued a safety communication informing the public that results from SARS-CoV-2 antibody tests should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.
- The authorized vaccines for prevention of COVID-19 induce antibodies to specific viral protein targets; post-vaccination antibody test results will be negative in individuals without a history of previous natural infection if the test used does not detect the type of antibodies induced by the vaccine.
- Currently authorized SARS-CoV-2 antibody tests are not validated to evaluate immunity or protection from COVID-19 infection. SARS-CoV-2 antibody tests should be ordered only by health care providers who are familiar with the use and limitations of the test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Lauren-Jei McCarthy
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