“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.
- 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 the 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.
- Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
- In Vitro Diagnostics EUAs – Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
- Centers for Disease Control and Prevention’s Guidelines for Antibody Testing