FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination

FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination

For Immediate Release: May 19, 2021

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.”



SOURCE
[link to www.fda.gov (secure)]