The U.S. Food and Drug Administration (FDA) has recently said that antibody testing for the coronavirus, called SARS-CoV-2, testing to determine immunity or protection from COVID-19 is not useful, especially among people who have been vaccinated.
The agency advised against using the antibody test results for these indications in a Safety Communication announced yesterday, according to Medscape.
Dr. Tim Stenzel said in a statement, “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.”
Dr. Stenzel is the director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“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,” he added. “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 antibodies created by the virus and the vaccines are different.
The FDA explained that the antibodies you develop from prior COVID-19 infection differ from antibodies produced by the COVID-19 vaccines. So, antibody testing for prior infection would not identify antibody protection from vaccination.
“SARS-CoV-2 antibody tests should be ordered only by healthcare professionals who are familiar with the use and limitations of the test,” the FDA said.
Dr. Stenzel added, “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 article was published on Medscape Medical News by staff reporter Damian McNamara, who covers medical specialties, including infectious diseases, gastroenterology, and critical care.
