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The U.S. Food and Drug Administration (FDA) is against antibody testing for SARS-CoV-2 testing to determine immunity or protection against COVID-19, especially among vaccinated individuals.
More than a reminder that a new policy, the FDA discouraged the use of antibody test results for these indications in Security communication announced today.
“The FDA reminds the public of the limitations of COVID-19 antibody or serology, testing and providing additional recommendations on the use of antibody testing in people who received a vaccine against COVID-19,” Tim said. Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Radiological Devices and Health, said in a statement.
“Antibody testing may 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 testing 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 the vaccine against COVID- 19 “.
Not all antibodies are created equal. The agency explained that antibodies from previous SARS-CoV-2 infection differ from antibodies induced by COVID-19 vaccines. Therefore, the pre-infection antibody test did not identify people with antibody protection against immunization.
SARS-CoV-2 antibody testing should only be ordered by healthcare professionals who are familiar with the use and limitations of the test, the agency notes.
“The FDA will continue to monitor the use of authorized tests for SARS-CoV-2 antibodies for purposes other than identifying people with an adaptive immune response to SARS-CoV-2 from a recent or previous infection,” he said. Stenzel.
Damian McNamara is a staff Miami-based journalist. It covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.