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FDA Guidance on Antibody Testing for COVID-19 Immunity

Reference:

U.S. Food and Drug Administration. (2021, May 19). Antibody testing is not currently recommended to assess immunity after COVID-19 vaccination: FDA safety communication. https://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination.

Summary:

The FDA has issued a warning that antibody tests for SARS-CoV-2 should not be used to determine immunity following COVID-19 vaccination. While these tests can indicate previous infection, they have not been validated for assessing immunity post-vaccination. A
positive result does not guarantee protection, which may lead individuals to lower their guard against the virus, increasing infection
risks. Healthcare providers are advised not to interpret antibody test results as indicators of immunity. Vaccinated individuals may test
negative if the test does not detect vaccine-specific antibodies. Ongoing research is necessary to fully understand the implications of
antibody tests, particularly in vaccinated populations. The FDA continues to monitor the situation and encourages reporting any issues
with antibody tests.

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