The FDA also reminded health care providers to be aware of the limitations of these tests and the risks to patients and the community, if the test results are used as the sole basis to diagnose COVID-19.
"The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 (the virus causing COVID-19) infection," said the release, adding the agency does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.
Serological tests detect antibodies present in the blood when the body is responding to a specific infection, like COVID-19. They detect the body's immune response to the infection caused by the virus rather than detecting the virus itself.
While antibody tests are of limited value in the immediate diagnosis of a patient where COVID-19 infection is suspected, using this type of test on patients may help the medical community better understand how the immune response against the SARS-CoV-2 virus develops in patients over time, and how people may have been infected, said the FDA.
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