Understanding COVID 19 Antibody Testing

 

Currently, CDC’s serologic test is designed and validated for broad-based surveillance and research that will give us information needed to guide the response to the pandemic and protect the public’s health. The test is not currently designed to test individuals who want to know if they have been previously infected with COVID-19.  FDA.gov update

Statement From:

Stephen M. Hahn M.D., Commissioner of Food and Drugs - Food and Drug Administration

 

 

How the Tests Work

Unlike a test designed to diagnose an active COVID-19 infection (specifically from the SARS-CoV-2 virus), serological tests can help identify individuals who have developed an immune response to the virus, either as part of an active infection or a prior infection. The tests detect the presence of antibodies in the blood – if antibodies are present, that indicates that the person has been exposed to the virus and developed antibodies against it, which may mean that person has at least some immunity to the coronavirus. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected, which is why serological tests should not be used as the sole basis to diagnose or exclude infection with the SARS-CoV-2 virus.  FDA.gov update

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