The United States Food and Drug Administration (FDA) on July 31 authorized the first two COVID-19 serology tests, which can tell how much antibody is present in the patient's blood. The tests approved by the FDA cannot tell the precise amount of antibodies present in the individual's blood but can give an estimate on the quantity of antibodies produced. The FDA, however, has also warned patients against using the results of these tests as an indication that they are immune to the disease because there are still many unknowns about what the COVID-19 antibodies may tell us about potential immunity.
"Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean. There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The ADVIA Centaur COV2G and Attelica COV2G, both tests are developed by Siemens, a German multinational conglomerate. The FDA also cautioned patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus, not the virus itself. Serology tests are blood test that looks for antibodies developed by the immune system in your blood.
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