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On Friday, the first serology test has been approved by the U.S. Food and Drug Administration to detect neutralizing antibodies from recent or previous SARS-CoV-2 infection, which bind to a particular part of a pathogen and have been shown to decrease SARS-CoV-2 viral cell infection in a laboratory environment.
FDA Emergency Use Authorizations (EUAs) have been granted over 50 other serology tests for COVID-19 antibodies. These are tests that can detect binding antibodies rather than the neutralizing antibodies found in the new test.
The FDA granted GenScript USA, which manufactures the test, an emergency use authorization. The tests can help in both cases to indicate that a person has had a recent or previous SARS-CoV-2 infection and should not be used to detect active COVID-19 disease.
As possible therapeutic agents for COVID-19 infection, monoclonal antibodies that neutralize the spike protein on SARS-CoV-2 are under investigation, and neutralizing antibody titers is a crucial test adopted by vaccine researchers regulators as a marker to determine the immunogenicity of candidates for COVID-19 vaccines.
The FDA also needs to warn patients that it is not appropriate to use serology tests to diagnose an active infection since they only detect antibodies that the immune system, not the virus itself, produces in reaction to the virus.
Tim Stenzel, director of the Center for Devices and Radiological Health of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said that detecting neutralizing antibodies will help people gain more insight into what the presence of antibodies can mean for patients.
The presence of antibodies to SARS-CoV-2 will inform us that possible immunity remains unknown. As scientists continue to research and study more about the COVID-19 virus, the test approval gives us another option to test those antibodies.
Patients should not view the findings as convincing them that they are immune to the virus or have any degree of immunity. They are advised by the FDA not to use the findings of this test or any serology test as an indicator that they should avoid taking precautions to protect themselves and others, such as stopping social distancing, stopping wearing masks, or returning to work.