The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.
These are antibodies that bind to a specific part of a pathogen, such as a virus. They have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
The EUA was issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit.
“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”
The FDA cautions patients against using the results from this test, or any serology test, as an indication that they can stop social distancing, wearing masks, or doing other things to limit the spread of the virus. The FDA also reminds patients that serology tests should not be used to diagnose an active infection. They only detect antibodies that the immune system develops in response to the virus, not the virus itself.