The US Food and Drug Administration (FDA) announced Friday it issued the first emergency use authorization (EUA) for a blood test that can detect neutralizing antibodies from a past coronavirus infection.
The agency said the cPass SARS-CoV-2 Neutralization Antibody Detection Kit made by GenScript USA Inc. specifically detects this type of antibody, which has been shown in labs to decrease the coronavirus’ infection of cells. The test is intended to be used to identify people with an adaptive immune response to the coronavirus, according to the authorization.
"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," Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement.
“Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus," he said.
The agency noted it has issued EUAs to more than 50 antibody tests, but those tests don’t specifically detect antibodies that decrease the infection of cells. Antibody tests should not be used to diagnose an active coronavirus infection, since they don’t detect the virus itself, the agency said.