New Test May Show If Immune Systems Can Neutralize the New Coronavirus

The U.S. Food and Drug Administration issued authorization for the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. The FDA issued an emergency use authorization (EUA) for New Jersey-based GenScript USA Inc. cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody.

Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies.

Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. It’s important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans is still being researched.

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, stated in a press release issued on November 6, 2020: “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.”