Last week, the Food and Drug Administration (FDA) issued an emergency use authorization (EAU) for the first serology test to identify individuals with neutralizing antibodies from recent or prior COVID-19. Researchers are still studying the effect of neutralizing antibodies in humans, but in laboratory settings, these antibodies have reduced the infection of cells. The FDA previously issued EUAs for serology tests that detect binding antibodies, which do not necessarily reduce cell infection. “Today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus,” said Tim Stenzel, MD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.” (FDA news release, 11/6/20)
