First COVID neutralizing antibody test okayed by FDA
The US Food and Drug Administration (FDA) has given an emergency use authorization to the first commercial laboratory test to detect neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19.Over 50 other serology tests for COVID-19 antibodies have been granted emergency use authorizations (EUAs) by FDA, but these are all tests that detect binding antibodies rather than the neutralizing antibodies detected in the new test. In both cases, the tests are useful to show that an individual has had recent or prior infection with SARS-CoV-2 and should not be used to diagnose active COVID-19 infection.
“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, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health (CDRH).
Monoclonal antibodies that neutralize the spike protein on SARS-CoV-2 are under investigation as potential therapeutic agents for COVID-19 infection, and neutralizing antibody titers are a key measure being followed by vaccine researchers and regulators as a marker to assess immunogenicity of COVID-19 vaccine candidates.
“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,” said Stenzel in a press release announcing the authorization. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus,” he cautioned.
FDA