USA – 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)…