USA – FDA authorizes first two semi-quantitative COVID-19 serology tests

The US Food and Drug Administration has authorized the first two serology tests that report semi-quantitative data about past infection with SARS-CoV-2, the virus that causes COVID-19 infection.

“Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean,” 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, in announcing the emergency use authorizations (EUAs) on 31 July…