The US Food and Drug Administration has issued emergency use authorizations for the first two Covid-19 serology tests that can tell not only whether someone has antibodies to the virus, but can give some idea of how much antibody is there.
“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,” Dr. Tim Stenzel, the director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a news release Friday.
The tests, the ADVIA Centaur COV2G and Attelica COV2G, are both from Siemens, the FDA said. Like other serology tests, these tests detect the body's immune response to the infection caused by the virus rather than detecting the virus itself.
“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus,” Stenzel said.
“Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus,” he added.