NEW YORK ─ The US Food and Drug Administration on Friday granted Emergency Use Authorizations for the first two COVID-19 serology tests that display an estimated quantity of antibodies present in a person's blood.
The tests, the Advia Centaur SARS-CoV-2 IgG (COV2G) and Atellica IM SARS-CoV-2 IgG (COV2G) developed by Siemens Healthineers, are semi-quantitative. They do not display a precise measurement, but they estimate the quantity of a patient's antibodies produced against SARS-CoV-2 infection, the FDA said.
"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," Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a statement. "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. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus."
In June, the FDA granted Emergency Use Authorization to Siemens Healthineers for its total antibody test to detect the presence of SARS-CoV-2 antibodies running on the firm's Dimension Vista and Dimension EXL analyzers.
At the end of May, the FDA had granted two EUAs for the company's laboratory-based total antibody test ─ one for its use on its Advia Centaur XP and Advia Centaur XPT systems, and the second for use on its Atellica next-generation system.
Siemens Healthineers' Atellica IM SARS-CoV-2 IgG (COV2G) detects IgG antibodies to SARS-CoV-2 using the firm's Atellica IM Analyzer. The Advia Centaur SARS-CoV-2 IgG (COV2G) detects IgG antibodies to SARS-CoV-2 using the firm's Advia Centaur XP and Advia Centaur XPT systems.