US FDA Authorizes First Tests from Siemens That Estimate Antibodies from Past COVID-19 Infections

The US Food and Drug Administration has authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in an individual’s blood.

Both tests from Siemens Healthineers (Erlangen, Germany), the ADVIA Centaur COV2G and Atellica COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

The ADVIA Centaur SARS-CoV-2 IgG (COV2G) assay is a chemiluminescent immunoassay intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 inhuman serum and plasma (potassium EDTA and lithium heparin) using the ADVIA Centaur XPand ADVIA Centaur XPT systems. The Atellica IM SARS-CoV-2 IgG (COV2G) assay is a chemiluminescent immunoassay intended for qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA and lithium heparin) using the Atellica IM Analyzer. Both the assays are intended for use as an aid in identifying individuals with an adaptive immune response toSARS-CoV-2, indicating recent or prior 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, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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.”