Siemens Healthineers has received CE mark for its SARS-CoV-2 IgG Antibody Test (sCOVG) which can be used across Europe and has filed a request with the US FDA (Food and Drug Administration) for EUA (Emergency Use Authorization).
It demonstrates the potential to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in blood serum of a patient, which are vital to fighting Covid-19 as they defend cells from viral infection.
An enhanced version of an assay launched recently which became available globally, including in the US.
Siemens Healthineers Laboratory Diagnostics president Deepak Nath said:
"At the onset of the pandemic, the scientific community had to learn about COVID-19 and how our immune systems would respond. We targeted the spike protein for our antibody tests, anticipating antibodies to this protein would eventually prove to be neutralizing".
"Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor binding domain. Healthcare providers can feel confident that our test will help them determine whether a patient's immune system is producing the right antibodies to stop or prevent COVID-19 infection."
The Siemens Healthineers SARS-CoV-2 IgG antibody tests are available on one of the largest installed bases of automated immunoassay analyzers worldwide, and the largest in the U.S. This includes the Atellica Solution and ADVIA Centaur XP and XPT families of analyzers and the Dimension Vista and Dimension EXL systems.