NEW YORK ─ Siemens Healthineers on Wednesday said that it has obtained the CE mark for a quantitative SARS-CoV-2 IgG antibody test, enabling its use in Europe and other regions that accept the designation.
The Erlangen, Germany-based firm said it has also applied to the US Food and Drug Administration for Emergency Use Authorization.
The CE-marked assay is an enhanced version of a test the firm made available globally this summer. It demonstrates the ability to detect neutralizing antibodies and measures the amount of the antibodies present in a patient's blood sample, Siemens Healthineers said.
As SARS-CoV-2 vaccines become available, the fully automated quantitative antibody test can be used to help inform whether broad vaccination programs are working, the company added.
Neutralizing antibodies are critical in the fight against COVID-19 because they defend cells from infection. Identifying the presence of antibodies and assessing the likely level needed to protect against future SARS-CoV-2 encounters are both critical to evaluating a vaccine's effectiveness, Siemens Healthineers noted.
"We targeted the spike protein for our antibody tests, anticipating antibodies to this protein would eventually prove to be neutralizing," Deepak Nath, president of laboratory diagnostics at Siemens Healthineers, said in a statement. "Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor binding domain."
The company noted that its SARS-CoV-2 IgG antibody tests are available worldwide on a large installed base of automated immunoassay analyzers, including its Atellica Solution, Advia Centaur XP and XPT, and Dimension Vista and Dimension EXL.