Siemens Healthineers’ COVID-19 Test Gets CE Mark
Siemens Healthineers has earned CE mark certification for its SARS-CoV-2 IgG antibody test and has filed a request with the FDA for Emergency Use Authorization.
The company said the test is an improved version of its previously cleared coronavirus assay that can detect and quantify neutralizing antibodies from a blood sample.
IgG antibodies are the most common type of antibodies found in the blood, developing in most patients within seven to 10 days after COVID-19 symptoms and remaining for some time after the patient has recovered from the infection.
The antibody test runs on the company’s Atellica analyzers as well as its ADVIA Centaur XP/XPT, Dimension Vista and Dimension EXL systems.