FDA has issued an emergency use authorization to Siemens Healthineers for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies, including IgM and IgG, in blood. Test data demonstrated 100% sensitivity and 99.8% specificity.
The total antibody test for covid-19 allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure. Testing can begin immediately, with more than one million tests already shipped to health systems and laboratories.
“As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with the capacity and reach necessary to help address a critical societal need,” says Deepak Nath, PhD, president of laboratory diagnostics for Siemens Healthineers. “The test targets both IgM and IgG antibodies, which allows for early identification of individuals infected with the virus who have developed an immune response, even if they were asymptomatic or never diagnosed with the disease.”
The total antibody test runs on Siemens’ Atellica Solution immunoassay analyzer, which can perform up to 440 tests per hour, as well as on the company’s Advia Centaur XP and XPT analyzers, which can test up to 240 samples per hour. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems are also being pursued.
For more information, visit Siemens Healthineers.