Siemens Healthineers, Erlangen, Germany, is now shipping worldwide its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood.

The total antibody test allows for the identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure. The test has received the CE mark; validation data demonstrated that the test has 100% sensitivity and 99.85% specificity.

With 20,000 Siemens Healthineers systems installed worldwide, the company is prepared to ramp up production as the pandemic evolves, with capacity exceeding 50 million tests per month across its platforms starting in June.

Deepak Nath, PhD, Siemens Healthineers.

Deepak Nath, PhD, Siemens Healthineers.

“Not all antibody tests are created equal. A high-quality test that targets the right protein and is highly scalable is essential for antibody testing to help ensure we effectively manage the threat of covid-19,” says Deepak Nath, PhD, president of laboratory diagnostics for Siemens Healthineers. “Siemens Healthineers sought to provide a highly accurate antibody test that could reach millions of people to address the current need for identifying immune response, and also for delivering long-term value as we look toward immunity and vaccination.”

The total antibody test runs on the company’s Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour, as well as its 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, Siemens Healthineers.

Featured image: The Atellica Solution by Siemens Healthineers.