Siemens Healthineers has started worldwide shipping of a laboratory-based total Covid-19 antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in the blood.
The CE-marked test has demonstrated 100% sensitivity and 99.8% specificity.
It helps to identify patients who have developed an adaptive immune response because of a recent infection or prior exposure.
Siemens Healthineers is prepared to scale up production at its Walpole, UK, and Glasgow, Scotland, facilities, with a capacity of over 50 million tests a month, beginning in June.
Siemens Healthineers Laboratory Diagnostics president Deepak Nath said: “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.
“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 antibody test is currently available on the Siemens Healthineers systems installed worldwide. This includes the Atellica Solution immunoassay analyser, which can deliver approximately 440 tests an hour.
By detecting both IgM and IgG antibodies, the test offers a clearer clinical picture over a longer period of time as the disease progresses.
Siemens Healthineers’ total antibody test is also available on the company’s installed base of ADVIA Centaur XP and XPT analysers. These systems can test approximately 240 samples an hour and deliver results in 18 minutes.
The company is also working on comparable tests for its Dimension Vista and Dimension EXL systems with a view to achieving clinical reach. It intends to develop an IgG test to further expedite testing availability as the pandemic evolves.