Siemens Healthineers is now shipping worldwide its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in the blood. The test received the CE mark and data has demonstrated 100 percent sensitivity and 99.8 % specificity. 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 company is prepared to ramp up production as the pandemic evolves with a capacity exceeding 50 million tests per month across its platforms starting in June. Siemens Healthineers is poised to increase production at the company’s Walpole (Walpole, Mass.) and Glasgow (Newark, Del.) facilities.
The antibody test is now available on the largest installed base in the US, and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide. This includes the Atellica Solution immunoassay analyzer, which can run up to 440 tests in an hour and enables a result in just 10 minutes. By detecting both IgM and IgG antibodies, the test claims to provide clearer clinical picture over a longer period as the disease progresses.
Importantly, the test detects antibodies to a key protein on the surface of the SARS-CoV-2 virus— a spike protein, which binds the virus to cells with a distinct human receptor found in lungs, heart, multiple organs and blood vessels. Studies indicate that specific (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate and infect human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.
“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,” said Deepak Nath, president, Laboratory Diagnostics, 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 for delivering long-term value as we look toward immunity and vaccination.”
The total antibody test also is available on the company’s expansive installed base of ADVIA Centaur XP and XPT analyzers, which can test up to 240 samples per hour, with a result in 18 minutes. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems also are being pursued, realizing clinical reach. The company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.