As a leading medical technology company, Siemens Healthineers responded quickly to the ongoing health crisis by offering a SARS-CoV-2 Molecular Test in March 2020, which can detect the virus that causes COVID-19. The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed. As of May, 2020 the test is CE marked for diagnostic use in the EU and FDA approved.
Shortly after, recognising the critical need for accurate diagnostic testing to manage COVID-19, the company developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood. Siemens officials say the company’s antibody tests demonstrate 100% sensitivity (ability to exclude false negatives) and 99.8% specificity (few false positives) in identifying SARS-CoV-2 antibodies. 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.
The antibody test is now available on the largest installed base in the U.S. 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 per hour and enables a result in just 10 minutes. By detecting both IgM and IgG antibodies, the test provides a clearer clinical picture over a longer period of time as the disease progresses. 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.
To meet demand, the company is ready to increase its production capacities if needed and will be able to manufacture more than 50 million tests a month beginning in June.