Siemens Healthineers announced it is expanding its infectious disease testing capabilities to aid in the COVID-19 pandemic. The company is developing a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood. The test, which detects both IgM and IgG, has demonstrated specificity and sensitivity of greater than 99 percent. This total antibody test, which is not yet available for sale, will provide a clear view of a patient’s disease progression by identifying individuals infected with the virus who have developed an immune response to the virus, even if they were asymptomatic or never diagnosed with the disease.
The test will be available on the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour, depending on test mix, and will enable a result in just 14 minutes. In addition, the serology test also is expected to be available on the company’s expansive installed base of ADVIA Centaur XP and XPT analyzers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these industry leading platforms ensures more patients are tested in a shorter time.
“Siemens Healthineers is working diligently to address the need for high-quality tests in the fight against COVID-19. This test is being designed with the precision and controls, sensitivity and specificity that laboratories have come to expect from our immunoassay tests,” said Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers. “I am especially proud of the dedication of our colleagues involved in development of this test—many of whom are based at the epicenter of the pandemic.”
Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, MA, manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) as well as the CE Mark. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems are being pursued in the coming weeks with a view to further expand clinical reach. In addition, the company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.
