Siemens Healthineers, Erlangen, Germany, is expanding its infectious disease testing capabilities to aid in the covid-19 pandemic. Recognizing the critical need for accurate testing to manage covid-19, the company is developing a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood.

The test detects both IgM and IgG antibodies, and has demonstrated specificity and sensitivity greater than 99%. The total antibody test 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.

Deepak Nath, PhD, Siemens Healthineers.

Deepak Nath, PhD, Siemens Healthineers.

The test will be available on the Atellica solution immunoassay analyzer, which can run up to 440 tests per hour and can produce a result in just 14 minutes. In addition, the serology test is also expected to be available on the company’s Advia Centaur XP and XPT analyzers, which can deliver up to 240 tests per hour, with a first result in 18 minutes. Availability of the test on these industry-leading platforms ensures more patients can be 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,” says Deepak Nath, PhD, president of laboratory diagnostics for 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, Mass, manufacturing facility will accommodate more than 25 million tests per month in June and beyond.

The company is pursuing the CE mark as well as FDA emergency use authorization for the test. 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.

For more information, visit Siemens Healthineers.