Expansion of SARS-CoV-2 testing to include a total antibody test

Siemens Healthineers is expanding its infectious disease testing capabilities to aid in the SARS-CoV-2 pandemic. Recognising the critical need for accurate diagnostic testing, the company has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood.

This total antibody test will provide a clear view of patients’ 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, which detects both IgM and IgG antibodies, has demonstrated specificity and sensitivity of greater than 99%.

Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, Massachusetts, manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) as well as CE marking.

The test will be available on the Atellica Solution immunoassay analyser, which can run up to 440 tests per hour and will provide 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 analysers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these platforms ensures more patients are tested in a shorter time.

The test will join a robust diagnostics portfolio from Siemens Healthineers currently aiding in the prognosis, treatment and follow-up of COVID-19 patients. For example, the molecular Fast Track Diagnostics (FTD) SARS-CoV-2 test kit is used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Additionally, the company’s imaging, blood gas, and broad and differentiated menu of tests, including D-dimer, provide actionable results that aid in the care of infected patients.