Siemens Healthineers said Wednesday that it would significantly expand its testing capacity for infectious diseases to deal with the new coronavirus.
The company has developed a diagnostics-based total antibody test that can detect the antibody of SARS-CoV-2 in the blood. The test can find both the antibodies of immunoglobin M (IgM) and immunoglobin (IgG)
Covid-19 patients form antibodies as a response to the virus in their body, and the antibody test checks for immune reaction in the blood. The test gives a clear view of the progress of the disease as it identifies those who developed immunity against Covid-19 after being infected. It also can confirm infection of people who have not been diagnosed or show no symptoms.
Siemens Healthineers is drastically expanding its manufacturing facility in Massachusetts State, U.S., to secure a sufficient amount of tests in the second half of this year. The company is preparing to apply for emergency use approval to the U.S. Food and Drug Administration and win the Conformite Europeen mark.
The company’s analyzing system can run up to 440 tests per hour and give results in as early as 14 minutes. Siemens Healthineers also plans to run a serology test, which will deliver up to 240 tests an hour and produce results in 18 minutes. These tests will allow more patients to receive tests quickly before long.
The new test can make rapid diagnoses because it can draw results within 14 minutes from the Atellica Solution immunoassay device, which can perform 440 tests per hour.
Also, the results can be confirmed in 18 minutes with ADVIA Centaur XP and XPT immunoassay system capable of conducting 240 tests per hour. This will allow more patients to get tested in a short time using Siemens Healthineers' existing platform.
"Siemens Healthineers is working hard to meet the need for high-quality tests to fight against Covid-19. Our antibody test has excellent precision and sensitivity that we expect for serum analysis,” said Deepak Nath, head of Laboratory Diagnostics at Siemens Healthineers. “I am proud of our staff who developed this test at the forefront to end the pandemic."
The test will fortify the existing testing portfolio of Siemens Healthineers by supporting the prognosis, treatment and follow-up of Covid-19 patients. For instance, the company's molecular fast track diagnostics SARS-CoV-2 test kit is used to help diagnose infection.
Moreover, the company's extensive and diverse tests, including medical imaging, blood gas system, and D-Dimer assay, are used to treat acutely infected patients.