Siemens Healthineers announced the U.S. Food and Drug Administration has issued an Emergency Use Authorization for its laboratory-based total antibody test to detect the presence of coronavirus antibodies.
Siemens Healthineers Glasgow, DE operation is one of two manufacturing sites for the tests.
The total antibody test, which has a low rate of false positives, allows for the identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.
Testing can begin immediately with more than one million tests already shipped to health systems and laboratories.
A spike protein on the surface of the SARS-CoV-2 virus enables the virus to penetrate and infect human cells found in multiple organs and blood vessels, according to a company release.
The Siemens Healthineers Total Antibody COV2T assay was designed to detect antibodies to the spike protein. The antibodies are believed to neutralize the virus and prevent infection. Multiple potential vaccines in development for COVID-19 include the spike protein within their focus.
“As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with the capacity and reach necessary to help address a critical societal need,” said Deepak Nath, president, Laboratory Diagnostics, Siemens Healthineers. “The test targets both IgM and IgG antibodies, which allows for early identification of individuals infected with the virus who have developed an immune response, even if they were asymptomatic or never diagnosed with the disease.”
The tests, manufactured in Walpole, MA. and Glasgow, and are distributed from Plainfield, IN. The company is prepared to ramp up production as the pandemic evolves with capacity exceeding 50 million tests per month starting this month.
For further information please see https://www.siemens-healthineers.com/laboratory-diagnostics.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services.
Siemens Healthineers is part of a diversified German company that with a presence in industrial automation, medical technologies railroad equipment and electrical equipment.
