Siemens Healthineers has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 total antibody test.
The EUA status allows the laboratory-based Siemens Healthineers Total Antibody COV2T assay to identify the presence of SARS-CoV-2 antibodies, including IgM and IgG in blood.
The total antibody test enables to detect patients who have developed an adaptive immune response, which indicates recent infection or previous exposure.
A spike protein on the surface of the SARS-CoV-2 virus allows the virus to enter and infect human cells in multiple organs and blood vessels, said the company.
Siemens Healthineers Total Antibody COV2T assay has been developed for the detection of antibodies attached to the spike protein. These antibodies are expected to neutralise the SARS-CoV-2 virus and prevent infection.
High-throughput analysers are suitable to run the SARS-CoV-2 total antibody test
The SARS-CoV-2 total antibody test can be run on high-throughput analysers, including the Atellica IM immunoassay analysers.
Atellica IM immunoassay analyser, which has the capacity to run up to 440 tests per hour, can deliver results within 10 minutes.
ADVIA Centaur XP and XPT analysers will help run up to 240 samples per hour with a result in 18 minutes.
Siemens said that it has started shipping comparable antibody tests for Dimension Vista and Dimension EXL systems, helping to expand the clinical reach across the firm’s 20,000 systems installed across the world.
The company has developed the tests in the epicentre of the pandemic, manufactured in Walpole facility of Massachusetts and Newark facility of Delaware, as well as distributed from Plainfield facility in Indiana.
Siemens Healthineers laboratory diagnostics president Dr Deepak Nath said: “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.
“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.”
In April this year, Siemens Healthineers introduced a molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit.
