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Siemens Healthineers has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a laboratory-based total antibody test for Covid-19.
The Covid-19 test detects the presence of SARS-CoV-2 antibodies, including IgM and IgG in blood. It enables identification of recent or prior Covid-19 infection, based on the patient’s adaptive immune response to the virus.
Test data demonstrated 100% sensitivity and 99.8% specificity, the company noted.
The SARS-CoV-2 virus penetrates and infects human cells found in multiple organs and blood vessels, using a spike protein found on its surface.
The Siemens Healthineers total antibody COV2T assay is developed to detect antibodies to the spike protein. The antibodies are anticipated to prevent infection by neutralising the SARS-CoV-2 virus.
In addition, multiple potential vaccines, which are currently in development for Covid-19, mostly focus on spike protein.
Siemens Healthineers Laboratory Diagnostics president 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.”
The test uses Atellica IM immunoassay analysers, which can test approximately 440 samples an hour and deliver a result in ten minutes.
It is also available on the company’s expansive installed base of ADVIA Centaur XP and XPT analysers, which can run up to 240 samples an hour with the result provided in 18 minutes.
Siemens Healthineers has shipped over one million tests to health systems and laboratories to immediately begin testing. The company will scale up the production to deliver more than 50 million tests a month across its testing platforms.