The Siemens Healthineers SARS-CoV-2 Total Antibody Test is CE-marked and FDA-approved for Emergency Use. The test detects the presence of IgM and IgG antibodies in the blood. This allows the identification of patients who have developed an adaptive immune response, indicating prior exposure to COVID-19.
Crucially, the test identifies antibodies against a key protein on the surface of the SARS-CoV-2 virus, a spike protein that binds the virus to human cells. Several potential vaccines in development for SARS-CoV-2 include spike protein within their focus, increasing the possibility that the Siemens Healthineers total antibody test could support the determination of the effectiveness of these vaccines in the future.
“High-quality antibody testing will be critical to successfully reopening economies around the world. From the beginning, our mission has been to develop high-precision tests for SARS-CoV-2 and we now have an external evaluation confirming that our test offers exceptional quality, ”said Deepak Nath, Ph.D.
President of Laboratory Diagnostics at Siemens. Healthineers. “Laboratories around the world can be confident that our assay offers the sensitivity and specificity that we promised.”
The role of public health in England
Public Health England is an executive agency of the Department of Health and Welfare and is not a regulator. PHE evaluations confirm that the Siemens Healthineers SARS-CoV-2 Total Antibody Test meets the target product profile.2 The Siemens Healthineers SARS-CoV-2 Total Antibody Test has been CE marked prior to testing by PHE.
The CE mark confirms that the test complies with EU regulatory standards and that it could already be legally marketed in the UK and the other Member States. Siemens Healthineers announced on June 1 that it received an Emergency Use Authorization from the FDA in the United States.