Public Health England Study Evaluates Siemens Healthineers SARS-CoV-2 Antibody Test Against Other Leading Antibody Assays
Jul 19 2020 Read 1118 Times
Public Health England, in partnership with the University of Oxford, recently conducted a head-to-head evaluation of four commercial immunoassay tests available in the UK and used for the detection of SARS-CoV-2 antibodies. Siemens Healthineers’ laboratory-based total antibody test distinguished itself as the only assay tested found to meet both the sensitivity and specificity requirements set out within the Target Product Profile (TPP) for immunoassays by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The test is broadly available globally.
The evaluation was commissioned by the Department of Health and Social Care (DHSC) and conducted by Public Health England, the clinical research team at the University of Oxford and Oxford University Hospitals NHS Foundation Trust. Several commercial antibody tests were appraised over a three-week period in May - June 2020, with a view to assessing respective performance metrics on precision, using a large, well-characterised sample set. Primary data included evaluation of the assays’ sensitivity and specificity, each of which is key to assessing the overall clinical performance of a test.
The SARS-CoV-2 total antibody test from Siemens Healthineers is CE marked and has FDA Emergency Use Authorization. The test detects the presence of both IgM and IgG antibodies in blood. This allows for the identification of patients who have developed an adaptive immune response, indicating prior exposure to COVID-19. Critically, the test identifies antibodies to a key protein on the surface of the SARS-CoV-2 virus – a spike protein, which binds the virus to human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus, raising 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 tests will be critical to successfully reopening economies across the globe. From the start, our mission has been to develop highly accurate tests for SARS-CoV-2 and now we have an external appraisal that confirms our test offers exceptional quality,” said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. “Laboratories worldwide can be confident that our assay delivers the sensitivity and specificity we promised.”
Do you like or dislike what you have read? Why not post a comment to tell others / the manufacturer and our Editor what you think. To leave comments please complete the form below. Providing the content is approved, your comment will be on screen in less than 24 hours. Leaving comments on product information and articles can assist with future editorial and article content. Post questions, thoughts or simply whether you like the content.
In This Edition Articles - The Movement Towards More Comprehensive Testing of Mycotoxins in Cannabis - Addressing proper HACCP implementation - Micropatterning: The art of micro-controlling...
View all digital editions
Feb 23 2021 Cologne, Germany
Feb 28 2021 Virtual event
Mar 03 2021 Guanghzou, China
Mar 08 2021 Virtual Event
Mar 22 2021 Digital event