Public Health England (PHE) in partnership with the University of Oxford has conducted a head-to-head evaluation of four commercial immunoassay tests available in the UK, used for the detection of SARS-CoV-2 antibodies. Siemens Healthineers’ laboratory-based total antibody test was found to meet both the sensitivity and specificity requirements set out within the target product profile for enzyme immunoassays by the UK Medicines and Healthcare products Regulatory Agency. The test, which is being shipped globally, is now available in the UK and Ireland, with capacity for up to one million to be distributed monthly in these countries.
The evaluation was commissioned by the Department of Health and Social Care and conducted by PHE, 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 to June, in order to determine performance metrics with precision, using a large, well-characterised sample set. Primary data includes an evaluation of sensitivity and specificity metrics, key to determining the overall effectiveness of a test.
The SARS-CoV-2 total antibody test from Siemens Healthineers is CE marked and 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 that binds the virus to human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein in 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.
Picture: The Siemens Healthineers SARS-CoV-2 total antibody test detects antibodies believed to neutralise the virus; specifically targeting antibodies that attach to a spike protein on the surface of the virus.
Published on page 20 of the August 2020 issue of RAD Magazine.