Health Policy
Covid antibody test from Siemens Healthineers satisfies mass screening criteria in PHE evaluation

By - Integrated Care Journal

New SARS-CoV-2 total antibody tests are appraised by Public Health England (PHE) in a new head-to-head evaluation of commercial tests in the UK.

Public Health England, 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 (TPP) for enzyme immunoassays by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The test, which is also being shipped globally, is now available in the UK and Ireland, with capacity for up to one million to be distributed monthly in these territories.

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, 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, 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.

“From the start, our mission has been to develop a highly accurate test for SARS-CoV-2 and we’re proud to see an external appraisal that confirms this,” states Stewart Hutton, Business Lead for Diagnostics at Siemens Healthineers GB&I.

“Our total antibody test was the only assay evaluated by PHE to meet both the sensitivity and specificity profile within the ‘Target Product Profile for enzyme immunoassays’ developed by the MHRA, specifically in support of Pillar 3 of the UK testing strategy. We encourage the utility of our assay to be further considered if it is wished to deliver the most accurate picture of virus exposure in the UK population,” he adds.

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The role of Public Health England 

Public Health England is an executive agency of the Department of Health and Social Care and is not a regulator. PHE evaluations confirm that the Siemens Healthineers SARS-CoV-2 total antibody test meets the Target Product Profile. The Siemens Healthineers SARS-CoV-2 total antibody test has received the CE mark before PHE testing. The CE mark confirms that the test meets EU regulatory standards and could already be lawfully placed on the market in the UK and other Member States.

Find out more here.

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