Research and analysis

COVID-19: head to head laboratory evaluation of 4 commercial serological assays

An independent appraisal of assay performance to determine performance metrics with precision using a large, well-characterised sample set.

• From: Public Health England
• Published: 8 July 2020

Documents

Evaluation of sensitivity and specificity of 4 commercially available SARS-CoV-2 antibody immunoassays

PDF, 3.76 MB, 31 pages

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Details

In partnership with academic collaborators at the University of Oxford and Oxford University Hospitals, PHE Porton Down carried out a head-to-head evaluation of 4 commercially available assays against the Medicines and Healthcare products Regulatory Agency (MHRA) Target Product Profile for laboratory tests to detect production of SARS-CoV-2 antibodies. This was in response to a commission from the Secretary of State for Health and Social Care.

The 4 commercial tests considered were manufactured by Abbott, DiaSorin, Roche and Siemens. Positive and negative sample sets were assembled for the evaluation comprising of approximately 1,000 pre-pandemic (negative) and over 500 positive convalescent samples from individuals confirmed to have had SARS-CoV-2 infection.

Published 8 July 2020