CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2020—Public Health England evaluated four commercial immunoassay tests used for the detection of SARS-CoV-2 antibodies and available in the United Kingdom.
The evaluation was commissioned by the Department of Health and Social Care and conducted by PHE and the clinical research team at the University of Oxford and Oxford University Hospitals NHS Foundation Trust. The antibody tests were appraised over a three-week period during May and June, with a view to assessing respective performance metrics on precision, using a large, well-characterized sample set. Primary data included evaluation of the assays’ sensitivity and specificity.
Siemens Healthineers’ laboratory-based total antibody test, the company reported, “distinguished itself as the only assay tested found to meet both the sensitivity and specificity requirements” set out within the Target Product Profile for immunoassays by the United Kingdom’s Medicines and Healthcare products Regulatory Agency.