Leading SARS-CoV-2 antibody tests meet specificity but fail current sensitivity guidelines
22 July 2020. Related: COVID-19: diagnostics, COVID-19.
Simon Collins, HIV i-Base
A 30-page report from Public Health England (PHE) found that four leading SARS-CoV-2 antibody tests – from Abbott, DiaSorin, Roche, and Siemens – met criteria for specificity, but that only the Siemens test also met requirements for sensitivity.
The study by independent researchers at the University of Oxford and Oxford University Hospitals NHS Foundation Trust was commissioned by the Department of Health and Social Care (DHSC).
Sensitivity was tested on 536 positive samples from adults with laboratory-confirmed SARS-CoV-2 infection at >20 days post-symptom onset. Specificity was tested on 994 pre-pandemic (2015-2018) specimens from unique, healthy adults.
Primary results are shown in Table 1.
In order for all four tests to meet sensitivity criteria, specificity thresholds needed to be optimized to >98% and the sample timeframe extended to >30 days post-symptom onset.
Table 1: Sensitivity and specificity of four commercial SARS-CoV-2 antibody tests
| Assay | Sensitivity [95% CI] |
Specificity [95% CI] |
Appraisal against MHRA target product profile (TPP) |
| Abbott | 92.7 (90.2, 94.8) | 99.9 (99.4, 100) | Meets specificity criterion |
| DiaSorin | 95.0 (92.8, 96.7) | 98.6 (97.6, 99.2) | Meets specificity criterion |
| Roche | 97.2 (95.4, 98.4) | 99.8 (99.3, 100) | Meets specificity criterion |
| Siemens | 98.1 (96.6, 99.1) | 99.9 (99.4, 100) | Meets sensitivity and specificity criteria |
Reference
PHE. Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. (July 2020).
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/898437/Evaluation__of_sensitivity_and_specificity_of_4_commercially_available_SARS-CoV-2_antibody_immunoassays.pdf (PDF)
This report was first published on 10 July 2020.