Background: Lateral flow device (LFD) viral antigen immunoassays have been developed around the world as diagnostic tests for SARS-CoV-2 infection. They have been proposed to deliver an infrastructure-light, cost-economical solution giving results within half an hour.
Methods: LFDs were initially reviewed by a Department of Health and Social Care team, part of the UK government, from which 64 were selected for further evaluation from 1st August to 15th December 2020. Standardised laboratory evaluations, and for those that met the published criteria, field testing in the Falcon-C19 research study and UK pilots were performed (UK COVID-19 testing centres, hospital, schools, armed forces).
Findings: 4/64 LFDs so far have desirable performance characteristics (orient Gene, Deepblue, Abbott and Innova SARS-CoV-2 Antigen Rapid Qualitative Test). All these LFDs have a viral antigen detection of >90% at 100,000 RNA copies/ml. 8951 Innova LFD tests were performed with a kit failure rate of 5.6% (502/8951, 95% CI: 5.1-6.1), false positive rate of 0.32% (22/6954, 95% CI: 0.20-0.48). Viral antigen detection/sensitivity across the sampling cohort when performed by laboratory scientists was 78.8% (156/198, 95% CI 72.4-84.3).
Interpretation: Our results suggest LFDs have promising performance characteristics for mass population testing and can be used to identify infectious positive individuals. The Innova LFD shows good viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training are potential issues. These results support the expanded evaluation of LFDs, and assessment of greater access to testing on COVID-19 transmission.
Bibliographical noteNote: Only persons listed in the writing committee are listed here. The full list of authors can be found in the appendix at https://doi.org/10.1016/j.eclinm.2021.100924
Funding Information: Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.
The report presents independent research funded by the National Institute for Health Research, Wellcome Trust and the Department of Health. The views expressed in this publication are those of the authors and not necessarily those of the NHS, Wellcome Trust, the National Institute for Health Research, the Department of Health or Public Health England.
The authors thank the participants and their families affected by COVID-19, NHS doctors and nurses and other medical staff, research scientists and support staff at Public Health England, Porton Down, NHS Test and Trace COVID-19 testing centres staff, the NIHR research network, the University of Birmingham medical school, the University of Oxford medical school, the University of Newcastle medical school, NHS Test and Trace and St John Ambulance. We would like to thank all members of the UK Lateral flow oversight group in contributing data at a challenging time as listed in the web appendix (appendix page 1), We would like to acknowledge the Department of Health and Social Care, NIHR, University of Manchester and University of Oxford Biomedical Research Council in funding this study. The NHS and funders had no role in data collection, analysis or decision to publish.
Open Access: This is an open access article under the CC BY-NC-ND license
Publisher Copyright: © 2021 The Author(s). Published by Elsevier Ltd.
Citation: Peto, Tim, et al. "COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing." EClinicalMedicine 36 (2021): 100924.
- Lateral flow
- Lateral flow tests
- Lateralflow devices
- National evaluation
- Public health
- United kingdom
- VIral antigen detection
- Viral antigen detection