TY - JOUR
T1 - COVID-19
T2 - Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing
AU - UK COVID-19 Lateral Flow Oversight Team
AU - Peto, Tim
AU - Affron, Dominic
AU - Afrough, Babak
AU - Agasu, Anita
AU - Ainsworth, Mark
AU - Allanson, Alison
AU - Allen, Katherine
AU - Allen, Collette
AU - Archer, Lorraine
AU - Ashbridge, Natasha
AU - Aurfan, Iman
AU - Avery, Miriam
AU - Badenoch, Ellena
AU - Bagga, Priya
AU - Balaji, Rishab
AU - Baldwin, Ella
AU - Barraclough, Sophie
AU - Beane, Carol
AU - Bell, John
AU - Benford, Tracy
AU - Bird, Susan
AU - Bishop, Marina
AU - Bloss, Angela
AU - Body, Richard
AU - Boulton, Rosie
AU - Bown, Abbie
AU - Bratten, Carla
AU - Bridgeman, Chris
AU - Brooks, Tim
AU - Broughton-Smith, Margaret
AU - Buck, Beverley
AU - Butcher, Elaine
AU - Byrne, Wendy
AU - Calderon, Gloria
AU - Campbell, Siobhan
AU - Carr, Olivia
AU - Carter, Penny
AU - Carter, Daniel
AU - Cathrall, Megan
AU - Catton, Matthew
AU - Chadwick, Jim
AU - Chau, Kevin K.
AU - Chaudary, Tanzina
AU - Chidavaenzi, Shaolin
AU - Chilcott, Samatha
AU - Choi, Bea
AU - Claasen, Hannah
AU - Clarke, Richard
AU - Clarke, Dawn
AU - Reynard, Charles
N1 - Funding Information:
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.
Funding Information:
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.
Funding Information:
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.
Publisher Copyright:
© 2021 The Author(s)
PY - 2021/5/29
Y1 - 2021/5/29
N2 - 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. Funding: Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.
AB - 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. Funding: Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.
KW - Coronavirus
KW - COVID-19
KW - Lateral flow
KW - Lateral flow tests
KW - Lateralflow devices
KW - LFD
KW - National evaluation
KW - Public health
KW - SARS-CoV-2
KW - Testing
KW - United kingdom
KW - VIral antigen detection
U2 - 10.1016/j.eclinm.2021.100924
DO - 10.1016/j.eclinm.2021.100924
M3 - Article
AN - SCOPUS:85107149706
SN - 2589-5370
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 100924
ER -