1. COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing
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Siobhan Campbell, Susan Hopkins, Richard Sedgewick, Kelly Hollier, Wendy Byrne, Ashley Pegg, Scott Nicol, Kimerbley Webster, Suzannah Pegler, Lottie Rawden, Gillian Rodger, Beverley Buck, Richard Clarke, Tom G. Ritter, Sally Hammond, Derrick W. Crook, Sulaksan Panchalingam, Deborah Wright, Victoria Hardy, Kathryn J Saunders, Matthew Catton, Sarah Mckee, Mark Pinkerton, Gloria Calderon, Joanne Waldron, Andrew Harris, Rishab Balaji, Dominic Affron, Penny Carter, Bea Choi, Ian Wickens, Chris D. Turnbull, Elena Hazell, Silvia D'Arcangelo, Tillie Graham, Alex Sienkiewicz, Louise Oliver, Arabella Legard, Freddie Mellor, Rima Colston, Geeta Ghadiali, Ella Baldwin, Stephen W. Wilson, Tim Brooks, Kate Webberley, T Peto, Pam Devall, Jenny Wang, Daniel P. Carter, Elena Turek, Shaolin Chidavaenzi, Gemma Nanson, Kate Allen, James Connolly, Mary-Anne Darby, Caroline Coulson, May Havinden-Williams, Emma Marshall, Mark Driver, Pauline Brown, Beinn Khulusi, Iman Aurfan, Codie Fahey, Zoe Lampshire, Emily A. Protheroe, Antoinette McNulty, Alison Vaughan, T Lockett, Sally-Anne Hurford, Juan Dobaldo Pavon, Rangeni Zinyama, John I. Bell, Toi Neibler, Heena Mistry, Helen Permain, Lorraine Archer, Neil McLeod, Amelia Sterry, Susan Johnston, Alexander Grassam-Rowe, Ruth Johns, Sian Tiley, Olivia Carr, Carly Tibbins, Arro Peace, Christopher H. Logue, Narindar Ghuman, Ellena Badenoch, Carla Bratten, Ashley Price, Patrick Robinson, Sophie Barraclough, Bertie Rowell, Marie Corcoran, Mollie French, Daniel Myers, Emily Eaton, Sophie Moore, Anna Sherkat, Julie Miller, Susan Ridge, Hellen Purnell, Tanzina Chaudary, Juliet Jones, Laura Seeney, Jim Chadwick, Julie Timmins, Sarah Hoosdally, Des Markham, John Vertannes, Sami Tatar, Richard Vipond, Lennard Y. W. Lee, Sara Read, Anita Agasu, Rosaline de Koning, Tegan Gumsley-Read, Ben Holloway, Thomas Knight, Cathy Rowe, Beth Hanney, Herika Willis, Shelha Siddiqui, Aleksander Stawiarski, Kevin K Chau, Ellie Watson, Simon Clark, Babak Afrough, Cara Tomas-Smith, Margaret Broughton-Smith, James O. Robinson, Joy Edwards, Ranoromanana Evans, Thomas Starkey, Anna Gronert, Graham Ellis, Lavanya Sinha, Jane Willcocks, Miriam Avery, Collette Allen, Natasha Ashbridge, Jane Mitchell, Natalie Draper, Anuradha Krishna, Kate Trigg-Hogarth, Bindhu Xavier, Joe Stevens, Leon Peto, Anila Sukumaran, Joseph Gernon, Emma Stanton, Alice Field, Rachel Evans, Vindhya Maripuri, Iftikhar Khan, Justin Liu, Jewel Jones Nwanaforo, Samatha Chilcott, Eloïse Cook, Sharon Kempson, Tom Foord, Lucy Hughes, Vanessa Lucas, Ben Corley, Chris Bridgeman, Grace Westland, David W Eyre, Sally Gordon, Peter Hammond, Kayleigh Collins, Priya Bagga, Gurvinder Gill, Claire Hall, Philippa C Matthews, Dominic Britton, Pauline Derbyshire, Jasmine Gan, Steve Hurdowar, Lloyd Shail, Harry Nuttall, Sheila F Lumley, Becky Evans, Mika Erik Moeser, Dimitris Papoulidis, Lucy Sheppard, Zarina Mirza, Rachel Michel, David Chapman, Kate Ellis, Bassam Hallis, Hannah Fuchs, Jodie Owen, Dawn Clarke, Joanne Henry, Sue Elwell, Rosie Boulton, Vanessa Fenech, Laura Costello, Alison Allanson, Mike Newbury, Prem Perumal, Mary Walters, Angela Bloss, Kate Gilmour, Charles Reynard, Mark A. Ainsworth, Jennifer Smith, Philip Walker, Tim E. A. Peto, Amanda Selassie, Lisa Zeidan, Jane Shallcross, Oliver Topping, Linda Wagstaff, Liam J Peck, Ella Smith, Karen Pearson, Thanh Pham, John Davis, Elizabeth Truelove, Kerry Gibbons, David Tyrrell, David Green, Wendy Osbourne, Anika Goel, Harriet Jackson, Michelle Platton, Daniel Lasserson, Barbara Wilson, Susan Bird, Mark Dolman, Tracy Benford, Joanne Jackman, Marion Evans, Nicole Stoesser, Jackie Sears, Alex Mighiu, Elaine Butcher, Ashley Otter, Akhila Muthuswamy, Tom Fowler, Janet Field, Angela Sweed, Katie Keating-Fedders, Megan Cathrall, Richard Body, Abbie Bown, Gabriella Harker, Richard Clayton, Kim Hicklin, Ant Crook, Sarah Sampson, Sarah Dyas, Cristina Leggio, Hannah Claasen, Rachel Sayers, Louise Woodhead, Carol Beane, Fiona Yelnoorkar, Jake Osbourne, Marina Bishop, Tinashe Kanyowa, Hema Thomas, Ruth Elderfield, H Pickford, Alexandra Rowlands, Patrick Lahert, Kirsten Lee, Ann Sarah Walker, Mark Stockbridge, and Deborah F. McKee
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VIral antigen detection ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,LFD ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Testing ,Population ,National evaluation ,01 natural sciences ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,Lateralflow devices ,Lateral flow tests ,Medicine ,Sampling (medicine) ,030212 general & internal medicine ,0101 mathematics ,education ,Lateral flow ,Public health ,education.field_of_study ,SARS-CoV-2 ,business.industry ,010102 general mathematics ,COVID-19 ,General Medicine ,Coronavirus ,United kingdom ,Cohort ,Emergency medicine ,False positive rate ,business ,Research Paper - Abstract
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.
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- 2021