Performance of antigen lateral flow devices in the UK during the alpha, delta, and omicron waves of the SARS-CoV-2 pandemic: a diagnostic and observational study.
| Autor: | Eyre DW; Big Data Institute, Nuffield Department of Population Health, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK; NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, University of Oxford, Oxford, UK. Electronic address: david.eyre@bdi.ox.ac.uk., Futschik M; UK Health Security Agency, London, UK; School of Biomedical Sciences, Faculty of Health, University of Plymouth, Plymouth, UK., Tunkel S; UK Health Security Agency, London, UK., Wei J; Nuffield Department of Medicine, University of Oxford, Oxford, UK., Cole-Hamilton J; UK Health Security Agency, London, UK., Saquib R; UK Health Security Agency, London, UK., Germanacos N; UK Health Security Agency, London, UK., Dodgson AR; UK Health Security Agency, Department of Microbiology, Manchester Public Health Laboratory, Manchester, UK., Klapper PE; Division of Evolution, Infections and Genomics, University of Manchester, Manchester, UK., Sudhanva M; South London Specialist Virology Centre, Infection Sciences, King's College NHS Foundation Trust, London, UK., Kenny C; UK Health Security Agency, London, UK., Marks P; UK Health Security Agency, London, UK., Blandford E; UK Health Security Agency, London, UK., Hopkins S; UK Health Security Agency, London, UK., Peto TEA; NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK; NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, University of Oxford, Oxford, UK; Nuffield Department of Medicine, University of Oxford, Oxford, UK., Fowler T; UK Health Security Agency, London, UK; Queen Mary University of London William Harvey Research Institute, London, UK. |
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| Jazyk: | angličtina |
| Zdroj: | The Lancet. Infectious diseases [Lancet Infect Dis] 2023 Aug; Vol. 23 (8), pp. 922-932. Date of Electronic Publication: 2023 Mar 28. |
| DOI: | 10.1016/S1473-3099(23)00129-9 |
| Abstrakt: | Background: Antigen lateral flow devices (LFDs) have been widely used to control SARS-CoV-2. We aimed to improve understanding of LFD performance with changes in variant infections, vaccination, viral load, and LFD use, and in the detection of infectious individuals. Methods: In this diagnostic study, paired LFD and RT-PCR test results were prospectively collected from asymptomatic and symptomatic participants in the UK between Nov 4, 2020, and March 21, 2022, to support the National Health Service (NHS) England's Test and Trace programme. The LFDs evaluated were the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the Orient Gene Rapid Covid-19 (Antigen) Self-Test, and the Acon Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Test results were collected across various community testing settings, including predeployment testing sites, routine testing centres, homes, schools, universities, workplaces, targeted community testing, and from health-care workers. We used multivariable logistic regression to analyse LFD sensitivity and specificity using RT-PCR as a reference standard, adjusting for viral load, LFD manufacturer, test setting, age, sex, test assistance, symptom status, vaccination status, and SARS-CoV-2 variant. National contact tracing data from NHS Test and Trace (Jan 1, 2021, to Jan 11, 2022) were used to estimate the proportion of transmitting index patients (with ≥1 RT-PCR-positive or LFD-positive contact) potentially detectable by LFDs (specifically Innova, as the most widely used LFD) with time, accounting for index viral load, variant, and symptom status. Findings: We assessed 75 382 pairs of LFD and RT-PCR tests. Of these, 4131 (5·5%) were RT-PCR-positive. LFD sensitivity versus RT-PCR was 63·2% (95% CI 61·7-64·6) and specificity was 99·71% (95% CI 99·66-99·74). Increased viral load was independently associated with being LFD positive (adjusted odds ratio [aOR] 2·85 [95% CI 2·66-3·06] per 1 log Interpretation: LFDs remained able to detect most SARS-CoV-2 infections throughout vaccine roll-out and across different viral variants. LFDs can potentially detect most infections that transmit to others and reduce the risk of transmission. However, performance is lower in asymptomatic individuals than in symptomatic individuals. Funding: UK Health Security Agency, the UK Government Department of Health and Social Care, National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, and the University of Oxford NIHR Biomedical Research Centre. (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.) |
| Databáze: | MEDLINE |
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