Raghavendran Kulasegaran-Shylini, Abbie Bown, Tom Collinge, Alex Sienkiewicz, David W Eyre, Derrick Crook, Ann Sarah Walker, John Bell, Deborah A Williamson, Isabel Oliver, Mark Wilcox, Sue Hill, Tim Peto, Richard Vipond, Susan Hopkins, Tom Fowler
{"title":"SARS-CoV-2横向流动装置灵敏度评价：系统实验室评估与制造商报告灵敏度的比较","authors":"Raghavendran Kulasegaran-Shylini, Abbie Bown, Tom Collinge, Alex Sienkiewicz, David W Eyre, Derrick Crook, Ann Sarah Walker, John Bell, Deborah A Williamson, Isabel Oliver, Mark Wilcox, Sue Hill, Tim Peto, Richard Vipond, Susan Hopkins, Tom Fowler","doi":"10.1016/j.eclinm.2025.103454","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Self-testing for SARS-CoV-2 infection using lateral flow devices (LFDs) was a key component of the COVID-19 pandemic response; however, LFD performance has shown a high degree of variability. Between August 2020 and July 2023, the UK Health Security Agency (UKHSA), including predecessor organisations, undertook a three-phase SARS-CoV-2 test development and evaluation programme to independently evaluate commercially available SARS-CoV-2 LFDs, incorporating standardised laboratory assessment of test sensitivity. Here we describe results from a comparison of UKHSA laboratory assessment findings with manufacturer-reported LFD sensitivity data.</p><p><strong>Methods: </strong>The UKHSA assessed the sensitivity of LFDs, by laboratory testing of surplus clinical samples from a secondary healthcare setting. These data were compared with manufacturer-reported clinical sensitivity data and analytical sensitivity (limit of detection [LOD; 50% tissue culture infectious dose [TCID<sub>50</sub>]/mL]) from LFD instructions for use (IFU).</p><p><strong>Findings: </strong>UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers' IFU that claimed clinical sensitivity ≥85%, and 49 claimed clinical sensitivity ≥95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity.</p><p><strong>Interpretation: </strong>Laboratory evaluation found no evidence of correlation between manufacturer-reported SARS-CoV-2 LFD sensitivity data and UKHSA laboratory-determined sensitivity, supporting previous reports of discrepancies. Our findings suggest that manufacturer-reported performance data and claims for SARS-CoV-2 LFDs should be interpreted with caution and support the need for independent monitoring and testing, and standardisation of analysis methodologies.</p><p><strong>Funding: </strong>This study was funded by UK Department of Health and Social Care; UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of Oxford NIHR Biomedical Research Centre.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103454"},"PeriodicalIF":10.0000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496196/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluation of SARS-CoV-2 lateral flow device sensitivity: a comparison of systematic laboratory assessments with manufacturer-reported sensitivity.\",\"authors\":\"Raghavendran Kulasegaran-Shylini, Abbie Bown, Tom Collinge, Alex Sienkiewicz, David W Eyre, Derrick Crook, Ann Sarah Walker, John Bell, Deborah A Williamson, Isabel Oliver, Mark Wilcox, Sue Hill, Tim Peto, Richard Vipond, Susan Hopkins, Tom Fowler\",\"doi\":\"10.1016/j.eclinm.2025.103454\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Self-testing for SARS-CoV-2 infection using lateral flow devices (LFDs) was a key component of the COVID-19 pandemic response; however, LFD performance has shown a high degree of variability. Between August 2020 and July 2023, the UK Health Security Agency (UKHSA), including predecessor organisations, undertook a three-phase SARS-CoV-2 test development and evaluation programme to independently evaluate commercially available SARS-CoV-2 LFDs, incorporating standardised laboratory assessment of test sensitivity. Here we describe results from a comparison of UKHSA laboratory assessment findings with manufacturer-reported LFD sensitivity data.</p><p><strong>Methods: </strong>The UKHSA assessed the sensitivity of LFDs, by laboratory testing of surplus clinical samples from a secondary healthcare setting. These data were compared with manufacturer-reported clinical sensitivity data and analytical sensitivity (limit of detection [LOD; 50% tissue culture infectious dose [TCID<sub>50</sub>]/mL]) from LFD instructions for use (IFU).</p><p><strong>Findings: </strong>UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers' IFU that claimed clinical sensitivity ≥85%, and 49 claimed clinical sensitivity ≥95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity.</p><p><strong>Interpretation: </strong>Laboratory evaluation found no evidence of correlation between manufacturer-reported SARS-CoV-2 LFD sensitivity data and UKHSA laboratory-determined sensitivity, supporting previous reports of discrepancies. Our findings suggest that manufacturer-reported performance data and claims for SARS-CoV-2 LFDs should be interpreted with caution and support the need for independent monitoring and testing, and standardisation of analysis methodologies.</p><p><strong>Funding: </strong>This study was funded by UK Department of Health and Social Care; UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of Oxford NIHR Biomedical Research Centre.</p>\",\"PeriodicalId\":11393,\"journal\":{\"name\":\"EClinicalMedicine\",\"volume\":\"87 \",\"pages\":\"103454\"},\"PeriodicalIF\":10.0000,\"publicationDate\":\"2025-08-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496196/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EClinicalMedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eclinm.2025.103454\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2025.103454","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Evaluation of SARS-CoV-2 lateral flow device sensitivity: a comparison of systematic laboratory assessments with manufacturer-reported sensitivity.
Background: Self-testing for SARS-CoV-2 infection using lateral flow devices (LFDs) was a key component of the COVID-19 pandemic response; however, LFD performance has shown a high degree of variability. Between August 2020 and July 2023, the UK Health Security Agency (UKHSA), including predecessor organisations, undertook a three-phase SARS-CoV-2 test development and evaluation programme to independently evaluate commercially available SARS-CoV-2 LFDs, incorporating standardised laboratory assessment of test sensitivity. Here we describe results from a comparison of UKHSA laboratory assessment findings with manufacturer-reported LFD sensitivity data.
Methods: The UKHSA assessed the sensitivity of LFDs, by laboratory testing of surplus clinical samples from a secondary healthcare setting. These data were compared with manufacturer-reported clinical sensitivity data and analytical sensitivity (limit of detection [LOD; 50% tissue culture infectious dose [TCID50]/mL]) from LFD instructions for use (IFU).
Findings: UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers' IFU that claimed clinical sensitivity ≥85%, and 49 claimed clinical sensitivity ≥95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity.
Interpretation: Laboratory evaluation found no evidence of correlation between manufacturer-reported SARS-CoV-2 LFD sensitivity data and UKHSA laboratory-determined sensitivity, supporting previous reports of discrepancies. Our findings suggest that manufacturer-reported performance data and claims for SARS-CoV-2 LFDs should be interpreted with caution and support the need for independent monitoring and testing, and standardisation of analysis methodologies.
Funding: This study was funded by UK Department of Health and Social Care; UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of Oxford NIHR Biomedical Research Centre.
期刊介绍：
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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