Abbie Bown, Tim Peto, Angela Sweed, Matthew Catton, Joshua Nelthorpe-Cowne, Tracy Benford, Tom Collinge, Donna Robinson, Louise Oliver, Susan Hopkins, Derrick Crook, Somya Agrawal, Hannah Fordham, Tom Fowler, Alex Sienkiewicz, Ann Sarah Walker, Sir John Bell, Richard Vipond
{"title":"Laboratory evaluation of 185 commercial assays for detecting SARS-CoV-2: the UK response for mass testing.","authors":"Abbie Bown, Tim Peto, Angela Sweed, Matthew Catton, Joshua Nelthorpe-Cowne, Tracy Benford, Tom Collinge, Donna Robinson, Louise Oliver, Susan Hopkins, Derrick Crook, Somya Agrawal, Hannah Fordham, Tom Fowler, Alex Sienkiewicz, Ann Sarah Walker, Sir John Bell, Richard Vipond","doi":"10.1016/j.eclinm.2025.103416","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In August 2020, Public Health England and Oxford University were commissioned to design and deliver (with NHS Test and Trace, NHSTT) a rapid evaluation programme of antigen Lateral Flow Devices (LFDs) for SARS-CoV-2 for mass community testing.</p><p><strong>Methods: </strong>A three-phase evaluation process was established: 1) desktop review of kits including claimed performance and supply; 2) laboratory testing with laboratory-grown SARS-CoV-2 virus and SARS-CoV-2 virus PCR negative volunteer samples; and 3) larger-scale laboratory testing of SARS-CoV-2 PCR positive and negative clinical samples. Variant of Concern (VOC) identification in the UK (December 2020), expanded laboratory methodology. Processes also evolved to improve workflow (irradiated viral stocks, dilution matrices, sample volumes, and replicates).</p><p><strong>Findings: </strong>Overall, 1017 kits were screened at phase 1, 185 kits tested at phase 2 and 91 at phase 3. Sixteen kits failed phase 3 due to poor performance and eight more failed to detect VOC satisfactorily. Sixty-four kits were redesigns of previously failed kits. The overall pass rate for the laboratory evaluation was 35% and 5 kits were procured for the UK National Covid 19 Testing Programme.</p><p><strong>Interpretation: </strong>The evaluation results had potential, time limited commercially sensitive aspects, and public sharing was limited to kits passing phase 3. Until now, the full data set has not been published. Over 2.5 billion self-test kits were deployed by the UK government following purchasing decisions informed by this work. We offer a potential blueprint for future evaluation programmes that might be required to assess LFDs to detect cases of a pandemic novel pathogen.</p><p><strong>Funding: </strong>This study was funded by UK Department of Health and Social Care (UKHSA); UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of OxfordNIHRBiomedical Research Centre.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103416"},"PeriodicalIF":10.0000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496213/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2025.103416","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}
引用次数: 0
Abstract
Background: In August 2020, Public Health England and Oxford University were commissioned to design and deliver (with NHS Test and Trace, NHSTT) a rapid evaluation programme of antigen Lateral Flow Devices (LFDs) for SARS-CoV-2 for mass community testing.
Methods: A three-phase evaluation process was established: 1) desktop review of kits including claimed performance and supply; 2) laboratory testing with laboratory-grown SARS-CoV-2 virus and SARS-CoV-2 virus PCR negative volunteer samples; and 3) larger-scale laboratory testing of SARS-CoV-2 PCR positive and negative clinical samples. Variant of Concern (VOC) identification in the UK (December 2020), expanded laboratory methodology. Processes also evolved to improve workflow (irradiated viral stocks, dilution matrices, sample volumes, and replicates).
Findings: Overall, 1017 kits were screened at phase 1, 185 kits tested at phase 2 and 91 at phase 3. Sixteen kits failed phase 3 due to poor performance and eight more failed to detect VOC satisfactorily. Sixty-four kits were redesigns of previously failed kits. The overall pass rate for the laboratory evaluation was 35% and 5 kits were procured for the UK National Covid 19 Testing Programme.
Interpretation: The evaluation results had potential, time limited commercially sensitive aspects, and public sharing was limited to kits passing phase 3. Until now, the full data set has not been published. Over 2.5 billion self-test kits were deployed by the UK government following purchasing decisions informed by this work. We offer a potential blueprint for future evaluation programmes that might be required to assess LFDs to detect cases of a pandemic novel pathogen.
Funding: This study was funded by UK Department of Health and Social Care (UKHSA); UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of OxfordNIHRBiomedical Research Centre.
背景：2020年8月，英国公共卫生部和牛津大学受委托（与NHS Test and Trace合作）设计并提供一个用于大规模社区检测的SARS-CoV-2抗原侧流装置（LFDs）快速评估计划。方法：建立三个阶段的评估流程：1)桌面审查试剂盒，包括声称的性能和供应；2)实验室检测实验室培养的SARS-CoV-2病毒和PCR阴性志愿者样本；3)加大实验室检测SARS-CoV-2 PCR阳性和阴性临床样本。英国VOC识别（2020年12月），扩展实验室方法。改进工作流程的过程也在不断发展（辐照病毒库、稀释基质、样本量和重复）。结果：总体而言，在第一阶段筛选了1017个试剂盒，在第二阶段测试了185个试剂盒，在第三阶段测试了91个试剂盒。16个试剂盒由于性能不佳而未能通过第3阶段，另有8个试剂盒未能令人满意地检测VOC。64个套件是对先前失败套件的重新设计。实验室评估的总体通过率为35%，为英国国家Covid - 19检测计划采购了5个试剂盒。解释：评估结果具有潜在的、时间有限的商业敏感性，并且仅限于通过第3阶段的试剂盒的公开共享。直到现在，完整的数据集还没有公布。英国政府根据这项工作做出的采购决定部署了超过25亿套自检试剂盒。我们为未来的评估规划提供了一个潜在的蓝图，这些规划可能需要评估lfd以发现大流行新型病原体的病例。资助：本研究由英国卫生和社会保障部（UKHSA）资助；英国卫生安全局（原英格兰公共卫生部和国民卫生服务检测与追踪局）；以及牛津大学nihr生物医学研究中心。
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
