COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing.
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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DOI：
10.1016/j.eclinm.2021.100924
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发表时间：
2021-06
影响因子：
15.1
通讯作者：
UK COVID-19 Lateral Flow Oversight Team
中科院分区：
文献类型：
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作者：
Peto T;UK COVID-19 Lateral Flow Oversight Team
侧流装置（LFD）病毒抗原免疫测定已在世界各地开发作为SARS-CoV-2感染的诊断测试。他们被提议提供一个基础设施轻，成本经济的解决方案，在半小时内提供结果。LFD最初由英国政府卫生和社会保障部团队进行审查，从中选出64名LFD在2020年8月1日至12月15日期间进行进一步评估。标准化的实验室评估，对于那些符合公布标准的，在Falcon-C19研究和英国试点中进行了现场测试（英国COVID-19检测中心，医院，学校，武装部队）。到目前为止，64个LFD中有4个具有理想的性能特征（orient Gene、Deepblue、Abbott和Innova SARS-CoV-2抗原快速定性检测）。所有这些LFD在100，000 RNA拷贝/ml下具有>90%的病毒抗原检测。进行了8951次Innova LFD检测，试剂盒失效率为5.6%（502/8951，95% CI：5.1-6.1），假阳性率为0.32%（22/6954，95% CI：0.20-0.48）。当由实验室科学家进行时，整个采样队列的病毒抗原检测/灵敏度为78.8%（156/198，95% CI 72.4-84.3）。我们的研究结果表明LFD具有用于大规模群体检测的有希望的性能特征，并且可用于识别传染性阳性个体。Innova LFD显示出良好的病毒抗原检测/灵敏度和出色的特异性，尽管试剂盒故障率和培训的影响是潜在的问题。这些结果支持扩大对LFD的评估，并评估更多的COVID-19传播检测。卫生和社会保健部。牛津大学。公共卫生英格兰波顿唐，曼彻斯特大学NHS基金会信托，国家卫生研究所。
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. 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). 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). 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. 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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DOI：
10.1007/978-1-59745-240-3_1
发表时间：
2008-10-31
期刊：
Lateral Flow Immunoassay
影响因子：
--
作者：
O’Farrell B
通讯作者：
O’Farrell B
影响因子：
19
作者：
Singanayagam, Anika;Patel, Monika;Gopal, Robin
通讯作者：
Gopal, Robin
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier
影响因子：
12.7
作者：
Carmo, Analia;Pereira-Vaz, Joao;Rodrigues, Fernando
通讯作者：
Rodrigues, Fernando
DOI：
10.1016/j.jcv.2020.104659
发表时间：
2020-12
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
--
作者：
Linares M;Pérez-Tanoira R;Carrero A;Romanyk J;Pérez-García F;Gómez-Herruz P;Arroyo T;Cuadros J
通讯作者：
Cuadros J