Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings.
Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings.
复制标题
DOI：
10.1371/journal.ppat.1008817
复制
发表时间：
2020-09
期刊：
影响因子：
6.7
通讯作者：
Edgeworth JD
中科院分区：
文献类型：
--
作者：
Pickering S;Betancor G;Galão RP;Merrick B;Signell AW;Wilson HD;Kia Ik MT;Seow J;Graham C;Acors S;Kouphou N;Steel KJA;Hemmings O;Patel A;Nebbia G;Douthwaite S;O'Connell L;Luptak J;McCoy LE;Brouwer P;van Gils MJ;Sanders RW;Martinez Nunez R;Bisnauthsing K;O'Hara G;MacMahon E;Batra R;Malim MH;Neil SJD;Doores KJ;Edgeworth JD
对准确的SARS-CoV-2抗体检测有明确的要求，作为现有诊断能力的补充，并用于确定社区血清阳性率。因此，我们评估了各种抗体检测技术的性能以及它们作为诊断工具的潜在用途。研制了用于检测抗S蛋白(S)、受体结合域(RBD)和核衣壳蛋白(N)抗体的高度特异的内部ELISA，并用于10种商业血清学分析方法的交叉比较，这些方法包括1个基于化学发光的平台、2个ELISA和7个胶体金侧向流动免疫分析(LFIA)，在同一组110份SARS-CoV-2阳性样本和50份大流行前阴性样本上进行了交叉比较。不同平台的表现差异很大，特异性在82%到100%之间，总体敏感性在60.9%到87.3%之间。然而，对同一样本集进行的多项血清诊断分析的逐头比较显示，性能高度依赖于采样时间，当评估症状出现后20天以上的样本时，在几项测试中的灵敏度超过95%。此外，这些分析确定了明确的外围样本，这些样本在所有测试中均为阴性，但后来被证明来自疾病表现最轻微的个人。抗体检测平台的严格比较将为在医疗保健环境中部署护理点技术及其在监测SARS-CoV-2感染方面的使用提供信息。基于聚合酶链式反应的新型冠状病毒(SARS-CoV-2)咽喉和鼻拭子检测可以确定某人是否感染了该病毒，而抗体检测可以确定某人过去是否感染过该病毒。然而，对于疾病后期的诊断，或在诸如儿科炎症性多系统综合征(PIMS)等延迟发作综合征中，抗体测试可以构成医院诊断能力的重要组成部分。它们也将是患者管理策略和社区血清抗体研究的关键。我们对10种商用抗体检测试剂盒进行了无偏见的面对面比较，使用的是在英国伦敦疫情高峰期住院的新冠肺炎患者的血液。由于目前还没有批准的诊断抗体测试，我们开发了自己的敏感测试，并用它来交叉比较商业测试。在这些测试中，表现的范围很广，但在症状开始后20天或更长时间使用时，所有测试都给出了最好的结果。此外，与无症状或轻度疾病的人相比，病情严重的人的抗体水平更高。一些表现最好的测试是快速横向流动免疫分析，这种方法负担得起，快速且易于使用，如果部署得当，可能在医疗保健环境中具有相当大的实用价值。
There is a clear requirement for an accurate SARS-CoV-2 antibody test, both as a complement to existing diagnostic capabilities and for determining community seroprevalence. We therefore evaluated the performance of a variety of antibody testing technologies and their potential use as diagnostic tools. Highly specific in-house ELISAs were developed for the detection of anti-spike (S), -receptor binding domain (RBD) and -nucleocapsid (N) antibodies and used for the cross-comparison of ten commercial serological assays—a chemiluminescence-based platform, two ELISAs and seven colloidal gold lateral flow immunoassays (LFIAs)—on an identical panel of 110 SARS-CoV-2-positive samples and 50 pre-pandemic negatives. There was a wide variation in the performance of the different platforms, with specificity ranging from 82% to 100%, and overall sensitivity from 60.9% to 87.3%. However, the head-to-head comparison of multiple sero-diagnostic assays on identical sample sets revealed that performance is highly dependent on the time of sampling, with sensitivities of over 95% seen in several tests when assessing samples from more than 20 days post onset of symptoms. Furthermore, these analyses identified clear outlying samples that were negative in all tests, but were later shown to be from individuals with mildest disease presentation. Rigorous comparison of antibody testing platforms will inform the deployment of point-of-care technologies in healthcare settings and their use in the monitoring of SARS-CoV-2 infections. PCR-based throat and nose swab tests for novel coronavirus (SARS-CoV-2) establish if someone is infected with the virus, while antibody tests can determine whether someone has had it in the past. However, for diagnosis later in disease, or in delayed-onset syndromes such as paediatric inflammatory multisystem syndrome (PIMS), antibody tests could form an important part of hospital diagnostic capabilities. They will also be essential for patient management strategies and community seroprevalence studies. We have conducted unbiased, head-to-head comparisons of ten commercial antibody test kits, using blood from patients admitted to hospital with COVID-19 throughout the peak of the epidemic in London, UK. As there was no existing approved diagnostic antibody test, we developed our own sensitive assay and used this to cross-compare the commercial tests. There was a broad range of performance among the tests, but all gave the best results when used 20 days or more after the start of symptoms. Furthermore, antibody levels were higher in individuals with severe illness compared to those with asymptomatic or mild disease. Some of the best-performing tests were rapid lateral flow immunoassays, which are affordable, quick and easy to use, and if they are deployed appropriately could have considerable utility in healthcare settings.
登录
查看更多内容
影响因子：
82.9
作者：
Long, Quan-Xin;Liu, Bai-Zhong;Huang, Ai-Long
通讯作者：
Huang, Ai-Long
影响因子：
82.9
作者：
Amanat F;Stadlbauer D;Strohmeier S;Nguyen THO;Chromikova V;McMahon M;Jiang K;Arunkumar GA;Jurczyszak D;Polanco J;Bermudez-Gonzalez M;Kleiner G;Aydillo T;Miorin L;Fierer DS;Lugo LA;Kojic EM;Stoever J;Liu STH;Cunningham-Rundles C;Felgner PL;Moran T;García-Sastre A;Caplivski D;Cheng AC;Kedzierska K;Vapalahti O;Hepojoki JM;Simon V;Krammer F
通讯作者：
Krammer F
影响因子：
19
作者：
Zhao, Bo;Liu, Qianqian;Wu, Hao Bin
通讯作者：
Wu, Hao Bin
影响因子：
56.3
作者：
To, Kelvin Kai-Wang;Tsang, Owen Tak-Yin;Yuen, Kwok-Yung
通讯作者：
Yuen, Kwok-Yung
SARS-COV-2血清学测定法的评估显示了一系列测试性能。
影响因子：
46.9
作者：
Whitman JD;Hiatt J;Mowery CT;Shy BR;Yu R;Yamamoto TN;Rathore U;Goldgof GM;Whitty C;Woo JM;Gallman AE;Miller TE;Levine AG;Nguyen DN;Bapat SP;Balcerek J;Bylsma SA;Lyons AM;Li S;Wong AW;Gillis-Buck EM;Steinhart ZB;Lee Y;Apathy R;Lipke MJ;Smith JA;Zheng T;Boothby IC;Isaza E;Chan J;Acenas DD 2nd;Lee J;Macrae TA;Kyaw TS;Wu D;Ng DL;Gu W;York VA;Eskandarian HA;Callaway PC;Warrier L;Moreno ME;Levan J;Torres L;Farrington LA;Loudermilk RP;Koshal K;Zorn KC;Garcia-Beltran WF;Yang D;Astudillo MG;Bernstein BE;Gelfand JA;Ryan ET;Charles RC;Iafrate AJ;Lennerz JK;Miller S;Chiu CY;Stramer SL;Wilson MR;Manglik A;Ye CJ;Krogan NJ;Anderson MS;Cyster JG;Ernst JD;Wu AHB;Lynch KL;Bern C;Hsu PD;Marson A
通讯作者：
Marson A