Real-world evaluation of a novel technology for quantitative simultaneous antibody detection against multiple SARS-CoV-2 antigens in a cohort of patients presenting with COVID-19 syndrome.
Real-world evaluation of a novel technology for quantitative simultaneous antibody detection against multiple SARS-CoV-2 antigens in a cohort of patients presenting with COVID-19 syndrome.
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DOI：
10.1039/d0an01066a
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发表时间：
2020-08-21
期刊：
影响因子：
--
通讯作者：
Edgeworth JD
中科院分区：
文献类型：
--
作者：
Shaw AM;Hyde C;Merrick B;James-Pemberton P;Squires BK;Olkhov RV;Batra R;Patel A;Bisnauthsing K;Nebbia G;MacMahon E;Douthwaite S;Malim M;Neil S;Martinez Nunez R;Doores K;Mark TKI;Signell AW;Betancor G;Wilson HD;Galão RP;Pickering S;Edgeworth JD
一种快速便携式金纳米技术的评价，该技术使用来自74名RNA（+）患者和47名RNA（+）对照患者的血清测量SARS-CoV-2 IgM、伊加和IgG抗体对刺突1（S1）、刺突2（S）和核衣壳（N）抗原的反应。对快速便携式金纳米技术进行了评估，该技术测量了SARS-CoV-2 IgM，伊加和IgG抗体浓度，针对刺突1（S1），刺突2（S）和核衣壳（N），使用了74名患者的血清样本，这些患者在入院时检测了SARS-CoV-2 RNA，并从2019年3月起检测了47名历史对照患者。59例为RNA（+），15例为RNA（-）。推导出所有三种抗原的血清（±）分类，并获得定量血清学特征。30%（95% CI 11-48）的初始RNA（-）患者、36%（95% CI 17-54）的RNA（+）患者在10天前、77%（95% CI 67-87）的10 - 20天之间和95%（95% CI 86-100）的21天后确定血清（+）。10天后相对于RNA（±）的患者水平诊断准确性显示88%的灵敏度（95%CI 75-95）和75%的特异性（95%CI 22-99），尽管与历史对照相比的特异性为100%（95%CI 91-100）。这项研究为在临床环境中进一步评估和验证这项新技术提供了强有力的支持，并强调了评估新型疾病（如COVID-19）血清学检测所固有的挑战。
An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody response to spike 1 (S1), spike 2 (S) and nucleocapsid (N) antigens using serum from 74 RNA(+) patients and RNA(+) 47 control patients. An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody concentrations against spike 1 (S1), spike 2 (S) and nucleocapsid (N) was conducted using serum samples from 74 patients tested for SARS-CoV-2 RNA on admission to hospital, and 47 historical control patients from March 2019. 59 patients were RNA(+) and 15 were RNA(–). A serum (±) classification was derived for all three antigens and a quantitative serological profile was obtained. Serum(+) was identified in 30% (95% CI 11–48) of initially RNA(–) patients, in 36% (95% CI 17–54) of RNA(+) patients before 10 days, 77% (95% CI 67–87) between 10 and 20 days and 95% (95% CI 86–100) after 21 days. The patient-level diagnostic accuracy relative to RNA(±) after 10 days displayed 88% sensitivity (95% CI 75–95) and 75% specificity (95% CI 22–99), although specificity compared with historical controls was 100% (95%CI 91–100). This study provides robust support for further evaluation and validation of this novel technology in a clinical setting and highlights challenges inherent in assessment of serological tests for an emerging disease such as COVID-19.
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影响因子：
12.7
作者：
Li, Zhengtu;Yi, Yongxiang;Ye, Feng
通讯作者：
Ye, Feng
Stard 2015：用于报告诊断准确性研究的基本项目的更新列表。
DOI：
10.1136/bmj.h5527
发表时间：
2015-10-28
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Bossuyt PM;Reitsma JB;Bruns DE;Gatsonis CA;Glasziou PP;Irwig L;Lijmer JG;Moher D;Rennie D;de Vet HC;Kressel HY;Rifai N;Golub RM;Altman DG;Hooft L;Korevaar DA;Cohen JF;STARD Group
通讯作者：
STARD Group
影响因子：
6.8
作者：
Lippi, Giuseppe;Simundic, Ana-Maria;Plebani, Mario
通讯作者：
Plebani, Mario
影响因子：
13.2
作者：
Zhang, Wei;Du, Rong-Hui;Zhou, Peng
通讯作者：
Zhou, Peng
影响因子：
105.7
作者：
Knottnerus, JA;van Weel, C;Muris, JWM
通讯作者：
Muris, JWM