Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.
Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.
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DOI：
10.1007/s10096-020-04092-3
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发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
Cardeñoso Domingo L
中科院分区：
文献类型：
--
作者：
Gutiérrez-Cobos A;Gómez de Frutos S;Domingo García D;Navarro Lara E;Yarci Carrión A;Fontán García-Rodrigo L;Fraile Torres AM;Cardeñoso Domingo L
抗体检测对于确定SARS-CoV-2的暴露、感染和免疫以及进行流行病学研究至关重要。全世界迫切需要新的诊断工具来控制大流行，这导致最近开发的血清学测定法迅速纳入临床实践。然而，由于只有很少的比较研究已经发表，有一个缺乏数据的诊断准确性，目前可用的检测。我们评价了10种不同检测方法检测IG G、IG M+A和/或伊加抗SARS-CoV-2的诊断准确性：侧流卡免疫测定法、4种酶联免疫吸附测定法（ELISA）和3种荧光颗粒免疫测定法（CMIA）。使用COVID-19的逆转录聚合酶链反应（RT-PCR）作为金标准，测定灵敏度、特异性、PPV和NPV。每种检测试剂均分为两组进行检测，即阳性对照组，由50例RT-PCR阳性的SARS-CoV-2肺炎患者的50份血清组成;阴性对照组，由50例非COVID-19呼吸道感染患者的50份血清组成。针对COVID-19 RT-PCR阳性患者评估的10种检测方法的灵敏度范围为40-77%（考虑IgG加IgM为65-81%）。特异性范围为83- 100%。VPP和VPN分别为81-100%和61.6- 81%。在侧流免疫检测中，Wondfo® SARS-CoV-2抗体检测的灵敏度和特异性最高。ELISA来自EUROIMMUN®的IgG和伊加是最灵敏的ELISA。然而，对于IgG的分离检测获得了较差的结果。我们发现Abbott®的Architect和Vircell®的ELISA对SARS-CoV-2的IgG的敏感性相似。在评价的试验中，获得的结果差异很大。由于特异性更好，在阳性结果的情况下，评价的测定的总体诊断准确性更高。另一方面，由于所描述的灵敏度较低，因此应小心缺乏抗体检测。ELISA和CMIA获得了最高的诊断准确性，但它们持续时间更长。
Antibody detection is essential to establish exposure, infection, and immunity to SARS-CoV-2, as well as to perform epidemiological studies. The worldwide urge for new diagnostic tools to control the pandemic has led to a quick incorporation in clinical practice of the recently developed serological assays. However, as only few comparative studies have been published, there is a lack of data about the diagnostic accuracy of currently available assays. We evaluated the diagnostic accuracy to detect Ig G, Ig M+A, and/or IgA anti SARS-CoV-2 of 10 different assays: lateral flow card immunoassays, 4 enzyme-linked immunosorbent assay (ELISA), and 3 chemiluminescent particle immunoassays (CMIA). Using reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19 as gold standard, sensitivity, specificity, PPV, and NPV were determined. Each assay was tested in 2 groups, namely, positive control, formed by 50 sera from 50 patients with SARS-CoV-2 pneumonia with positive RT-PCR; and negative control, formed by 50 sera from 50 patients with respiratory infection non-COVID-19. Sensitivity range of the 10 assays evaluated for patients with positive COVID-19 RT-PCR was 40–77% (65–81% considering IgG plus IgM). Specificity ranged 83–100%. VPP and VPN were respectively 81–100% and 61.6–81%. Among the lateral flow immunoassays, the highest sensitivity and specificity results were found in Wondfo® SARS-CoV-2 Antibody Test. ELISA IgG and IgA from EUROIMMUN® were the most sensitive ELISA. However, poor results were obtained for isolated detection of IgG. We found similar sensitivity for IgG with SARS-CoV-2 for Architect by Abbott® and ELISA by Vircell®. Results obtained varied widely among the assays evaluated. Due to a better specificity, overall diagnostic accuracy of the assays evaluated was higher in case of positive result. On the other side, lack of antibody detection should be taken with care because of the low sensitivity described. Highest diagnostic accuracy was obtained with ELISA and CMIAs, but they last much longer.
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影响因子：
168.9
作者：
Huang, Chaolin;Wang, Yeming;Cao, Bin
通讯作者：
Cao, Bin
影响因子：
158.5
作者：
Guan, W.;Ni, Z.;Zhong, N.
通讯作者：
Zhong, N.
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
影响因子：
2
作者：
Mercaldo, Nathaniel D.;Lau, Kit F.;Zhou, Xiao H.
通讯作者：
Zhou, Xiao H.
影响因子：
158.5
作者：
Zhu, Na;Zhang, Dingyu;Tan, Wenjie
通讯作者：
Tan, Wenjie