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本文引用的文献

1
Accuracy of serological tests for COVID-19: A systematic review and meta-analysis.血清学检测在 COVID-19 中的准确性:系统评价和荟萃分析。
Front Public Health. 2022 Dec 16;10:923525. doi: 10.3389/fpubh.2022.923525. eCollection 2022.
2
The role and diagnostic accuracy of serology for COVID-19.血清学检测在 COVID-19 中的作用和诊断准确性。
BMC Infect Dis. 2022 Apr 19;22(1):390. doi: 10.1186/s12879-022-07361-y.
3
Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients.对住院患者的六种 SARS-CoV-2 免疫测定方法进行头对头验证。
J Clin Virol. 2021 Jun;139:104821. doi: 10.1016/j.jcv.2021.104821. Epub 2021 Apr 18.
4
In silico detection of SARS-CoV-2 specific B-cell epitopes and validation in ELISA for serological diagnosis of COVID-19.基于计算机的 SARS-CoV-2 特异性 B 细胞表位预测及 ELISA 验证在 COVID-19 血清学诊断中的应用。
Sci Rep. 2021 Feb 22;11(1):4290. doi: 10.1038/s41598-021-83730-y.
5
Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.评价 10 种血清学检测方法用于检测 SARS-CoV-2 抗体的诊断准确性。
Eur J Clin Microbiol Infect Dis. 2021 May;40(5):955-961. doi: 10.1007/s10096-020-04092-3. Epub 2020 Nov 24.
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Development of Diagnostic Tests for Detection of SARS-CoV-2.用于检测新型冠状病毒(SARS-CoV-2)的诊断测试的开发
Diagnostics (Basel). 2020 Nov 5;10(11):905. doi: 10.3390/diagnostics10110905.
7
A systematic review of antibody mediated immunity to coronaviruses: kinetics, correlates of protection, and association with severity.冠状病毒抗体介导免疫的系统评价:动力学、保护相关性及与严重程度的关系。
Nat Commun. 2020 Sep 17;11(1):4704. doi: 10.1038/s41467-020-18450-4.
8
A systematic review on recent trends in transmission, diagnosis, prevention and imaging features of COVID-19.关于新型冠状病毒肺炎传播、诊断、预防及影像特征近期趋势的系统评价
Process Biochem. 2020 Nov;98:233-240. doi: 10.1016/j.procbio.2020.08.016. Epub 2020 Aug 20.
9
Single-copy sensitive, field-deployable, and simultaneous dual-gene detection of SARS-CoV-2 RNA via modified RT-RPA.通过改良的逆转录-重组酶聚合酶扩增技术实现对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)RNA的单拷贝灵敏、可现场部署的同时双基因检测。
Cell Discov. 2020 May 28;6(1):37. doi: 10.1038/s41421-020-0175-x. eCollection 2020.
10
Serology characteristics of SARS-CoV-2 infection after exposure and post-symptom onset.感染 SARS-CoV-2 后的血清学特征:暴露后及症状出现后。
Eur Respir J. 2020 Aug 27;56(2). doi: 10.1183/13993003.00763-2020. Print 2020 Aug.

新型冠状病毒刺突蛋白和核衣壳蛋白候选肽血清学诊断试验的性能评估。

Performance assessment of a new serological diagnostic test for COVID-19 with candidate peptides from spike and nucleocapsid viral proteins.

机构信息

Laboratory of Virology and Experimental Therapy, Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (Fiocruz), Recife, Pernambuco, Brazil.

Laboratory of Experimental Immunology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, Brazil.

出版信息

Braz J Microbiol. 2024 Sep;55(3):2797-2803. doi: 10.1007/s42770-024-01446-3. Epub 2024 Jul 23.

DOI:10.1007/s42770-024-01446-3
PMID:39042245
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11405565/
Abstract

Numerous commercial tests for the serological diagnosis of COVID-19 have been produced in recent years. However, it is important to note that these tests exhibit significant variability in their sensitivity, specificity, and accuracy of results. Therefore, the objective of this study was to utilize bioinformatics tools to map SARS-CoV-2 peptides, with the goal of developing a new serological diagnostic test for COVID-19. Two peptides from the S protein and one from the N protein were selected and characterized in silico, chemically synthesized, and used as a serological diagnostic tool to detect IgM, IgG, and IgA anti-SARS-CoV-2 antibodies through the ELISA technique, confirmed as positive and negative samples by RT-qPCR or serology by ELISA. The results showed a sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of 100% (p < 00001, 95% CI) for the proposed test. Although preliminary, this study brings proof-of-concept results that are consistent with the high-performance rates of the ELISA test when compared to other well-established methods for diagnosing COVID-19.

摘要

近年来,已经有许多用于 COVID-19 血清学诊断的商业检测方法问世。然而,需要注意的是,这些检测方法在灵敏度、特异性和结果准确性方面存在显著差异。因此,本研究的目的是利用生物信息学工具对 SARS-CoV-2 肽进行映射,以期开发一种新的 COVID-19 血清学诊断检测方法。选择来自 S 蛋白的两个肽和一个来自 N 蛋白的肽进行计算机分析、化学合成,并通过 ELISA 技术用作血清学诊断工具,通过 RT-qPCR 或 ELISA 血清学确认为阳性和阴性样本。结果显示,该检测方法的灵敏度、特异性、阳性预测值和阴性预测值均为 100%(p < 00001,95%CI)。虽然这只是初步研究,但与其他用于诊断 COVID-19 的成熟方法相比,该 ELISA 检测方法的性能较高,本研究结果提供了与该方法性能一致的概念验证结果。