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四种基于化学发光法的免疫分析试剂盒和一种免疫层析法检测试剂盒评估 SARS-CoV-2 的血清阳性率。

Seroprevalence of SARS-CoV-2 Assessed by Four Chemiluminescence Immunoassays and One Immunocromatography Test for SARS-Cov-2.

机构信息

Centro di Referenza Nazionale per l'Analisi e Studio di Correlazione tra Ambiente, Animale e Uomo, Istituto Zooprofilattico Sperimentale del Mezzogiorno, Portici, Italy.

Department of Medicine, Surgery, and Dentistry 'Scuola Medica Salernitana', University of Salerno, Baronissi, Italy.

出版信息

Front Public Health. 2021 Apr 29;9:649781. doi: 10.3389/fpubh.2021.649781. eCollection 2021.

Abstract

The onset of the new SARS-CoV-2 coronavirus encouraged the development of new serologic tests that could be additional and complementary to real-time RT-PCR-based assays. In such a context, the study of performances of available tests is urgently needed, as their use has just been initiated for seroprevalence assessment. The aim of this study was to compare four chemiluminescence immunoassays and one immunochromatography test for SARS-Cov-2 antibodies for the evaluation of the degree of diffusion of SARS-CoV-2 infection in Salerno Province (Campania Region, Italy). A total of 3,185 specimens from citizens were tested for anti-SARS-CoV-2 antibodies as part of a screening program. Four automated immunoassays (Abbott and Liaison SARS-CoV-2 CLIA IgG and Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays) and one lateral flow immunoassay (LFIA Technogenetics IgG-IgM COVID-19) were used. Seroprevalence in the entire cohort was 2.41, 2.10, 1.82, and 1.85% according to the Liaison IgG, Abbott IgG, Siemens, and Roche total Ig tests, respectively. When we explored the agreement among the rapid tests and the serologic assays, we reported good agreement for Abbott, Siemens, and Roche (Cohen's Kappa coefficient 0.69, 0.67, and 0.67, respectively), whereas we found moderate agreement for Liaison (Cohen's kappa coefficient 0.58). Our study showed that Abbott and Liaison SARS-CoV-2 CLIA IgG, Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays, and LFIA Technogenetics IgG-IgM COVID-19 have good agreement in seroprevalence assessment. In addition, our findings indicate that the prevalence of IgG and total Ig antibodies against SARS-CoV-2 at the time of the study was as low as around 3%, likely explaining the amplitude of the current second wave.

摘要

新型严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)的出现促使人们开发新的血清学检测方法,这些方法可以作为实时逆转录聚合酶链反应(RT-PCR)检测方法的补充。在这种情况下,迫切需要研究现有检测方法的性能,因为这些方法刚刚开始用于血清流行率评估。本研究旨在比较四种化学发光免疫分析和一种免疫层析试验检测 SARS-CoV-2 抗体,以评估 SARS-CoV-2 在意大利坎帕尼亚大区萨莱诺省的传播程度。共有 3185 名公民的样本作为筛查计划的一部分被检测抗 SARS-CoV-2 抗体。使用了四种自动化免疫分析(雅培和 Liaison SARS-CoV-2 CLIA IgG 以及罗氏和西门子 SARS-CoV-2 CLIA IgM/IgG/IgA 分析)和一种侧向流动免疫分析(LFIA Technogenetics IgG-IgM COVID-19)。根据 Liaison IgG、Abbott IgG、西门子和罗氏总 Ig 检测,整个队列的血清流行率分别为 2.41%、2.10%、1.82%和 1.85%。当我们探索快速检测与血清学检测之间的一致性时,我们发现雅培、西门子和罗氏的一致性较好(Cohen's Kappa 系数分别为 0.69、0.67 和 0.67),而 Liaison 的一致性为中等(Cohen's kappa 系数为 0.58)。我们的研究表明,雅培和 Liaison SARS-CoV-2 CLIA IgG、罗氏和西门子 SARS-CoV-2 CLIA IgM/IgG/IgA 检测以及 LFIA Technogenetics IgG-IgM COVID-19 在血清流行率评估方面具有良好的一致性。此外,我们的研究结果表明,在研究时,针对 SARS-CoV-2 的 IgG 和总 Ig 抗体的流行率低至约 3%,这可能解释了当前第二波疫情的幅度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/166b/8116632/02ed8da56965/fpubh-09-649781-g0001.jpg

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