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多中心评估 8 种商业抗 SARS-CoV-2 抗体检测试剂盒的敏感性及其与血清阳性受试者中病毒中和滴度的相关性。

Multicentric evaluation of sensitivity of eight commercial anti-SARS-CoV-2 antibody assays and their correlation to virus neutralization titers in seropositive subjects.

机构信息

Institute of Clinical Microbiology, University Hospital in Hradec Kralove, Sokolska 581, Hradec Kralove, 50005, Czech Republic.

Faculty of Medicine in Hradec Kralove, Charles University, Hradec Kralove, Czech Republic.

出版信息

Sci Rep. 2024 Jan 16;14(1):1421. doi: 10.1038/s41598-024-51968-x.

Abstract

Diagnosis of SARS-CoV-2 virus is mainly based on direct detection. Determination of specific antibodies has been used mostly for epidemiological reasons. However, select immunoassays showed good correlation to plaque reduction virus neutralization test (PRNT) in smaller patient cohorts, which suggests their potential as predictors of virus neutralization titer. A total of 3,699 samples from Covid-19 patients were included in the multicentric study performed in the Czech Republic. Anti-SARS-CoV-2 antibody levels were evaluated by 8 commercial antibody assays. Simultaneously, PRNT evaluations were performed with the SARS-CoV-2 B.1.258 variant. All immunoassays showed an overall high true positive diagnostic value ranging from 79.17 to 98.04%. Several commercial EIA methods showed highly positive correlation between the assay results and PRNT levels, e.g., Liaison CoV-2 TrimericS IgG DiaSorin (Spearman r = 0.8833; Architect SASRS-CoV-2 IgG Abbott (r = 0.7298); NovaLisa SARS-CoV-2 IgG NovaTec (r = 0.7103) and Anti-SARS-CoV-2 ELISA IgG Euroimmun (r = 0.7094). While this correlation was less positive for other assays, those, conversely, presented higher true positive values. For most immunoassays, the positive percent agreement of the results was ≥ 95% in sera exhibiting PRNT levels of 1:80 and higher. The assays tested have shown variable correlation to PRNT. Those possessing high positive predictive values serve well as qualitative tests, while others can be utilised as quantitative tests highly predictive of neutralization antibody levels.

摘要

SARS-CoV-2 病毒的诊断主要基于直接检测。确定特定抗体主要用于流行病学原因。然而,在较小的患者队列中,一些选择的免疫分析与蚀斑减少病毒中和试验(PRNT)具有良好的相关性,这表明它们作为病毒中和滴度预测因子的潜力。共有 3699 份来自 COVID-19 患者的样本纳入了在捷克共和国进行的多中心研究。通过 8 种商业抗体分析试剂盒评估抗 SARS-CoV-2 抗体水平。同时,使用 SARS-CoV-2 B.1.258 变体进行 PRNT 评估。所有免疫分析均表现出总体较高的真阳性诊断价值,范围为 79.17%至 98.04%。几种商业 EIA 方法显示出与 PRNT 水平之间高度正相关的检测结果,例如 Liaison CoV-2 TrimericS IgG DiaSorin(Spearman r=0.8833;Architect SASRS-CoV-2 IgG Abbott(r=0.7298);NovaLisa SARS-CoV-2 IgG NovaTec(r=0.7103)和 Anti-SARS-CoV-2 ELISA IgG Euroimmun(r=0.7094)。虽然对于其他检测方法,这种相关性不太积极,但这些方法的真阳性值却较高。对于大多数免疫分析,在 PRNT 水平为 1:80 及以上的血清中,结果的阳性百分比一致性≥95%。所测试的检测方法与 PRNT 具有不同的相关性。那些具有高阳性预测值的检测方法可作为定性检测良好,而其他检测方法则可作为高度预测中和抗体水平的定量检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e037/10792077/a0fdebfd9d11/41598_2024_51968_Fig1_HTML.jpg

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