alinii型HSV-1 IgG和HSV-2 IgG化学发光免疫分析性能评价

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2025-03-06 DOI:10.1016/j.jcv.2025.105776

Joachim Bourdin , Maud Salmona , Nadhira Fidouh , Sébastien Fouéré , Jérôme LeGoff , Sarah Maylin

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引用次数: 0

摘要

随着时间的推移，检测单纯疱疹病毒1型和2型（HSV-1和HSV-2）抗体（IgG）的诊断检测方法也在不断发展。本研究旨在评价ality -i化学发光免疫分析法检测特异性抗hsv -1和HSV-2 IgG的分析性能。方法对2023年6月~ 2024年7月采集的155例患者157份血清样本进行回顾性分析。比较三种检测方法：Alinity®HSV-1和HSV-2 IgG (Abbott)， Liaison®HSV-1和HSV-2型特异性IgG (Diasorin), BioPlex®2200 HSV-1 &；HSV-2 IgG （Bio-Rad）。结果根据指标值进行解释。在结果不一致的情况下，使用抗hsv -1/HSV-2-gG2 EUROLINE Western blot提供明确的结论。结果该方法对1型单纯疱疹病毒IgG的敏感性为98%，特异性为100%；对2型单纯疱疹病毒IgG的敏感性为92%，特异性为98%。三种方法的解释一致性较高，Cohen’s kappa值在0.82 ~ 0.90之间。在27份不一致的样本中，Western-blot分析发现假阴性如下：Liaison 2份和14份，ality -i 3份和5份，BioPlex 2份和0份，HSV-1和HSV-2 IgG分别阴性。此外，Western Blot结果显示，3份Liaison和1份BioPlex样品的HSV-1假阳性，1份Liaison和2份ality -i样品的HSV-2假阳性。结论与Liaison法和BioPlex法相比，ality -i型HSV-1和HSV-2 IgG血清学具有良好的敏感性和特异性。这些发现强调了ality -i在临床诊断中的有效性，表明它是在不同患者群体中检测HSV-1和HSV-2抗体的可靠工具。

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Evaluation of the analytical performances of the Alinity-i HSV-1 IgG and HSV-2 IgG chemiluminescent immunoassays

Background

The landscape of diagnostic assays for detecting herpes simplex virus type 1 and 2 (HSV-1 and HSV-2) antibodies (IgG) has evolved over time. This study aims to evaluate the analytical performance of Alinity-i chemiluminescence immunoassays in detecting specific anti-HSV-1 and HSV-2 IgG.

Methods

A retrospective analysis was conducted on 157 serum samples collected from 155 patients between June 2023 and July 2024. Three assays were compared: Alinity® HSV-1 and HSV-2 IgG (Abbott), Liaison® HSV-1 and HSV-2 Type Specific IgG (Diasorin), and BioPlex® 2200 HSV-1 & HSV-2 IgG (Bio-Rad). Results were interpreted based on index values. The Anti-HSV-1/HSV-2-gG2 EUROLINE Western blot was used to provide definitive conclusions in cases of discordant results.

Results

The sensitivities and specificities of the Alinity-i assays were respectively 98 % and 100 % for HSV-1 IgG and 92 % and 98 % for HSV-2 IgG. The interpretation concordance among the three assays was high with Cohen's kappa values ranging from 0.82 to 0.90. Of the 27 discordant samples, Western-blot analysis identified false negatives as follows: 2 and 14 for Liaison, 3 and 5 for Alinity-i, and 2 and 0 for BioPlex, for HSV-1 and HSV-2 IgG respectively. Additionally, Western Blot revealed false positives in 3 Liaison and 1 BioPlex sample for HSV-1, and in 1 Liaison and 2 Alinity-i samples for HSV-2.

Conclusion

The Alinity-i HSV-1 and HSV-2 IgG serology demonstrated excellent sensitivities and specificities compared to Liaison and BioPlex assays. These findings underline the efficacy of Alinity-i in clinical diagnostics, suggesting it as a reliable tool for HSV-1 and HSV-2 antibody detection in diverse patient populations.

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)