Evaluation of urinary hepatitis E virus antigen colloidal gold immunochromatographic assay in clinical diagnosis of hepatitis E virus infection

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2025-06-11 DOI:10.1016/j.jcv.2025.105825

Conglin Zhao , Shuai Tao , Mengxin Lu , Weixia Li , Han Zhao , Shuangshuang Sun , Weijia Lin , Chong Chen , Qiang Li , Yuxian Huang , Liang Chen

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引用次数: 0

Abstract

Background

Hepatitis E virus (HEV) is a significant public health concern worldwide. Current diagnostic methods for HEV infection have limitations in terms of accessibility and timeliness.

Objective

To assess the diagnostic performance of the Wantai urinary HEV antigen (Ag) colloidal gold immunochromatographic assay (GICA) in HEV infection.

Methods

This prospective study enrolled 150 patients with suspected acute hepatitis E and 50 healthy controls. Paired urine, fecal, and serum samples were collected during initial clinical evaluation. Serum and fecal HEV RNA levels were quantified via reverse transcription-quantitative polymerase chain reaction (RT-qPCR), with genotyping performed by nested RT-PCR. Serum anti-HEV IgM/IgG levels were measured by Enzyme-Linked Immunosorbent Assay (ELISA), and urinary HEV antigen was detected using GICA. Diagnostic accuracy metrics were calculated against the reference standard of HEV RNA detection.

Results

HEV RNA was detected in 58 % (87/150) of suspected cases. All successfully genotyped cases (69 %, 60/87) were HEV genotype 4. All healthy controls tested negative for HEV RNA and urinary HEV Ag.The urinary HEV Ag GICA showed 98.9 % sensitivity and 87.6 % specificity, with high concordance with RT-qPCR (Kappa = 0.85). Longitudinal follow-up revealed viral clearance and liver function normalization in most patients within 3–4 weeks post-symptom onset. 85.7 % of patients achieved urinary HEV Ag negative conversion within 6–7 weeks, while anti-HEV IgM remained positive in all patients at follow-up conclusion.

Conclusion

Urinary HEV Ag GICA demonstrates high diagnostic reliability for acute HEV infection, offering a practical non-invasive option for resource-limited settings.

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尿戊型肝炎病毒抗原胶体金免疫层析法在临床诊断戊型肝炎病毒感染中的应用价值

戊型肝炎病毒（HEV）是世界范围内一个重要的公共卫生问题。目前的HEV感染诊断方法在可及性和及时性方面存在局限性。目的评价万台尿HEV抗原（Ag）胶体金免疫层析法（GICA）对HEV感染的诊断价值。方法本前瞻性研究纳入150例疑似急性戊型肝炎患者和50例健康对照。在最初的临床评估中收集成对的尿液、粪便和血清样本。通过逆转录-定量聚合酶链反应（RT-qPCR）定量血清和粪便HEV RNA水平，并采用巢式RT-PCR进行基因分型。采用酶联免疫吸附试验（ELISA）检测血清抗HEV IgM/IgG水平，采用GICA检测尿HEV抗原。根据HEV RNA检测参考标准计算诊断准确性指标。结果58.8%（87/150）的疑似病例检出shev RNA。所有成功分型的病例（69%,60/87）均为HEV基因4型。所有健康对照者的HEV RNA和尿HEV Ag检测均为阴性。尿HEV Ag GICA的敏感性为98.9%，特异性为87.6%，与RT-qPCR具有较高的一致性（Kappa = 0.85）。纵向随访显示，大多数患者在症状出现后3-4周内病毒清除和肝功能恢复正常。85.7%的患者在6-7周内实现尿HEV Ag阴性转化，而在随访结束时，所有患者的抗HEV IgM均为阳性。结论尿HEV Ag GICA对急性HEV感染具有较高的诊断可靠性，为资源有限的环境提供了一种实用的非侵入性选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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)