HBV DNA 原位检测的评估：慢性乙型肝炎的观察性真实世界研究

StephenW

HBV DNA 原位检测的评估：慢性乙型肝炎的观察性真实世界研究
常丽1、张伟2、毕生1、陈刚2、叶政1、永安2、孙咪咪2、冯燕玲1、清华尚2、张晓楠1 3
隶属关系
隶属关系

    1
    复旦大学上海公共卫生临床中心，上海，中国。
    2
    中国人民解放军联合后勤保障部队第960医院肝病诊疗中心，山东泰安。
    3
    澳大利亚首都领地堪培拉大学科技学院生物医学科学治疗解决方案研究中心。

    PMID：34664859 DOI：10.1097/MD.0000000000027220

抽象的

通过原位杂交 (ISH) 对肝内乙型肝炎病毒 (HBV) DNA 的可视化揭示了单细胞水平上 HBV 生命周期的一些有趣方面。在当前的研究中，我们打算评估该检测在真实世界临床场景中的可靠性和稳健性，以及它与慢性乙型肝炎 (CHB) 患者目前可用的临床生物标志物的关系。在这项横断面研究中，94 名 CHB 患者10例非HBV相关肝病患者入组。进行了肝活检和常规组织病理学分析。分别通过ISH和免疫组织化学（IHC）检测肝内HBV DNA和病毒抗原（HBsAg和HBcAg）。测定丙氨酸转氨酶、血清HBV DNA、血清HBsAg等基本生化和病毒学参数。 HBV DNA-ISH检测显示CHB患者阳性率为55.8%（53/94例），非患者未发现假阳性。 HBV相关肝炎。 HBsAg和HBcAg的IHC阳性率分别为94.7%（89/94例）和19.5%（17/87例）。 HBV DNA-ISH 信号的定量显示与血清 HBV DNA 显着相关（rs = 0.6223，P < .0001）。此外，在胶原沉积背景下 HBV DNA 的原位染色模式告知慢性肝病的组织病理学进展。该 ISH 测定在评估真实世界 CHB 患者肝内病毒复制中的应用显示出良好的性能。它可以作为常规肝脏组织病理学检查和病毒抗原 IHC 检测的补充。该方法提供了对 CHB 患者病毒学和病理状态的直观评估，并进一步支持临床诊断和管理。

版权所有 © 2021 作者。由 Wolters Kluwer Health, Inc. 出版。
利益冲突声明

作者没有要披露的利益冲突。

StephenW

  Evaluation of the in situ assay for HBV DNA: An observational real-world study in chronic hepatitis B
Chang Li  1 , Wei Zhang  2 , Bisheng Shi  1 , Gang Chen  2 , Ye Zheng  1 , Yong An  2 , Mimi Sun  2 , Yanling Feng  1 , Qinghua Shang  2 , Xiaonan Zhang  1   3
Affiliations
Affiliations

    1
    Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
    2
    Chinese PLA Diagnosis and Treatment Center for Liver Diseases, The 960th Hospital of Chinese PLA Joint Logistics Support Force, Tai'an, Shandong, China.
    3
    Centre for Research in Therapeutic Solutions, Biomedical Sciences, Faculty of Science and Technology, University of Canberra, ACT, Australia.

    PMID: 34664859 DOI: 10.1097/MD.0000000000027220

Abstract

The visualization of intrahepatic hepatitis B virus (HBV) DNA by in situ hybridization (ISH) has uncovered some interesting aspects of HBV life cycle at the single-cell level. In the current study, we intend to evaluate the reliability and robustness of this assay in the real-world clinical scenario and its relationship with currently available clinical biomarkers in chronic hepatitis B (CHB) patients.In this cross-sectional study, 94 CHB patients and 10 patients with non-HBV related liver diseases were enrolled. Liver biopsies and routine histopathology analysis were performed. Intrahepatic HBV DNA and viral antigens (HBsAg and HBcAg) were detected by ISH and immunohistochemistry (IHC), respectively. The basic biochemical and virological parameters such as alanine transaminase, serum HBV DNA, and serum HBsAg were measured.The HBV DNA-ISH assay showed 55.8% (53/94 cases) positive rate in CHB patients, no false positive was found in non-HBV related hepatitis. The IHC of HBsAg and HBcAg showed a positive rate of 94.7% (89/94 cases) and 19.5% (17/87 cases), respectively. Quantification of HBV DNA-ISH signal showed a significant correlation with serum HBV DNA (rs = 0.6223, P < .0001). In addition, the staining pattern of HBV DNA in situ in the context of collagen deposition informed the histopathological progression of chronic liver disease.The application of this ISH assay in evaluating intrahepatic viral replication in real-world CHB patients showed favorable performance. It can be a complementation to conventional liver histopathology examination and IHC detection of viral antigens. This methodology provides an intuitive assessment of virological and pathological state of CHB patients, and further supports clinical diagnosis and management.

Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
Conflict of interest statement

The authors have no conflicts of interest to disclose.

StephenW

https://journals.lww.com/md-jour ... HBV_DNA__An.35.aspx