Evaluation of the in situ assay for HBV DNA: An observational real-world study in chronic hepatitis B.
Evaluation of the in situ assay for HBV DNA: An observational real-world study in chronic hepatitis B.
复制标题
HBV DNA 原位测定的评估 慢性乙型肝炎的观察性真实世界研究
DOI：
10.1097/md.0000000000027220
复制
发表时间：
2021-09-17
期刊：
影响因子：
1.6
通讯作者：
Zhang X
中科院分区：
文献类型：
--
作者：
Li C;Zhang W;Shi B;Chen G;Zheng Y;An Y;Sun M;Feng Y;Shang Q;Zhang X
肝内B型肝炎病毒（HBV）DNA的原位杂交（ISH）显示揭示了HBV在单细胞水平上的生命周期的一些有趣的方面。在本研究中，我们打算评价该检测方法在实际临床环境中的可靠性和稳健性，以及其与慢性B型肝炎（CH B）患者中现有临床生物标志物的关系。在这项横断面研究中，94例CHB患者和10例非HBV相关肝病患者入选。进行肝活检和常规组织病理学分析。分别用原位杂交和免疫组化法检测肝内HBV DNA和病毒抗原（HBsAg和HBcAg）。检测丙氨酸转氨酶、血清HBV DNA和血清HBsAg等基本生化和病毒学指标。HBV DNA-ISH检测在CHB患者中的阳性率为55.8%（53/94例），非HBV相关性肝炎无假阳性。HBsAg和HBcAg的阳性率分别为94.7%（89/94例）和19.5%（17/87例）。HBVDNA-ISH信号定量与血清HBVDNA呈显著相关性（rs = 0.6223，P <.0001）。 此外，胶原沉积背景下HBV DNA原位染色模式告知慢性肝病的组织病理学进展。该ISH检测在评估现实世界CHB患者肝内病毒复制中的应用显示出良好的性能。可作为常规肝组织病理学检查和病毒抗原免疫组化检测的补充。这种方法提供了一个直观的评估病毒学和病理状态的慢性乙型肝炎患者，并进一步支持临床诊断和管理。
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.