TY - JOUR
T1 - Evaluation of the in situ assay for HBV DNA
T2 - An observational real-world study in chronic hepatitis B
AU - Li, Chang
AU - Zhang, Wei
AU - Shi, Bisheng
AU - Chen, Gang
AU - Zheng, Ye
AU - An, Yong
AU - Sun, Mimi
AU - Feng, Yanling
AU - Shang, Qinghua
AU - Zhang, Xiaonan
N1 - Funding Information:
This study was funded by National Science and Technology Major project of China (2017ZX10203202, 2017ZX10302201001005), National Natural Science Foundation (81671998, 81873962), Shanghai Municipal Hospital of Joint Research Projects in Emerging Cutting-Edge Technology (SHDC12016237), and Shanghai Science and Technology Commission (16411960100).
Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/9/17
Y1 - 2021/9/17
N2 - 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.
AB - 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.
KW - Adult
KW - Biological Assay/methods
KW - China
KW - Cross-Sectional Studies
KW - Female
KW - Hepatitis B Core Antigens/analysis
KW - Hepatitis B Surface Antigens/analysis
KW - Hepatitis B virus/genetics
KW - Hepatitis B, Chronic/diagnosis
KW - Humans
KW - Liver/pathology
KW - Male
KW - Middle Aged
UR - https://www.scopus.com/pages/publications/85119458036
U2 - 10.1097/MD.0000000000027220
DO - 10.1097/MD.0000000000027220
M3 - Short Survey/Scientific Report
C2 - 34664859
SN - 0025-7974
VL - 100
SP - 1
EP - 7
JO - Medicine
JF - Medicine
IS - 37
M1 - e27220
ER -
SDG 3 Good Health and Well-being