Time to revisit the gap between current laboratory testing for hepatitis B virus and clinical needs for diagnosis and treatment of chronic hepatitis B
10.3760/cma.j.cn114452-20240819-00463
- VernacularTitle:再认识乙型肝炎病毒检验现状与慢性乙型肝炎临床诊治需求的距离
- Author:
Ruifeng YANG
1
;
Hongsong CHEN
Author Information
1. 北京大学首钢医院检验科,北京100144
- Publication Type:Journal Article
- Keywords:
Hepatitis B virus;
Hepatitis B, chronic;
Clinical laboratory techniques;
Pregenomic RNA;
Hepatitis B core-related antigen
- From:
Chinese Journal of Laboratory Medicine
2025;48(1):8-14
- CountryChina
- Language:Chinese
-
Abstract:
Development of curative drugs for hepatitis B virus (HBV) infection is facing challenges currently. Current treatment of chronic hepatitis B (CHB) still bases on optimizing the existing therapeutic regimens. Meanwhile, with the rapid development of immunology and molecular technologies, high-sensitivity and quantification have become the mainstream of diagnostic kits development in terms of HBV laboratory diagnosis, and new biomarkers are being developed and widely used clinically. Advancement of laboratory technology favors the personalized management of HBV infection and CHB in one hand and on the other hand, it makes the interpretation of the results of these biomarkers more complicated. The sensitivity of HBV DNA assay is closely related to the natural history of HBV infection and the indication of antiviral therapy. Application of ultra-sensitive HBV DNA assay may cause unnecessary excessive concern for the management of low level viremia on nucleos(t)ide analogue treatment. Availability of ultra-sensitive HBsAg assay challenges the antiviral therapy indication in special populations and the concept of clinical cure of CHB. Necessity of quantification of all HBV serological (immunological) markers remains an issue of debate. Meanwhile, the clinical scenarios of novel markers such as HBV pregenomic RNA and hepatitis B core-related antigen should be defined to avoid misuse, overuse and over-interpretation of their clinical significance.