Misuse of the Lower Limit of Detection in HBV DNA Testing and Anti‐ HBe Positive Status Will Significantly Impact the Diagnosis of Occult HBV Infection

作者：Bo Wang, Xinru Wang, Xiao Li, Jianchun Xian · 发表于：Journal of Viral Hepatitis · 年份：2024 · DOI：10.1111/jvh.14046 · 被引用次数：4 · 研究领域：Hepatitis B Virus Studies、Hepatitis C virus research、HIV, Drug Use, Sexual Risk

The diagnosis of occult hepatitis B virus (HBV) infection (OBI) is influenced by factors such as the lower limit of detection (LOD) of the HBV DNA test. However, in clinical practice and scientific research, the lower limit of quantification (LOQ) is often misused as the LOD. This study aims to investigate the impact of misuse of the LOD of the HBV DNA test on the detection rate of OBI, as well as the risk factors for OBI. Four hundred twelve patients who were HBsAg-negative and had undergone high-sensitivity HBV DNA testing were included in this study. HBV DNA was detected using the Cobas 6800 System with an LOD of 2.4 IU/mL and an LOQ of 10 IU/mL. The effect of using the LOQ as the LOD on the detection rate of OBI was compared, and univariate and multivariate logistic regression analyses were used to explore the risk factors for OBI. (1) Of the 412 patients, 63.3% (n = 261) were male, with a median age of 47 (range 34-55) years. A total of 473 HBV DNA test results were obtained, with 366 individuals undergoing only one HBV DNA test and the remaining 46 patients undergoing 2 to 5 HBV DNA tests (resulting in a total of 107 test results). (2) Considering only the first HBV DNA test result, the detection rate of OBI was 4.1% (17/412). However, when the LOQ (10 IU/mL) was used as the LOD, the detection rate of OBI was only 1.5% (6/412) (p < 0.001). (3) Univariate analysis showed that there were statistically significant differences in age, anti-HBe positivity rate and anti-HBc p...