一种新的高灵敏度乙型肝炎核心相关抗原测定在确定 HBV 再激

StephenW

一种新的高灵敏度乙型肝炎核心相关抗原测定在确定 HBV 再激活治疗开始的临床应用

    铃木隆典、井上贵子、松浦健太郎、草本茂、萩原慎也、小川慎太郎、八木慎太郎、金子敦、藤原圭、渡边武久、青柳克己、浦田幸友、田森明弘、片冈博美、田中康仁

胃肠病学杂志第 57 卷，第 486–494 页（2022 年）引用这篇文章

    184 次访问

    指标详情

抽象的
背景

一种全自动、新型、高灵敏度的乙型肝炎核心相关抗原检测（iTACT-HBcrAg）正在开发中。本研究的目的是与超高灵敏度 HBsAg (iTACT-HBsAg) 和 HBV DNA 检测相比，评估使用该检测方法测量 HBcrAg 在多中心环境中诊断 HBV 再激活的效果。
方法

从 2008 年到 2020 年，44 名 HBV 再激活患者在四家医院入组。通过 iTACT-HBcrAg（检测下限；2.0 log U/mL）和 iTACT-HBsAg（检测下限；0.0005 IU/mL）对来自患者的系列血清样本的 HBcrAg 水平和 HBsAg 水平进行回顾性评估；这些与HBV DNA水平进行了比较。 HBV再激活被定义为检测到血清HBV DNA，包括无法量化的检测。
结果

在 HBV 再激活和/或之后，27 名患者的血清中 HBV DNA 水平被量化（≥ 1.3 log IU/mL），17 名患者的血清中低于量化水平（< 1.3 log IU/mL）。在 27 名 HBV 再激活且血清 HBV DNA 定量的患者中，iTACT-HBcrAg 和 iTACT-HBsAg 分别为 26 名和 24 名患者（96.3% 和 88.9%）的血清阳性。在 27 名患者中有 15 名患者的 HBV DNA 可量化之前，iTACT-HBcrAg 可检测到 HBcrAg。在 11 名 HBV 再激活且在 HBV 再激活时和/或之后通过 iTACT-HBcrAg 检测不到 HBcrAg 的患者中，10 名患者的 HBV DNA 无法量化，并且没有人发展为 HBV 再激活相关性肝炎。
结论

iTACT-HBcrAg 检测可用于监测 HBV 再激活以确定是否开始使用核苷（酸）类似物进行治疗。

StephenW

Clinical usefulness of a novel high-sensitivity hepatitis B core-related antigen assay to determine the initiation of treatment for HBV reactivation

    Takanori Suzuki, Takako Inoue, Kentaro Matsuura, Shigeru Kusumoto, Shinya Hagiwara, Shintaro Ogawa, Shintaro Yagi, Atsushi Kaneko, Kei Fujiwara, Takehisa Watanabe, Katsumi Aoyagi, Yukitomo Urata, Akihiro Tamori, Hiromi Kataoka & Yasuhito Tanaka

Journal of Gastroenterology volume 57, pages 486–494 (2022)Cite this article

    184 Accesses

    Metrics details

Abstract
Backgrounds

A fully automated, novel, high-sensitivity hepatitis B core-related antigen assay (iTACT-HBcrAg) has been developing. The purpose of this study is to evaluate the efficacy of measuring HBcrAg, using that assay, to diagnose HBV reactivation in a multi-center setting, compared with ultra-high-sensitivity HBsAg (iTACT-HBsAg) and HBV DNA assays.
Methods

Forty-four patients with HBV reactivation from 2008 to 2020 were enrolled in four hospitals. Serial serum specimens from the patients were assessed retrospectively for their HBcrAg levels by iTACT-HBcrAg (lower limit of detection; 2.0 log U/mL) and HBsAg levels by iTACT-HBsAg (lower limit of detection; 0.0005 IU/mL); these were compared to the HBV DNA levels. HBV reactivation was defined as detection of serum HBV DNA, including unquantifiable detection.
Results

At HBV reactivation and/or thereafter, HBV DNA levels were quantified (≥ 1.3 log IU/mL) in the sera of 27 patients, and were below the level of quantification (< 1.3 log IU/mL) in the sera of 17 patients. Of the 27 patients with HBV reactivation and whose serum HBV DNA was quantified, the sera of 26 and 24 patients (96.3% and 88.9%) were positive by iTACT-HBcrAg and iTACT-HBsAg, respectively. HBcrAg was detectable by iTACT-HBcrAg before HBV DNA was quantifiable in 15 of the 27 patients. Of the 11 patients with HBV reactivation and undetectable HBcrAg by iTACT-HBcrAg at HBV reactivation and/or thereafter, 10 had unquantifiable HBV DNA and none developed HBV reactivation-related hepatitis.
Conclusions

The iTACT-HBcrAg assay is useful for monitoring HBV reactivation to determine the initiation of treatment with nucleos(t)ide analogues.