Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Advanced Life Science Institute, Inc., Hachioji, Tokyo, Japan.
J Gastroenterol. 2022 Jul;57(7):486-494. doi: 10.1007/s00535-022-01872-w. Epub 2022 Apr 28.
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.
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.
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.
The iTACT-HBcrAg assay is useful for monitoring HBV reactivation to determine the initiation of treatment with nucleos(t)ide analogues.
一种全新的、高灵敏度的乙型肝炎核心相关抗原检测试剂盒（iTACT-HBcrAg）已被开发出来。本研究旨在评估该试剂盒在多中心环境下检测乙型肝炎病毒（HBV）再激活的效果，与超高敏乙型肝炎表面抗原（iTACT-HBsAg）和 HBV DNA 检测方法相比，用于诊断 HBV 再激活。
本研究纳入了 2008 年至 2020 年期间在四家医院就诊的 44 例 HBV 再激活患者。回顾性检测患者的连续血清标本，采用 iTACT-HBcrAg（检测下限为 2.0 log U/mL）检测 HBcrAg 水平，采用 iTACT-HBsAg（检测下限为 0.0005 IU/mL）检测 HBsAg 水平，并与 HBV DNA 水平进行比较。HBV 再激活定义为检测到血清 HBV DNA，包括无法定量检测到的情况。
在 HBV 再激活及之后，27 例患者的血清 HBV DNA 水平可定量（≥1.3 log IU/mL），17 例患者的血清 HBV DNA 水平低于定量下限（<1.3 log IU/mL）。在 27 例 HBV 再激活且血清 HBV DNA 可定量的患者中，26 例（96.3%）和 24 例（88.9%）患者的血清 iTACT-HBcrAg 和 iTACT-HBsAg 检测结果为阳性。在 27 例 HBV 再激活患者中，有 15 例患者在可定量检测 HBV DNA 之前即可检测到 HBcrAg。在 11 例 HBV 再激活且此后 iTACT-HBcrAg 检测结果为阴性的患者中，10 例患者的 HBV DNA 不可定量，且均未发生与 HBV 再激活相关的肝炎。
iTACT-HBcrAg 检测试剂盒可用于监测 HBV 再激活，以确定是否开始使用核苷（酸）类似物进行治疗。
