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为改善乙肝核心相关抗原作为生物标记物的超范围稀释:协议验证和应用示例

Maria Pfefferkorn¹, Jessica Brehm², Martin Brehm²

¹Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.

|May 20, 2025

概括

稀释B型肝炎核心相关抗原 (HBcrAg) 超过检测极限提高了可比性. 基于胎儿小牛血清的稀释精确地反映了B型肝炎患者早期治疗反应.

科学领域:

肝病学肝病学是一种肝病学.
病毒学病毒学
生物化学生物化学

背景情况:

乙型肝炎核心相关抗原 (HBcrAg) 是预测乙型肝炎病毒 (HBV) 治疗结果的生物标志物.
目前对HBcrAg的自动化测定具有有限的线性范围,需要在高滴度样本中进行稀释.
不同稀释剂对HBcrAg测定可比性和交叉反应性的影响仍未得到充分研究.

研究的目的:

为了验证HBcrAg标本超过量化上限 (7.0 logU/mL) 的稀释方法.
为了提高HBcrAg测量在不同研究和测试中的可比性.
评估稀释HBcrAg水平与HBV感染患者治疗反应的相关性.

主要方法:

使用高HBcrAg水平的患者样本进行稀释程序的双站点验证.
与使用胎儿小牛血清 (FCS) 或人类血清 (HS) 手动稀释的Fujirebio特异性稀释试剂 (SD1) 的比较.
在三个患者队列中进行验证:未经治疗的HBV,治疗的核类相似物 (NA) 和接受基化干扰素-2α (PEG-IFN) 治疗的患者.

主要成果:

与HS或FCS相比,使用SD1的车载稀释显示出更高的背景信号和低估的HBcrAg水平.
用FCS进行手动稀释,在不同地点显示可重复的结果.
在NA和PEG-IFN治疗期间,以FCS为基础的稀释显示了HBcrAg水平在NA和PEG-IFN治疗期间的显著早期降低,与治疗反应相关.

结论:

特定的稀释试剂 (SD1) 是不适合超范围的HBcrAg量化由于高的背景和低估.
基于胎儿小牛血清 (FCS) 的手动稀释是量化高HBcrAg水平的可行方法.
基于FCS的超范围稀释改善了HBcrAg动态和B型肝炎患者治疗反应之间的相关性.

关键词:

生物标志物生物标志物这是HBV HBV.这就是HBcrAg.

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