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评估α-Fetoprotein参考材料的可交换性:使用多个系统准确地赋值和真实性验证

Jianping Zhang¹, Jing Zhao¹, Qingtao Wang¹

¹Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University; Beijing Center for Clinical Laboratories, Beijing, China.

Annals of laboratory medicine

|July 2, 2024

概括

标准化α-fetoprotein (AFP) 测量对于准确的临床诊断至关重要. 这项研究发现,使用CLSI方法的候选参考材料 (RMs) 显示出良好的交换性,支持它们在外部质量评估计划中的使用.

科学领域:

临床化学临床化学
免疫检测标准化标准化
生物标志物测量生物标志物测量

背景情况:

准确的α-fetoprotein (AFP) 测量对于临床诊断至关重要.
不同的AFP免疫测试结果之间存在差异.
标准化工作需要适当的参考材料 (RMs) 来进行外部质量评估 (EQA).

研究的目的:

评估候选AFP参考材料 (Can-RMs) 适用于外部质量评估 (EQA) 程序的适用性.
评估Can-RMs在不同免疫试验中的可交换性.
为了改善临床诊断,标准化AFP测量.

主要方法:

准备好的候选RM (Can-RMs) 和临床样本.
用五种免疫测试对Can-RMs分配了目标值,这些免疫测试与世卫组织72/225.5国际标准进行校准.
使用CLSI和IFCC方法评估交换性,并评估分析性能 (TE,偏差,CV).

主要成果:

通过CLSI方法,Can-RMs显示了所有免疫试验的可交换性.
与IFCC方法相比,可交换性有所不同,一些结果是不可交换的.
准确性,真实性和精度的平均通过率分别为91%,81%和95%.

结论:

在CLSI和IFCC评估方法之间,RM的可交换性有所不同.
在Can-RM中,与CLSI方法的交换性很好.
这些Can-RM适用于EQA程序,以监测AFP测量性能.

关键词:

阿尔法-胎儿蛋白是一种α-胎儿蛋白.可换性可换性是指可换性.外部质量评估外部质量评估免疫测试是一种免疫测试.参考标准是一个参考标准.

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