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我们应该依赖制造商包装插件中的参考间隔吗? 将四家制造商的TSH和FT4参考间隔与现代间接方法和直接方法的结果进行比较

Niek F Dirks^1,2,3, Wendy P J den Elzen^4,5, Jacquelien J Hillebrand^1,6

¹Endocrine Laboratory, Department of Laboratory Medicine, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.

Clinical chemistry and laboratory medicine

|January 11, 2024

概括

使用历史实验室数据的间接方法提供了对甲状腺刺激激素 (TSH) 和自由甲状腺素 (FT4) 参考间隔 (RI) 的成本有效验证,比制造商提供的RI更准确.

科学领域:

临床化学临床化学
实验室医学实验室医学
内分泌学在内分泌学.

背景情况:

准确解释甲状腺功能测试需要精确的甲状腺刺激激素 (TSH) 和自由甲状腺素 (FT4) 的参考间隔 (RIs).
ISO15189标准要求定期验证RI,这给实验室带来了成本和后勤挑战.
调查成本有效的替代方法直接确定RI对于实验室的合规性和效率至关重要.

研究的目的:

评估间接方法的有效性,利用历史实验室数据,作为直接RI确定的替代品.
为了比较 TSH 和 FT4 的间接 RI (IRI) 与直接 RI (DRI) 以及制造商提供的 RI.
评估RI验证间接方法的稳定性和成本效益.

主要方法:

收集了13个荷兰实验室使用自动化平台 (罗氏,阿博特,贝克曼,西门子) 的历史TSH和FT4数据 (2008-2022年).
建立的间接RI (IRI) 使用TMC用于TSH和refineR用于FT4,按实验室和年份,按制造商分类.
在每个平台的125名健康个体中建立了直接的RI (DRI),用于比较.

主要成果:

在研究期间,TSH IRI在所有制造商中都表现出一致的稳定性.
罗氏,贝克曼和西门子的FT4IRI强,但阿博特的上限RI从2015年开始大幅下降.
IRI和DRI显示与适当的年龄分层密切一致; TSH和FT4的制造商提供的RI显示不适当的上限.

结论:

制造商提供的RI常常是不准确的,这凸显了对RI验证的关键需求.
间接方法为特定实验室和特定平台的RI验证提供了强大且具有成本效益的替代方案.
定期验证RI对于准确的甲状腺功能测试解释至关重要.

关键词:

直接方法是直接方法.间接方法是间接的方法.参考时间间隔的参考时间间隔.甲状腺疾病是一种甲状腺疾病.

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