评估当前总维生素B12测量方法的协调:相关性和影响
Bruno Mario Cesana1, Simona da Molin2, Nuthar Jassam3
1Laboratory of Medical Statistics, Biometry and Epidemiology "G.A. Maccacaro", University of Milan, Milan, Italy.
Clinical chemistry and laboratory medicine
|August 19, 2025
概括
维生素B12 (B12) 测定值不是普遍适用的,因为方法之间缺乏一致性. 这影响了在不同实验室分析中准确识别B12缺乏.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 诊断检测试验 诊断检测试验
背景情况:
- 国家卫生和护理卓越研究所 (NICE) 建议维生素B12 (B12) 测试值用于缺陷诊断.
- 这些门假定不同B12检测方法的结果可以互换.
研究的目的:
- 评估不同维生素B12 (B12) 测定方法之间的一致性.
- 为了确定NICE推的值是否适用于所有B12测定.
主要方法:
- 比较了Alinity,Architect,Access DXi,Atellica和ADVIA Centaur与Cobas (罗氏诊断) 的B12结果,使用了19个外部质量评估 (EQA) 练习和97个血清样本.
- 使用普通最小平方和布兰德-阿尔特曼分析来评估方法协议和偏差.
主要成果:
- 与罗氏相比,观察到B12度的显著高估 (阿博特) 和低估 (贝克曼).
- 系统和比例错误模式在EQA和血清样本之间是一致的.
- 广泛的协议限制表明大多数方法和比较器之间的协议很差,尽管一些方法间偏差低于9.4%的目标.
结论:
- 建议的血清总维生素B12 (B12) 值不应普遍应用于所有测定.
- 当前B12检测方法之间缺乏一致性,限制了标准化值的可靠使用.
- 这种限制仍然存在,即使有世界卫生组织 (WHO) 国际标准 (IS) 03/178.8.
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