对血清25-基维生素D的免疫试验和LC-MS/MS方法的测量不确定性的评估
Etienne Cavalier1, Harjit P Bhattoa2, Annemieke C Heijboer3
1Department of Clinical Chemistry, University of Liège, CIRM, CHU de Liège, Liège, Belgium.
Clinical chemistry and laboratory medicine
|August 11, 2025
概括
准确的维生素D测试对健康至关重要. 这项研究表明,虽然一些测试具有很高的测量不确定性,但其他测试可靠地检测变化,强调需要仔细选择测试.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 分析科学 分析科学
背景情况:
- 准确的25-氧维生素D (25-OH) D测量对于有关维生素D状态的临床决定至关重要.
- 像维生素D标准化计划 (VDSP) 这样的标准化计划旨在减少25-OH) D测定中的变异性.
研究的目的:
- 为了评估各种25-OH) D试验的测量不确定性 (MU).
- 评估这些试验检测维生素D水平随时间变化的能力.
主要方法:
- 在两个实验室中使用LC-MS/MS和免疫检测分析了聚合和单一供体血清样本.
- 评估不准确性,偏差和MU与参考测量程序相比.
- 与VDSP,JCTLM-TF-RMSI和IFCC C-BM. 的分析性能规范 (APS) 进行比较.
主要成果:
- LC-MS/MS方法始终符合所有APS标准.
- 一些免疫测试显示了可接受的MU,但另一些具有显著的偏差或实验室间的变异性.
- 超过一半的试验达到理想的JCTLM MU值 (≤10%),其中四个超过最低可接受限值 (≤15%).
结论:
- 测量不确定性是25-OH) D测定的一个重大挑战.
- 集成基于MU的APS和图形可视化为测试评估提供了一个强大的框架.
- 选择具有可靠性能的试验对于检测维生素D状态的临床意义上的变化至关重要.
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