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探索用于血清叶酸测量的可切换材料:跨方法协调的挑战
Xiaerbanu Nizhamuding1,2, Qian Zhang3, Lizi Jin1,2
1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China.
Clinical chemistry and laboratory medicine
|June 25, 2025
概括
参考材料 (RMs) 对于准确的叶酸测量至关重要. 这项研究确定了可切换的RM,cRM-3在各种测试中表现最好,改善了临床诊断.
科学领域:
- 临床化学 临床化学
- 计量学 计量学 计量学
- 分析化学 分析化学
背景情况:
- 参考材料 (RM) 的可交换性对于在不同测量系统中获得准确和同等的分析结果至关重要.
- 在叶酸量化中,可切换的RM确保了分析行为在各种检测平台上反映了原生临床标本.
- 血清叶酸测量的协调和计量可追溯性对于可靠的临床诊断至关重要.
研究的目的:
- 识别和描述用于血清叶酸分析的可切换候选参考材料.
- 提高临床诊断中叶酸测量的协调性和计量可追溯性.
主要方法:
- 在四个实验室中使用了两种同位素稀释液体染色学串联质谱法 (ID-LC-MS/MS) 和三种免疫试验.
- 评估了30份研究材料,包括组合的临床血清样本和各种参考材料.
- 德明回归分析和差异偏差方法评估了可换性.
主要成果:
- 候选RM 3 (cRM-3) 在所有测试试验中表现出可交换性,被确定为最合适的候选物.
- 发现七种材料,包括cRM-1,cRM-2和cRM-3,无论采用哪种统计方法,都可用于ID-LC-MS/MS方法.
结论:
- 血清叶酸物种的复杂性和免疫试验和ID-LC-MS/MS方法之间的不同检测原则对测量协调提出了挑战.
- 免疫试验之间的校准基质的变化进一步复杂化了叶酸测量的可换性评估.
- 识别像cRM-3这样的可切换RM对于标准化血清叶酸量化和改善临床实验室结果至关重要.
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