血仁素活性测量候选参考材料的可交换性评估:当前的挑战
Zhenni Liu1,2, Lizi Jin1,2, Zijia Ma1,2
1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China.
寻找可交换的参考材料 (RMs) 用于血胆固醇活性 (PRA) 测定具有挑战性. 大规模的外部质量评估 (EQA) 材料表现出比小规模的尖池更好的交换性,这表明它们适合作为RMS.
科学领域:
- 临床化学 临床化学
- 生物标志物测试开发
- 在诊断中进行质量控制.
背景情况:
- 精确测量血蛋白活性 (PRA) 对于诊断和管理各种疾病至关重要,包括高血压和病.
- 外部质量评估 (EQA) 材料和候选参考材料 (RMs) 对于确保不同实验室PRA测定结果的可靠性和可比性至关重要.
- 评估这些材料的可换性对于它们在质量保证计划中的有效使用至关重要.
研究的目的:
- 评估候选参考材料 (RMs) 和现有的外部质量评估 (EQA) 材料的可交换性,用于血蛋白活性 (PRA) 测定.
- 为了比较不同PRA测试方法的性能,包括LC-MS/MS和化学发光免疫测试,在材料交换性方面.
- 确定影响PRA材料交换性的因素,如池的大小和尖端.
主要方法:
- 评估了16个候选RM和40个临床样本的可交换性,使用四个常规PRA测定 (三个LC-MS/MS,一个化学发光免疫测定).
- 利用偏差和线性回归的差异与预测间隔方法来确定可换性.
- 通过双向差异分析分析了和池大小对通用性的影响,并进行了稳定性和同质性研究.
主要成果:
- 偏差方法的差异表明大多数材料的交换性很差 (14/16不可交换),在使用不同的化缓冲器时观察到显著的样本特异效应.
- 预测间隔方法在尖小规模池中没有显示出交换性,而EQA材料 (4/9) 显示出比小规模池 (2/7) 更好的交换性.
- 大规模的池,无论是尖的还是没有尖的,在所有测试的试验中都表现出更好的交换性趋势.
结论:
- 获得PRA试验的可切换RM是可行的,但存在挑战.
- 目前的EQA材料提供了良好的交换性,稳定性和均性的平衡,使它们适合作为RMS.
- 大型池通常更易切换;在小规模池中不建议用于RM准备. 建议在未来的研究中对化缓冲器进行标准化.
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