用中国国家外部质量评估方案数据和生物变异数据对凝血因子测定允许总错误规范进行比较分析
Chengshan Xu1, Zhongli Du1, Gaofeng Hu1
1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, PR China.
Clinica chimica acta; international journal of clinical chemistry
|January 18, 2025
概括
通过将外部质量评估 (EQA) 数据与生物变异 (BV) 数据相结合,建立了凝血因子测试的新总误差规范. 这些规格因分析物度而异,反映了当前的测试能力和临床需求.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 质量控制 质量控制 质量控制
背景情况:
- 为凝血因子测定建立可行的总误差规范对于质量控制至关重要.
- 当前的规范往往缺乏实用性和合理的可实现性.
- 将外部质量评估 (EQA) 数据与生物变异 (BV) 结合起来,提供了一种新的方法.
研究的目的:
- 建立新的,依赖度的凝血因子测定总误差规范.
- 将可靠的生物变异数据与EQA结果相结合.
- 根据性能数据提出推的总错误规范.
主要方法:
- 分析了来自中国1381个实验室的28408个EQA结果.
- 通过参考区间对EQA数据进行分层,以创建依赖度的规范.
- 基于表现最好的参与者的"最先进"总错误的定义.
- 与BV衍生的总误差进行比较,以设定推规格.
主要成果:
- 没有测量值达到最佳的生物变异衍生总误差.
- 八个参数 (FII,FVIII,FX,FVII,FIX) 在特定度水平上达到理想的标准.
- 低度的FXI不符合最低标准.
结论:
- 凝血因子检测的总误差规范应取决于度,并考虑技术可行性.
- 临床要求和区域监管标准是制定规范的重要因素.
- 分析剂度对实验室的性能产生重大影响,因此需要定期更新总误差规范.
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