在血液机构估计血红蛋白测量不确定性的新兴实践
Maria Helena Sousa Timóteo1, Ana Sofia R Tavares1, Paulo Pereira1
1Lisbon School of Health, Polytechnic University of Lisbon, Portugal.
概括
在血红蛋白检测中测量不确定性 (MU) 对输血安全至关重要. 这项研究证实MU估计符合绩效目标,支持输血实验室的最佳实践.
科学领域:
- 临床化学 临床化学
- 输血医学 输血医学
- 实验室质量管理的质量管理.
背景情况:
- 测量不确定性 (MU) 在ISO和欧洲法规中至关重要.
- 准确的血红蛋白检测对于供体资格和输血安全至关重要.
研究的目的:
- 为了估计血红蛋白测试中的MU,使用甲血红蛋白方法.
- 在不同的不确定性场景 (不精确性,校准器,偏差) 下评估MU.
- 评估是否符合可允许的不确定性性能目标.
主要方法:
- 应用ISO/TS 20914:2019指南的方法.
- 使用EFLM生物变异数据的参数模拟模型.
- 在EDTA-K3静脉血液中对血红蛋白检测的分析.
主要成果:
- 所有评估的场景都满足了可允许不确定性的理想 (2.7%) 和最低 (4.1%) 绩效目标.
- 甲球蛋白方法证明了可接受的MU用于临床应用.
- 整合MU估计是可行的和有益的.
结论:
- MU估计是输血实验室医学的ISO和欧洲认可的最佳实践.
- 这种方法提高了可追溯性,在输血服务中基于风险的决策.
- 结果与ISO 15189:2022实验室质量要求保持一致.
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