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经常进行校准是否足够? 基于患者的血液气体和实验室分析仪的质量控制视角
1Department of Medical Biochemistry, Umraniye Training and Research Hospital, Istanbul, Turkey.
Clinica chimica acta; international journal of clinical chemistry
|October 12, 2025
概括
基于患者的质量控制 (PBQC) 与传统方法相比,提供了优越的分析错误检测. 中央实验室分析仪表现出比医疗保健点血液气体分析仪表更稳定的性能,这表明需要提高POCT的质量保证.
科学领域:
- 临床化学和实验室诊断.
- 医疗保健中的质量保证
- 分析性绩效评价分析性绩效评价
背景情况:
- 传统的质量控制 (QC) 材料可能不反映患者样本的行为,导致非可换性和潜在的分析错误.
- 基于患者的质量控制 (PBQC) 使用真实患者数据来提高检测分析偏差的灵敏度.
- 医疗中心 (POC) 和中央实验室分析仪之间的校准策略 (自动 vs 操作员驱动) 的差异需要性能比较.
研究的目的:
- 使用基于患者的质量控制 (PBQC) 指标,比较中央实验室分析仪和照顾点血气分析仪的分析性能.
- 评估PBQC在不同实验室环境中检测分析错误的有效性.
- 评估校准方法对测试结果可靠性的影响.
主要方法:
- 在三个月内对112,898名患者的葡萄糖,和血红蛋白结果进行了回顾性分析.
- 数据从中央实验室分析仪 (罗氏COBAS 8000,Mindray BC6000) 和医疗点血液气体分析仪 (西门子Rapidpoint 500) 中收集.
- 基于患者的质量控制 (PBQC) 分析使用了指数加权移动平均 (EWMA) 图表,评估了假阳性标志率,错误检测前患者结果的平均数量 (ANPed) 和错误检测概率 (Ped).
主要成果:
- 与血液气体分析仪相比,中央实验室的分析仪显示出持续较低的假阳性标志率.
- 中央实验室和POC分析仪均显示低ANPed值,表明有效的错误检测能力.
- 对于葡萄糖 (快点) 和 (COBAS 8000),观察到高错误检测概率 (Ped) 值,而对于快点和血红蛋白,观察到较低的Ped值.
结论:
- 基于患者的质量控制 (PBQC) 是传统质量控制的宝贵补充,用于在中央实验室和临床检测中早期检测分析偏差.
- 中央实验室分析仪表现出更稳定的性能,而血液气体分析仪尽管经常进行自动校准,但产生了更多假阳性警报.
- 将基于PBQC的算法集成到血液气体分析仪软件中,可以优化校准触发器,提高分析可靠性和护理点设置中的质量保证.
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