使用常规和替代公式对Sigma指标进行比较分析
Kamil Taha Uçar1, Abdulkadir Çat2
1Health Science University, Istanbul Basaksehir Cam and Sakura City Hospital, Department of Medical Biochemistry, Istanbul, Turkey.
Clinica chimica acta; international journal of clinical chemistry
|September 11, 2023
概括
通过比较分析性能评估的Sigma Metrics (SM),这项研究发现,选择容忍范围显著影响结果. 实验室必须根据质量目标和分析物的特性选择合适的方法.
科学领域:
- 临床化学 临床化学
- 分析性绩效评价分析性绩效评价
- 质量管理系统 质量管理系统
背景情况:
- 六西格玛 (SM) 广泛用于评估临床实验室分析性能.
- 传统的SM公式使用了允许的总误差 (TEa) 和偏差,但它的适用性仍在争论中.
- 已经提出了使用体内生物变异 (CVI) 作为耐受范围 (TR) 的替代性SM配方.
研究的目的:
- 使用常规和替代公式计算和比较Sigma Metric (SM) 值.
- 评估不同容忍范围 (TR) 定义对分析性能评估的影响.
- 为了确定SM公式对临床化学参数的适用性.
主要方法:
- 分析了20个临床化学参数.
- 使用常规公式计算SM值,其中包括CLIA和生物变异 (BV) TEa目标.
- 使用CVI作为TR的替代公式,也计算了SM值.
- 中间精度 (CVA%) 和偏差数据来源于质量控制和外部质量评估报告.
主要成果:
- 使用常规公式,11个SM值 (CLIA TEa) 和21个SM值 (BV TEa) 是不可接受的 (SM<3).
- 用替代公式计算的22个SM值也低于3.
- 观察到,所选择的TR对评估的分析性能有很大的影响.
结论:
- 宽容范围 (TR) 的定义在很大程度上影响了分析性能的评估.
- 实验室必须根据具体的质量目标,分析物质特性和操作环境,仔细选择合适的SM配方和TR.
- 这凸显了临床实验室对质量指标的批判性评估的必要性.
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