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使用Bland-Altman基于图形的协调算法来优化免疫试验的协调.

Huiling Fang1, Ruifeng Yang2,3, Jiayue Guo1

  • 1Department of Clinical Chemistry and Immunology, Shanghai Center for Clinical Laboratory, Shanghai, P.R. China.

Clinical chemistry and laboratory medicine
|May 14, 2024
PubMed
概括
此摘要是机器生成的。

一个新的布兰德-阿尔特曼基于图形的协调算法 (BA-BHA) 显示了与权重的德明回归基于协调算法 (WD-BHA) 相比,体外诊断测量设备 (IVD-MDs) 的准确性得到了改进. BA-BHA为优化免疫测试协调提供了一个可行的替代方案.

关键词:
布兰德 - 阿尔特曼地块统一化和化 统一化和化协调参考材料的协调参考材料.有权重的德明回归.

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科学领域:

  • 临床化学 临床化学
  • 生物医学工程 生物医学工程
  • 医学诊断 医学诊断 医学诊断

背景情况:

  • 在体外诊断测量设备 (IVD-MDs) 的协调对于获得同等结果至关重要,这是国际标准化组织 (ISO) 建议的.
  • 现有的方法,比如加权德明回归基协调算法 (WD-BHA),可能会掩盖分析差异.

研究的目的:

  • 评估一种新的基于Bland-Altman图片的协调算法 (BA-BHA) 的有效性.
  • 为了比较BA-BHA与ISO 21151:2020推的WD-BHA,用于IVD-MD协调.

主要方法:

  • 开发了IVD-MD特定的协调算法,使用80个患者血清作为协调参考材料 (HRM).
  • 在一个由40名患者组成的单独小组中验证了算法.
  • 在协调之前和之后,比较了回归斜率,交叉点,布兰德-阿尔特曼地图布局,百分比差异,协议极限 (LoAs) 和方法之间的变化系数 (CV).

主要成果:

  • WD-BHA协调导致了可接受的斜率/截面,但显示了很大的平均差异 (-33.9~23.9%) 和广泛的LoA (-64.6~74.6%),具有高的方法间CV (22.9%).
  • 在加权的Deming和Passing-Bablok回归中,BA-BHA协调产生了协调的结果,平均差异明显较小 (-1.1至1.6%),LoA较窄 (-23.3至23.2%) 和方法间CV较低 (8.4%).
  • 在BA-BHA之后的Bland-Altman图表显示了平均值周围的数据分布.

结论:

  • 尽管可接受的斜率和拦截值,WD-BHA可能会隐藏不可接受的分析差异.
  • 新的BA-BHA协议证明了其作为优化免疫试验协调的可行替代方案的潜力.
  • BA-BHA提供了一种更准确,更可靠的方法来协调IVD-MD的结果.