一个概念验证的实用方法,在等待协调期间,从非协调的测量方法获得同等的结果:CA 125的例子
Hikmet Can Çubukçu1, Oğuzhan Zengi2, Hamit Hakan Alp3
1Rare Diseases Department, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Turkey; Department of Medical Biochemistry, Sincan Training and Research Hospital, Ankara, Turkey.
概括
一种新方法使不同测试之间的实验室测试结果协调一致,大大减少了差异. 这可以通过在各种测量系统中确保一致的诊断数据来改善患者监测.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 在诊断中的计量学.
背景情况:
- 由于缺乏测量协调,实验室测试结果不一致妨碍了临床决策.
- 高级参考文献往往无法获得,导致不同诊断试验中的可比性问题.
研究的目的:
- 引入和验证一种方法,以提高不同测量系统的实验室测试结果的可比性.
- 提供一个解决方案,使测试结果的解释一致,直到实现完全的计量协调.
主要方法:
- 开发了一个线性转换公式,使用源和目标方法的2.5和97.5百分位数.
- 测试了配方与碳水化合物抗原125 (CA 125) 来自罗氏和阿博特测试的数据.
- 使用差异图和Passing-Bablok回归来评估有效性,并为该过程开发了一个Web应用程序.
主要成果:
- 在CA 125试验之间的初始中位数相对差异为37.7%,斜率为1.450.
- 在转换后,中位数相对差异减少到6.0%,在可接受的偏差目标范围内.
- 回归斜率和截面显著改善,表明结果可比性提高.
结论:
- 拟议的线性转换方法有效地提高了不同诊断试验之间的结果的可比性.
- 这种方法可以在随访期间更一致地解释患者测试结果.
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