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建立,验证和应用度间隔对应于尿道蛋白质测量棒等级的度间隔
Chun-Yan Tan1, Ying Zhou2, Hong-Ying Zhao1
1Department of Clinical Laboratory, Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region, 6 Taoyuan RD, Nanning, Guangxi 530021, China.
概括
这项研究开发了一种方法,用于使用百分比协议 (PA) 建立准确的度间隔 (GCI) 用于滴杆测试. 该方法显示,由于特定等级的重叠很小,两个测量棒设备是不可比较的.
科学领域:
- 临床化学 临床化学
- 诊断测试 诊断测试 诊断测试 诊断测试 诊断测试
- 医疗器械评估 医疗器械评估
背景情况:
- 制造商和文献数据对于度区间 (CI) 的准确性不足.
- 开发了一种新方法来确定可靠的度量杆等级与度间隔 (GCIs).
- 该方法使用百分比协议 (PA) 并评估GCI适用性,用于比较当前的测量棒测试.
研究的目的:
- 为了确定准确的度间隔 (GCIs) 用于测量棒测试.
- 为了验证这些GCI的准确性,使用百分比协议 (PA).
- 为了评估基于GCI重叠的不同测量棒设备的可比性.
主要方法:
- 两个测量棒测试 (iChem,KU-500) 的结果与定量测试 (AU5800) 的结果进行了比较.
- 基于计算的PAs作为准确性指标的经过验证和建立的GCI.
- 计算了每个年级的两个计量器件的GCI之间的百分比重叠,以评估一致性.
主要成果:
- 在各种等级中为iChem Velocity和KU-500建立了GCI和PA组合.
- 发现设备之间的特定等级 (±,1+) 的GCI重叠低于既定拒绝限值 (分别为45%和56%).
- 总体重叠率为72%,也低于80%的拒绝极限,表明这两种测量棒装置之间没有可比性.
结论:
- 使用PA,可以准确地验证和建立GCI,从而实现杆测试的行业标准.
- 叠加分析提供了一种方法,用于大致确定测量棒装置,历史数据和文献之间的可比性.
- 该研究强调了GCI准确性和重叠对于可靠的诊断测试比较的重要性.
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