贝塔-二项式统计模型用于对具有二进制响应的分析物的验证研究
Robert A LaBudde1, Paul Wehling2
1Least Cost Formulations, Ltd, 824 Timberlake Dr, Virginia Beach, VA 23464, USA.
Journal of AOAC International
|July 14, 2023
概括
一个新的β-双项模型提高了用于分析验证研究的检测概率 (POD) 模型. 这种先进的统计方法改善了对二进制结果数据分析中的方法差异和协作者的可重复性评估.
科学领域:
- 分析化学 分析化学
- 生物统计学 生物统计学
- 方法验证方法验证
背景情况:
- 检测概率 (POD) 模型被广泛用于分析具有二元结果的验证研究.
- 在过去的十年中,它已经应用于各种分析物.
- 现有的模型需要改进,以获得更广泛的应用.
研究的目的:
- 为POD模型提供坚实的理论基础.
- 将POD模型扩展到一个更普遍的β-二项式框架中.
- 将合作者的可重复性作为一个关键参数.
主要方法:
- 重新审视POD模型并将其嵌入到β-双项分布中.
- 引入两个分布参数:检测的总概率 (LPOD) 和类内相关性 (ICC) 的可重现性.
- 使用LPOD值差异 (dLPOD) 测量方法差异.
主要成果:
- 开发精确的统计估计器和置信区间,通过模拟验证.
- 新的β-双项模型适用于各种定性二进制方法.
- 包括微生物,毒素,过敏原,生物威胁和植物分析剂.
结论:
- 贝塔双项模型提供了简单的等价性测试.
- 以95%的可信度证明了可接受的方法差异和协作者的可重现性.
- 通过使用POD.成功修改和验证了使用POD.验证定性二进制方法的系统.
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