具有二元响应的分析物验证研究的β -二项统计模型。

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL Journal of AOAC International Pub Date : 2023-11-02 DOI:10.1093/jaoacint/qsad085
Robert A LaBudde, Paul Wehling
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引用次数: 0

摘要

背景:在过去的十年里,检测概率(POD)模型在统计分析单一和多个合作者验证研究中得到了广泛的应用,这些研究使用了各种分析物的二元结果数据。目的:POD模型建立在坚实的理论基础上,并扩展为更广义的β二项式模型。方法:重新访问POD模型,并将其嵌入β二项式模型中。这种概括包括作为特定参数的合作者再现性。新模型只包括两个分布参数:整体跨合作者检测概率(LPOD)和合作者组内相关性(ICC),测量不可复制性。方法之间的差异通过LPOD值的差异来衡量,表示为dLPOD。结果:通过模拟验证了准确的统计估计量和置信区间。这种新的β二项式模型将适用于提供二元定性结果的所有候选方法,包括微生物、毒素、过敏原、生物阈值和植物分析物。结论:新的β-二项式模型提供了简单的等效性测试,以表明该研究清楚地证明(95%的置信度)方法差异和合作者的再现性是可接受的。亮点:使用分析物检测概率(POD)作为感兴趣参数的定性二元方法的验证系统已经进行了修改和进一步验证。
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Beta-Binomial Statistical Model for Validation Studies of Analytes with a Binary Response.

Background: The probability of detection (POD) model has had widespread application for statistically analyzing single and multiple collaborator validations studies with binary outcome data for a wide range of analytes over the last decade.

Objective: The POD model is placed on a firm theoretical foundation, and extended to a more generalized beta-binomial model.

Methods: The POD model is revisited and embedded in the beta-binomial model. This generalization includes collaborator reproducibility as a specific parameter. The new model includes only two distributional parameters: the overall across-collaborator probability of detection (LPOD) and the intraclass correlation of collaborators (ICC), measuring irreproducibility. Differences between methods are measured by the difference in LPOD values, denoted dLPOD.

Results: Accurate statistical estimators and confidence intervals are provided with validation by simulation. This new beta-binomial model will be applicable to a full range of candidate methods giving binary qualitative results, including microbiological, toxin, allergen, biothreat, and botanical analytes.

Conclusions: The new beta-binomial model provides easy equivalence tests to show the study clearly demonstrates (with 95% confidence) that the method differences and collaborator reproducibility are acceptable.

Highlights: The validation system for qualitative binary methods using probability of detection (POD) of an analyte as the parameter of interest has been modified and further validated.

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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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