本指南涵盖了使用患者样本进行测量程序比较实验的设计，以及用于确定两种体外诊断测量程序之间偏差的后续数据分析技术。临床和实验室标准协会指南EP09——使用患者样本的测量程序比较和偏差估计是为实验室和制造商编写的。它描述了确定两个测量程序之间偏差的程序，并确定了使用患者样本设计和分析测量程序比较实验时需要考虑的因素。测量程序对比实验的概述包括制造商和实验室的注意事项。提供了有关如何创建差异图和散点图以便对数据进行目视检查的详细信息。 一旦对数据进行了表征，就会引入各种方法来量化两个测量程序之间的关系，包括偏差估计和回归技术。最后一章包含制造商评估偏差的建议，以及偏差索赔的声明格式。

This guideline covers the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures.Clinical and Laboratory Standards Institute guideline EP09 -Measurement Procedure Comparison and Bias Estimation Using Patient Samplesis written for laboratorians and manufacturers. It describes procedures for determining the bias between two measurement procedures, and it identifies factors for consideration when designing and analyzing a measurement procedure comparison experiment using patient samples. An overview of the measurement procedure comparison experiment includes considerations for both manufacturers and laboratorians. Details on how to create difference and scatter plots for visual inspection of the data are provided. Once the data are characterized, various methods are introduced for quantifying the relationship between two measurement procedures, including bias estimates and regression techniques. The final chapter contains recommendations for manufacturers' evaluation of bias and statement format for bias claims.