摘要：本文探讨了体外诊断试剂临床试验常用的统计方法。根据使用条件、限制和接受准则的不同分析了定性分析方法中的四格表统计、Kappa检验、配对卡方检验和定量分析方法中的线性相关性分析、回归分析、偏倚估计、Bland -Altman一致性分析。

    关键词：统计方法；定性分析；定量分析

    Study on Statistical Methods of in Vitro Diagnostic Reagents

    LI Xiao-jiang

    (Review and Certification Center，Guangdong food and Drug Administration，Guangzhou 510080，Guangdong，China)

    Abstract：This paper just focuses on the statistical methods used in the clinical test of in vitro diagnostic reagents. It discusses of qualitative methods and quantitative methods according to the use of conditions ......