诊断试验一致性评价中几种方法的比较及应用

目的 对诊断试验中评价一致性的几种方法进行比较.方法 对实例及3种模拟情况进行一致性评价,比较几种方法的优劣.结果 检验试剂与参考试剂测量游离前列腺特异抗原(FPSA)的实例分析中,除配对t检验外,几种方法均显示出良好的一致性;在系统误差较大的模拟情况下,简单相关分析所得结果相对实例而言没有变化;在随机误差较大的模拟情况下,配对t检验得出两种试剂具有良好的一致性;在系统误差和随机误差均小的模拟情况下,组内相关系数所得结果显示一致性较差.结论 配对t检验、简单相关分析用于一致性评价都只适用于部分资料,组内相关系数法适用于存在系统误差和/或随机误差的时候,而Bland-Altman法以及ATE/LER区域可作为一致性评价的优先考虑方法.

Evaluation and Application on Different Assessment Methods of Consistency of Diagnostic Test

Objective To evaluate different assessment methods of consistency of diagnostic test.Methods Different assessment methods were adopted to evaluate the consistency of a true example with good consistency in fact and three simulation situations developed from the true one.Results All assessment methods showed good consistency for the true example except paired t test.Simple correlation analysis was insensitive in the situation of obvious systematic bias.And in the situation with comparatively large random err...