目的:评价SM-1A 中医四脉脉诊测量仪脉象诊断的准确性。方法：应用诊断性试验设计，评价SM-1A 中医四脉脉诊测量仪对120 例受试者溢脉、聚脉、韧脉、紊脉4 种基本脉象与中医专家脉诊结果对照的一致性及其自身重复性。结果：与中医专家脉诊结果对照，SM-1A 中医四脉脉诊测量仪对溢脉、聚脉、韧脉、紊脉的诊断敏感度分别为0.859、0.945、0.957 和0.898；特异度分别为0.875、0.8、0.907 和0.833；Kappa 值分别为0.733、0.631、0.763 和0.549；正确率为0.867，0.933，0.917 和0.892；Youden 指数分别为0.734、0.745、0.864 和0.731。其自身两次重复诊断的完全符合率为81.7%。结论：SM-1A 中医四脉脉诊测量仪可以较为准确地进行四脉诊断，具有较好的信度和效度。

This study aimed to assess the reproducibility of SM-1A TCM pulse detector according to traditional Chinese medicine (TCM) experts. A total of 120 subjects were enrolled. Each subject was diagnosed by the SM-1A TCM pulse detector and TCM expert, respectively. And the pulse diagnosis was based on four types of pulse, including yimai,ju-mai, ren-mai and wen-mai. The Kappa test was applied. Compared to TCM expert, the sensitivity of the pulse detector for yi-mai was 0.859, for ju-mai was 0.945, for ren-mai was 0.957, and for wen-mai was 0.898. The specificity of the pulse detector for yi-mai was 0.875, for ju-mai was 0.8, for ren-mai was 0.907, and for wen-mai was 0.833. The Kappa value for yi-mai was 0.733, for ju-mai was 0.631, for ren-mai was 0.763, and for wen-mai was 0.549. The coincidence rate for yi-mai was 0.867, for ju-mai was 0.933, for ren-mai was 0.917, and for wen-mai was 0.892. The Youden index for yi-mai was 0.734, for ju-mai was 0.745, for ren-mai was 0.864, and for wen-mai was 0.731. The coincidence rate of SM-1A TCM pulse detector in the successive diagnosis of the same patient was 81.7%. Therefore, the SM-1A TCM pulse detector is able to diagnose the pulse accurately based on the four types of pulse. The test-retest reliability was good.

国家科技重大专项课题（008ZX09312-012）：中药新药临床研究技术平台规范建设，负责人：胡镜清。