Objective: To investigate the intra-observer reproducibility of Ki-67 assessment in breast cancers using three methods based on digital slide. Methods: Thirty cases of invasive breast cancer tissues were immunostained for Ki-67 by automatic stainer, and then scanned into digital pathological slides. Ki-67 positive index was measured individually by three pathologists using size-set visual assessment of hot spot (SSVAHS), size-set semi-automatic counting of hot spot(SSSACHS), and size-set automatic counting of hot spot (SSACHS), respectively, and repeated for 10 times. Intraclass correlation coefficient (ICC) of each assessment method was calculated, and the intraobserver reliability was classified as excellent, good, fair and poor according to ICC. Results: The ICC by 3 pathologists using SSVAHS was 0.832, 0.843 and 0.826, respectively, The ICC using SSSACHS was 0.926,0.938,0.929, and the ICC using SSACHS was 0.964, 0.971 and 0.968.The intraobserver reliability level of all three methods was excellent. Conclusion: The three methods of Ki-67 assessment achieve satisfactory intraobserver reproducibility, and the order of reproducibility from high to low is SSACHS, SSSACHS, and SSVAHS.
目的： 运用新近建立的基于数字切片的Ki-67判读法进行乳腺癌Ki-67重复判读并探讨其重现性，为临床应用奠定基础。 方法： 运用机染法对2014年5月至2016年5月解放军联勤保障部队第九二〇医院30例浸润性乳腺癌标本行Ki-67免疫组织化学染色，制作数字病理切片，由3位主治以上病理医师分别采用热点区设定面积视觉评估、热点区设定面积半自动计数、热点区设定面积全自动计数方法进行10次重复判读，计算组内相关系数（ICC）并据此将判读者信度划分为优、良、中、差。 结果： 3人应用热点区设定面积视觉评估法重复判读的ICC分别是0.832、0.843、0.826；应用热点区设定面积半自动计数法重复判读的ICC分别是0.926、0.938、0.929；应用热点区设定面积全自动计数法重复判读的ICC分别为0.964、0.971、0.968，观察者信度等级均为优。 结论： 上述3种基于数字切片的Ki-67判读方法均可获得满意的判读者内重现性，重现性由高到低依次为热点区设定面积全自动计数法、热点区设定面积半自动计数法、热点区设定面积视觉评估法。.
Keywords: Breast neoplasms; Immunohistochemistry; Ki-67 antigen; Reproducibility of results.