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目的探讨病理医师对乳腺浸润性导管癌HER2免疫组化(immunohistochemistry,IHC)检测结果判定的重复性及其影响因素,寻求提高判读重复性和准确性的措施。方法参照《乳腺癌HER2检测指南》,2位乳腺专科病理医师共同读片选取56例浸润性导管癌的HER2IHC切片作为研究对象。4位非专科病理医师独立盲法完成对该组病例IHC切片的前后两轮结果判定。对第一轮4位观察者间的判读重复性和观察者自身的判读重复性进行Kappa分析。同时将2位专科医师共同确定的判读结果作为HER2判读参考分级,4位非专科医师第一轮的判读结果分别与之进行配对Kappa分析。结果观察者间的判读重复性为中等(K=0.5939),重复性最高的级别是HER2为0(K=0.8114),最低的是HER2为2+(K=0.4736)。判读级别简化为阳性和阴性后,观察者间的重复性明显提高(K=0.7230)。4位观察者自身的判读重复性极好(Kw=0.8219~0.9165),判读的准确性则与经验有关。结论采用标准化的检测手段、深入学习和实践现有的判读标准以及联合判读等措施应有助于提高HER2IHC判读的重复性和准确性。
OBJECTIVE: To investigate the repeatability and influencing factors of pathological examination of HER2 immunohistochemistry (IHC) in pathological breast invasive ductal carcinoma (IHC) and to find ways to improve the repeatability and accuracy of interpretation. Methods According to “Guideline for HER2 detection in breast cancer”, two breast specialist pathologists read a total of 56 cases of invasive ductal carcinoma HER2IHC slice as the research object. Four non-specialist pathologists completed the independent blinded determination of the two rounds of results before and after the IHC section of the group. Kappa analysis was conducted on the repetitiveness of the first four rounds of observers and the observer’s own repetitiveness of interpretation. At the same time, the interpretation results jointly determined by two specialists were graded as HER2 interpretation reference, and the results of the first round of four non-specialists were paired with Kappa analysis respectively. RESULTS: Repeatability of interobserver readability was moderate (K = 0.5939), with the most repetitive levels being HER2 at 0 (K = 0.8114) and lowest at HER2 (2+ = 0.4736). Repeatability between observers was significantly improved after the interpretation class was reduced to positive and negative (K = 0.7230). Four observers had excellent repeatability of their interpretation (Kw = 0.8219-0.9165), and the accuracy of interpretation was related to experience. Conclusion The standardized testing methods, in-depth study and practice of existing standards of interpretation and joint interpretation should help improve the repeatability and accuracy of HER2IHC interpretation.