CAJ | 학술논문

目的探讨乳腺癌HER2免疫组织化学(IHC)检测的实验室自身重复性及影响其重复性的因素,同时比较单克隆抗体CB11与HercepTest试剂盒染色结果的一致性及其意义.方法使用CB11抗体以相同的实验方法和步骤对37例乳腺浸润性导管癌进行5次IHC染色,检测结果由两位乳腺专科病理医师共同判读确定,判读标准包括HercepTest评分系统和美国临床肿瘤协会/美国病理学家学院(ASCO/CAP)2007年HER2检测指南评分系统.运用Kappa分析对5次染色结果的重复性进行评估并比较两种评分系统的一致性.然后用HercepTest试剂盒对该组标本进行检测,将CB11染色结果与其比较.结果实验室5次CB11染色的自身重复性较好;排除抗体批号影响后所获得的染色重复性接近"极好"等级(HercepTost评分系统Kappa值为0.7858).两种评分系统的判读一致性"极好"(Kappa值为0.8549).HercepTest试剂盒与CB11染色结果划分为阳性和阴性时符合率为83.78%.结论管理和训练良好的实验室能够保证其内部较好的HER2染色结果重复性.重复性分析是必要的实验室内部HER2检测的质量评估方法 .规范操作下的不同批号的抗体所获染色结果对实验室内部重复性有一定影响,但尚不会导致染色结果等级的变化.与已获认证的方法进行一致性分析后证实,CB11抗体进行的HER2染色在日常病理工作中具有筛查意义.
목적 탐토유선암HER2면역조직화학(IHC)검측적실험실자신중복성급영향기중복성적인소,동시비교단극륭항체CB11여HercepTest시제합염색결과 적일치성급기의의.방법 사용CB11항체이상동적실험방법 화보취대37례유선침윤성도관암진행5차IHC염색,검측결과 유량위유선전과병리의사공동판독학정,판독표준포괄HercepTest평분계통화미국림상종류협회/미국병이학가학원(ASCO/CAP)2007년HER2검측지남평분계통.운용Kappa분석대5차염색결과 적중복성진행평고병비교량충평분계통적일치성.연후용HercepTest시제합대해조표본진행검측,장CB11염색결과 여기비교.결과 실험실5차CB11염색적자신중복성교호;배제항체비호영향후소획득적염색중복성접근"겁호"등급(HercepTost평분계통Kappa치위0.7858).량충평분계통적판독일치성"겁호"(Kappa치위0.8549).HercepTest시제합여CB11염색결과 화분위양성화음성시부합솔위83.78%.결론 관리화훈련량호적실험실능구보증기내부교호적HER2염색결과 중복성.중복성분석시필요적실험실내부HER2검측적질량평고방법 .규범조작하적불동비호적항체소획염색결과 대실험실내부중복성유일정영향,단상불회도치염색결과 등급적변화.여이획인증적방법 진행일치성분석후증실,CB11항체진행적HER2염색재일상병리공작중구유사사의의.
Objectives To investigate the intralaboratory reproducibility of immunohistochemistry (IHC) testing for HER2 status in breast cancer, and to evaluate the factors which influence the reproducibility. The concordance between monoclonal antibody CB11 and HercepTest was also assessed. Methods HER2 overexpression on paraffin sections from thirty-seven cases of breast invasive ductal carcinoma was evaluated using CB11 and the evaluation procedure had been repeated for five times scored the tests together according to the HercepTest and new American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) grading schemes by 2 experienced pathologists together. Reproducibility rates of the five rounds were assessed using Kappa statistic, and the results from two scoring systems were compared. HercepTest kit was applied to the same cases afterward and the results were compared with CB11. Results Substantial intralaboratory reproducibility was achieved among 5 rounds tests. Excluding the influence effect of changing antibody lots, the intralaboratory reproducibility was closed to the perfect threshold (Kappa =0.7858, HercepTest scheme). The results derived from the two grading schemes had an almost perfect agreement ( Kappa = 0.8549 ). The concordance ( positive vs. negative) between CB11 and HercepTest was 83.78%. Conclusions Laboratory work with strict supervision and more experience will ensure a reliable testing consistency. Reproducibility analysis could be adopted to evaluate the intralaboratory staining quality on HER2 testing. Different antibody lots bring some influence to the intralaboratory reproducibility,but not significant. CB11 could be accepted to screen HER2 status in routine practice after testing validation.