全自动免疫组化仪在标准化染色质量控制中的应用  

Application of immunohistochemistry autostainer in the quality control of standardized dyeing

作　　者：彭大云[1] 赖续文[1] 张伟[1] 陈晓东[1] 赖日权[1] 闫广宁[1] 

机构地区：[1]广州军区广州总医院病理科,广东广州510010

出　　处：《中国医学装备》2017年第3期36-39,共4页China Medical Equipment

摘　　要：目的:探讨全自动免疫组化仪在标准化染色质量控制中的应用。方法:选择广谱细胞角蛋白(CKpan)、雌激素受体(ER)、突触素(Syn)、上皮生长因子受体(EGFR)及C-erbB-2蛋白(HER2)等34种抗体(一抗),使用统一的第二抗体(二抗),分别采用手工操作和全自动免疫组化仪两种方法对340张病理切片进行染色,统计比较两种方法的染色优良率,同时回顾性分析室间质量控制染色评价结果。结果:两种方法染色质量结果比较:1手工操作的170张病理切片中染色质量优等101张(占59.4%),良49张(占28.8%),差20张(占11.8%),优良率为88.2%;2全自动免疫组化仪染色的170张病理切片中染色质量优等140张(占82.3%),良28张(占16.5%),差2张(占1.2%),优良率为98.8%;两种方法优良率比较差异显著有统计学意义(x^2=15.746,P<0.05);室间质量控制平均判读符合率为97.9%,染色符合率为96.0%,整体符合率为93.9%。结论:全自动免疫组化仪染色标准化程度高,染色均匀,定位准确,背景干净,无边缘效应,重复性好,能保证染色结果的准确与稳定,为临床病理诊断、判断预后和指导用药提供科学、准确及可靠的依据。Objective： To discuss the application of immunohistochemistry autostainer in the quality control of standardized dyeing. Methods： 34 categories primary antibodies, such as cytokeratin pan（CKpan）, estrogen Receptor（ER）, synaptophysin（Syn）, epidermal growth factor receptor（EGFR）, C-erb B-2（HER2） and so on, and uniformly second antibody were used in the manual operation（dyed 170 pathological section） and immunohistochemistry autostainer（dyed 170 pathological section）, respectively. And to statistic and compare the excellent rate of dyeing for the two methods, at the same time, retrospective analysis study was used to analyze the dyeing results of external quality control assessment. Results： Quality control of standardized dyeing by manual： 59.4%（101/170） were evaluated as excellent, 28.8%（49/170） were evaluated as good and 11.8%（20/170） were evaluated as poor; the overall excellent and good rate was 88.2%（150/170）. Quality control of standardized dyeing by immunohistochemistry autostainer： 82.3%（140/170）were evaluated as excellent, 16.5%（28/170） were evaluated as good and 1.2%（2/170） as poor; the overall excellent and good rate was 98.8%（168/170）. The difference between two groups was statistical significant（χ2=15.746, P〈0.05）. The average interpretation coincidence rate of external quality control was 97.9%, and the dyeing coincidence rate was 96.0% and overall coincidence rate was 93.9%. Conclusion： Immunohistochemistry autostainer is highly standardized, with uniform staining, accurate positive results, clear background and good repeatability, without edge effect; and it can ensured accuracy and stability for dyeing result, which can provide more scientific, accurate and reliable evidences for clinical pathological diagnosis, judgment prognosis and guiding medication.

关 键 词：临床病理诊断 免疫组织化学 全自动免疫组化仪 手工操作染色 质量控制 

分 类 号：R446.8[医药卫生—诊断学]