Sáez A, Andreu F J, Seguí M A, Baré M L, Fernández S, Dinarés C, Rey M
Department of Pathology, UDIAT Centre Diagnòstic-Corporació Parc Taulí, Parc Taulí s/n 08208 Sabadell, Barcelona, Spain.
Breast. 2006 Aug;15(4):519-27. doi: 10.1016/j.breast.2005.09.008. Epub 2005 Nov 14.
The purpose of the study was to compare two methods used to analyse HER-2 gene amplification (fluorescence in situ hybridisation (FISH) and chromogenic in situ hybridisation (CISH)), and determine the accuracy of the antibodies CB11 and HercepTest for immunohistochemical detection of HER-2 overexpression from archival breast cancer tissue. Additionally, interobserver variability in the interpretation of CISH and immunohistochemical tests was measured. Two hundred cases of invasive breast carcinoma diagnosed between 2000 and 2003 were selected. Immunohistochemistry (IHC) was performed with HercepTest and CB11, and gene amplification was determined by FISH (PathVision, Vysis) and CISH (Zymed) using tissue macroarrays. An excellent concordance (94.8%) was found between CISH and FISH. Considering FISH as gold standard, sensitivity of CISH was 97.5% and specificity 94%. Overall interobserver agreement of CISH was 97.5% and of IHC 84%. Both antibodies showed a sensitivity of 95.2% and a specificity of 70.7% (CB11) and 81.2% (HercepTest). Our results show that CISH is a highly accurate, reproducible and practical technique to determine HER-2 gene amplification. CB11 and HercepTest are good screening methods with a high sensitivity. The performance of tissue macroarrays to test HER-2 status by IHC, FISH and CISH has demonstrated to be an available and effective method to study large series of tumours.
本研究的目的是比较两种用于分析HER-2基因扩增的方法（荧光原位杂交（FISH）和显色原位杂交（CISH）），并确定抗体CB11和HercepTest对存档乳腺癌组织中HER-2过表达进行免疫组织化学检测的准确性。此外，还测量了观察者间对CISH和免疫组织化学检测结果解读的变异性。选取了2000年至2003年间诊断的200例浸润性乳腺癌病例。使用HercepTest和CB11进行免疫组织化学（IHC）检测，并使用组织芯片通过FISH（PathVision，Vysis）和CISH（Zymed）确定基因扩增情况。发现CISH和FISH之间具有极好的一致性（94.8%）。以FISH作为金标准，CISH的敏感性为97.5%，特异性为94%。CISH的观察者间总体一致性为97.5%，IHC为84%。两种抗体的敏感性均为95.2%，CB11的特异性为70.7%，HercepTest的特异性为81.2%。我们的结果表明，CISH是一种用于确定HER-2基因扩增的高度准确、可重复且实用的技术。CB11和HercepTest是具有高敏感性的良好筛查方法。通过IHC、FISH和CISH检测HER-2状态的组织芯片表现已证明是研究大量肿瘤的一种可行且有效的方法。
