Endocrine Cancer Group, Edinburgh, Scotland.
Am J Clin Pathol. 2011 Jan;135(1):157-62. doi: 10.1309/AJCPVPRKK1ENEDGQ.
We performed a multicenter assessment of a new HER2 dual-color chromogenic in situ hybridization (CISH) test and herein report on concordance of CISH data with fluorescence in situ hybridization (FISH) data and intraobserver and interlaboratory scoring consistency. HER2 results were evaluated using duplicate cores from 30 breast cancers in 5 laboratories using the Ventana HER2 dual-color ISH assay (Ventana Medical Systems, Cambridgeshire, England) and in 1 central laboratory using a standard FISH assay. Overall 93.3% of cases were successfully analyzed by CISH across the 5 participating laboratories. There was excellent concordance (98.0% overall) for diagnosis of HER2 amplification by CISH compared with FISH. Intraobserver variability (7.7%) and intersite variability (9.1%) of absolute HER2/chromosome enumeration probe 17 ratios were tightly controlled across all participating laboratories. The Ventana HER2 dual-color ISH assay is robust and reproducible, shows good concordance with a standard FISH assay, and complies with requirements in national and international guidelines for performance of ISH-based diagnostic tests.
我们对一种新的 HER2 双色显色原位杂交（CISH）检测进行了多中心评估，在此报告 CISH 数据与荧光原位杂交（FISH）数据的一致性，以及观察者内和实验室间评分一致性。使用来自 5 个实验室的 30 例乳腺癌的重复核心，使用 Ventana HER2 双色原位杂交检测试剂盒（Ventana Medical Systems，英国剑桥郡）进行了 HER2 检测，并在 1 个中心实验室使用标准 FISH 检测进行了检测。在所有参与的 5 个实验室中，CISH 分析成功的病例占 93.3%。与 FISH 相比，CISH 对 HER2 扩增的诊断具有极好的一致性（总体 98.0%）。在所有参与的实验室中，HER2/染色体计数探针 17 比值的观察者内变异性（7.7%）和站点间变异性（9.1%）得到了严格控制。Ventana HER2 双色原位杂交检测试剂盒是一种强大且可重复的检测方法，与标准 FISH 检测具有良好的一致性，并符合国家和国际指南对基于ISH 的诊断检测性能的要求。
