免疫组织化学法在非小细胞肺癌EML4-ALK融合基因检测中的应用  

Ventana IHC test for the echinoderm microtubule associated protein like 4-anaplastic lymphomakinase fusion gene in non-small cell lung cancer

作　　者：范军振 吕亚莉[1] 宋欣[1] 钟梅[1] 王琼[1] 朱凤伟[1] 孙海波[1] 石怀银[1] 

机构地区：[1]解放军总医院病理科,北京100853

出　　处：《解放军医学院学报》2017年第4期342-344,356,共4页Academic Journal of Chinese PLA Medical School

摘　　要：目的探讨免疫组织化学法检测非小细胞肺癌(non small cell lung cancer,NSCLC)患者EML4-ALK融合基因的效果。方法选取2014年6月-2016年7月本院病理诊断为非小细胞肺癌的患者281例(其中腺癌259例,鳞癌17例,腺鳞癌5例)为研究对象,分别采用PCR法和免疫组化法(Ventana)检测281例患者石蜡组织EML4-ALK融合基因改变情况。以PCR法为金标准,比较两种方法的阳性率,计算Ventana法的敏感度、特异度、阳性预测值、阴性预测值。结果 281例样本中,PCR检测法检测EML4-ALK融合基因阳性率10.0%,Ventana法阳性率为12.8%,两种方法无统计学差异(P=0.057);Ventana法的敏感度、特异度、阳性预测值、阴性预测值分别为89.3%、95.7%、69.4%、98.8%。结论 Ventana法可有效检测EML4-ALK融合基因,有较好的敏感度、特异度、阳性预测值、阴性预测,且较经济、简便、快捷。Objective To explore the accuracy of Ventana IHC to detect EML4-ALK in non-small cell lung cancer. Methods Total of 281 formalin-fixed paraffin-embedded samples（259 adenocarcinoma,17 squamous carcinoma,5 gland-scale cancer） diagnosed as NSCLC in Chinese PLA General Hospital from June 2014 to July 2016 were included in this study,and the EML4-ALK fusion gene of whom were detected by PCR and Ventana IHC,respectively. The PCR method was regarded as the golden standard,the positive rate between the two methods were compared and the sensitivity,specificity,positive predictive value and negative predictive value of Ventana IHC were calculated. Results The positive rates of PCR and Ventana IHC were 10.0% and 12.8%,respectively with no significant difference between the two methods（P=0.057）. The sensitivity,specificity,positive predictive value and negative predictive value of Ventana IHC were 89.3%,95.7%,89.3% and 95.7%,respectively. Conclusion The Ventana IHC is efficient in detection of EML4-ALK fusion gene of NSCLC with favorable sensitivity,specificity,positive predictive value and negative predictive value,and it is economical,simple and convenient to be performed.

关 键 词：非小细胞肺癌 EML4-ALK融合基因 基因扩增 免疫组化 

分 类 号：R734.2[医药卫生—肿瘤]