目的：验证EGFR 19delE746-A750和21L858R突变抗体的灵敏度和特异性以及免疫组织化学与RT-PCR方法的一致性，并探讨免疫组化在肺腺癌EGFR基因突变状态评价中的应用。方法：采用免疫组织化学方法对139例经过RT-PCR验证EGFR基因突变状态的病例进行检测。并采用SPSS19.0软件对两种方法的检测结果进行一致性分析。结果：与RT-PCR结果相比，EGFR delE746-A750和L858R突变抗体的总体敏感性为78.5%，特异性为93%。分别分析EGFR delE746-A750和L858R特异抗体，前者的敏感性和特异性分别是64.3%和97.8%，后者为90.3%和95.2%。采用SPSS19.0软件进行Kappa检验显示免疫组化和RT-PCR的结果高度一致。结论：EGFR delE746-A750和L858R突变抗体具有良好的灵敏度和特异性，结合全自动免疫组化仪进行EGFR基因突变检测是一种经济便捷可靠的方法。
Evaluation of EGFR mutations in lung adenocarcinoma with two mutation specific antibodies
Objective: To verify the sensitivity and specificity of the two EGFR mutation antibodies: 19delE746-A750 and 21L858R, and to discuss the application of immunohistochemistry in evaluating the EGFR mutations in lung adenocarcinoma. Methods: 139 cases were detected by immunohistochemistry which the EGFR mutation status were verified by RT-PCR firstly, then analysis the consistency of the results by software SPSS19.0. Results: Compared to the results of RT-PCR, the overall sensitivity and specificity of EGFR delE746-A750 and L858R mutation antibodies were 78.5% and 93%. The sensitivity and specificity of EGFR delE746-A750 mutation antibodies was 64.3% (former) vs. 90.3% (the latter), and the sensitivity and specificity of EGFR L858R mutation antibodies was 97.8% (former) vs. 93% (the latter). The results of immunohistochemical and RT-PCR were highly consistent analysed by SPSS19.0. Conclusion: The EGFR delE746-A750 and L858R mutation antibodies have a good sensitivity and specificity, combined with automatic immune-histochemical method for EGFR mutation detection which is economical and convenient and reliable.