摘要目的 探讨胃癌标本离体后在两个不同时段内固定对其HER2检测结果影响,进一步强调胃癌HER2检测操作流程规范性的实践意义.方法 参照中国2011年版的《胃癌HER2检测指南》,收集2012年11月至2013年5月期间的胃癌根治性手术切除标本41例,每一病例收集标本离体30 min内(＜30 min)及1～2h内(＞30 min)固定的胃癌组织配对蜡块(共82个),应用免疫组织化学(IHC)和荧光原位杂交(FISH)技术检测胃癌组织中HER2的表达.结果 41例不同时段内固定的配对胃癌组织蜡块行IHC检测发现＜30 min与＞30 min固定标本的HER2蛋白表达比较差异有统计学意义(P＜0.05),＜ 30 min固定标本的IHC检测到的HER2阳性率高;对其中所有的配对蜡块行FISH检测,＜30 min与＞30 min固定标本的HER2基因扩增状态比较差异无统计学意义(P＞0.05).＜30 min固定标本的IHC和FISH检测结果正相关(系数为0.724,P＜0.05),HER2阳性及阴性病例的检测符合率均为100.0％;＜30 min固定标本的HER2蛋白表达与肿瘤的Lauren组织学分型、分化程度、TNM临床分期及患者的性别等临床病理学参数有关(P＜0.05).结论 胃癌标本离体后＜ 30 min对IHC和FISH检测HER2没有影响,而＞30 min(1～2 h)固定使IHC检测到标本的HER2蛋白水平降低.

abstractsObjective To evaluated HER2,status using immunohistochemistry (IHC) assay and fluorescence in situ hybridization (FISH) at two different time points of tissue fixation after surgical resection of gastric cancer,emphasizing the importance of standard operation and quality control in HER2 testing.Methods Forty-one resection specimens of advanced gastric cancer were collected with tissue fixation periods of ＜ 30 min or ＞ 30 min after surgical resection.HER2 status was evaluated by immunohistochemistry (IHC) assay and fluorescence in situ hybridization (FISH).Results The frequency of HER2 expression by IHC in the samples with fixation time of ＜ 30 min was higher than that in those of ＞ 30 min(P ＜ 0.05).However,no significant difference was observed by FISH (P ＞ 0.05)between the two groups.Samples of ＜30 min fixation time had high concordant results between IHC and FISH (100.0％ for both positive and negative cases,Rho =0.724,P ＜ 0.05).In addition,HER2 expression by IHC was significantly correlated with Lauren classification,histologic differentiation,TNM stage and gender (P ＜ 0.05).Conclusion The time to tissue fixation after surgical resection of more than 30 min has deleterious effect on the detection of HER2 by IHC although FISH testing is not affected.