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环保型组织样本释放剂在HER2 IHC2+乳腺原发性浸润癌HER2基因检测中的应用

Application of environment-friendly tissue sample release agent in HER2 gene detection of HER2 IHC 2+invasive primary breast cancer
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摘要 目的 探究环保型组织样本释放剂在人类表皮生长因子受体2(HER2)蛋白表达不确定的乳腺原发性浸润癌(IPBC)HER2基因检测中的应用价值。方法 随机选取619例IPBC标本作为研究对象,标本固定切开,随机选取其中的两块病变组织,分为对照组和观察组,采用传统试剂(甲醛固定-乙醇脱水-二甲苯透明脱蜡)和环保型组织样本释放剂对标本进行处理,完成石蜡切片制作。采用免疫组织化学法(IHC)染色检测两组IPBC切片的HER2蛋白表达,对其中HER2 IHC 2+的202例IPBC标本再次切片,使用荧光原位杂交(FISH)法检测HER2基因扩增情况。比较两组IPBC切片的HER2蛋白表达与基因扩增差异和符合率。结果 (1)两组切片的HER2 IHC染色均定位精准,表现为特异性的细胞膜着色。(2)配对两组切片的HER2 IHC检测结果(阳性、不确定型、阴性)比较,差异无统计学意义(P=0.73)。(3)两组切片HER2基因扩增均表现为特异性的细胞核内HER2以及Ch17信号明了、易于判定;细胞轮廓清晰;细胞核形态完整;背景洁净且无斑点伪影。(4)配对两组HER2 IHC2+切片的FISH检测成功细胞数量比较,差异无统计学意义(t=0.39,P=0.69)。(5)配对两组HER2 IHC2+切片的FISH检测信号数量比较,差异无统计学意义(P>0.05)。(6)配对两组HER2IHC2+切片的FISH检测阳性率比较,差异无统计学意义(P=1.00)。(7)两组切片的HER2总阳性率比较,差异无统计学意义(χ^(2)=0.04, P=0.84)。结论 使用环保型组织样本释放剂,可确保IPBC标本的HER2 IHC和FISH检测效果,具有良好的应用前景。 Objective To explore the application value of environment-friendly tissue sample release agent in human epidermal growth factor receptor 2(HER2)gene detection of invasive primary breast cancer(IPBC)with uncertain expression of HER2 protein.Methods A total of 619 IPBC specimens were randomly selected as research subjects.After fixation and sectioning,two pieces of lesional tissue were randomly taken from each specimen and assigned to a control group and an observation group,respectively.The control group was treated with traditional reagents(formaldehyde fixation-ethanol dehydration-xylene clearing and dewaxing),while the observation group was treated with the environmentally friendly tissue sample release agent,and paraffin sections were prepared for both groups.Immunohistochemical(IHC)staining was used to detect the expression of HER2 protein in the IPBC sections of the two groups.For the 202 IPBC specimens with HER2 IHC 2+,additional sections were made,and fluorescence in situ hybridization(FISH)was employed to detect the HER2 gene amplification.The differences and concordance rates of HER2 protein expression and gene amplification between the two groups were compared.Results HER2 IHC staining in sections of both groups showed accurate localization,manifested as specific cell membrane staining.There was no statistically significant difference in HER2 IHC results(positive,indeterminate,negative)between paired sections of the two groups(P=0.73).For HER2 gene amplification in the sections of both groups,the HER2 and Ch17 signals in the specific cell nuclei were clear and easy to identify;the cell contours were distinct,nuclear morphology was intact,and the background was clean without spot artifacts.There was no statistically significant difference in the number of successfully detected cells by FISH between paired HER2 IHC 2+sections of the two groups(t=0.39,P=0.69).There was no statistically significant difference in the number of FISH detection signals between paired HER2 IHC2+sections of the two groups(P>0.05).There was no statistically significant difference in the positive rate of FISH detection between paired HER2 IHC 2+sections of the two groups(P=1.00).There was no statistically significant difference in the total positive rate of HER2 between sections of the two groups(χ^(2)=0.04,P=0.84).Conclusion The use of environment-friendly tissue sample release agent can ensure the effectiveness of HER2 IHC and FISH detection for IPBC specimens,and has promising application prospects.
作者 单健 董思佳 邓嘉璐 李芯 林子芹 米贤军 王德望 SHAN Jian;DONG Sijia;DENG Jialu;LI Xin;LIN Ziqin;MI Xianjun;WANG Dewang(Department of Pathology,People's Hospital of Zhongshan Torch Development Zone,Zhongshan 528437,China;Department of Breast Surgery,People's Hospital of Zhongshan Torch Development Zone,Zhongshan 528437,China;Department of Pathology,Bo'ai Hospital of Zhongshan,Zhongshan 528400,China)
出处 《诊断病理学杂志》 2025年第10期1278-1283,共6页 Chinese Journal of Diagnostic Pathology
基金 中山市医学科研项目立项项目(NO.20231A020117)。
关键词 环保 样本释放剂 乳腺原发性浸润癌 人类表皮生长因子受体2 蛋白表达 Environment-friendly Tissue sample release agent Invasive primary breast cancer Human epidermal growth factor receptor 2(HER2) Protein expression
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