目的

探讨细胞核微阵列技术及组织微阵列技术用于检测乳腺癌组织中HER-2 基因扩增和蛋白表达状态。

方法

将248 例乳腺癌普通组织蜡块制成组织微阵列组,应用免疫组织化学法(IHC)和荧光原位杂交法(FISH)分别检测HER-2 基因和蛋白表达。两种检测方法的一致性采用检验,并以FISH 检测结果为金标准,绘制IHC 检测乳腺癌HER-2 表达的ROC 曲线图。

结果

248 例乳腺癌FISH 与IHC 检测结果一致性分析显示:Kappa=0.711,P=0.000,两种检测方法的一致性尚可。IHC 检测乳腺癌HER-2 ROC 曲线下面积为0.888,P= 0.000,约登指数为0.700,准确率为87.9%。IHC(++)中4 例为17 号染色体单体型,占FISH 阳性病例总数的5.26%(4/76)。IHC(+++)中5 例为17 号染色体多倍体型,FISH 检测均为阴性,占FISH 阴性总例数的2.9%(5/172)。IHC 的检测可以较好地反映出FISH 的结果。

结论

细胞核微阵列及组织微阵列技术用于检测乳腺癌HER-2 基因状态有着节约实验成本、同一性好、结果可靠的优点。

Objective

To investigate the usage of nuclei and tissue microarrays technique in detecting HER-2 gene amplification and protein expression in breast carcinoma.

Methods

Two hundred and forty-eight breast carcinoma paraffin embedded tissue blocks were used to construct tissue microarray groups.Fluorescence in situ hybridization (FISH)and immunohistochemistry (IHC) were used to detect the expressions of HER-2 gene and protein.The detection results of the two methods were analyzed using Kappa test.Taking the results obtained from FISH analysis as the gold standard, the ROC curve of IHC detecting HER-2 expression was drawn.

Results

The Kappa test of the two methods showed an acceptable consistency (Kappa=0.711,P=0.000).The area under the ROC curve of IHC detecting HER-2 expression was 0.888 (P=0.000), the Youden's index was 0.700 and an accuracy was 87.9%.Four of the IHC(++) cases had haplotype of chromosome 17, with a positive rate of 5.26% (4/76) of the FISH positive cases.Five of the IHC(+++)cases had polyploid of chromosome 17, with a negative rate of 2.9% (5/172) of the FISH negative cases, indicating IHC results could better reflect FISH results.

Conclusions

Nuclei and tissue microarrays technique can be used in detecting HER-2 gene amplification and protein expression, and has the advantages of low cost and relatively reliable results.