Abstract
目的 建立乳腺癌患者血清HER-2/neu 胞外域蛋白(ECD)水平检测方法,为乳腺癌治疗及预后判断提供参考.方法以识别HER-2/neu 不同抗原表位的2种抗HER-2/neu单克隆抗体(McAb)为基础,建立可定量检测血清HER-2/neu ECD水平的双抗夹心酶联免疫吸附试验法(ELISA).结果本研究建立的HER-2/neu ECD水平检测ELISA所用试剂[包括抗HER-2/neu McAb 5A12包被的酶标板、辣根过氧化物酶(HRP)标记的HER-2/neu McAb 1-2及HRP 底物四甲基联苯胺(TMB)溶液]在1年内保持稳定;批内、批间变异系数分别为3.6%±4.2%、6.9%±3.3%;与HER-2 ECD同源性很高的人表皮生长因子受体(EGFR/HER-1)ECD不发生交叉反应.自制ELISA试剂盒与Bender Medsystems试剂盒检测人血清HER-2 ECD水平的相关性较好(r＞0.75).健康人群(20名)与乳腺癌患者(140例)血清HER-2 ECD阳性率之间的差异无统计学意义(P＞0.05),但与转移乳腺癌患者(10例)血清HER-2 ECD阳性率之间差异有统计学意义(P＜0.01).结论本研究建立的HER-2/neu ECD 双抗夹心ELISA检测方法特异、稳定、可靠,可定量检测乳腺癌患者血清HER-2/neu ECD水平。
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