In this study, a novel dual-label time-resolved fluoroimmunoassay (TRFIA) is described for simultaneous quantification of human epidermal growth factor receptor 2 (HER-2) and human epididymis protein 4 (HE4) in serum to screen gynecologic cancers. A double-antibody sandwich TRFIA was introduced with europium and samarium chelates to simultaneously detect the concentrations of HER-2 and HE4. Under optimal conditions, the proposed method exhibited wide linear ranges for HER-2 of 0.07–500 ng ml −1 and for HE4 of 0.32–1000 pmol l −1 with the average coefficient of variation below 10%. The specificity was satisfied through determining the other common tumor markers. The recovery rates were 94.5% and 96.6% on average for HER-2 and HE4, respectively. Good correlations were observed in clinical samples between developed method and commercial chemiluminescence immunoassay kits. The results demonstrated that dual-label TRFIA for HER-2 and HE4 was rapid and precise, and therefore could have a promising use in large sample detection for gynecological cancer screening.

中文翻译：

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双标记时间分辨荧光免疫分析同时测量血清中的人表皮生长因子受体 2 和人附睾蛋白 4

在这项研究中，描述了一种新的双标记时间分辨荧光免疫分析 (TRFIA)，用于同时量化血清中的人类表皮生长因子受体 2 (HER-2) 和人类附睾蛋白 4 (HE4) 以筛查妇科癌症。引入铕和钐螯合物的双抗体夹心TRFIA，同时检测HER-2和HE4的浓度。在最佳条件下，所提出的方法对HER-2 0.07-500 ng ml -1 和HE4 0.32-1000 pmol l -1 表现出较宽的线性范围，平均变异系数低于10%。通过确定其他常见的肿瘤标志物来满足特异性。HER-2 和 HE4 的平均回收率分别为 94.5% 和 96.6%。在开发的方法和商业化学发光免疫测定试剂盒之间的临床样品中观察到良好的相关性。结果表明，HER-2 和 HE4 的双标记 TRFIA 快速而精确，因此在妇科癌症筛查的大样本检测中具有广阔的应用前景。