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目的采用光激化学发光免疫分析技术建立快速定量检测人附睾分泌蛋白4(HE4)的方法。方法用两株配对的HE4单克隆抗体,一株HE4单克隆抗体包被受体微球,另一株HE4单克隆抗体用生物素标记,与链霉亲合素的供体微球共同组成检测试剂。结果自制HE4试剂分析灵敏度为0.81 pmol/L,分析内和分析间的精密度分别为4.3%~7.2%和6.1%~7.7%,均低于10%,与癌抗原15-3(CA15-3)、甲胎蛋白(AFP)、癌胚抗原(CEA)、癌抗原125(CA125)无明显交叉反应,120份临床血清样本用本试剂与罗氏电化学发光检测试剂盒平行检测,其相关系数为0.95。结论自制HE4光激化学发光免疫分析试剂各项指标均能达到临床要求,有望替代国外同类产品。
OBJECTIVE: To establish a rapid and quantitative method for the detection of human epididymal secreted protein 4 (HE4) by using photoactivated chemiluminescence immunoassay. Methods Two matched HE4 monoclonal antibodies and one HE4 monoclonal antibody were used to coat the receptor microspheres. The other HE4 monoclonal antibody was labeled with biotin and detected with streptavidin donor microspheres Reagents. Results The sensitivity of homemade HE4 reagent was 0.81 pmol / L, and the precision of intra-assay and inter-assay was 4.3% -7.2% and 6.1% -7.7%, both lower than 10% ), AFP, CEA and CA125, and 120 clinical serum samples were detected in parallel with the Roche chemiluminescence detection kit, and the correlation coefficients were 0.95. Conclusion The self-made HE4 chemiluminescence immunoassay reagents can meet the clinical requirements and are expected to replace similar foreign products.