总PSA光激化学发光免疫分析法的建立  

Development of an amplified luminescent proximity homogenous immunoassay AlphaLISA kit for the detection of total prostate specific antigen in human serum

作　　者：邹丽萍[1] 贺安[1] 林冠峰[1] 董志宁[1] 李明[1] 吴英松[1] 

机构地区：[1]南方医科大学生物技术学院抗体工程研究所,广州510515

出　　处：《现代免疫学》2011年第6期462-466,共5页Current Immunology

基　　金：国家科技重大专项资助(2009ZX10004-706)

摘　　要：为了采用光激化学发光免疫分析技术建立快速定量检测总前列腺特异性抗原(tPSA)的方法。用两株配对的tPSA单克隆抗体,一株tPSA单克隆抗体包被受体微球,另一株tPSA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tPSA试剂分析灵敏度为0.006ng/ml,线性测量范围为0.006～150ng/ml,分析内和分析间的精密度分别为3.90%～6.67%、4.71%～6.90%,与AFP、CA125、CA19-9和人白蛋白无明显交叉反应,136份临床血清样本用本试剂与罗氏化学发光试剂检测,其相关系数为0.979。提示:自制tPSA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。To establish an amplified luminescent proximity homogeneous immunoassay（Alpha） determination of the total prostate specific antigen（tPSA） in human serum,anti-tPSA monoclonal antibodies were used to develop the sandwich AlphaLISA kit for detection of this antigen in serum in which one of them was coated on AlphaLISA acceptor beads and the other was biotinylated.These monoclonal antibodies and the donor beads coated with streptavidin constituted as the kit used,and the optimal test conditions and analytical performance of this method were determined.It was demonstrated that the analytical sensitivity of AlphaLISA for tPSA was 0.006 ng/ml,and the measure range of developed kit was 0.006~150 ng/ml.The intra-and inter-assay coefficient of variation were 3.90~6.67% and 4.71~6.90%,respectively.There was no cross-reaction to AFP,CA125,CA19-9 and albumin.The correlation coefficient of blood samples detection results between home-made and commercially available commercially available elecsys tPSA kit（Roche） was 0.979.This newly developed tPSA AlphaLISA kit is a valuable test for clinical application with better sensitivity,specificity,and accuracy.

关 键 词：总前列腺特异性抗原 光激化学发光 测定 

分 类 号：R392.33[医药卫生—免疫学]