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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。
In order to establish a rapid and quantitative method for detecting total prostate specific antigen (tPSA) using photochemical chemiluminescence immunoassay technique. Two paired tPSA monoclonal antibodies, one tPSA monoclonal antibody coated with the acceptor microsphere, the other tPSA monoclonal antibody labeled with biotin, and the streptavidin donor microspheres together constitute the detection reagent . Results: The analytical sensitivity of home-made tPSA reagent was 0.006 ng / ml and the linear range was 0.006-150 ng / ml. The precision of analysis between in-house and in-house analysis was 3.90% -6.67% and 4.71% -6.90% CA19-9 and human albumin no significant cross-reaction, 136 clinical serum samples with this reagent and Roche chemiluminescence reagent detection, the correlation coefficient of 0.979. Tip: Homemade tPSA photochemical chemiluminescence immunoassay reagents all meet the clinical requirements, is expected to replace similar foreign products.