一株PSA单抗用于固相包被,另一株单抗与辣根过氧化物酶偶联制备抗PSA酶标记物,以四甲基联苯胺(TMB)为底物,采用二步法,建立了PSA酶联免疫分析试剂盒(ELISA)制备方法.本方法的灵敏度为0.2 μg/L,批内变异系数<5.3%,批间变异系数<6.4%,回收率为96.6%～105.5%,特异性鉴定显示与其他肿瘤标志物无明显交叉反应.正常参考值<4.0 μg/L.本法所制试剂盒与PSA-ELISA试剂盒(Maxim Biotech, Inc.)对照,两者相关方程为y=0.993x-0.16,相关系数r=0.932 (n=48).该方法具有简便、快速和准确的特点,适于临床检测和科研应用.

Objective: To develop a clinical method to measure ovarian cancer marker CA125 in serum. Methods:ZThe onestep assay is based on enzymelinked immunosorbent assay (ELISA). One monoclonal antibody is employed for coating, another for labeling with horseradish peroxidase. Results: The minimum detectable dose is 2.00 U/ml and analytical recovery of CA125 is 91.1% to 107.4%. The betweenruns CVs and the withinruns CVs of 3 samples are lower than 7.39% and 5.32% respectively. The average concentration of CA125 in sera from 60 healthy women is 9.20 U/ml. The correlation of results with CA125 IRMA is 0.960 0. Conclusion: The assay is a rapid, sensitive and precise method and simple to perform. It is suitable for clinical and research application.