前列腺特异抗原化学发光免疫分析方法的建立及初步应用

The Establishment and Primary Application of Prostate Specific Antigen Chemiluminescent Immunoassay

建立的前列腺特异抗原(PSA)化学发光免疫分析(CLIA)使用2株抗PSAMcAb,一株McAb包被微孔板,另一株McAb与HRP连接。底物是鲁米诺/H2O2/对碘苯酚系统的双抗体夹心一步法,测定范围0.5～64ng/mL,最低检出值为0.13ng/mL,平均回收率为100.6%,批内和批间CV分别小于8.3%和11.5%,正常参考值小于3.5ng/mL。1000份血清临床考核,与参比试剂盒临床符合率一致,具有同等的临床诊断价值。

Chemiluminescent immunoassay （CLIA） for human prostate specific antigen （PSA）in serum was developed using a double antibody sandwich method,in which one strain of McAb was coated on the microplate and another strain of McAb was labelled with horseradish peroxidase（HRP）. The chemiluminescent system was a lumino/H2O2 / HRP/enhance system. The reaction between antigen and antibody was carried out by one-step method . The PSA detection range was from 0.5 to 64ng/mL, the correlation coefficient of the standard curve was more than 0. 995, the lowest detection level was 0. 13ng/mL , the average recovery rate was 100. 6%, the intraassay CV was less than 8.3% , the interassay CV was less than 11.5%, and the PSA normal concentration in serum of healthy men was less than 3.5ng/mL. The detected results closely corresponded to those of PSA CLIA Kit of diagnostic automation inc. One thousand serum samples were tested by this method, and the results of the CLIA corresponded to those of the control kits .