前列腺抗原酶促化学发光免疫分析方法学的建立

Chemiluminescence Immunoassay for Prostate-Specific Antigen

应用鲁米诺-过氧化氢发光体系建立定量测定血清前列腺特异性抗原含量的酶促化学发光免疫分析方法。该方法测量范围为1.5～80μg/L,灵敏度为0.12μg/L,批内变异<5%,批间变异<15%。回收率为83.8%～118.7%,稀释实验测定值与稀释度呈线性相关,相关系数为0.999。本方法与免疫放射分析方法的相关方程y=1.07x+0.68,相关系数r=0.97。

The chemiluminescence immunoassay （CLIA） for serum total prostate-specific antigen （T-PSA） was developed. The reaction of luminol with hydrogen peroxide was introduced into this chemiluminescence system. The detection limit is established as 0.12 μg/L （n=10, mean of zero standard ＋ 2SD） and the analytical recovery of PSA is 83.8%-118.7%. The intra-assay and inter-assay CVs vary from 4.4%-5.0% and 6.2%-11.7%, respectively. The experimental correlation coefficient of dilution is found to be 0. 999. Compared with immunoradiometric assay （IRMA） kits, the correlative equation is y= 1. 07x＋0. 68, and correlation coefficient r= 0.97. The standard range for the method is 1.5-80 μg/L, and it presents good linearity.