游离前列腺特异性抗原酶促化学发光免疫分析方法学的建立

Chemiluminescence Immunoassay for Free Prostate-Specific Antigen

摘要: 采用双抗体夹心法建立了定量测定血清游离前列腺特异性抗原含量的酶促化学发光免疫分析方法，其中，1株抗总前列腺特异性抗原的单克隆抗体作为包被抗体，另1株抗游离前列腺特异性抗原的单克隆抗体作为标记抗体。总测量范围为0.2～10 ng/mL，灵敏度为0.01 ng/mL，批内变异<10%，批间变异<20%。本方法与Monobind游离前列腺特异性抗原化学发光测定试剂盒比对的相关方程为y＝0.72x-0.22，相关系数r＝0.90。

Abstract: A sandwich chemiluminescence immunoassay (CLIA) for serum free prostate-specific antigen (F-PSA) was developed. One antibody against total PSA was coated on the micro-plate, the other antibody against F-PSA was labeled with horseradish peroxidase. The detection limit is established as 0.01 ng/mL (n＝10, mean of zero standard+2SD) and the intra- and inter-assay coefficients of variation (CV) is in the range of 3.8%-5.4% and 10.8%-17.7%, respectively. Compared with Monobind F-PSA CLIA kits, the correlative equation is y＝0.72x-0.22, and r＝0.90. The standard range for the method is 0.2-10 ng/mL, and it presents good linearity.