癌抗原15-3酶促化学发光免疫分析方法的建立

Development of a Chemiluminescent Immunoassay for Cancer Antigen 15-3

目的建立癌抗原15-3（CA15-3）酶促化学发光免疫分析方法。方法利用双抗体夹心法建立CA15-3化学发光检测体系,分别对该体系的最低检测限、线性、分析特异性、准确度和精密度进行评估,并与进口全自动化学发光检测结果进行对比。结果本方法灵敏度为0.26 U/m L,线性范围为0-300 U/m L,与CEA和CA125无交叉反应,添加回收率在97.0%-105.6%之间,分析内与分析间CV均小于10%,与进口全自动化学发光试剂同时检测160份样本的CA15-3浓度,检测结果的线性相关系数为0.987。结论成功建立了CA15-3酶促化学发光免疫分析方法。该方法灵敏度高、重复性好,在临床应用中可替代进口化学发光检测试剂。

Objective To evaluate using chemiluminescent immunoassay（ CLIA） system to detect serum cancer antigen 15-3（ CA 15-3）. Methods The system was evaluated in its limit of detection,linearity,analytical specificity,accuracy and repetitiveness. A total of 160 clinical specimens were detected and evaluated. Results The limit of detection was 0. 26 U / m L and the recovery rate for accuracy was 97. 0%-105. 6%. The assay had a good linear relationship between 5-300 U / m L and had no cross reaction with CEA and CA125. All samples were detected by two CLIA systems,and the results were consistent and trusted.Conclusion The CLIA system for detecting CA15-3 has been established,which has satisfied sensitivity,repeatability,and will be widely used in clinical testing.