胰岛素光激化学发光免疫分析法的建立  

Development of an AlphaLISA kit for the detection of insulin in human serum

作　　者：邹丽萍[1] 贺安[1] 董志宁[1] 刘天才[1] 林冠峰[1] 李明[1] 吴英松[1] 

机构地区：[1]南方医科大学生物技术学院抗体工程研究所,广州510515

出　　处：《免疫学杂志》2011年第11期983-986,共4页Immunological Journal

基　　金：国家科技重大专项(2009ZX10004-706)

摘　　要：目的建立血清中胰岛素(INS)光激化学发光免疫分析的定量检测方法。方法用2株配对的INS单克隆抗体,一株INS单克隆抗体包被受体微球,另一株INS单克隆抗体用生物素标记,与链霉亲合素的供体微球共同组成检测试剂检测人血清中的INS。结果 INS-AlphaLISA的灵敏度为0.753μU/ml,线性测量范围为0.753～180μU/ml,分析内和分析间的精密度分别为7.46%～9.74%、5.24%～7.31%,与C肽无明显交叉反应、与胰岛素原有轻微交叉反应,125份临床血清样本用本试剂与罗氏化学发光试剂检测,其相关系数为0.983。结论本法建立的INS-AlphaLISA是一个各项指标均能达到临床要求的、可靠的检测,有望替代国内外同类产品用于临床。In this study,we aim to establish and evaluate an Amplified Luminescent Proximity Homogeneous immunoassay（Alpha） for Insulin（INS） detection in human serum.Two anti-INS monoclonal antibodies,one was coated on AlphaLISA acceptor beads and the other was biotinylated,and donor beads coated with streptavidin were used to used to detect serum INS lever with AlphaLISA kit.The analytical sensitivity of AlphaLISA for INS was 0.753 μU/ml.The measure range of the developed kit was 0.753-180 μU/ml.The intra-and inter-assay coefficients of variation were 7.46%-9.74% and 5.24%-7.31%,respectively.There was slightly cross-reaction to proinsulin but no cross-reaction to C-peptide.The correlation coefficient of blood samples detection results between home-made and commercially available Elecsys INS kit（Roche） was 0.983.The results indicate that newly developed INS AlphaLISA kit is a valuable test for clinical application with low sample consumption,better sensitivity,specificity,accuracy,and a broad analytical range.

关 键 词：胰岛素 光激化学发光 测定 

分 类 号：R446.6[医药卫生—诊断学]