血清铁蛋白时间分辨荧光免疫分析试剂盒的研制  

Preparation of time-resolved fluoroimmunoassay kit for detection of human serum ferritin

作　　者：杭建峰[1] 吴英松[1] 徐伟文[1] 周志聪[2] 黄颖[3] 李明[1] 

机构地区：[1]南方医科大学生物技术学院热带病研究室,广州510515 [2]达瑞抗体工程技术有限公司质检部,广州510663 [3]中国药品生物制品检定所药理室,北京100050

出　　处：《免疫学杂志》2006年第z1期160-163,共4页Immunological Journal

基　　金：广州市重大科技攻关项目(2003U130021)

摘　　要：目的血清铁蛋白(sFER)时间分辨荧光免疫(TRFIA)分析试剂盒的研制。方法采用双抗体夹心法建立sFER-TRFIA试剂盒,并对试剂盒的各项指标进行评价。结果试剂盒的线性测量范围为2.2-1 070 ng/mL,灵敏度为0.22 ng/mL,批内、批间的精密度分别为4.6%-7.2%、5.4%-8.9%,与癌胚抗原(CEA)、甲胎蛋白(AFP)和人白蛋白无交叉反应。86份血清样本用本试剂盒与国外其他试剂盒同时检测,其相关系数为0.994。结论试剂盒各项指标均达到临床检测要求,可替代国外同类产品试剂盒。Objective To prepare a time-resolved fluoroimmunoassay(TRFIA) kit for detection of human serum ferritin(sFER).Methods The sandwich TRFIA kit for detection of sFER was developed using monoclonal antibody of anti-FER.Results The measure range of kit was 2.2-1 070 ng/mL.The analytical sensitivity was 0.22 ng/mL.There was no cross-reaction with CEA,AFP,and human Albumin.The intra-and inter-assay coefficients of variation were 4.6%-7.2% and 5.4%-8.9%,respectively.The correlation coefficient of the detection results between prepared TRFIA and commercially available FER-TRFIA kit (Wallac) was 0.994.Conclusion sFER-TRFIA kit was a valuable test for clinical application with better sensitivity,specificity,and accuracy.

关 键 词：铁蛋白 时间分辨荧光免疫分析 试剂盒 

分 类 号：R446.6[医药卫生—诊断学]