人血红蛋白时间分辨荧光免疫分析试剂的研制及初步应用  

Research and Primary Application of Reagent for Detection of Human Hemoglobin by Time-Resolved Fluoroimmunoassay

作　　者：杨凤爱[1,2] 王征 李来庆 李明[1] 吴英松[1] 

机构地区：[1]南方医科大学生物技术学院,广州510515 [2]阳江市人民医院,阳江529500 [3]广州市达瑞抗体工程技术有限公司,广州510663

出　　处：《热带医学杂志》2009年第5期490-492,共3页Journal of Tropical Medicine

基　　金：广东省科技攻关项目(No.2005B10401045)

摘　　要：目的建立人血红蛋白(Hb)时间分辨免疫荧光分析(TRFIA)试剂,探讨在大便潜血(FOB)检测中的应用。方法采用固相双抗体夹心法建立检测Hb的TRFIA方法,并对该试剂的各项性能指标进行评价。结果自制试剂盒的最低检测量为0.8ng/mL或32ng(Hb)/g(粪便),线性范围为0.8～1000ng/mL或32～40000ng(Hb)/g(粪便)。分析内和分析间变异系数分别为3.4%～8.9%和5.2%～13.4%。与羊、鸡、牛、猪、兔、狗Hb不发生交叉反应。90份临床确诊标本用本试剂盒和胶体金免疫层析(GICA)试剂同时测试,TRFIA法的敏感性和特异性均为100%,GICA法的灵敏度和特异性分别为95.6%、100%。结论Hb-TRFIA试剂盒各项指标均达到临床检测要求,适用于临床上大便潜血Hb的检测。Objective To establish a time-resolved fluoroimmunoassay （TRFIA） kit for the detection of human hemoglobin （Hb） in fecal occult blood （FOB）. Methods Two anti-Hb monoclonal antibodies were used to develop the sandwich TRFIA kit for detection of Hh in FOB. Results The limit of detection was 0.8 ng/mL and the measure range of kit was 0.8-1000 ng/mL. The intra- and inter-assay coefficients of variation were 3.4%-8.9% and 5.2%- 13.4%, respectively. There was no cross reactivity with Hb of goat, chicken, bull, pig, rabbit and dog. 90 samples were detected by TRFIA and Gold-immunochromatography assay （GICA）. Compared with clinical results, TRFIA had sensitivities and specificity of 100%, and GICA had sensitivities of 95.6% and specificity of 100%. Conclusion The developed Hb-TRFIA kit in this study was valuable for clinical application with better sensitivity, specificity, and accuracy.

关 键 词：人血红蛋白 时间分辨免疫荧光分析 大便潜血 

分 类 号：R446.133[医药卫生—诊断学]