β_2-MG时间分辨荧光免疫试剂盒的研制及质量考核  

Development and Quality Evaluation of β_2-MG TRFIA Kit

作　　者：孙有香[1] 焦岩[1] 马智鸿[2] 张珏[2] 张艺[2] 刘海燕[2] 黄飚[2] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]江苏省原子医学研究所,江苏无锡214063

出　　处：《标记免疫分析与临床》2007年第3期164-166,175,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：为建立灵敏度好、特异性高的TRFIA检测β2-MG,以羊抗鼠IgG固相抗体,Eu3＋标记的β2-MG与标本β2-MG共同竞争限量的抗β2-MG鼠单克隆抗体（mAb）,以Log-Logit制作标准曲线。本法检测灵敏度为0.01 mg/L,检测范围为0.1-8.0 mg/L;试剂及包被板在37℃放置7天后,监测标准曲线的ED20、ED50、ED80未见明显偏移;批内CV,批间CV分别为4.1%和7.8%,与美国PE试剂盒所测结果的相关系数为0.9364,说明两者具有良好的相关性。本法检测β2-MG灵敏度高,特异性好,试剂盒存放时间长且无放射性污染,是一种有应用前景的检测方法。To develop a high sensitive and specific TRFIA for β2-MG, the goat-anti-mouse IgG was coated on the 96-well microtitre plates and the Eu^3＋ labeled β2-MG and β2-MG samples were added to compete with limited anti-β2-MG monoclonal antibody. The standard curve was made by Log-Logit function of the DELFIA instrument. The detection range of β2-MG was from 0.1 to 8.0 mg/L, and the sensitivity was 0.01 mg/L. The intra-assay and inter-assay CV were 4.1% and 7.8% respectively. The reagent and coaled microtitre plates were stable at 37℃ for 7 days. The β2-MG levels in same samples tested by PE＇s kit were closely corresponded to our TRFIA kits （r=0. 9346）. The β2-MG levels can be detected in high sensitivity and specific with TRFIA kit developed in this study.

关 键 词：时间分辨荧光免疫分析 Β2-微球蛋白 

分 类 号：R446.6[医药卫生—诊断学]