全自动化学发光免疫分析仪及配套研发试剂盒质量的评价  

Quality Assessment of Automated Chemiluminescence Immunoassay Analyzer and CLEN-kit

作　　者：朱龙佼 刘萍 周子莹 马丽艳[3] 张磊 黄昆仑[1,3,4] 孟扬[1] 许文涛[1,3,4] 

机构地区：[1]中国农业大学食品科学与营养工程学院,北京100083 [2]博奥赛斯(天津)生物科技有限公司,天津300300 [3]农业部转基因生物食用安全监督检验测试中心,北京100083 [4]食品质量与安全北京实验室,北京100083

出　　处：《农业生物技术学报》2014年第5期651-660,共10页Journal of Agricultural Biotechnology

基　　金：北京市科技计划项目(No.D121100003112004);国家科技支撑计划(No.2011BAK10B02)

摘　　要：化学发光免疫分析仪的仪器质量对化学发光免疫分析方法的灵敏度有着极其重要的影响。为了提高化学分析仪仪器性能,本研究采用光纤传导方式作为检测系统,更加贴近待检物的光纤探头作为运动系统自主研发了一款化学发光免疫分析仪,为了对仪器应用性能进行评估,本研究配套研发了一款盐酸克伦特罗的酶促化学发光免疫分析试剂盒(clenbuterol chemiluminescent immunoassay kit,CLENkit),并设计了一套针对CLEN-kit的质量评价试验对试剂盒的综合性能质量进行评价。通过CLEN-kit质量评价试验的验证,得出研发CLEN-kit检测线性范围为0.313～40.000 ng/mL,灵敏度为0.397 7 ng/mL,最低检测限为0.023～0.041 ng/mL,与特布他林、妥布特罗和肾上腺素结构类似物无交叉反应。研究结果显示,CLEN-kit具有良好的检测能力,并同时有力的验证了自主研发的化学发光免疫分析仪性能良好,在化学发光试剂盒研发中应用性强。The sensitivity of chemiluminescence immunoassay method mainly depends on the quality of chemiluminescence analyzer. This paper reports a chemiluminescence immunoassay apparatus that was developed independently. In this research, we employed the optical fiber conduction as the detecting system and fiber-optic probe which was more close to the analyte as the movement system to improve the detection performance. And then a clenbuterol chemiluminescent immunoassay kit （CLEN-kit） was also developed to evaluate the analyzer quality. A set of quality evaluation tests were designed to evaluate the comprehensive quality of the kit. Results showed that the linear detection range of CLEN-kit was 0.313-40.000 ng/mL, the sensitivity was 0.397 7 ng/mL, and the detection limit was 0.023-0.041 ng/mL. Besides, its cross-reactivity with its structural analogues, terbutaline, tulobuterol and adrenaline was not appeared. It was validated that CLEN-kit has a good ability to detect trace clenbuterol and the self-developed chemiluminescence immunoassay analyzer has a good performance when applied in CLEN-kit＇s development.

关 键 词：盐酸克伦特罗 兔多克隆抗体 化学发光免疫分析仪 试剂盒质量评价 

分 类 号：S859.84[农业科学—临床兽医学]