新生儿TSH-时间分辨免疫荧光分析检测试剂的评价  

Evaluation of time-resolved fluoroimmunoassay kit for detection of thyroid stimulating hormone in neonates

作　　者：李月[1] 吴英松[1] 汤永平[2] 李明[1] 

机构地区：[1]南方医科大学生物技术学院,广东广州510515 [2]广州市达瑞抗体工程技术有限公司

出　　处：《中国妇幼保健》2009年第12期1677-1680,共4页Maternal and Child Health Care of China

基　　金：广州市大科技攻关项目(编号:2004ZI-E4021);广东省科技攻关项目(编号:2005B10401045)

摘　　要：目的:利用时间分辨免疫荧光分析(TRFIA)技术建立新生儿TSH的检测试剂。方法:采用双抗体夹心法建立新生儿TSH-TRFIA检测试剂,对试剂的各项指标进行评价。结果:TSH-TRFIA检测试剂的灵敏度为2.0μU/ml,测量范围为2.0～250μU/ml,分析内和分析间的精密度分别为6.2%～7.5%和9.6%～9.9%。100份新生儿干血片测试结果表明,该试剂与同类试剂同时检测,其相关系数为0.993。结论:TSH-TRFIA检测试剂各项指标均达到临床检测要求,可替代同类产品。Objective：To establish a kit for detection of neonatal thyroid stimulating hormone（TSH） by time-resolved fluoroimmunoassay.Methods：Time-resolved fluoroimmunoassay kit for detection of thyroid stimulating hormone in neonates was developed by double antibody snadwich method.Results：The sensitivity of the kit was 2.0 μU/ml,the detection range was 2.0~250 μU/ml,the intra and inter-assay precisions were 6.2%~7.5% and 9.6%~9.9%,respectively.The correlation coefficient of 100 samples detection results between the kit and the other similar kits was 0.993.Conclusion：The time-resolved fluoroimmunoassay kit for detection of thyroid stimulating hormone in neonates is valuable for clinical application,which maybe replace the other kits.

关 键 词：先天性甲状腺功能减低症 促甲状腺激素 时间分辨免疫荧光分析 诊断试剂 

分 类 号：R446.1[医药卫生—诊断学]