人表皮生长因子受体2时间分辨荧光免疫分析法的建立  

Establishment of a time-resolved fluoroimmunoassay in detection of human epidermal growth factor receptor 2

作　　者：范俊[1] 张艺[1] 王珂[2] 孙文伟[3] 张珏[1] 周彬[1] 傅利新 黄飚[1] 杨琴[5] Fan Jun;Zhang Yi;Wang Ke;Sun Wenwei;Zhang Jue;Zhou Bin;Fu Lixin;Huang Biao;Yang Qin(Key Laboratory of Nuclear Medicine, Ministry of Health, Jiangsu Key Laboratory of Molecular Nuclear Medicine, Jiangsu Institute of Nuclear Medicine, Wuxi 214063, China;Department of Clinical Laboratory, Jiangyin People＇s Hospital, Wuxi 214400, China;Department of Nuclear Medicine, China-Japan Union Hospital of Jilin University, Changchun 130033, China;Wuxi Jiangyuan Industrial Technology and Trade Corporation, Wuxi 214063, China;Department of Clinical Laboratory, Shengli Oilfield Central Hospital, Dongying 257034, China)

机构地区：[1]江苏省原子医学研究所、卫生部核医学重点实验室、江苏省分子核医学重点实验室,无锡214063 [2]江阴市人民医院检验科,214400 [3]吉林大学中日联谊医院核医学科,长春130033 [4]无锡市江原实业技贸总公司,214063 [5]山东省东营市胜利油田中心医院检验科,257034

出　　处：《中华核医学与分子影像杂志》2018年第5期336-339,共4页Chinese Journal of Nuclear Medicine and Molecular Imaging

基　　金：江苏省卫生与计划生育委员会课题（Z201506,H201637）

摘　　要：目的建立人表皮生长因子受体（HER）2的时间分辨荧光免疫分析（TRFIA）检测方法并进行方法学评价。方法以HER2单克隆抗体H7包被，Eu^3＋标记HER2单克隆抗体E5，建立双抗夹心HER2－TRFIA法，考核该方法的灵敏度、稳定性、特异性、测量范围及正常参考值范围，并与德国Siemens公司的化学发光免疫分析（CLIA）进行相关性分析。结果HER2－TRFIA法的检测灵敏度为0.214 ng/ml；测量范围为0.214～1 000 ng/ml；批内和批间CV的均值分别为3.48%和4.13%；与HER1无交叉反应，正常参考值范围为0～13.20 ng/ml；与CLIA的相关性良好（r＝0.997）；同一批试剂4 ℃下可稳定放置6个月以上。结论HER2－TRFIA法是一种灵敏度高、特异性好、精密度佳的检测方法，能满足临床使用的需要。ObjectiveTo set up a time-resolved fluoroimmunoassay （TRFIA） method for human epidermal growth factor receptor 2 （HER2） detection and to evaluate its performance.MethodsEach well of the 96-microwell plate was coated with monoclonal antibody of HER2（H7） and another monoclonal antibody of HER2（E5） was labeled by Eu^3＋ . The sensitivity, stability, specificity, measurement range and reference value of this method were tested. The correlation between chemiluminescence （CLIA） method and TRFIA method was analyzed.ResultsThe sensitivity of HER2-TRFIA method was 0.214 ng/ml. The measurement range was 0.214-1 000 ng/ml. The mean within-run CV and mean between-run CV were 3.48% and 4.13%, respectively. HER2-TRFIA method had no cross-reaction with HER1 and its reference range was 0-13.20 ng/ml. The correlation coefficient between TRFIA and CLIA was 0.997. The same batch of reagents were found to be stable for more than 6 months at 4 ℃.ConclusionsHER2-TRFIA method has high sensitivity, specificity, stability and wide detecting range. It might be suitable for clinical use.

关 键 词：受体 表皮生长因子 乳腺肿瘤 荧光免疫测定 

分 类 号：R446.6[医药卫生—诊断学]