人促卵泡激素时间分辨荧光免疫分析检测试剂的研制

Timed-resolved Fluoroimmunoassay Kit for Detection of Human Follicle Stimulating Hormone

目的利用时间分辨荧光免疫分析（TRFIA）技术建立人血清促卵泡激素（hFSH）的检测试剂。方法采用双抗体夹心法建立hFSH—TRFIA检测试剂，对试剂的各项指标进行评价。结果hFSH—TRFIA检测试剂的测量范围为1～256U／L，灵敏度为0．08U／L，分析内和分析间的精密度分别为2．6％～4．2％，6．1％～8．6％，与人黄体生成素（hLH）、人促甲状腺素（hTsH）和人绒毛膜促性腺激素（hCG）的交叉率分别为0．14%，0．08％和0．01％。30份异常血样用该试剂与进口的同类试剂同时检测，其相关系数为0．993。结论试剂各项指标均达到临床检测要求，可替代国外同类产品。

Objective To prepare a kit for detection of human follicle stimulating hormone （hFSH） in serum by time-resolved fluoroimmunoassay（TRFIA）. Methods Two anti-hFSH monoelonal antibodies were used to develop the sandwich TRFIA kit for detection of hFSH in serum, Results The measure range of developed kit was 1-256 U/L. Its assay sensitivity was 0. 08 U/L. The cross reactivity rate was 0. 14% ,0.08% and 0. 01% with human luteinizing hormone,human thyroid stimulating hormone and human ehorionic gonadotropin ,respectively. The intra-and inter-assay coefficients of variation were 2.6%-4. 2% and 6.1-8. 5% ,respectively. The correlation coefficient of blood samples detection results between home-made and commercially available DELFIA FSH kits （PerKinElmer） was 0. 993. Conclusion The developed hFSH-TRFIA kit in this study is a valuable test for clinical application with better sensltivity,specificity and accuracy.