游离雌三醇时间分辨免疫荧光分析法的建立

Development of A Time-Resolved Fluoroimmunoassay Kit for the Detection of Human Unconjugated-Estriol

目的建立游离雌三醇(uE_3)时间分辨免疫荧光分析(TRFIA)方法。方法采用竞争抑制一步法建立检测uE_3的TRFIA分析方法,并对该试剂的各项性能指标进行评价。结果该方法的灵敏度为0.14nmol/L,线性范围为0.14～120nmol/L,回收率为97.7%。分析内和分析间变异系数分别为1.6%～4.1%和4.4%～8.8%。与E_2、孕酮和睾酮的交叉反应率分别为0.24%、0.36%和0.40%。149份血样用本试剂与进口的同类试剂同时检测,其相关系数为0.925。结论试剂盒各项指标均达到临床检测要求,可替代国外同类产品试剂盒。

Objective To develop a time-resolved fluoroimmunoassay （TRFIA） kit for the detection of human unconjugated-estriol （uE3）. Methods Competitive-binding TRFIA kit for the detection of uE3 was developed using the monoclonal antibody E3. Results The sensitivity of this home-made uE3-TRFIA kit was in the range of 0.14-120 nmol/ L. The recovery rate was 97.7%. The percentage of cross reactivity with E2, Progestin and Progestone was 0.24%, 0.36% and 0.40%, respectively. The intra- and inter-assay coefficients of variation were 1.6%-4.1% and 4.4%-8.8%, respectively. When compared with the commercially available uE3 kit （PerKin Elmer）, the coefficient of correlation of 149 blood tests was 0.925. Conclusion The uE3 TRFIA kit developed in this study is sensitivie, accurate and suitable for clinical application.