TSHBAS-CLIA方法的建立

Chemiluminescent Immunoassay for TSH Using Biotin-streptavidin System

吖啶酯DMAE·NHS标记链亲和素 ,用生物素标记一株TSH单克隆抗体 ,另一株TSH单抗包被 96微孔板 ,建立TSHBAS -CLIA方法。该方法标准曲线的线性相关系数为 0 .999,分析灵敏度为 0 .0 0 7mIU/L。批内变异系数为 2 .36 % - 3.6 6 % ,批间变异系数为 2 .4 4 % - 4 .35 % ,平均回收率为 10 1.7%。与TSHIRMA法的回归方程为 :Y =- 0 .0 15 +1.0 2X ,相关系数为 0 .989;与本文的TSHCLIA也有明显相关 ,相关方程为 :Y =- 0 .2 4 +1.0 1X ,相关系数为 0 .992 ;与CibaCoriningTSHCLIA临床测量值也呈明显相关。

TSH chemiluminescent immunoassay using biotin-streptavidin system was established and studied. Two monoclonal antibodies of TSH were used in the assay,with one coated to 96 well plate and the other labeled with biotin. Streptavidin was labeled by DMAE·NHS. Assay sensitivity was 0.007 mIU/L. Intrassay coefficient of variation was 1.47%-5.65%. Interassay coefficient of variation was 2.45%-8.72%. Average recovery was 101.7%.Correlation coefficient and correlation equation of the assay with TSH IRMA were 0.989 and Y=-0.015+1.02X, respectively. The assay sensitivity and CPS of this assay were higher than those of TSH-CLIA, in which no biotin-streptavidin system was used.