促甲状腺素光激化学发光免疫测定法的建立和初步应用

The establishment of light-initiated chemiluminescence assay of TSH and its clinical application

采用光激化学发光免疫测定法(LICA)技术建立促甲状腺素(TSH)快速定量检测方法。采用两株针对TSH不同表位的单克隆抗体,一株单抗包被发光微粒,另一株为生物素化单抗,两者与链亲和素包被的感光微粒一起构建双抗体夹心LICA。数据处理采用双对数函数处理程序。方法的灵敏度为0.015mIU/L;批内CV为2.5%～3.6%,批间CV为2.6%～4.4%;平均回收率为100.60%。与时间分辨荧光免疫分析法(TRFIA)比对,相关系数达0.9681;与TRFIA临床测定值呈明显相关;正常值范围为0.33～3.09mIU/L。本文建立的TSH光激化学发光免疫测定法是目前TSH检测中最快速灵敏的方法之一,该方法稳定性好,具有很好的应用前景。

To establish a quantitative light-initiated chemiluminescence assay （LICA） for the determination of TSH concentration, two specific monoclonal antibodies against different epitopes on TSH were selected. One antibody was coated with chemiluminescence particles and the other with biotin. These two modified antibodies and a streptidin-eoated sensitizer particles were used to construct the TSH-LICA system. The assay sensitivity was 0. 015 mIU/L, the intrassay coefficient of variation was 2.5%-3.6%. and the interassay coefficient of variation was 2.6%-4.4%. Average recovery was 100.60%. Correlation coefficient of the assay with TSH-TRFIA was 0. 9681. The normal range of TSH was 0.33- 3.09mIU/L. The results showed that TSH-LICA was a sensitive, simple and convenient method in detecting TSH. The high sensitivity and wide optimal range of this method showed its good application prospect.