血清真胰岛素化学发光免疫分析方法学研究  

The Study of Chemiluminescence Immunoassay for Determination of Human Serum True Insulin

作　　者：马世俊[1] 应希堂 李振甲[1] 胡国茂[1] 

机构地区：[1]北京科美东雅生物技术有限公司,北京100094

出　　处：《标记免疫分析与临床》2005年第3期164-167,共4页Labeled Immunoassays and Clinical Medicine

基　　金：科技部中小型企业技术创新基金资助项目(04C26221100313)

摘　　要：建立一种高灵敏度真胰岛素临床常规检测方法.采用两株特异的抗胰岛素单抗体,分别抗胰岛素肽链上两个不同的抗原决定簇,用一株制备固相抗体,另一株标记碱性磷酸酶C,以金刚烷衍生物为发光底物建立化学发光免疫分析(CLIA)法.结果表明本方法灵敏度为0.06μIU/mL,标准曲线量程为1.0～150μIU/mL,批内和批间CV分别为5.0%、7.8%,平均回收率为94.4%.分别测定了男、女成人空腹血清各100份,男性实测范围0.52～11.23μIU/mL,平均值为3.86μIU/mL,女性实测范围为0.75～10.66μIU/mL,平均值为3.62μIU/mL.真胰岛素CLIA法简便快速,能真实反应血清胰岛素的水平,对临床糖尿病的诊疗和病理生理研究具有实用价值.To develop a highly sensitive CLIA to detect human serum true insulin, two specific monoclonal antibodies having different and distinct epitopes on insulin molecule were used in this study： one was coated on microtiter plate as the solid phase antibody and the other was labeled with alkaline phosphatase. Adamantine derivate was used as the subsadte. The results showed that the sensitivity was 0.06μIU/mL, and the linear calibrator was in the range of 1.0-150μIU/mL. TheCVofintra-andinterbatches were 5.0%and 7.8%, respectively, and the mean recovery rate was 94.4%. According to measurement results of 200 samples （100 men and 100 women） the determination range was 0. 52 - 11.23μIU/mL for males, 0.75 10.66μIU/mL for females, and the mean value was 3.86, 3.62μIU/mL. There was no obvious difference between men and women. Chemiluminescence immunoassay （CLIA） is a simple and convenient, and can reflect truly the level of serum insulin. CLIA of insulin has application value in diagnosis and pathological research of diabetes mellitus.

关 键 词：真胰岛素 糖尿病 化学发光免疫分析 

分 类 号：R446.6[医药卫生—诊断学]