基于全自动管式化学发光免疫检测系统的人结核感染T细胞检测方法的建立  

Development of detection kit for T cell infected with Mycobacterium tuberculosis based on fullautomatic chemiluminescence immune analyzer

作　　者：陈鹭颖 林海军[2] 翁祖星[2] 徐飞海[2] 葛胜祥[2] 张军[2] 

机构地区：[1]福建省食品药品认证审评中心,福建福州350003 [2]厦门大学国家传染病诊断试剂与疫苗工程技术研究中心,福建厦门361102

出　　处：《分子诊断与治疗杂志》2015年第5期296-301,共6页Journal of Molecular Diagnostics and Therapy

基　　金：国家高技术研究发展计划(863计划)(2011AA02A101)

摘　　要：目的建立基于化学发光平台的人结核感染T细胞检测方法。方法将一株γ-干扰素单抗标记在磁微粒上,另一株γ-干扰素单抗标记在吖啶酯上,然后将检测体系与已有的细胞刺激培养体系相结合。结果本研究成功建立基于化学发光平台的人结核感染T细胞检测方法。以ELISA平台检测试剂的检测结果作为参考,该方法的灵敏度为98.3%,特异性为99.2%,总体符合率达到98.8%。结论该方法具有更高的分析灵敏度(可达0.27 pg/m L)、更宽的线性范围(1 pg/m L^5 000 pg/m L)、更好的重复性(批内与批间变异系数均<6.0%)及更易实现高通量检测,为临床诊断结核感染提供了有力的工具。Objective To develop the detection kit for T cell infected with Mycobacterium tuberculosis based on full-automatic chemiluminescence immune analyzer. Mehtods An antilFN-γ/Mab was coated on the surface of microparticle. Another anti IFN-γ/Mab was labelled to acridinium ester. After that, the detection system was combined with the in vitro cell culture system. Results This research developed the detection kit for T cell infected with Mycobacterium tuberculosis based on full-automatic c immune analyzer. Compared with the testing results of the ELISA kit, the sensitivity, specificity and total matching ratio of the CLIA kit was 98.3%, 99.2% and 98.8%, respectively. Conclusion The CLIA kit has better sensitivity （0.27 pg/mL）, wilder linear range （1 pg/mL - 5 000 pg/mL）, and better repeatability （intra and inter coefficient of variation 〈 6.0%）. It makes a high throughput detection available. It will contribute to the clinical diagnosis of Mycobacterium tuberculosis.

关 键 词：结核感染T细胞 γ-干扰素定量检测 化学发光 

分 类 号：R446.6[医药卫生—诊断学]