人心肌肌钙蛋白I冻干质控品的制备及评价  

Preparation and evaluation of freeze-drying control materials for human cardiac troponin I

作　　者：才蕾 武建伟 邓秋菊 方琦 王继华 唐时幸 

机构地区：[1]广州万孚生物技术股份有限公司研发中心,广州510660

出　　处：《临床检验杂志》2014年第8期615-617,共3页Chinese Journal of Clinical Laboratory Science

基　　金：广东省战略性新兴产业核心技术攻关项目(2012A080800007)

摘　　要：目的制备性能稳定、具有良好免疫反应性的冻干人心肌肌钙蛋白I亚基(cTnI),用作cTnI定量检测试剂的质控品。方法利用基因工程方法构建表达载体,转化大肠埃希菌后,诱导表达重组cTnI,经纯化后制备冻干质控品,同时考察该质控品的稳定性。结果成功诱导表达可溶性cTnI蛋白,其冻干品与标准参考物质SRM 2921具有相同的免疫反应性,且该质控品用于检测具有良好的精密度和稳定性。结论制备的冻干cTnI使用方便、结果稳定,可以满足室内质控要求,适合作为cTnI定量试剂盒的质控品。Objective To prepare freeze-drying control materials of human cardiac troponin I （cTnI） with stable capability and good immunoreactivity for the quantitative detection of cTnI. Methods Recombinant eTnI was expressed in E. coli by genetic engineering method, and further purified. Then, the purified cTnI was prepared as the freeze-drying control materials, and its stability and immu- noreactivity were assessed. Results The soluble recombinant cTnI protein was successfully obtained, and the corresponding freeze-dr- ying control materials had similar immunoreactivity with standard reference material （SRM） 2921, and good precision and stability. Conclusion The prepared freeze-drying control materials of cTnI, which are easy to use and have good stability, may meet the re- quirement of internal quality control, and be used as the control materials for the quantitative detection kit of cTnI.

关 键 词：心肌肌钙蛋白 质控品 质量控制 稳定性 

分 类 号：R446[医药卫生—诊断学]