人心肌肌钙蛋白I质控品的制备及应用  

Preparation and Application of Freeze-Drying Control Materials for Human Cardiac Troponin I

作　　者：张小燕 周齐洋 ZHANG Xiao-yan;ZHOU Qi-yang(Jiangsu Medical Device Inspection Institute,Jiangsu Nanjing 210012)

机构地区：[1]江苏省医疗器械检验所,江苏南京210012

出　　处：《中国医疗器械信息》2023年第5期39-41,共3页China Medical Device Information

摘　　要：目的:制备出性能稳定、均匀性良好、互通性较好,具有良好免疫反应的人心肌肌钙蛋白I(cTnI),可以用作cTnI定量检测系统的质控品。方法:利用购自Hytest的天然复合抗原作为主要原料,使用经过处理的天然血清作为主要稀释基质,制备成质控品,同时考察该质控品的稳定性、均匀性、互通性。结果:购自Hytest的天然复合抗原与目前IFCC发布的标准参考物质SRM2921所使用的原料相同,且制备的质控品与SRM2921具有相同的免疫反应,且该质控品具有良好的稳定性、均匀性和互通性。结论:制备的冻干cTnI质控品使用方便、结果稳定,可以满足室内质控和室间质评的要求,适用于cTnI定量试剂盒的质量控制。Objective:To prepare freeze-drying control materials of human cardiac troponin I(cTnI)with stable capability,good uniformity,fair intercommunity and good immunoreactivity for the quantitative detection of cTnI.Methods:Quality control materials are prepared by mixing natural antigen complex(commercially available from Hytest)and serum dilution matrix which is treated from nature serum.The quality control products have been scrutinized among properties as stability,uniformity and interoperability.Results:Natural antigen complexes(purchased form Hytest)are in consistent with the raw materials used in latest IFCC reference substance SRM2921.More importantly,quality controls products and SRM2921 can cause same immune response,and pass through stability,uniformity and interoperability tests.Conclusion:The quality control of cTnI prepared by lyophilized process is convenient to use and the results are stable.Thus it can meet the requirements of internal quality control and external quality assessment which widely used in quality control of cTnI quantitative kit.

关 键 词：心肌肌钙蛋白Ⅰ 质控品 质量控制 稳定性 均匀性 互通性 

分 类 号：TH776[机械工程—仪器科学与技术]