摘要
目的研制人血清基质的胱抑素C标准物质。方法收集无溶血、黄疸、乳糜的血清样本,去除血清中的不稳定成分,经过浓度配比、过滤、混匀、分装后制成4个浓度的胱抑素C标准物质。在单一实验室内采用10种免疫透射比浊法测量原理的常规方法同时测量系列浓度ERM-DA471/IFCC溶液和各标准物质中胱抑素C浓度,以经过ERM-DA471/IFCC量值传递后的胱抑素C浓度均值作为标准物质的认定值。依据文件分别评估胱抑素C标准物质的均匀性、稳定性及互换性。结果4个水平的胱抑素C标准物质定值结果为0.89±0.10mg/L、1.82±0.13mg/L、3.55±0.28mg/L、5.25±0.29mg/L。制备的标准物质均匀性良好。-70℃以下条件可稳定半年,2~8℃条件可稳定144h,复融后室温条件可稳定8h。常规测量系统中的互换性良好。结论该标准物质符合国家二级标准物质的要求,现已通过全国标准物质管理委员会的审批,编号为GBW(E)091173-091176,可用于临床实验室胱抑素C的质量评价。
Objective To prepare and develop reference materials of cystatin C in frozen human serum.Methods Serum samples without hemolysis,jaundice and chylous were collected for the study.The unstable components in the serum were removed.Four concentrations of cystatin C were prepared after concentration matching,filtration,mixing and packing.The concentration of cystatin C in ERM-DA471/IFCC solution and each reference material was measured simultaneously by 10 conventional methods in a single laboratory and the mean value of cystatin C concentration transferred by ERM-DA471/IFCC quantity was used as the identification value of reference material.The homogeneity,stability and commutability of cystatin C reference material were evaluated according to relevant documents.Results The values of the four levels of cystatin C were 0.89±0.10mg/L,1.82±0.13mg/L,3.55±0.28mg/L,and 5.25±0.29mg/L.The reference materials had good homogeneity.It was kept stable for half a year under-70℃,144 hours at 2-8℃and 8 hours at room temperature after re-melting.The commutability in the conventional measuring system was good.Conclusion The reference materials meet the requirements of national secondary reference material and can be used for the quality evaluation of cystatin C in clinical laboratory.
作者
李敏
邵燕
孙江漫
孟祥兆
于洪远
LI Min;SHAO Yan;SUN Jiangman;MENG Xiangzhao;YU Hongyuan(Beijing Aerospace General Hospital,Beijing 100076,China)
出处
《标记免疫分析与临床》
CAS
2022年第2期344-348,共5页
Labeled Immunoassays and Clinical Medicine
基金
国家重点研发计划“国家质量基础的共性技术研究与应用”(编号:ZLJC1706-1-1)。
关键词
胱抑素C
标准物质
血清基质
均匀性
稳定性
Cystatin C
Reference material
Serum matrix
Homogeneity
Stability
