胱抑素C冰冻人血清国家标准品的建立及溯源性研究  

Establishment and Traceability Study of Cystatin C Frozen Human Serum National Standard

作　　者：贾峥[1] 曲守方[1] 高瑛瑛 张文新 孙楠[1] 沈敏 李丽莉[1] 张河战[1] Jia Zheng;Qu Shoufang;Gao Yingying;Zhang Wenxin;Sun Nan;Shen Min;Li Lili;Zhang Hezhan(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局体外诊断试剂质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2024年第1期38-44,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:对胱抑素C进行量值溯源性研究,研制胱抑素C冰冻人血清国家标准品,建立用于胱抑素C检测试剂盒准确度评价的质量评价标准,提升检验检测水平。方法:以人血清样本为原料进行无菌分装、制备胱抑素C冰冻人血清国家标准品,采用多实验室联合赋值的方法对胱抑素C国家标准品候选品进行赋值、标定,建立可溯源至国际标准物质ERM-DA471/IFCC的溯源链,并采用免疫比浊的方法对其均匀性、稳定性进行验证。结果:建立了包含2个水平量值的胱抑素C冰冻人血清国家标准品,水平1为(0.94±0.03)mg·L^(-1)(k=2),水平2为(3.52±0.09)mg·L^(-1)(k=2)。该国家标准品均匀性和稳定性良好。30天短期稳定性研究结果显示,室温条件下,国家标准品(水平1和水平2)可稳定5天;2~8℃条件下,水平1可稳定10天,水平2可稳定20天;-20℃条件下,水平1和水平2均至少可稳定30天。溯源准确性采用血清参考盘和临床血清样本进行验证,研究结果显示,该国家标准品和国际标准品ERM-DA471/IFCC具有良好的溯源性。结论:通过对胱抑素C进行量值溯源性研究,研制出胱抑素C冰冻人血清国家标准品(360046-202001),并获得批准向社会提供,可用于人血清中胱抑素C检测试剂盒正确度评价及临床实验室检测系统量值准确性评价。Objective:To carry out a quantitative traceability study on cystatin C,and to develop cystatin C frozen human serum national standard,which can be used for evaluating the accuracy of cystatin C test kits,and improving the ability of human serum cystatin C detection.Methods:Human serum samples were used as raw materials for aseptic sub-packaging and preparation of cystatin C frozen human serum national standard.The candidate of cystatin C frozen human serum national standard was assigned and calibrated by the method of multi-laboratory joint assignment,which was traceable to the international standard ERM-DA471/IFCC,and the accuracy of the traceability chain has been verifi ed.The homogeneity and stability of the national standard was verifi ed by the method of immune turbidimetry.Results:The cystatin C frozen human serum national standard was established,which contains two concentration levels:level 1(0.94±0.03)mg·L^(-1)(k=2),Level 2(3.52±0.09)mg·L^(-1)(k=2);cystatin C frozen human serum national standard has good homogeneity and stability.The results of the 30-day short-term stability study showed that cystatin C frozen human serum national standard(level 1 and level 2)were stable for 5 days at room temperature;at 2-8℃,level 1 can be stable for 10 days and level 2 can be stable for 20 days.At-20℃,both level 1 and level 2 can be stable for at least 30 days.The accuracy of the traceability was verifi ed by using the serum reference panel and clinical serum samples,study results show that the national standard and international standard ERM-DA471/IFCC have good traceability.Conclusion:The Cystatin C frozen human serum national standard(360046-202001)has been approved and provided to the society with the quantitative traceability study,which can be used for the accuracy evaluation of the cystatin C detection kit in human serum and the accuracy evaluation of clinical laboratory detection system values.

关 键 词：胱抑素C 量值溯源 国际标准物质 免疫比浊法 

分 类 号：R917[医药卫生—药物分析学]