冰冻人血清尿素和肌酐国家二级标准物质的研制  

Development of national secondary reference materials of urea and creatinine in frozen human serum

作　　者：张鹏伟 王建兵 韩丽乔 林海标 展敏 张乔轩 严君 庄俊华 黄宪章 Zhang Pengwei;Wang Jianbing;Han Liqiao;Lin Haibiao;Zhan Min;Zhang Qiaoxuan;Yan Jun;Zhuang Junhua;Huang Xianzhang(Department of Laboratory Medicine,the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,China)

机构地区：[1]广州中医药大学第二附属医院检验医学部,广州510120

出　　处：《中华检验医学杂志》2023年第8期845-852,共8页Chinese Journal of Laboratory Medicine

基　　金：国家重点研发计划(2022YFF0710300,2022YFF0710302);广东省中医院拔尖人才科研专项(BJ2022KY04);广东省中医院中医药科学技术研究专项(YN2019MJ04)。

摘　　要：目的联合使用同位素稀释液相色谱串联质谱及酶学参考方法研制冰冻人血清尿素、肌酐国家二级标准物质,作为量值溯源的载体。方法参照JJF1343-2012《标准物质定值的通用原则及统计学原理》和JJF 1006-1994《一级标准物质技术规范》的要求对候选物质进行均匀性、稳定性、互换性评价;联合广东省中医院、北京航天总医院、深圳迈瑞生物医疗电子股份有限公司、迈克生物股份有限公司、北京利德曼生化股份有限公司、浙江美康生物科技股份有限公司的6家参考实验室采用国际检验医学溯源联合委员会推荐的同位素稀释液相色谱串联质谱法及酶学参考方法共同对标准物质进行定值,计算不确定度。结果所研制标准物质均匀性的方差分析结果为P>0.05,稳定性评价t值小于t(0.05)查表时的t值,互换性评价结果位于4个常规检测系统测量值95%置信区间内,最终定值结果为尿素:14.7 mmol/L,扩展不确定度0.3 mmol/L(k=2),肌酐:313.9μmol/L,扩展不确定度14.5μmol/L(k=2)。结论成功研制的冰冻人血清尿素、肌酐二级标准物质标示值可靠,均匀性、稳定性较好,不同检测系统间具有良好互换性。Objective To develop a national secondary reference material of Urea and Creatinine in frozen human serum as a standard for metrological traceability.Methods According to JJF1343-2012"General and Statistical Principles for Characterization of Reference Materials"and JJF 1006-1994"Technical Norm of Primary Reference Material",the homogeneity,stability,and commutability were evaluated;Using the JCTLM recommended methods,the value of the reference materials was assigned through collaboration with 6 accredited reference laboratories from Guangdong Provincial Hospital of Chinese Medicine,Beijing Aerospace General Hospital,Shenzhen Mindray Bio-Medical Electronics,Maccura Biotechnology,Beijing Leadman Biochemistry,and Zhejiang MedicalSystem Biotechnology.Uncertainty components including inhomogeneity,stability and value assignment were evaluated.Results The results of one-way analysis of variance of homogeneity for the reference materials showed P>0.05,and the stability evaluation was less than the critical value of the t-test.The measured values were in the 95%confidence interval in the four conventional detection systems for commutability,and the certified values and expanded uncertainties were urea:(14.7±0.3)mmol/L(k=2),Cr:(313.9±14.5)μmol/L(k=2).Conclusion The prepared secondary reference materials of urea and creatinine had promising homogeneity,stability,and commutable,the values of urea and creatinine concentration in reference materials were accurate and reliable.

关 键 词：尿素 肌酐 同位素稀释液相色谱串联质谱 标准物质 均匀性 稳定性 互换性 

分 类 号：R446.1[医药卫生—诊断学]