Development of national secondary reference materials of urea and creatinine in frozen human serum
10.3760/cma.j.cn114452-20221231-00760
- VernacularTitle:冰冻人血清尿素和肌酐国家二级标准物质的研制
- Author:
Pengwei ZHANG
1
;
Jianbing WANG
;
Liqiao HAN
;
Haibiao LIN
;
Min ZHAN
;
Qiaoxuan ZHANG
;
Jun YAN
;
Junhua ZHUANG
;
Xianzhang HUANG
Author Information
1. 广州中医药大学第二附属医院检验医学部，广州510120
- Keywords:
Urea;
Creatinine;
ID-LC-MS/MS;
Reference material;
Homogeneity;
Stability;
Commutability
- From:
Chinese Journal of Laboratory Medicine
2023;46(8):845-852
- CountryChina
- Language:Chinese
-
Abstract:
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.
