Development of Glucose in Human Serum Reference Material
LI Wu-rong1,2,YANG Bin3,HUANG Yan-jie1,ZHANG Ning3,LUO Si-ting1, WANG Jing3,WU Quan-zhou2,WU Li-Qing3
1. Guangdong Provincial Key Laboratory of Modern Geometric and Mechanical Metrology Technology, Guangdong Provincial Institute of Metrology,Guangzhou, Guangdong 510405, China
2. School of Pharmaceutical Sciences,Guangzhou University of Chinese Medicine, Guangzhou, Guangdong 510006, China
3. Center for Advanced Measurement Science (Division of Life Science Metrology), National Institute of Metrology, Beijing 100029, China
Abstract:Blood glucose is a direct indicator for diagnosis and discrimination of diabetes, and reference materials are important guarantee for the accuracy and comparability of blood glucose detection results.The process of developing glucose in human serum reference materials with six different concentration levels includes the preparation, value determining, uniformity, stability test, uncertainty evaluation and interoperability evaluation of reference materials. Two different principles of isotope dilution liquid chromatography tandem mass spectrometry and isotope dilution gas chromatography mass spectrometry were used to determine the concentration value of glucose in human serum, and the differences and causes between the analysis results of the two methods were analyzed. The quantitative value of glucose in human serum reference material at different concentration levels in human serum covers 1.70~28.12mmol/L. This series of reference material have good uniformity and stability, and have obtained the gradation certificate of national secondary certified reference material, the number is GBW (E) 091140~GBW(E) 091145, which are expected to be used in clinical tests and related areas for quality evaluation of measurement of serum glucose items and other aspects.
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