人血清中葡萄糖标准物质的研制  

Development of Glucose in Human Serum Reference Material

作　　者：李务荣 杨彬[3] 黄彦捷 张宁[3] 罗思婷 王晶[3] 邬泉周[2] 武利庆 LI Wu-rong;YANG Bin;HUANG Yan-jie;ZHANG Ning;LUO Si-ting;WANG Jing;WU Quan-zhou;WU Li-Qing(Guangdong Provincial Key Laboratory of Modern Geometric and Mechanical Metrology Technology,Guangdong Provincial Institute of Metrology,Guangzhou,Guangdong 510405,China;School of Pharmaceutical Sciences,Guangzhou University of Chinese Medicine,Guangzhou,Guangdong 510006,China;Center for Advanced Measurement Science(Division of Life Science Metrology),National Institute of Metrology,Beijing 100029,China)

机构地区：[1]广东省计量科学研究院广东省现代几何与力学计量技术重点实验室,广东广州510405 [2]广州中医药大学中药学院,广东广州510006 [3]中国计量科学研究院前沿计量科学中心(生命科学计量研究所),北京100029

出　　处：《计量学报》2023年第2期304-310,共7页Acta Metrologica Sinica

基　　金：广东省市场监督管理局科技项目(2020HBZ01);中国计量科学研究院基本科研业务费项目(AKY1907,AKY1959)。

摘　　要：血糖是诊断和判别糖尿病的直接指标,标准物质是血糖检测结果准确可比的重要保障。研制人血清中6个不同浓度水平的葡萄糖标准物质的过程包括标准物质的制备、定值、均匀性、稳定性检验、不确定度评定以及互通性评价等内容。其中标准物质定值采用了两种不同原理的方法即同位素稀释-液相色谱-串联质谱法及同位素稀释-气相色谱-质谱法,准确测定人血清中葡萄糖的浓度,并重点分析了两种方法测试结果的差异及成因。人血清中葡萄糖标准物质的量值覆盖1.70~28.12 mmol/L,具有良好的均匀性和稳定性,已获得国家二级标准物质定级证书,编号为GBW(E)091140~GBW(E)091145,有望用于临床检验及相关领域对血清葡萄糖项目测量的质量评价等方面。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 1.70~28.12 mmol/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.

关 键 词：计量学 人血清 葡萄糖 标准物质 ID-LC-MS/MS ID-GC-MS 

分 类 号：TB99[一般工业技术—计量学]