IFCC参考方法在五种糖化血红蛋白检测系统评价中的应用  

The application of IFCC reference methods in methodological evaluation of glycated hemoglobin measurement systems

作　　者：张天娇[1] 蒲云罡 周慧娟 马嵘[1] 张江涛[1] 王大光[3] 李传保[3] 李淼[4] 王玉飞 张传宝[1] Zhang Tianjiao;Pu Yungang;Zhou Huijuan;Ma Rong;Zhang Jiangtao;Wang Daguang;Li Chuanbao;Li Miao;Wang Yufei;Zhang Chuanbao(Beijing Clinical Laboratory Medicine Engineering Technology Research Center,National Center of Gerontology,National Center for Clinical Laboratories,Beijing Hospital,Beijing 100730,China)

机构地区：[1]北京医院国家老年医学研究中心卫生部临床检验中心北京市临床检验工程技术研究中心,100730 [2]中国医学科学院北京协和医学院 [3]北京医院检验科 [4]北京医院内分泌科

出　　处：《中华检验医学杂志》2018年第11期821-826,共6页Chinese Journal of Laboratory Medicine

基　　金：北京生物医药产业跨越发展工程（Z161100001816043）;国家高技术研究发展计划（2011AA02A102）

摘　　要：要目的以国际临床化学与检验医学联合会（IFCC）糖化血红蛋白参考方法为参比方法，对4个离子交换高效液相色谱法检测系统和1个毛细管电泳检测系统进行方法学评价研究。方法制备40个浓度水平的溶血液样本，分别用IFCC参考方法和待评价的5个糖化血红蛋白检测系统进行测定，按照美国临床实验室标准化协会（CLSI）EP9-A3文件的程序进行正确度验证。使用全血样本，对5种系统的精密度、线性和分析干扰进行评价。结果IFCC参考方法测定40个溶血液样本的平均变异系数（CV）为1.4%（范围0.2%～2.5%）。经统计，5个系统测定结果未检出离群值，回归方程的斜率范围为0.990 2～1.026 7，截距范围为－0.152 6 mmol/mol ～ ＋0.151 2 mmol/mol，决定系数的范围为0.996 2～0.997 1，两个医学决定水平处估计值的偏倚均小于0.3%HbA1c。各系统实验室内CV均小于2%（NGSP单位）。线性评价中所有系统测定结果与理论值的百分偏差均小于5%。高浓度葡萄糖对糖化血红蛋白检测存在一定的分析干扰。结论5个糖化血红蛋白检测系统测定结果与IFCC参考方法具有较好的可比性，精密度和线性评价的结果符合相关标准的要求。ObjectiveTo perform a methodological evaluation study of 4 HPLC based systems and a capillary electrophoresis based system, with the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC） glycated hemoglobin reference method as a comparative method.Methods40 hemolysis samples of variety concentrations were prepared. The samples were measured by IFCC reference method and 5 glycated hemoglobin testing systems, respectively and trueness verification was performed according to the Clinical ＆ Laboratory Standards Institute （CLSI） guideline EP9-A3. Whole blood samples were used to test the systems′ precision, linearity and analytical interferences.ResultsThe average CV of IFCC reference method results of 40 hemolysis samples was 1.4%（range from 0.2% to 2.5%）. No outlier was found in the results of the 5 testing system. The slopes ranged from 0.990 2 to 1.026 7, and intercepts from -0.152 6 mmol/mol to ＋ 0.151 2 mmol/mol, squared correlation coefficient from 0.996 2-0.997 1, biases at two medical decision level were less than 0.3% HbA1c. Within-laboratory precisions were less than 2% （NGSP unit）. Bias between all test results and predicted results were less than 5%. High concentration of glucose showed certain interference to glycated Hemoglobin tests but had little influence in clinical practice.ConclusionsThe results of the 5 testing system are comparable to the IFCC reference method, the results of precision and linearity evaluation meet the requirements of related guidelines.

关 键 词：血红蛋白A  糖基化 参考值 参考标准 色谱法  高压液相 色谱法 离子交换 电泳  毛细管 评价研究 

分 类 号：R446[医药卫生—诊断学]