硼酸盐亲和色谱法检测糖化血红蛋白的分析性能评价  

Evaluation of Analytical Performance of Glycated Hemoglobin by Borate Affinity Chromatography

作　　者：田原 温冬梅 王伟佳 胡婷 王霞 胡耀宗 TIAN Yuan;WEN Dong-mei;WANG Wei-jia;HU Ting;WANG Xia;HU Yao-zong(Laboratory Medical Center,Zhongshan Hospital Affiliated to Sun Yat-sen University,Zhongshan 528403,Guangdong,China)

机构地区：[1]中山大学附属中山医院检验医学中心

出　　处：《医学信息》2020年第4期77-79,共3页Journal of Medical Information

基　　金：中山市科技计划重大项目(编号：2015B1002)

摘　　要：目的评价硼酸盐亲和色谱法(AC-HPLC)检测糖化血红蛋白(HbA1c)的分析性能。方法参考美国临床与实验室标准化协会(CLSI)发布的方法学评价系列文件(EP文件)及相关文献,对Premier Hb9210系统检测HbA1c的精密度、正确度、分析测量范围以及生物参考区间进行验证,并与厂商声明的性能和有关质量标准进行比较。结果硼酸盐亲和色谱法检测HbA1c两个不同水平的批内精密度(CV%)分别为0.8%和0.6%;总精密度(CV%)分别为1.53%和0.9%。与离子交换高效液相色谱法(IE-HPLC)的VariantⅡ检测系统的相对偏倚为3.26%。与来源于美国国家糖化血红蛋白标准化计划(NGSP)定值样本靶值的相对偏差为2.3%~3.2%,HbA1c浓度为4.1%~16.4%,理论值与实测均值呈线性相关,回归方程为Y=1.0018x+0.3903,r2=0.9942。随机选择的20名健康参考个体糖化血红蛋白浓度均在厂商提供的参考区间内。结论Premier Hb9210糖化血红蛋白分析仪的主要分析性能达到了厂商声明的性能和有关的质量要求,适用于我室检测糖化血红蛋白。Objective To evaluate the analytical performance of glycosylated hemoglobin(HbA1c)by borate affinity chromatography(AC-HPLC).Methods Refer to the Methodological Evaluation Series Documents(EP files)and related documents issued by the American Society for Clinical and Laboratory Standardization(CLSI)to verify the precision,accuracy,analytical measurement range and biological reference interval of the Premier Hb9210 system for detecting HbA1c And compare with the manufacturer's stated performance and relevant quality standards.Results The intra-batch precision(CV%)of two different levels of HbA1c detected by borate affinity chromatography was 0.8%and 0.6%,respectively;the total precision(CV%)was 1.53%and 0.9%.The relative bias of the Variant II detection system with ion exchange high performance liquid chromatography(IE-HPLC)was 3.26%.The relative deviation from the target value of the fixed sample from the National Glycated Hemoglobin Standardization Program(NGSP)is 2.3%~3.2%,the HbA1c concentration is 4.1%~16.4%,the theoretical value is linearly related to the measured mean,and the regression equation is Y=1.0018x+0.3903,r2=0.9942.Glycated hemoglobin concentrations of 20 randomly selected healthy reference individuals were within the reference interval provided by the manufacturer.Conclusion The main analytical performance of Premier Hb9210 glycated hemoglobin analyzer has reached the performance and relevant quality requirements declared by the manufacturer.

关 键 词：糖化血红蛋白 硼酸盐亲和色谱法 性能评价 

分 类 号：R446.6[医药卫生—诊断学]