4种糖化血红蛋白检测系统的IFCC二级参考方法认证  

IFCC Secondary Reference Measurement Procedure for 4 HbA1c determination systems

作　　者：刘文彬 居漪 唐立萍 王美娟 欧元祝 虞啸炫 李卿 LIU Wenbin;JU Yi;TANG Liping;WANG Meijuan;OU Yuanzhu;YU Xiaoxuan;LI Qing(Shanghai Center for Clinical Laboratory,Shanghai 200126,China)

机构地区：[1]上海市临床检验中心

出　　处：《检验医学》2019年第5期443-446,共4页Laboratory Medicine

基　　金：上海市社区糖尿病防治公共卫生体系(15GWZK0301[0]);上海市卫生和计划生育委员会公共卫生三年行动计划(15GWZK0301)

摘　　要：目的通过溯源至国际临床化学和检验医学联合会(IFCC)糖化血红蛋白(HbA1c)一级参考方法,为上海市临床检验中心建立二级参考方法,完善HbA1c量值溯源体系。方法分别采用HA-8180糖化血红蛋白分析仪(简称HA-8180)、Hb-9210糖化血红蛋白分析仪(简称Hb-9210)、Capillarys2FlexPiercing毛细管电泳仪(简称Cap2)、MQ2000-PT糖化血红蛋白分析仪(简称MQ2000-PT)及各自的配套试剂组成的4种检测系统检测IFCCHbA1c工作组提供的24份样本,将检测结果与IFCC公布的靶值比较,并根据IFCC的评价规则评价4种检测系统的性能。结果HA-8180、Hb-9210、Cap2和MQ-2000PT的变异系数(CV)分别为1.1%、2.0%、2.2%、2.0%,不精密度分别为0.6、1.0、1.1、1.0mmol/mol;根据回归方程得出的结果与50mmol/mol水平的|偏移|分别为1.0、1.1、0.4、1.0mmol/mol;全年整体总误差(TE)分别为2.2、3.1、2.6、3.2mmol/mol。HA-8180的评价结果为“Sliver”,Hb-9210、Cap2和MQ-2000PT的评价结果均为“Bronze”。结论HA-8180、Hb-9210、Cap2和MQ-2000PT4种检测系统均符合HbA1cIFCC二级参考方法的认证要求。Objective To improve the traceability of glycated hemoglobin A1c(HbA1c) in Shanghai Center for Clinical Laboratory with establishing the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Secondary Reference Measurement Procedure,through tracing from the IFCC Primary Reference System. Methods Using 4 HbA1c determination systems,including HA-8180,Hb-9210,Capillarys 2 Flex Piercing (Cap2) and MQ2000-PT with their original reagents and calibrators,the results of 24 samples sent by IFCC were compared with the target values assigned by the IFCC Primary Reference System. The performance of the 4 determination systems were evaluated by the IFCC rules. Results The coefficients of variation (CV) of the 4 determination systems were 1.1% for HA-8180,2.0% for Hb-9210,2.2% for Cap2 and 2.0% for MQ2000- PT. The imprecisions were 0.6,1.0,1.1 and 1.0 mmol/mol,respectively. The |biases| at the level of 50 mmol/mol were 1.0,1.1,0.4 and 1.0 mmol/mol,respectively. The total errors (TE) of whole year were 2.2,3.1,2.6 and 3.2 mmol/mol,respectively. According to the rules,HA-8180 got a "Sliver" score,and Hb-9210,Cap2 and MQ2000-PT got "Bronze" score. Conclusions The 4 determination systems demonstrate traceability to the IFCC Secondary Reference Measurement Procedure.

关 键 词：糖化血红蛋白 参考方法 总误差 生物医学变异 

分 类 号：R446.1[医药卫生—诊断学]