上海地区糖化血红蛋白一致性计划研究进展  

Research progress of Shanghai Glycohemoglobin Harmonization Program

作　　者：邵文琦[1] 孙林[1] 王蓓丽[1] 吴炯[1] 宋斌斌[1] 张春燕 郭玮[1] 潘柏申[1] 

机构地区：[1]上海复旦大学附属中山医院检验科,上海200032

出　　处：《检验医学》2015年第9期948-952,共5页Laboratory Medicine

基　　金："十二五"国家科技支撑计划课题资助项目(2012BAI37B01);国家临床重点检验专科建设项目资助课题;上海市卫生系统先进适宜推广技术项目(2013SY065)

摘　　要：目的：提高参加上海地区糖化血红蛋白（HbA1c）一致性计划（SHGHP）的实验室间HbA1c检测结果的一致性，以辅助临床糖尿病诊疗。方法通过上海地区4家获得美国HbA1c标准化计划组织（ NGSP）认证的Ⅰ级实验室和1家获得国际临床化学和检验医学联合会（ IFCC ）认可的参考实验室组成定值检测的实验室网络，组织建立了SHGHP官方网站和信息平台，通过向参加实验室发放全血校准品和比对标本，比较各实验室间校准前后检测结果的一致性。采用SPSS 16．0统计软件统计校准前、后HbA1c检测结果的差异，计算其均值、标准差和变异系数（CV）。结果5家定值检测实验室间低水平和高水平全血稳定物质HbA1c检测结果的CV分别为2．27％和1．58％。参加SHGHP的三级医院实验室校准后的HbA1c检测结果CV较校准前明显降低（P＜0．001），校准后CV降至0．94％～4．22％。2012年和2013年参加SHGHP实验室HbA1c检测结果的通过率均高于90％，其中三级医院的通过率为100％。结论 SHGHP通过使用无明显基质效应的新鲜全血标本校准不同的检测方法，提高了参加实验室HbA1c检测结果的一致性。Objective To improve the harmonization of hemoglobin A1c （ HbA1c ） results from laboratories participating in Shanghai Glycohemoglobin Harmonization Program（ SHGHP） in order to improve the diagnosis of diabetes mellitus.Methods A total of 4 level Ⅰ laboratories certificated by the National Glycohemoglobin Standardization Program （ NGSP） and a laboratory by the International Federation of Clinical Chemistry and Laboratory Medicine（ IFCC） were comprised the proposed reference laboratory network.SHGHP website was established, and whole blood calibrators and comparative specimens were sent to all participating clinical laboratories.The harmonization of results before and after calibration was compared.The mean value, standard deviation and coefficient of variation（ CV） of HbA1c detected by the laboratories before and after calibration were calculated and analyzed for difference statistically.Results The CV of low-level and high-level HbA1c by the 5 reference laboratories were 2.27% and 1.58%, respectively.The CV of HbA1c detected by the third-grade hospitals after calibration decreased significantly than that before calibration （ P〈0.001）.The CV after calibration ranged from 0.94%to 4.22%.The percentages of passed laboratories in SHGHP from 2012 to 2013 were above 90% in which the third-grade hospitals all passed the evaluation.Conclusions SHGHP calibrates the different methods by fresh whole blood with no significant matrix effects and improves the harmonization of HbA1c significantly among the participating laboratories.

关 键 词：糖化血红蛋白A1C 糖尿病 一致性 

分 类 号：R446.1[医药卫生—诊断学]