离子交换层析法测量糖化血红蛋白的不确定度评定及应用  

Evaluation and application of uncertainty in HbA1c measurement by ion exchange chromatography

作　　者：刁奇志[1] 黄利君 莫展[1] 曾强[1] 汪开华 DIAO Qizhi1, HUANG Lijun1, MO Zhan1, ZENG Qiang1, WANG Kaihua2(1.Yongchuan Hospital, Chongqing Medical University, Chongqing 402160, China; 2.the Second Hospital of Dazu Dis- trict, Chongqing 402163, Chin)

机构地区：[1]重庆医科大学附属永川医院检验科,重庆402160 [2]重庆市大足区第二人民医院,重庆402163

出　　处：《中国医药导报》2018年第10期131-134,共4页China Medical Herald

基　　金：重庆医科大学附属永川医院资助项目(YJLCX201545)

摘　　要：目的评定离子交换层析法测量糖化血红蛋白(HbA_(1c))不确定度,以此为例探讨不确定度在临床诊疗上的应用价值。方法从分析前、分析中、生理变异及其他疾病影响因素等各个环节梳理离子交换层析法测量HbA_(1c)的不确定度来源,合成、计算其标准不确定度及扩展不确定度;举例探讨HbA_(1c)不确定度在临床诊疗上的应用。结果分析中的不精密度、系统误差、校准品不确定度、校准品复溶产生的误差、为HbA_(1c)测量不确定度的主要来源,而分析前因素可通过分析前质量控制加以控制,生理变异及其他疾病影响因素仅针对个别群体,不具有普遍性因此均可以不予考虑。5.11及10.04两个室内质控水平的相对标准不确定度分别为6.33%、4.54%,标准不确定度分别为0.32%、0.46%,扩展不确定度分别为0.64%、0.92%。在5.11%和10.04%附近水平的同一患者前后两次测量结果差值分别大于0.45%、0.41%,结果才具有显著性意义。考虑到测量不确定度,HbA_(1c)<5.86%,可排除患糖尿病的可能,HbA_(1c)>7.14%可确诊糖尿病,HbA_(1c)值位于5.86%及7.14%之间,不能确定是否患有糖尿病,需进一步检查确诊。结论测量的不精密度、系统误差、校准品赋值的不确定度、校准品复溶产生的误差是离子交换层析法测量HbA_(1c)的不确定度主要来源,不确定度在疾病的诊断、疗效评估方面有重要意义。Objective To evaluate the uncertainty of glycosylated hemoglobin（HbA_（1c）） measuredby ion-exchange chromatography, and todiscussthe application value of uncertainty in clinical diagnosis and treatment. Methods The source of uncertainty were combed from pre-analysis, analytical phase, physiological variation, some diseases influence factors,and so on. Then the standard uncertainty and expanded uncertainty were calculated and the clinical applications of uncertainty in clinical diagnosis and treatmentwere illustrated. Results The main source of the uncertainty on HbA_（1c）measured by ion exchange chromatography were imprecision, systematic error, the uncertainty of calibration product and errors caused by calibration product redissolved during measurement. The pre-analysis factors could be controlled by pre-analysis quality control. Physiological variation and other disease affecting factors wereonly related to some individuals without universality, which could not taken into consideration. The relative standard uncertainties of the internal quality control concentrationsin 5.11% and 10.04% were 6.33% and 4.54% respectively, the standard uncertainties were 0.32% and 0.46% respectively and the expanded uncertainty were 0.64% and 0.92% respectively. Two HbA_（1c） measurements near by 5.11%, 10.04% for respectively. Taking the uncertainty into consideration, the possibility of suffering from diabetes could be excluded when HbA_（1c）concentration of patient 5.86%, in addition diabetes could be diagnosed when HbA_（1c）7.14%. While patientscould not be determined whether suffering from diabetes when HbA_（1c）value is located between 5.86% and 7.14%, which needed further examination to confirm. Conclusion The main source of the uncertainty on HbA_（1c）measurement by ion exchange chromatography are measurement imprecision, systematic error, the uncertainty of calibrator productand the errors caused by calibrator product redissolving. The uncertainty is significant to diagnose clinical diseases and

关 键 词：糖化血红蛋白 离子交换层析法 不确定度 评定与应用 

分 类 号：R576.2[医药卫生—消化系统]