刁奇志 黄利君 莫展 曾强 汪开华

[摘要] 目的 評定离子交换层析法测量糖化血红蛋白（HbA1c）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HbA1c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HbA1c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HbA1c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，HbA1c<5.86%，可排除患糖尿病的可能，HbA1c>7.14%可确诊糖尿病，HbA1c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HbA1c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。

[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

[中图分类号] R576.2 [文献标识码] A [文章编号] 1673-7210（2018）04（a）-0131-04

[Abstract] Objective To evaluate the uncertainty of glycosylated hemoglobin （HbA1c） 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 HbA1c 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 HbA1c measurements near by 5.11%， 10.04% for respectively. Taking the uncertainty into consideration， the possibility of suffering from diabetes could be excluded when HbA1c concentration of patient <5.86%， in addition diabetes could be diagnosed when HbA1c>7.14%. While patientscould not be determined whether suffering from diabetes when HbA1c value is located between 5.86% and 7.14%， which needed further examination to confirm. Conclusion The main source of the uncertainty on HbA1c 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 evaluate curative effect.

[Key words] Glycosylated hemoglobin； Ion exchange chromatography； Uncertainty； Evaluation and application value

目前，全世界糖尿病患者为2亿人，我国糖尿病也达到了4千万人，随着生活水平的提高，工作节奏的加强及运动逐渐减少，糖尿病患病率还在不断上升。……