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
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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 evaluate curative effect.
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 evaluate curative effect.
引文
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[2]徐建国.糖化血红蛋白测定在在糖尿病诊断中的临床意义[J].中国实用医药,2011,6(30):28-29.
[3]王晨秀,霍亚南.糖化血红蛋白用于诊断2型糖尿病及糖尿病前期的临床研究[J].天津医药,2012,40(5):443-445.
[4]朱亚梅.糖化血红蛋白、空腹血糖、尿微量白蛋白检测对糖尿病肾病患者的临床意义[J].中国现代医生,2012,14(6):153-154.
[5]麻勇.测量误差与测量不确定度的联系[J].铁道技术监督,2009,37(4):22-23.
[6]王成忠.测量不确定度原理及在理化检验中的应用[J].理化检验物理分册,39(1):57-58.
[7]陈辉,邓小玲,毕小云,等.人血清胆固醇常规测量不确定度的研究[J].临床检验杂志,2010,28(5):373-373.
[8]张秀明,杨志钊,杨有业,等.临床基础检验质量管理与标准化操作程序[M].北京:人民军医出版社,2012:70-71.
[9]齐会红,李扬,史爱欣,等.HPLC-MS/MS法测定人血浆中马来酸甲麦角新碱浓度的不确定度评价[J].中国新药杂志,2014,23(10):1127-1129.
[10]王治国.临床检验方法确认与性能验证[M].北京,人民卫生出版社,2013:307-307.
[11]中国合格评定国家认可委.医学实验室-测量不确定度测量与表达[S].2012:18-20.
[12]国家质量监督检验检疫总局.中华人民共和国国家计量检定规程[S].2006,2-3.
[13]杨有业,张秀明.临床检验方法学评价[M].北京:人民卫生出版社,2008:334-335.
[14]American Diabetes Association.Standards of medical care in diabetes-2010[J].Diabetes Care,2010,33(S1):S1-S61.
[15]李卿,居漪.糖化血红蛋白A1c的检测方法和干扰因素[J].临床检验杂志,2012,30(6):418-420.
[16]索艳,李强.糖化血红蛋白测定方法及影响因素的研究进展[J].医学研究生学报,2010,23(2):211-212.