糖化血红蛋白不同检测系统的偏倚评估和方法学比对研究
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摘要
目的比对分析并评估离子交换高效液相色谱法(IE-HPLC)和免疫比浊法的偏倚,为提高糖化血红蛋白(HbA1c)检测质量、推进HbA1c标准化提供依据。方法依据美国临床和实验室标准化协会(CLSI)EP9-A3文件进行方法学比对和偏倚评估。方法学比对前进行参比方法正确度验证和试验方法精密度验证。采用经美国国家糖化血红蛋白标准化计划(NGSP)样本赋值传递的新鲜全血实施校准,校准后进行可比性验证。量值溯源分析结果满足临床需要。结果 2种试验方法的批内、批间的高、中、低值变异系数均小于2.0%;正确度评估中,检测结果均在靶值×(±6%)内;IE-HPLC与免疫比浊法的医学决定水平偏倚分别为0.158 4%和0.148 8%,用经NGSP赋值传递的新鲜全血校准后,偏倚为0.019 7%和0.018 5%,均小于美国病理学家协会2015年能力验证允许误差。结论不同方法对HbA1c的测定结果可能存在差异,但2种方法测定HbA1c的精密度符合要求,检测的正确度水平符合标准,采用赋值传递的新鲜全血对不可比的方法实施校准,可实现检验结果的可比性,完全满足临床对HbA1c检测要求,临床实验室需共同努力来实现我国HbA1c检测的标准化。
Objective To perform the comparative analysis and bias evaluation on ion exchange high performance liquid chromatography(IE-HPLC)and immunoturbidimetry,in order to improve the quality of glycated hemoglobin(HbA1c)detection and promote the standardization of HbA1c.Methods Methodological comparisons and bias assessments were performed according to the American Society for Clinical and Laboratory Standards(CLSI)EP9-A3 document.The methodological comparison was performed before the correctness of the reference method and the precision of the test method.Calibration was performed using fresh whole blood delivered by the National Glycohemoglobin Standardization Program(NGSP)sample assignment,and the calibration was performed for comparability verification.The value traceability analysis results meet the clinical needs.Results The intra-and inter-assay coefficients of variation of the high,medium and low values of the two test methods were less than 2.0%;in the accuracy evaluation,the test results were within ±6% of the target value;IE-HPLC and immunoturbidimetry The determined horizontal bias was 0.158 4% and 0.148 8%,respectively.After calibration with fresh whole blood delivered by NGSP assignment,the bias was 0.019 7% and 0.018 5%,both less than 1/2CAP TEa.Conclusion Different methods may have different results for HbA1c determination,but the accuracy of HbA1c is determined by the two methods.The accuracy level of the test meets the standard.The fresh whole blood delivered by the assignment is calibrated to the incomparable method,and the test result can be realized.Comparable,fully meet the clinical requirements for HbA1c testing,clinical laboratories need to work together to achieve standardization of HbA1c testing in China.
Objective To perform the comparative analysis and bias evaluation on ion exchange high performance liquid chromatography(IE-HPLC)and immunoturbidimetry,in order to improve the quality of glycated hemoglobin(HbA1c)detection and promote the standardization of HbA1c.Methods Methodological comparisons and bias assessments were performed according to the American Society for Clinical and Laboratory Standards(CLSI)EP9-A3 document.The methodological comparison was performed before the correctness of the reference method and the precision of the test method.Calibration was performed using fresh whole blood delivered by the National Glycohemoglobin Standardization Program(NGSP)sample assignment,and the calibration was performed for comparability verification.The value traceability analysis results meet the clinical needs.Results The intra-and inter-assay coefficients of variation of the high,medium and low values of the two test methods were less than 2.0%;in the accuracy evaluation,the test results were within ±6% of the target value;IE-HPLC and immunoturbidimetry The determined horizontal bias was 0.158 4% and 0.148 8%,respectively.After calibration with fresh whole blood delivered by NGSP assignment,the bias was 0.019 7% and 0.018 5%,both less than 1/2CAP TEa.Conclusion Different methods may have different results for HbA1c determination,but the accuracy of HbA1c is determined by the two methods.The accuracy level of the test meets the standard.The fresh whole blood delivered by the assignment is calibrated to the incomparable method,and the test result can be realized.Comparable,fully meet the clinical requirements for HbA1c testing,clinical laboratories need to work together to achieve standardization of HbA1c testing in China.
引文
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[8]陈雨,胡莹莹,郝英英,等.变异血红蛋白对糖化血红蛋白检测的影响与分析[J].中华医学杂志,2014,94(6):438-441.
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[10]BRAGA F,PANTEGHINI M.Standardization and analytical goals for glycated hemoglobin measurement[J].Clin Chem Lab Med,2013,51(9):1719-1726.
[11]莫喜明,刘茵茵,李影,等.应用国际糖化血红蛋白诊断标准对中国长沙地区成年人糖代谢异常筛查的比较研究[J].现代检验医学杂志,2013,28(2):18-22.
[12]RAZI F,NASLI EE,RAHNAMAYE F M,et al.Effect of the different assays of HbA1con diabetic patients monitoring[J].J Diabetes Metab Disord,2015,14(1):65.
[2]中华医学会糖尿病学分会.中国2型糖尿病防治指南[M].北京:北京大学医学出版社,2013.
[3]温冬梅,张秀明,吴剑杨,等.新鲜全血赋值传递实现不同HbA1c检测系统测定结果的溯源性和可比性[J].临床检验杂志,2014,32(10):790-792.
[4]居漪,吕元,唐立萍,等.上海地区医疗机构糖化血红蛋白正确度验证计划3年结果分析[J].检验医学,2015,30(11):1059-1069.
[5]BADIOU S,GUILLOT J,KUSTER N,et al.Comparison of arkray/ELITech ADAMS HA-8180V with Bio-Rad variant,112.0and tosoh bioscience HLc-723C8for HbA1c determination[J].J Clin Lab Anal,2014,28(6):428-434.
[6]RHEA JM,MOLINARO R.Pathology consultation on HbA1c methods and interferences[J].Am J Clin Pathol,2014,14(1):5-16.
[7]索明环,温冬梅,王伟佳,等.5个糖化血红蛋白检测系统对Hb NewYork合并β地中海贫血标本异常结果预警能力比较[J].临床检验杂志,2017,35(9):649-653.
[8]陈雨,胡莹莹,郝英英,等.变异血红蛋白对糖化血红蛋白检测的影响与分析[J].中华医学杂志,2014,94(6):438-441.
[9]王冬环,陈文祥,张传宝,等.糖化血红蛋白实验室检测指南[J].中国糖尿病杂志,2013,21(8):673-678.
[10]BRAGA F,PANTEGHINI M.Standardization and analytical goals for glycated hemoglobin measurement[J].Clin Chem Lab Med,2013,51(9):1719-1726.
[11]莫喜明,刘茵茵,李影,等.应用国际糖化血红蛋白诊断标准对中国长沙地区成年人糖代谢异常筛查的比较研究[J].现代检验医学杂志,2013,28(2):18-22.
[12]RAZI F,NASLI EE,RAHNAMAYE F M,et al.Effect of the different assays of HbA1con diabetic patients monitoring[J].J Diabetes Metab Disord,2015,14(1):65.