[1]田 原,温冬梅,王伟佳,等.硼酸盐亲和色谱法检测糖化血红蛋白的分析性能评价[J].医学信息,2020,33(04):77-79.[doi:10.3969/j.issn.1006-1959.2020.04.023]
　TIAN Yuan,WEN Dong-mei,WANG Wei-jia,et al.Evaluation of Analytical Performance of Glycated Hemoglobin by Borate Affinity Chromatography[J].Medical Information,2020,33(04):77-79.[doi:10.3969/j.issn.1006-1959.2020.04.023]
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硼酸盐亲和色谱法检测糖化血红蛋白的分析性能评价()

医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
33卷
期数:
2020年04期
页码:
77-79
栏目:
论著
出版日期:
2020-02-15

文章信息/Info

Title:
Evaluation of Analytical Performance of Glycated Hemoglobin by Borate Affinity Chromatography
文章编号:
1006-1959（2020）04-0077-03
作者:
田 原; 温冬梅; 王伟佳; 等
（中山大学附属中山医院检验医学中心，广东 中山 528403）
Author(s):
TIAN Yuan; WEN Dong-mei; WANG Wei-jia; et al
(Laboratory Medical Center,Zhongshan Hospital Affiliated to Sun Yat-sen University,Zhongshan 528403,Guangdong,China)
关键词:
糖化血红蛋白; 硼酸盐亲和色谱法; 性能评价
Keywords:
Glycated hemoglobin; Borate affinity chromatography; Performance evaluation
分类号:
R446.6
DOI:
10.3969/j.issn.1006-1959.2020.04.023
文献标志码:
A
摘要:
目的 评价硼酸盐亲和色谱法（AC-HPLC）检测糖化血红蛋白（HbA1c）的分析性能。方法 参考美国临床与实验室标准化协会（CLSI）发布的方法学评价系列文件（EP文件）及相关文献，对Premier Hb9210系统检测HbA1c的精密度、正确度、分析测量范围以及生物参考区间进行验证，并与厂商声明的性能和有关质量标准进行比较。结果 硼酸盐亲和色谱法检测HbA1c两个不同水平的批内精密度（CV%）分别为0.8%和0.6%；总精密度（CV%）分别为1.53%和0.9%。与离子交换高效液相色谱法（IE-HPLC）的VariantⅡ检测系统的相对偏倚为3.26%。与来源于美国国家糖化血红蛋白标准化计划（NGSP）定值样本靶值的相对偏差为2.3%~3.2%，HbA1c浓度为4.1%~16.4%，理论值与实测均值呈线性相关，回归方程为Y=1.0018x+0.3903,r2=0.9942。随机选择的20名健康参考个体糖化血红蛋白浓度均在厂商提供的参考区间内。结论 Premier Hb9210糖化血红蛋白分析仪的主要分析性能达到了厂商声明的性能和有关的质量要求，适用于我室检测糖化血红蛋白。
Abstract:
Objective To evaluate the analytical performance of glycosylated hemoglobin (HbA1c) by borate affinity chromatography (AC-HPLC). Methods Refer to the Methodological Evaluation Series Documents (EP files) and related documents issued by the American Society for Clinical and Laboratory Standardization (CLSI) to verify the precision, accuracy, analytical measurement range and biological reference interval of the Premier Hb9210 system for detecting HbA1c And compare with the manufacturer’s stated performance and relevant quality standards.Results The intra-batch precision (CV%) of two different levels of HbA1c detected by borate affinity chromatography was 0.8% and 0.6%, respectively; the total precision (CV%) was 1.53% and 0.9%. The relative bias of the Variant II detection system with ion exchange high performance liquid chromatography (IE-HPLC) was 3.26%. The relative deviation from the target value of the fixed sample from the National Glycated Hemoglobin Standardization Program (NGSP) is 2.3% ~ 3.2%, the HbA1c concentration is 4.1% ~ 16.4%, the theoretical value is linearly related to the measured mean, and the regression equation is Y=1.0018x+0.3903,r2=0.9942.Glycated hemoglobin concentrations of 20 randomly selected healthy reference individuals were within the reference interval provided by the manufacturer.Conclusion The main analytical performance of Premier Hb9210 glycated hemoglobin analyzer has reached the performance and relevant quality requirements declared by the manufacturer.

参考文献/References:

[1]Marathe PH,Gao HX,Close KL.American Diabetes Association Standards of Medical Care in Diabetes 2017[J].Journal of Diabetes,2017,9(4):320-324. [2]Wang W, Ning G, Ma J,et al.A randomized clinical trial of the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus inadequately controlled by acarbose alone[J].Current Medical Research&Opinion,2017,33(4):693-699. [3]Ji L,Li L,Kuang J,et al.Efficacy and safety of fixed-dose combination therapy,alogliptin plus metformin,in Asian patients with type 2 diabetes:A phase 3 trial[J].Diabetes,Obesity and Metabolism,2017,19(5):754-758. [4]Cunha-VazJ.Standards of Medical Care in Diabetes-2009:American Diabetes Association[M].Diabetic Retinopathy,2015. [5]Association AD.6.Glycemic Targets[J].Diabetes Care,2015,(38):S33-S40. [6]Weng J,Ji L,Jia W,et al.Standards of care for type 2 diabetes in China[J].Diabetes Metab Res Rev,2016,32(5):442-458. [7]van Gammeren AJ,van Gool N, de Groot MJ,et al.Analytical performance evaluation of the Cobas 6000 analyzer-special emphasis on trueness verification[J].Clinical Chemistry&Laboratory Medicine,2008,46(6):863-871. [8]Hsieh E, Liu JP.On Statistical Evaluation of the Linearity in Assay Validation[J].Journal of Biopharmaceutical Statistics,2018,18(4):677-690. [9]Sasse EA.Determination of reference intervals in the clinical laboratory using the proposed guideline National Committee for Clinical Laboratory Standards C28-P[J].Arch Pathol Lab Med,1992,116(7):710-713. [10]王冬环,张传宝,陈文祥,等.应重视糖化血红蛋白测定技术及其量值溯源[J].中华检验医学杂志,2008,31(9):965-968． [11]Flückiger R,Mortensen HB.Glycated Haemoglobins[J].Journal of Chromatography B Biomedical Sciences&Applications,1988(429):279-292. [12]王冬环,陈文祥,张传室,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． [13]Little RR,Wiedmeyer HM,England JD,et al.Interlaboratory comparison of glycohemoglobin results:College of American Pathologists Survey data[J].Clinical Chemistry,1991,37(10 Pt 1):1725-1729.

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更新日期/Last Update: 2020-02-15