Capillarys 2 Flex Piercing糖化血红蛋白检测系统的综合评估

doi:10.3969/j.issn.1673-8640.2016.02.011

检验医学 ›› 2016, Vol. 31 ›› Issue (2): 123-127.DOI: 10.3969/j.issn.1673-8640.2016.02.011

• 技术研究与评价·论著 • 上一篇下一篇

Capillarys 2 Flex Piercing糖化血红蛋白检测系统的综合评估

徐安平¹, 纪玲¹, 陈卫东¹, 夏勇¹, 黄静之², 喻晶¹, 周宇¹, 李璐¹

1. 北京大学深圳医院,广东深圳 518036
2. 南方医科大学检验系,广东广州 510515

收稿日期:2015-03-19 出版日期:2016-02-20 发布日期:2016-04-07
作者简介:null
作者简介：徐安平,男,1978年生,硕士,副主任技师,主要从事生物化学检验工作。

通讯作者：纪玲,联系电话：0755-83923333-5225。
基金资助:
深圳市科技计划资助项目（CYJ20140415162338838）

Comprehensive evaluation of Capillarys 2 Flex Piercing glycated hemoglobin A_1c determination system

XU Anping¹, JI Ling¹, CHEN Weidong¹, XIA Yong¹, HUANG Jingzhi², YU Jing¹, ZHOU Yu¹, LI Lu¹

1. Shenzhen Hospital,Peking University,Shenzhen 518036,Guangdong,China
2. Department of Laboratory Medicine,Southern Medical University,Guangzhou 510515,Guangdong,China

Received:2015-03-19 Online:2016-02-20 Published:2016-04-07

摘要/Abstract

摘要：

目的综合评估基于毛细管电泳法的Capillarys 2 Flex Piercing糖化血红蛋白（HbA_1c）检测系统。方法验证Capillarys 2 Flex Piercing HbA_1c检测系统的相关性、精密度和线性范围等基本性能指标,并采用干扰实验评价其抗干扰能力,项目包括胆红素（Bil）、甘油三酯（TG）、血红蛋白（Hb）、不稳定糖化血红蛋白（LA_1c）、HbF和广东地区常见的Hb变异体（Hb E、Hb J-Bangkok、Hb New York、Hb G-Taipei和Hb G-Coushatta）。采用Capillarys 2 Flex Piercing HbA_1c检测系统检测HbA₂,评价其与毛细管电泳法的相关性;采用Capillarys 2 Flex Piercing HbA_1c检测系统测定40份美国国家糖化血红蛋白标准化计划（NGSP）HbA_1c临床实验室认证样本,分析其与NGSP参考实验室结果的差异,验证正确度。结果 Capillarys 2 Flex Piercing HbA_1c检测系统与Variant Ⅱ Turbo 2.0 HbA_1c分析仪的相关性良好（r=0.997,P=0.000）;总精密度[变异系数（CV）]<2.00%;HbA_1c在3.8%~17.1%范围内呈线性;当Bil≤355 μmol/L、TG≤25.3 mmol/L、Hb为28~182 g/L、LA_1c为1.2%~7.8%、HbF≤22.3%时不受干扰;能分离广东地区常见的Hb变异体（Hb E、Hb J-Bangkok、Hb New York、Hb G-Taipei和Hb G-Coushatta）。Capillarys 2 Flex Piercing HbA_1c检测系统检测HbA₂和毛细管电泳法相关性良好（r=0.993,P=0.000）;与NGSP参考实验室结果的偏差均<6%。结论 Capillarys 2 Flex Piercing HbA_1c检测系统完全能满足临床需求,可同时提供HbA₂的结果用于地中海贫血的筛查,是一种多用途的HbA_1c检测系统。

关键词: 糖化血红蛋白, 毛细管电泳法, Capillarys 2 Flex Piercing糖化血红蛋白检测系统, 美国国家糖化血红蛋白标准化计划

Abstract:

Objective To comprehensively evaluate Capillarys 2 Flex Piercing glycated hemoglobin A_1c （HbA_1c） determination system based on capillary electrophoresis. Methods The correlation,precision and linear range of Capillarys 2 Flex Piercing HbA_1c determination system were verified. Samples with different levels of bilirubin （Bil）,triglyceride （TG）,hemoglobin （Hb）,labile glycated hemoglobin A_1c （LA_1c）, fetal hemoglobin（HbF） and 5 common hemoglobin variants （Hb E,Hb J-Bangkok,Hb New York,Hb G-Taipei and Hb G-Coushatta） were collected and used to evaluate the anti-interference ability of the system. The glycated hemoglobin A₂ （HbA₂） values were determined by Capillarys 2 Flex Piercing HbA_1c determination system,which was used to evaluate the correlation with capillary electrophoresis. The 40 samples whose HbA_1c values were assigned by the National Glycohemoglobin Standardization Program （NGSP） were determined by Capillarys 2 Flex Piercing HbA_1cdetermination system,and the result difference between Capillarys 2 Flex Piercing HbA_1c determination system and NGSP reference laboratory results was analyzed,in order to verify accuracy. Results Capillarys 2 Flex Piercing HbA_1c determination system and Variant Ⅱ Turbo 2.0 HbA_1c analyzer were correlated well （r =0.997,P=0.000）. The total precision[coefficient of variation （CV）] was <2.00%. The linearity proved to be good within a range of HbA_1c values of 3.8%-17.1%. Capillarys 2 Flex Piercing HbA_1c determination system was not influenced at Bil≤355 μmol/L,TG≤25.3 mmol/L,Hb 28-182 g/L,LA_1c 1.2%-7.8% and HbF≤22.3%. The 5 common hemoglobin variants （Hb E,Hb J-Bangkok,Hb New York,Hb G-Taipei and Hb G-Coushatta） could be separated. HbA₂ values from Capillarys 2 Flex PiercingHbA_1c determination system and capillary electrophoresis were correlated well （r =0.993,P=0.000）. The result differences with NGSP reference laboratory results were all <6%. Conclusions The analysis performance of Capillarys 2 Flex Piercing HbA_1c determination system meets the requirements of routine clinical application,and the determination system also provides practical HbA₂ values for thalassemia screening. Capillarys 2 Flex Piercing HbA_1c determination system is a multifunctional HbA_1c determination system.

Key words: Glycated hemoglobin A1c, Capillary electrophoresis, Capillarys 2 Flex Piercing glycated hemoglobin A1c determination system, The National Glycohemoglobin Standardization Program

中图分类号:

R446.1

徐安平, 纪玲, 陈卫东, 夏勇, 黄静之, 喻晶, 周宇, 李璐. Capillarys 2 Flex Piercing糖化血红蛋白检测系统的综合评估[J]. 检验医学, 2016, 31(2): 123-127.

XU Anping, JI Ling, CHEN Weidong, XIA Yong, HUANG Jingzhi, YU Jing, ZHOU Yu, LI Lu. Comprehensive evaluation of Capillarys 2 Flex Piercing glycated hemoglobin A_1c determination system[J]. Laboratory Medicine, 2016, 31(2): 123-127.

图/表 4

图1 Capillarys 2 Flex Piercing HbA1c检测系统与Variant Ⅱ Turbo 2.0 HbA1c分析仪的相关性分析

图2 Capillarys 2 Flex Piercing HbA1c检测系统糖化模式检测5种Hb变异体的图谱

图3 Capillarys 2 Flex Piercing HbA1c检测系统与毛细管电泳法HbA2检测结果的相关性

图4 本实验室HbA1c检测结果与NGSP参考实验室的偏差

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Capillarys 2 Flex Piercing糖化血红蛋白检测系统的综合评估

Comprehensive evaluation of Capillarys 2 Flex Piercing glycated hemoglobin A_1c determination system

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