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 A1c determination system

作　　者：徐安平[1] 纪玲[1] 陈卫东[1] 夏勇[1] 黄静之 喻晶[1] 周宇[1] 李璐[1] 

机构地区：[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

出　　处：《检验医学》2016年第2期123-127,共5页Laboratory Medicine

基　　金：深圳市科技计划资助项目(CYJ20140415162338838)

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（Hb A1c）检测系统。方法验证Capillarys 2 Flex Piercing Hb A1c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（LA1c）、Hb F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 Hb A1c检测系统检测Hb A2,评价其与毛细管电泳法的相关性;采用Capillarys 2 Flex Piercing Hb A1c检测系统测定40份美国国家糖化血红蛋白标准化计划（NGSP）Hb A1c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 Hb A1c检测系统与VariantⅡTurbo 2.0 Hb A1c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%;Hb A1c在3.8%~17.1%范围内呈线性;当Bil≤355μmol/L、TG≤25.3 mmol/L、Hb为28~182 g/L、LA1c为1.2%~7.8%、Hb F≤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 Hb A1c检测系统检测Hb A2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 Hb A1c检测系统完全能满足临床需求,可同时提供Hb A2的结果用于地中海贫血的筛查,是一种多用途的Hb A1c检测系统。Objective To comprehensively evaluate Capillarys 2 Flex Piercing glycated hemoglobin A1c（Hb A1c）determination system based on capillary electrophoresis. Methods The correlation,precision and linear range of Capillarys 2 Flex Piercing Hb A1 c determination system were verified. Samples with different levels of bilirubin（Bil）,triglyceride（TG）,hemoglobin（Hb）,labile glycated hemoglobin A1c（LA1c）, fetal hemoglobin（Hb F） 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（Hb A2） values were determined by Capillarys 2 Flex Piercing Hb A1 c determination system,which was used to evaluate the correlation with capillary electrophoresis. The 40 samples whose Hb A1 c values were assigned by the National Glycohemoglobin Standardization Program（NGSP） were determined by Capillarys 2 Flex Piercing Hb A1 c determination system,and the result difference between Capillarys 2 Flex Piercing Hb A1 c determination system and NGSP reference laboratory results was analyzed,in order to verify accuracy. Results Capillarys 2 Flex Piercing Hb A1 c determination system and Variant Ⅱ Turbo 2.0 Hb A1 canalyzer 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 Hb A1 c values of 3.8%-17.1%. Capillarys 2 Flex Piercing Hb A1 c determination system was not influenced at Bil ≤ 355 μmol/L,TG ≤ 25.3 mmol/L,Hb 28-182 g/L,LA1 c 1.2%-7.8% and Hb F ≤ 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. Hb A2 values from Capillarys 2 Flex Piercing Hb A1 c 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 Pierc

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 

分 类 号：R446.1[医药卫生—诊断学]