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

被引：4

作者：

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
]}

机构：

[1] 北京大学深圳医院

[2] 不详

来源：

检验医学 | 2016年 / 31卷 / 02期

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;

D O I：

暂无

中图分类号：

R446.1 [生物化学检验、临床检验];

学科分类号：

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28182 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。

引用

页码：123 / 127

页数：5

共 12 条

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