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首页> 中文期刊> 《检验医学》 >Capillarys 2 Flex Piercing糖化血红蛋白检测系统的综合评估

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

         
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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（HbA1c）检测系统。方法验证Capillarys 2 Flex PiercingHbA1c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）、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 PiercingHbA1c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 PiercingHbA1c检测系统测定40份美国国家糖化血红蛋白标准化计划（NGSP）HbA1c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 PiercingHbA1c检测系统与VariantⅡ Turbo 2.0 HbA1c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%；HbA1c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%、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 PiercingHbA1c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 PiercingHbA1c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HbA1c检测系统。%Objective To comprehensively evaluate Capillarys 2 Flex Piercing glycated hemoglobin A1c(HbA1c) determination system based on capillary electrophoresis.MethodsThe correlation,precision and linear range of Capillarys 2 Flex Piercing HbA1c determination system were verified. Samples with different levels of bilirubin(Bil), triglyceride(TG),hemoglobin(Hb),labile glycated hemoglobin A1c(LA1c), 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 HbA1c determination system,which was used to evaluate the correlation with capillary electrophoresis. The 40 samples whose HbA1c values were assigned by the National Glycohemoglobin Standardization Program(NGSP) were determined by Capillarys 2 Flex Piercing HbA1c determination system,and the result difference between Capillarys 2 Flex Piercing HbA1c determination system and NGSP reference laboratory results was analyzed,in order to verify accuracy.ResultsCapillarys 2 Flex Piercing HbA1c determination system and VariantⅡ Turbo 2.0 HbA1c 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 HbA1c values of 3.8%-17.1%. Capillarys 2 Flex Piercing HbA1c determination system was not influenced at Bil≤355μmol/L,TG≤25.3 mmol/L,Hb 28-182 g/L,LA1c 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 PiercingHbA1c determination systemand capillary electrophoresis were correlated well(r=0.993,P=0.000). The result differences with NGSP reference laboratory results were all <6%. ConclusionsThe analysis performance of Capillarys 2 Flex PiercingHbA1c determination systemmeets the requirements of routine clinical application,and the determination system also provides practical HbA2 values for thalassemia screening. Capillarys 2 Flex Piercing HbA1c determination system is a multifunctional HbA1c determination system.

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