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