Abstract：Objective: To evaluate the performance of automatic glycohemoglobin analyzer MQ-2000PT for the determination of HbA1c (glycosylated hemoglobin A1c) by the method of HPLC (ion-exchange highperformance liquid chromatography). Methods: The linearity, carryover rate and precision of MQ-2000PT were calculated. Among 41 healthy subjects, the reference interval of HbA1c was also verified.Results: The within-run of both high and low levels of HbA1c were 0.45%、0.58%,and between-run coefficients of variation ( CV) were 0.92%、1.12%,respectively. An perfect linearity was found for HbA1c in the range of 4.6%~15.95% (R2 =0.9998, P<0.001). There was no significantly carryover rate between high and low level samples, the carryover rate was only 0.997%.The distribution range of HbA1c among the 41 healthy subjects were 4.4%-6.2 %, the determination results of 39 subjects(95.1%) were in the range(4.0%-6.0 %) provided by manufacturers. Conclusions: The performance of MQ-2000PT for the determination of HbA1c is good, and can be used for routine clinical determination.
[1] American, Diabetes, Association. Standards of medical care in diabetes-2016: Summary of Revisions[J].Diabetes Care, 2016,39(Suppl.1): S4~S5 . [2] 王冬环,陈文祥.糖化血红蛋白诊断糖尿病的时代-糖化血红蛋白实验室检测指南解读[J].中国糖尿病杂志,2013,21(8):679~681. [3] 刘彤,戴长生,张少波,等.对自动分析仪“样本携带污染率”测试方法的探讨[J].中国医疗器械信息,2013(2):49~55. [4] 彭海林,金梅,钱锦,等. HbA1c在住院患者隐性糖尿病筛查中的应用[J].实用医学杂志,2017,33(14):2386~2388. [5] 赖春苗,郭志绿.高效液相色谱法测定糖化血红的建立与评价[J].检验医学与临床,2016,13(13):1839~1841. [6] Juliana Frezza Silva , Ana Laura Pimentela, Joíza Lins Camargo. Effect of iron deficiency anaemia on HbA1c levels is dependent on the degree of anaemia[J].Clinical Biochemistry, 2016,49(1-2):117~120.
2018, Vol. 24 
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