Keramati Tahereh, Razi Farideh, Tootee Ali, Larijani Bagher
Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
J Diabetes Metab Disord. 2014 Oct 30;13(1):94. doi: 10.1186/s40200-014-0094-1. eCollection 2014.
The present study is designed to evaluate the validity of the measurement of capillary blood hemoglobin A1c levels in comparison with venous blood hemoglobin A1c.
The data of this cross-sectional study are collected from a sample of 45 Iranian diabetic patients referred to one particular laboratory for the assessment of HbA1c level during a period from April to December 2013. Venous and simultaneous capillary blood samples were obtained from each subject for measurement of hemoglobin A1c levels. Both samples were tested using two different NGSP certified systems: CERA STAT 2000 (Ceragem Medisys Inc) and NycoCard Reader II (Axis-Shield).
The mean hemoglobin A1c in venous and capillary blood samples measured using CERA STAT 2000 assays were 6.30 ± 1.68% and 6.34 ± 1.65% respectively (p = 0.590). However, when NycoCard Reader II assay was employed, the mean hemoglobin A1c in venous and capillary blood samples were 6.73 ± 1.35% and 6.92 ± 1.50% (p = 0.007). Moreover, a strong correlation was observed between venous and capillary hemoglobin A1c levels with Pearson's concordance correlation coefficients of 0.96 and 0.94 with the use of NycoCard Reader II and CERA STAT 2000 assays respectively. Application of CERA STAT 2000 demonstrated to be of a considerably higher value using the ROC curve analysis assay (AUC = 0.991). Also, similar analysis by using NycoCard Reader II assay demonstrated that capillary hemoglobin A1c measurement had high value for differentiation of uncontrolled from controlled blood glucose level (AUC = 0.935).
It was demonstrated that capillary hemoglobin A1c measurement had a considerably high value for differentiating between poorly-controlled and well-controlled blood glucose levels.
本研究旨在评估与静脉血糖化血红蛋白相比，毛细血管血糖化血红蛋白水平测量的有效性。
这项横断面研究的数据收集自2013年4月至12月期间转诊至某一特定实验室评估糖化血红蛋白水平的45名伊朗糖尿病患者样本。从每位受试者采集静脉血和同步毛细血管血样本以测量糖化血红蛋白水平。两个样本均使用两种不同的经美国国家糖化血红蛋白标准化计划（NGSP）认证的系统进行检测：CERA STAT 2000（Ceragem Medisys公司）和NycoCard Reader II（Axis-Shield公司）。
使用CERA STAT 2000检测法测得的静脉血和毛细血管血样本中的平均糖化血红蛋白分别为6.30±1.68%和6.34±1.65%（p = 0.590）。然而，当采用NycoCard Reader II检测法时，静脉血和毛细血管血样本中的平均糖化血红蛋白分别为6.73±1.35%和6.92±1.50%（p = 0.007）。此外，静脉血和毛细血管血糖化血红蛋白水平之间观察到强相关性，使用NycoCard Reader II和CERA STAT 2000检测法时，皮尔逊一致性相关系数分别为0.96和0.94。使用ROC曲线分析检测法显示，CERA STAT 2000的应用具有相当高的价值（曲线下面积[AUC]=0.991）。同样，使用NycoCard Reader II检测法进行的类似分析表明，毛细血管糖化血红蛋白测量对于区分血糖控制不佳和控制良好具有很高的价值（AUC = 0.935）。
结果表明，毛细血管糖化血红蛋白测量对于区分血糖控制不佳和良好具有相当高的价值。
