Abstract
BackgroundThe present study is designed to evaluate the validity of the measurement of capillary blood hemoglobin A1c levels in comparison with venous blood hemoglobin A1c.MethodsThe 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).ResultsThe 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).ConclusionIt was demonstrated that capillary hemoglobin A1c measurement had a considerably high value for differentiating between poorly-controlled and well-controlled blood glucose levels.
Highlights
Millions of people are living with diabetes mellitus and suffer from its adverse and even life-threatening consequences all around the world and a 58% increase in its prevalence by 2025 is predicted [1,2]
According to a recent American Diabetes Association, the cost involved in the management of diabetic patients is $245 billion in 2012, which is remarkably higher in comparison with non-diabetic individuals [3]
The mean hemoglobin A1c levels in venous and capillary blood samples measured using CERA STAT 2000 assay were 6.30 ± 1.68% and 6.34 ± 1.65% respectively with no significant differences demonstrated by t-test (p = 0.590)
Summary
Millions of people are living with diabetes mellitus and suffer from its adverse and even life-threatening consequences all around the world and a 58% increase in its prevalence by 2025 is predicted [1,2]. Iran is one of the main focuses of diabetes in the Middle East and the overall prevalence of diabetes mellitus and Venous blood sampling is currently the gold standard for the assessment of blood glucose levels. This method of sampling is hindered by several factors such as cumbersome transportation of the samples to laboratories and noncompliance of patients with venous blood sampling [6,7]. Capillary blood glucose testing, using portable point of care devices, is hailed as an alternative method to venous blood sampling considering its better compliance, lower cost, and its potential for selfmonitoring [8]. 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
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