Comparison of HbA1c results obtained by Quo-Test device
and Vitros 5,1 FS analyzer in children with type 1 diabetes.
Introduction: The increase in the prevalence of diabetes, considered as the disease of civilization, is a health and economic problem also in paediatric population. One of the main parameter for monitoring glycaemia is glycated haemoglobin (HbA1c). Determination of HbA1c concentration in blood can be performed on both biochemical analyzers and small devices used at the point of care testing (POCT). Validity of HbA1c results obtained in POCT system is continuously verified. Aim: Comparison of HbA1c results obtained by using Quo-Test device (EKF Diagnostics) and Vitros 5,1 FS analyzer (Diasorin). Materials and methods: The study included 98 children (48 boys, 50 girls) with type 1 diabetes. Diagnosis was done based on the criteria of Polish Diabetes Association (PTD). Venous K2EDTA blood was collected and the HbA1c level was determined on the Quo-Test device (method based on reaction with the boronic acid derivative) and Vitros 5,1 FS analyzer (turbidimetric method). Statistical analysis was performed using Statistica10 (StatSoft). Results: Statistically significantly higher HbA1c concentrations were noticed in the results obtained on Quo-Test compared to Vitros 5,1 FS for all the measurements of HbA1c (p=0.001) and for HbA1c <6.5% (p=0.001), for results HbA1c ≥6.5% obtained concentrations were significantly lower (p=0.014). Analysis of Passing-Bablock regression showed no difference between the methods for HbA1c <6.5%. For HbA1c ≥6.5%, as well as for all HbA1c results, regression coefficients did not confirm the comparability of the two methods. Mean bias ± 95% limits of agreement (LOA) was 0.14% [(-0.32) – 0.61]). The Bland-Altman index was equal to 5.15%. Conclusion: The Quo-Test device can be used only for monitoring HbA1c level in children with type 1 diabetes as long as it will not be used interchangeably with Vitros 5,1 FS.