Development and Evaluation of a Glucose Control Material with Red Blood Cells for Finger-stick Blood Glucose Meters

Abstract

Finger-stick blood glucose meters have an increasing role in glycemic control for the prevention of diabetic complications. Blood glucose meters’ performance, especially the precision, is crucial in the quality control process. Currently, commercial control materials with the same matrices as the finger-stick blood sample are not commercially available. Therefore, the aim of this study was to develop control materials containing red blood cells and evaluate them for the application in the quality control process of finger-stick blood glucose meters. The control materials containing glutaraldehyde-fixed red blood cells were prepared, and examined for homogeneity, stability and precision. The results showed that the control materials containing 2% glutaraldehyde-fixed red blood cells were suitable for determination of glucose at three concentration levels (low, medium and high) by using finger-stick blood glucose meter. The homogeneity of the control materials was acceptable (Ss ≤ 0.3σpt). In addition, the stability at all three concentration levels lasted for at least 8 weeks at 4 ํC (|(y1 - y2| ≤ 0.3σpt+2√u2 (y1) + u2 (y2) ). Moreover, when the control materials were periodically measured for 8 weeks by five finger-stick blood glucose meters with either GDH or GOD principles, the coefficients of variation were acceptable for all three levels; 5.99, 2.06, 4.57, 4.78 and 5.07% for the low level; 5.36, 2.88, 5.12, 6.39 and 5.14% for the medium level and 6.01, 2.48, 5.09, 6.59 and 3.48% for the high level. Remarkably, the accuracy result shows that two finger-stick blood glucose meters with the GDH principle reached the minimum acceptable ISO15197:2013 of ≥ 95% of the measured glucose values fall within criteria less than ± 15 %. In conclusion, the control material developed could be applied for the quality control process of glucose meters. However, further study is needed for the development of control materials for performance assessment of finger-stick blood glucose meters with various principles.