Vol 3, No 2 (2014)
Research paper
Published online: 2014-05-14

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Analytical evaluation of the Contour® Plus glucose meter

Maria Kapusta, Krystyna Słowińska-Solnica, Jan Skupień, Maciej T. Małecki, Bogdan Solnica
Diabetologia Kliniczna 2014;3(2):62-68.

Abstract

Introduction. Glucose meters are widely used for self­-monitoring of blood glucose considered an integral part of the treatment of diabetes. In this study we evaluated the analytical performance of the Contour® Plus glucose meter utilizing glucose dehydrogenase reaction and amperometric measurement technique, intended for use in self-monitoring of blood glucose as well as for point-of-care testing. Material and methods. The evaluation of precision and test strips lot dependent variability was based on a series of measurements of glucose concentration in venous blood collected on EDTA. With the use of the evaluated meter, glucose concentrations were measured with 208 fresh venous blood samples. As a comparator hexokinase method on the Maxmat PLII analyzer was used. The hematocrit effect was assessed by measuring glucose concentrations in blood samples with hematocrit modified by adding or removing a de­fined volume of plasma. Results. Results of glucose concentration measure­ments using both methods correlated with each other (r = 0.99, P < 0.0001). The within-run imprecision coefficients of variation for glucose concentrations of ~72 mg/dl and ~222 mg/dl amounted to 2.40% and 2.37%, respectively. The between-run coefficient of variation for glucose concentration of ~123 mg/dl was 2.14%. Lot dependent relative differences between the results were equal to 0.88% and 1.16%. Glucose meter error calculated for the entire range of glucose con­centrations was 3.7%. The error grid analysis yielded 99.5% of the results within zone A. The meter meets the accuracy requirements of the ISO 15197:2013. Su­pplementing a blood sample in the test strip did not affect the accuracy. Hematocrit dependent change of glucose concentration amounted to –0.126 mg/dL (0.073%) per 1% increase in hematocrit. Conclusions. The evaluated glucose meter meets the current requirements of analytical quality and suitable for use in self-monitoring of blood glucose as well as in the hospital and outpatient setting.