Evaluate Performance of Prodigy Glucose Meter versus Reference Hexokinase Method in Addis Ababa, Ethiopia

Introduction: Point of Care Glucometer device (POCG) is the most commonly applied method to monitor Diabetes Mellitus (DM) worldwide. The aim of this study was to assess the accuracy of the prodigy glucose meter by using the hexokinase method as a reference. Methods: A prospective cross-sectional study was done on a total of 52 randomly selected DM suspected patients from March 22 to April 13, 2019, in the Department of Medical Laboratory, Addis Ababa University, Ethiopia. Glucose value was determined by using prodigy glucose meter and the hexokinase method and data were entered and analyzed using SPSS software. The minimum and maximum accuracy of the prodigy glucometer were determined based on ISO 15197:2003 and ISO 15197:2013 criteria. Results: The average serum glucose value measured by prodigy glucose meter and reference hexokinase methods was 132.52 mg/dl and 130.94 mg/ dl respectively. There was a statistically significant difference between the two methods (p-value <0.001). The bias of prodigy from the comparative method was 1.56 with a strong positive relationship (R=0.975; >80%). Besides, the prodigy glucose meter did not fulfill the minimum accuracy requirements of ISO 15197:2003 and ISO15197:2013. Conclusion: The present study demonstrated that prodigy glucose meter readings are relatively higher than the reference method. In addition, the prodigy glucose meter did not fulfill the expected standards set by ISO. Thus DM patients need to evaluate the device before using it in standard laboratories. Furthermore, large scale studies including both DM and healthy study participants should be undertaken.