Evaluation of 6 Glucose Testing Systems

Lee, Soo Youn; Lee, Nam Yong; Kim, Jong Won

Abstract

BACKGROUND
Glucometers are widely used for self-monitoring and point-of-care testing in the management of diabetic patients. We performed the present study to evaluate the performance of 6 glucometers. METHODS: Glucometers were evaluated for linearity, precision, and accuracy. The effect of sample volume, hematocrit, reapplication, operator, reagent stability, and user acceptability were also evaluated. RESULTS: All glucometers revealed excellent linearity and precision. High variances were found within and between operators. High correlation was found between each glucometer and the Hitachi 747. But all the glucometers showed a variable positive or negative bias compared with the reference method. Application of an insufficient amount of blood or sample reapplication could produce some changes in test results. Overestimation or underestimation of glucose values was found with the change in hematocrit concentration. Some strips exhibited a significant effect of exposure time at room temperature on glucose measurements. Glucometers with rapid turnaround time and ease of operation received high ratings. CONCLUSIONS: Glucometers showed excellent linearity, precision, and correlation in the reference method. However, they showed different calibration status. The effect of hematocrit, sample volume, reapplication or storage condition for test strips and operator variances were also noted. Therefore, users should fully understand the testing system and continuous quality control activity including sufficient training is warranted.