Evaluation of Glucophone as a POCT Glucometer

Park, Hyung Doo; Park, Kyoung Un; Song, Junghan; Kim, Jin Q

Abstract

BACKGROUND: To prevent complications of diabetes mellitus, diabetic patients should test blood glucose level frequently. In these days, glucometers are widely used for self-monitoring and many kinds of products are introduced. We performed the present study to evaluate the performance of glucophone (GlucoPack(TM), Infopia Co. Ltd., Anyang, Korea) as a point-of-care testing glucometer.
METHODS
Glucometers including glucophone and Finetest(TM) (Infopia Co. Ltd., Anyang, Korea) were evaluated for precision, linearity, and accuracy. The interpersonal variation by different operators, reagent stability, comparison capillary blood with venous blood, and user acceptability were also evaluated.
RESULTS
Glucophone and Finetest glucometer showed excellent precisions wtih less than 5% of CVs of within-run and total precision. Linearity was also satisfactory from 24 to 517 mg/dL for glucophone and Finetest glucometer. Comparison with routine chemistry autoanalyzer, TBA-200FR showed close concordance over the entire range of evaluated concentrations (y = 0.8397x + 3.8351, x = TBA-200FR, y=glucophone, R2=0.9523). There were no significant changes in test results during exposure period at room temperature after opening the reagents. Generally random users expressed high satisfaction to glucophone with the exception of complicated operating method.
CONCLUSION
Glucophone showed excellent precision, linearity, and correlation with the reference method. Because POCT glucometers are influenced by operator and multiple external factors, it is important that users recognize interfering factors and preservation conditions of test strips. It is hoped that glucophone is a good POCT glucose meter by establishment continuous quality control system and improvement of operation.