[Evaluation of GLUCOCARD X-METER glucose monitoring system].
BACKGROUND
Point-of-care testing (POCT) glucometers are increasingly being used for making important therapeutic decisions and managing diabetes. We examined the analytical performance of GLUCOCARD X-METER (ARKRAY Global Business Inc., Japan) against three other glucometers and a reference laboratory method.


METHODS
We evaluated the analytical performance of GLUCOCARD X-METER in comparison with three other glucometers. Studies on precision, linearity, the analysis time, and effects of hematocrit and temperature were carried out and the results were compared with those of the laboratory reference method (hexokinase method by Hitachi 760, Hitachi Co., Japan).


RESULTS
GLUCOCARD X-METER showed a good linearity and within-run and total-run precision. Comparison between each glucometer and the Hitachi 7600 showed a good correlation. Although differences with the reference method were within an allowable range, all glucometers showed variable bias. Application of an insufficient amount of blood could produce some changes in test results. Changes in hematocrit were found to cause overestimation or underestimation of glucose values. For some test strips, the results were affected by prolonged exposure to room temperature or 4 degrees C refrigerator.


CONCLUSIONS
GLUCOCARD X-METER showed a good analytical performance in linearity, precision, and comparison. The effect of hematocrit, sample volume, and storage condition for test strips were noted and glucometers had variable deviations to both directions from laboratory reference values (<20%). The GLUCOCARD X-METER provided rapid and reliable measurements of blood glucose. It could be appropriate for monitoring blood glucose values in diabetic patients.
Kwon
Min Jung
MJ
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Lee
Soo Youn
SY
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood; D006400:Hematocrit; D006801:Humans; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D001786:Blood Glucose