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Abstract
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°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.
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Fig. 1.
Linearity of glucose concentrations measured by the 4 glucometers, GLUCOCARD X-METER, A, B, and C.
Fig. 2.
Correlation of glucose concentrations measured by Hitachi 7600 vs. the 4 glucometers, GLUCOCARD X-METER, A, B,and C.
Fig. 3.
Bias plots of the difference (mg/dL) and % difference against the means between the glucometers, GLUCOCARD X-METER, A, B, and C, and Hitachi 7600.
Fig. 4.
Effect on glucose results of applying different sample volumes to respective test strips for the 3 glucometers, A, B, and GLUCOCARD X-METER.
Fig. 5.
Effect of exposure time at room temperature and 4°C refrigerator on the glucose concentrations measured by the 3 glucometers A, B, and GLUCOCARD X-METER.
Fig. 6.
Effect of hematocrit on glucose measurements by the 3 glucometers, A, B, and GLUCOCARD X-METER.
Table 1.
Precision of 4 glucometers including 2 different strip Lot. numbers in GLUCOCARD X-METER at 3 glucose concentrations
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