J Lab Med Qual Assur 2007; 29(1): 187-194
Published online March 31, 2007
Copyright © Korean Association of External Quality Assessment Service.
Background: We evaluated the analytical performance of the recently developed glucometer Gluchec Fine (KMH Co., Ltd., Anyang, Gyeonggi, Korea) in Korea.
Methods: Within-run precision and total precision were assessed according to CLSI guideline EP5-A2 with control material of low and high level. Linearity was evaluated in the range of 51-473 mg/dL made by patient samples. Correlations with SureStep (Lifescan, Milpitas, CA, USA) and TBA200-FR (Toshiba, Tokyo, Japan) were evaluated using 99 patient samples in the range of 23-473 mg/dL. Interferences by acetaminophen, ascorbic acid, bilirubin, cholesterol, galactose, and uric acid were elvauated according to CLSI guideline EP7-A. Effect of hematocrit, user variability and reagent stability were assessed.
Results:The CVs of within-run precision were 2.5-3.0% and the CVs of total precision were 3.6-4.7%. The linearity was R2=0.998. The correlations with TBA200-FR (R=0.982) and Surestep (R=0.984) were acceptable. Glucose concentrations measured by Gluchec Fine were lower than those by TBA200-FR (mean 2.7%, 95% CI 0.3-5.1%) in the range of 23-473 mg/dL. Acetaminophen, galactose, and cholesterol did not interfere with glucose measurements on Gluchec Fine. High concentrations of ascorbic acid, bilirubin, and uric acid resulted in positive interferences. Hematocrit and user variability did not significantly influence the glucose concentration. Reagent was stable until one week after opening.
Conclusions:Gluchec Fine glucometer showed acceptable and comparable analytical performance. This instrument can be used for therapeutic monitoring of diabetes patients.
Keywords: Glucometer, Glucose, Point of care test, Analytical performance
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