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KMID : 0927720100110010067
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Korean Clinical Diabetes
2010 Volume.11 No. 1 p.67 ~ p.74
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The Estimation of Glucocard X-METER and Glucocard 01 METER According to International Organization for Standardization (ISO) Guideline
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Kim Ji-Hoon
Bae Yoo-Mi
Yoo Seung-Hyun
Park Se-Eun
Rhee Eun-Jung
Park Cheol-Young
Lee Won-Young
Oh Ki-Won
Park Sung-Woo
Kim Sun-Woo
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Abstract
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Background: Glucometers are simple and rapid method for self monitoring blood glucose which is widely being used by diabetic clinics and patients. However, there is no specific criteria exist regarding accuracy, precision and its clinical acceptance. The objective of the study was to measure the performance of these two recent products from ARKREY Company to determine whether it met the proposed International Organization for Standardization (ISO) guideline or not.
Methods: 100 capillary blood samples were collected and tested using Glucocard X- METER and Glucocard 01 METER of one brand (ARKREY) and two different types (GOD,GDH) of glucose test strips. Studies on precision, linearity, effect of Hematocrit were carried out and the results were compared with those of the laboratory reference method.
Results: On linearity, the coefficients of determination of Glucocard X-METER and Glucocard 01METER showed respectively, 0.9994 and 0.9904. The coefficient variation precision of Glucocard X-METER and Glucocard 01 METER concentration for each of the high, middle, low showed by 2.1% , 2.7%, 3.3% and 2.8%, 3.2%, 3.3% respectively.
Conclusion: Glucocard X-METER and Glucocard 01 -METER showed acceptable precision, coefficiency requirements stated by the ISO 15197.
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KEYWORD
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Blood glucose self-monitoring, Diabetes mellitus
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