J Korean Diabetes > Volume 11(1); 2010 > Article
The Journal of Korean Diabetes 2010;11(1):67-74.
DOI: https://doi.org/10.4093/kcd.2010.11.1.67   
국제 표준화 기구(ISO) 기준에 따른 혈당측정기 Glucocard X-METER와 Glucocard 01 METER의 평가
김지훈, 배유미, 유승현, 박세은, 이은정, 박철영, 이원영, 오기원, 박성우, 김선우
The Estimation of Glucocard X-METER and Glucocard 01 METER According to International Organization for Standardization (ISO) Guideline
Ji Hoon Kim, Yoo Mi Bae, Seung Hyun Yoo, Se Eun Park, Eun Jung Rhee, Cheol Young Park, Won Young Lee, Ki Won Oh, Sung Woo Park, Sun Woo Kim
Abstract
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. (Korean Clinical Diabetes J 11:67-74, 2010)
Key Words: Blood glucose self-monitoring, Diabetes mellitus
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