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저자명
홍경섭,배균섭,임형석,정재용,김묘경,백정미,강경자,박귀주,신상구,장인진,Hong. Kyoung-Sup,Bae. Kyun-Seop,Lim. Hyeong-Seok,Chung. Jae-Yong,Kim. Myo-Kyoung,Baik. J
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
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2002년|10권 1호|pp.34-39 (6 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Background : Measurement of blood glucose is a basic part of patient care. Increasingly, blood glucose measurement has become a part of self-care. Devices featuring convenience and quickness are used to measure blood glucose and are used in settings often unsupervised by knowledgeable health care personnel. In this context, a validation test of a handy assurances that the devices that they are using or purchasing are capable of producing valid results. Method : In this study, we fulfilled requirements from the ICH Q2 guidelines for assurance of accuracy, precision, linearity and range. From the two subjects, blood glucose was measured repeatedly at post-prandial 1h/2h/3h/4h, 12 times each, by two investigators and with two instruments. Then, we compared the results of a handy blood sugar measuring instrument with those of a chemistry analyzer, Hitachi 7070 auto-analyzer, in a core laboratory in Clinical Trial Center, Seoul National University Hospital. Results : Mean accuracy, intra-assay precision and intermediate precision were 92.6%, 2.3%(min. 1.07%, max. 4.51%), 1.73%(min. 0%, max. 5.65%) each. In scatter plot of the results of a handy blood sugar measuring instrument and Hitachi 7070 auto-analyzer, linearity was apparent and the correlation coefficient(r), $r^2$ was 0.986 and 0.972 each. Conclusions : Mean accuracy was not satisfactory regarding the criteria for quality control of blood glucose $measurement(within {pm}5%)$ in SNUH. The intermediate precision was also not satisfactory regarding the criteria for Quality Control (less than 5%).