Validation of the Assay for the Glucose of Human Venous Blood Using a Handy Blood Sugar Measuring Instrument

간이혈당측정기를 이용한 정맥 혈당 측정의 타당성 검증 - 간이혈당측정기의 타당성 검증 -

  • Hong, Kyoung-Sup (Clinical Trial Center, Seoul National University Hospital, Department of Pharmacology, Seoul National University, College of Medicine) ;
  • Bae, Kyun-Seop (Clinical Research Support Center, Asan Medical Center) ;
  • Lim, Hyeong-Seok (Clinical Trial Center, Seoul National University Hospital, Department of Pharmacology, Seoul National University, College of Medicine) ;
  • Chung, Jae-Yong (Clinical Trial Center, Seoul National University Hospital, Department of Pharmacology, Seoul National University, College of Medicine) ;
  • Kim, Myo-Kyoung (Department of Pharmacology, Seoul National University, College of Medicine) ;
  • Baik, Jung-Mi (Clinical Trial Center, Seoul National University Hospital) ;
  • Kang, Kyoung-Ja (Clinical Trial Center, Seoul National University Hospital) ;
  • Park, Gui-Ju (Clinical Trial Center, Seoul National University Hospital) ;
  • Shin, Sang-Goo (Clinical Trial Center, Seoul National University Hospital, Department of Pharmacology, Seoul National University, College of Medicine) ;
  • Jang, In-Jin (Clinical Trial Center, Seoul National University Hospital, Department of Pharmacology, Seoul National University, College of Medicine)
  • 홍경섭 (서울대학교병원 임상시험센터, 서울대학교 의과대학 약리학교실) ;
  • 배균섭 (서울아산병원 임상연구지원센터) ;
  • 임형석 (서울대학교병원 임상시험센터, 서울대학교 의과대학 약리학교실) ;
  • 정재용 (서울대학교병원 임상시험센터, 서울대학교 의과대학 약리학교실) ;
  • 김묘경 (서울대학교 의과대학 약리학교실) ;
  • 백정미 (서울대학교병원 임상시험센터) ;
  • 강경자 (서울대학교병원 임상시험센터) ;
  • 박귀주 (서울대학교병원 임상시험센터) ;
  • 신상구 (서울대학교병원 임상시험센터, 서울대학교 의과대학 약리학교실) ;
  • 장인진 (서울대학교병원 임상시험센터, 서울대학교 의과대학 약리학교실)
  • Published : 2002.06.30

Abstract

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%).

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