의료기관용 네트워크 혈당측정기 BAROZEN H의 성능 평가
Performance Evaluation of BAROZEN H, a Networking Blood Glucose Monitoring System for Medical Institutions
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배경: 의료기관용 네트워크 기능을 탑재한 혈당측정기 Barozen H (i-SENS Inc., Korea)의 분석적 성능을 ISO 15197:2003 및 ISO/DIS 15197:2011 가이드라인에 따라 평가하였다. 방법: 10대의 Barozen H의 정밀도를 반복성 및 중간정밀도로 평가하고, 자동화학분석기 AU5421 (Beckman Coulter, USA)을 기준으로 정확도를 평가하였다. 정확도, 적혈구용적률에 의한 간섭 영향을 3종의 외산 혈당측정기 Precision PCx (Abbott Diabetes Care, USA), Glucocard Sigma (Arkray, Japan), SureStep Flexx (Johnson & Johnson, USA)와 비교평가 하였다. 결과: Barozen H의 반복성 및 중간정밀도 평가 결과, 표준편차는 0.11-0.15 mmol/L, 변이계수는 2.3-3.6%였다. 정확도에 있어서 ISO 15197:2003에 따라 평가했을 때, 전체 결과의 98.0%가 ±0.83 mmol/L 및 ±20% 이내의 오차를 보여 허용기준을 만족했다. ISO/DIS 15197:2011에 따라 평가할 경우, 전체 결과의 95.2%가 ±0.83 mmol/L 및 ±15% 이내의 오차를 보여 평가대상 장비 중 유일하게, 강화된 ISO/DIS 15197:2011 허용기준을 만족하였다. Error grid 분석결과 모든 결과가 A 영역에 속하는 매우 우수한 임상적 정확도를 보였다. 적혈구용적률 20-60% 범위에서, 적혈구용적률에 의한 의미있는 간섭현상은 관찰되지 않았다. 결론: Barozen H는 우수한 혈당분석 성능을 보였고 비교 평가한 혈당측정기 중 임상적으로 가장 정확한 결과를 보여주었다. Barozen H는 기존의 ISO 15197:2003뿐만 아니라 ISO/DIS 15197:2011 기준을 만족하는 신뢰할 만한 결과를 제공할 것으로 기대된다.
Abstract
Background: We evaluated the analytical performance of Barozen H (i-SENS Inc., Korea), a new glucometer equipped with networking function for medical institutions, according to the ISO 15197:2003 and ISO/DIS 15197:2011 guidelines. Methods: We measured the precision of 10 Barozen H glucometers, in terms of repeatability and intermediate precision, and determined their accuracy relative to that of automatic chemistry analyzer AU5421 (Beckman Coulter, USA). Three other glucometers-Precision PCx (Abbott, USA), Glucocard Sigma (Arkray, Japan), and SureStep Flexx (Johnson & Johnson, USA) were also evaluated, and their accuracies and hematocrit interferences were compared. Results: The standard deviation and coefficient of variation of Barozen H for repeatability and intermediate precision were 0.11-0.15 mmol/L and 2.3-3.6%, respectively. With respect to accuracy, in accordance with ISO 15197:2003 criteria, Barozen H yielded 98.0% of results within ±0.83 mmol/L or ±20%. Further, per the ISO/DIS 15197:2011 criteria, 95.2% of results were within ±0.83 mmol/L or ±15%; Barozen H was the only glucometer satisfying the more stringent ISO/DIS 15197:2011 criteria. Error grid analysis showed that all results from Barozen H were in zone A, indicating its excellent clinical accuracy. Hematocrit, ranging from 20% to 60% did not cause any significant interference. Conclusions: Barozen H showed excellent analytical performance, and it was the most clinically accurate glucometer tested. It can be expected to provide reliable results satisfying ISO/DIS 15197:2011 as well as ISO 15197:2003 criteria.
참고문헌 (14)
- The Diabetes Control and Complications Trial Research Group, "The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus", N Engl J Med, 329, pp.977~986 (1993)
- UK Prospective Diabetes Study (UKPDS) Group, "Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)", Lancet, 352, pp.837~853 (1998)
- Sacks DB, "Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus", Diabetes Care, 34, pp.e61~e99 (2011)
- Burtis CA, "Tietz textbook of clinical chemistry" (1999), W.B. Saunders
- 박애자, "혈당 현장검사의 전산망 연결 경험", Annals of Laboratory Medicine, 26(4), pp.294~298 (2006), 대한진단검사의학회
- The International Organization for Standardization, "In vitro diagnostic test systems-requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO", TC 212, ISO, pp.2003, ~
- TC 212, "In vitro diagnostic test systems-requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO", pp.The International Organization for Standardization, SC. Draft International Standard ISO
- Parkes JL, "A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose", Diabetes Care, 23, pp.1143~1148 (2000)
- Tonyushkina K, "Glucose meters : a review of technical challenges to obtaining accurate results", J Diabetes Sci Technol, 3, pp.971~980 (2009)
- Sacks DB, "Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus", Clin Chem, 57, pp.e1~e47 (2011)
- The International Organization for Standardization, "In vitro diagnostic test systems -- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO", TC 212, ISO, pp.2013, ~
- 안동희, "ISO15197에 따른 혈당측정기의 분석적 수행능 평가", Annals of Laboratory Medicine, 29(5), pp.423~429 (2009), 대한진단검사의학회
- Hussain K, "The inaccuracy of venous and capillary blood glucose measurement using reagent strips in the newborn period and the effect of haematocrit", Early Hum Dev, 57, pp.111~121 (2000)
- Tang Z, "Effects of different hematocrit levels on glucose measurements with handheld meters for point-of-care testing", Arch Pathol Lab Med, 124, pp.1135~1140 (2000)