개인용혈당측정시스템 표준시험방법 가이드라인에 따른 GlucoDr.S 성능 평가
Evaluation of the Self-Testing Blood Glucose Monitoring System GlucoDr.S According to ISO 15197:2013 Guidelines
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
배경: 당뇨 환자의 엄격한 혈당 관리를 위하여 개인용혈당측정기의 성능은 적합하게 평가되어야 한다. 저자들은 본 연구에서 개인용 혈당측정시스템인 GlucoDr.S™ (All Medicus Co., Ltd., Korea)의 성능을 평가하고자 하였다. 방법: 120명의 분당서울대병원 내과 환자의 모세관혈액과 정맥혈액을 대상으로, 개정된 ISO 15197:2013에 맞추어 국내 식품의약품안전처 식품의약품안전평가원에서 제시한 지침에 따라 GlucoDr.S™을 평가하였다. 평가 항목은 정밀도(측정 반복성, 중간 측정 정밀도), 직선성, 적혈구용적률 및 기타 간섭물질에 대한 영향, 시스템 정확도(모세관혈액 및 정맥혈액) 그리고 사용자 성능 평가로 이루어져 있다. 평가에 사용된 기준 장비는 YSI 2300 STAT PLUS Glucose Analyzer (YSI Life Sciences, USA)이다. 결과: GlucoDr.S™의 측정 반복성 평가 결과, 당 농도 100 mg/dL 미만 구간에서 표준편차는 2.7–3.2 mg/dL, 100 mg/dL 이상 구간에서 변이계수는 3.4–3.7%였고, 중간 측정 정밀도 평가 결과, 당 농도 100 mg/dL 미만 구간에서 표준편차는 3.7 mg/dL, 100 mg/dL 이상 구간에서 변이계수는 2.1–2.6%였다. 직선성 평가에서는 결정계수(R2)가 0.99 이상이었다. 적혈구용적률 및 24종의 간섭물질 영향 평가에서는 xylose를 제외한 모든 간섭물질이 참고 범위 혹은 치료범위 농도에서 측정값에 의미 있는 영향을 주지 않을 것으로 나타났다. 시스템 정확도 평가에서는 95% 이상의 시료가, 혈당 100 mg/dL 미만에서는 오차 ±15 mg/dL 이내, 혈당 100 mg/dL 이상에서는 오차 ±15% 이내에 포함되었다. 이 모든 결과는 일치 오류 격자 A영역 혹은 B영역에 분포한다. 일반 사용자가 직접 처음부터 끝까지 스스로 기기를 사용하여 검사한 사용자 성능 평가 결과 역시 허용 가능 범위에 포함되었다. 결론: 이번 연구는 ISO 15197:2013 지침을 완벽하게 따라 개인용혈당측정시스템 GlucoDr.S™의 기능을 평가하고 결과를 발표한 것에 의의가 있다. GlucoDr.S™ 개인용 혈당측정시스템은 지침의 기준을 충족시켰으며, 효과적인 개인용 혈당측정기로 사용될 수 있음을 확인하였다.
Abstract
Background: The performance of the self-monitoring of blood glucose in patients with diabetes should be properly evaluated to ensure strict glycemic control. This study evaluated the self-testing Blood Glucose Monitoring System GlucoDr.S™ (All Medicus Co., Ltd., Korea). Methods: This study recruited 120 patients. Use of the glucometer was evaluated according to ISO 15197:2013 guidelines. The YSI 2300 STAT PLUS Glucose Analyzer (YSI Life Sciences, USA) was used as the reference device. Results: The standard deviation and coefficients of variation ranges for measurement repeatability and intermediate measurement precision conducted with 10 meters and 3 reagent lots on the same day were 2.7–3.2 mg/dL (<100 mg/dL) and 3.4–3.7% (≥100 mg/dL), respectively, and 3.7 mg/dL (<100 mg/dL) and 2.1–2.6% (≥100 mg/dL), respectively. Each coefficient of determination (R2) for linearity of the 3 reagent lots was >0.99. The influence effect of hematocrit and the 24 interference agents was not significant, except for xylose. A system accuracy test was conducted with 100 subjects taking duplicate measurements from each of the 3 reagent lots. When glucose levels were <100 mg/dL and ≥100 mg/dL, >95% of the samples were within ±15 mg/dL and within ±15% of the average measured values of the reference measurement, respectively. In Consensus Error grid analysis, all results were distributed in zone A and B. The results of the user performance evaluation using 115 lay persons were also included in the acceptance range. Conclusions: The GlucoDr.S™ showed acceptable performance according to the ISO 15197:2013 guidelines and could be a clinically useful self-testing glucometer.
참고문헌 (31)
- "Diabetes fact sheet in Korea 2013"[URL]
- "Korean diabetes fact sheet 2015"[URL]
- Mazze RS, "Reliability of blood glucose monitoring by patients with diabetes mellitus", Am J Med, 77, pp.211~217 (1984)[DOI]
- Korean Diabetes Association, "Treatment guideline for diabetes", J Korean Diabetes, 12(S1), pp.S1~S244 (2011)
- Diabetes Control, "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)[DOI]
- Mahoney J, "Assessing the quality of glucose monitor studies: a critical evaluation of published reports", Clin Chem, 53, pp.1122~1128 (2007)[DOI]
- Yoo EH, "Glucose biosensors: an overview of use in clinical practice", Sensors (Basel), 10, pp.4558~4576 (2010)[DOI]
- International Organization for Standardization, "In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus" (2003)
- International Organization for Standardization, "In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus" (2013)
- Clinical and Laboratory Standards Institute, "Effects of different sample types on glucose measurements" (2015), Clinical and Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Evaluation of precision of quantitative measurement procedures; approved guideline" (2014), Clinical and Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline" (2003), Clinical and Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Interference testing in clinical chemistry; approved guideline" (2005), Clinical Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Measurement procedure comparision and bias estimation using patient samples; approved guideline" (2013), Clinical Laboratory Standards Institute
- Freckmann G, "Analytical performance requirements for systems for self-monitoring of blood glucose with focus on system accuracy relevant differences among ISO 15197: 2003, ISO 15197: 2013, and current FDA recommendations", J Diabetes Sci Technol, 9, pp.885~894 (2015)[DOI]
- "Evaluation of self-testing glucometer according to ISO 15197:2013 guidelines"[URL]
- Ko DH, "Performance evaluation of the GlucoDr plus glucometer", Diabetes Technol Ther, 12, pp.307~312 (2010)[DOI]
- Food and Drug Administration, "Self-monitoring blood glucose test systems for over-the-counter use-draft guidance for industry and food and drug administration staff" (2014), Food and Drug Administration
- Clinical and Laboratory Standards Institute, "Interference testing in clinical chemistry; approved guideline" (2010), Clinical and Laboratory Standards Institute
- MacRury S, "Performance of a new meter designed for assisted monitoring of blood glucose and point-of-care testing", J Diabetes Sci Technol, 7, pp.389~398 (2013)[DOI]
- "Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period", Fed Regist, 57, pp.7002~7186 (1992)
- Cryer PE, "Hypoglycemia in diabetes", Diabetes Care, 26, pp.1902~1912 (2003)[DOI]
- Lacher DA, "Biological variation of laboratory analytes based on the 1999-2002 National Health and Nutrition Examination Survey" (2010)
- 김영빈, "ISO 15197 지침에 따른 혈당측정기 바로잰 H 성능 평가", Laboratory Medicine Online, 5(1), pp.6~14 (2015), 대한진단검사의학회
- Kuo CY, "Accuracy and precision evaluation of seven self-monitoring blood glucose systems", Diabetes Technol Ther, 13, pp.596~600 (2011)[DOI]
- 안동희, "ISO15197에 따른 혈당측정기의 분석적 수행능 평가", Annals of Laboratory Medicine, 29(5), pp.423~429 (2009), 대한진단검사의학회
- Schifman RB, "Point-of-care glucose critical values: a Q-probes study involving 50 health care facilities and 2,349 critical results", Arch Pathol Lab Med, 140, pp.119~124 (2016)[DOI]
- Burmeister JJ, "Accuracy of the YSI stat plus analyzer for glucose and lactate", Analytical Letters, 28, pp.581~592 (1995)[DOI]
- Tack C, "Accuracy evaluation of ve blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects", Diabetes Technol Ther, 14, pp.330~337 (2012)[DOI]
- Pfutzner A, "Clinical assessment of the accuracy of blood glucose measurement devices", Current Med Res Opin, 28, pp.525~531 (2012)[DOI]
- Rajendran R, "Point-of-care blood glucose testing for diabetes care in hospitalized patients: an evidence-based review", J Diabetes Sci Technol, 8, pp.1081~1090 (2014)[DOI]