ISO 15197 지침에 따른 혈당측정기 바로잰 H 성능 평가
Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards
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배경: 저자들은 최근 국내에서 개발된 병원전산망에 연결 가능한 혈당측정기 바로잰 H (i-SENS Inc., Korea)의 검사성능을 평가하고자 하였다. 방법: ISO 15197:2011 지침에 따라 정밀도 평가는 10대의 바로잰 H 기기를 대상으로 반복성과 중간정밀도 두 가지로 평가하였다. 직선성은 30.7-551.2 mg/dL의 혈당 범위에서 환자 검체로 평가하였다. 상관성 및 정확도 평가는 150건의 모세혈과 정맥혈 전혈에 대해 바로잰 H 및 두 종류의 타사 간이 혈당기로 혈당을 측정하고, 이를 중앙검사실 기준장비인 Modular D (Roche Diagnostics Ltd., Switzerland)로 구한 정맥혈 혈장 혈당값과 비교하고 그 차이를 분석하였다. 결과: 바로잰 H의 반복성 평가에서 5가지 혈당 농도의 변이계수는 1.58-4.61%의 범위에 있었고, 중간정밀도는 변이계수가 2.85-5.48%의 범위에 있었다. 바로잰 H의 직선성은 y=0.9681x+2.0791에 결정계수(R²) 값이 0.9996이었다. 정맥혈 전혈로 측정한 바로잰 H와 정맥혈 혈장으로 측정한 중앙 검사실 장비 간의 상관계수(r)는 0.9914이었다. 150개의 검체 중 Modular D로 측정한 혈당값이 100 mg/dL 미만인 경우의 95.2%에서 바로잰 H의 측정값 차이가 ±15 mg/dL 안에 들었으며, 100 mg/dL 이상인 경우의 97.2%에서 측정값의 차이가 ±15% 안에 들었다. 모세혈 검체 평가시, 바로잰 H는Modular D로 측정한 정맥혈 혈장 혈당값이 100 mg/dL 미만인 검체 중 41.4%가 기준값의 ±15 mg/dL 이내에, 100 mg/dL 이상인 검체 중 55.4%가 기준값의 ±15% 이내에 각각 포함되었다. 결론: 정맥혈을 검체로 사용시 바로잰 H는 ISO 15197:2011 기준을 충족시키는 결과를 보였으며, 간이 혈당측정기로서 유용하게 사용될 가능성을 확인하였다.
Abstract
Background: We have evaluated the analytical performance of Barozen H (i-SENS Inc. Seoul, Korea), which was developed for glucose testing and can be connected to hospital information network systems. Methods: We evaluated the precision of ten glucometers based on repeatability and intermediate precision according to the guidelines of the International Standardization Organization (ISO) 15197:2011. The linearity of patient samples was in the range of 30.7-551.2 mg/dL. The accuracy of the results of Barozen H and the correlation of these results and those of the two other glucometers in comparisons with the Modular D reference device (Roche Diagnostics Ltd., Switzerland) were evaluated using 150 capillary blood and venous whole blood samples. Results: The ranges for the repeatability and intermediate precision of ten Barozen H glucometers were 1.58-4.61% and 2.85–5.48%, respectively. The linearity was expressed by y=0.9681x+2.0791, and the coefficient of determination (R²) was 0.9996. When venous whole blood samples were used, the correlation coefficient (r) was 0.9914. When glucose levels were under 100 mg/dL, 95.2% of Barozen H results were within ±15 mg/dL, and when glucose levels were 100 mg/dL or higher, 97.2% were within ±15%. When capillary blood samples were used, 41.4% (under 100 mg/dL) and 55.4% (100 mg/dL or higher) of Barozen H results were within ±15 mg/dL and ±15%, respectively. Conclusions: Barozen H provided reliable results and satisfied the ISO15197:2011 criteria when venous whole blood samples were used. It is thought to be clinically useful as a hospital point-of-care glucometer.
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