ISO15197에 따른 혈당측정기의 분석적 수행능 평가
Analytical Performance Evaluation of Glucose Monitoring System Following ISO15197
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초록
배경 : 저자들은 결과값을 혈장 값으로 환산하여 보고하고 병 원 전산망과 연결 가능한 SureStep Flexx (Johnson and Johnson, USA)의 분석적 수행능을 혈당측정기 평가지침인 ISO- 15197에 따라 최초로 평가하였다. 방법 : ISO15197에 따라 정밀도와 정확도를 평가하였다. 정밀 도는 10대 장비로 반복성과 중간정밀도를 평가하였고, 정확도는 GEM Premier 4000 (Instrumentation Laboratory, USA)을 혈당 측정 참고법으로 사용하였다. 또한, CLSI 지침에 따라 중 앙 장비 측정치와 상관성 및 직선성 평가를 하였다. 중앙 장비 측정치와 상관성 평가를 위하여 혈당 측정 참고법으로 TBA- 200FR 자동화학분석기(Toshiba Medical Systems, Japan)를 사용하였다. 이를 위하여 환자 검체와 시판되는 대조물질을 사 용하였다. 결과 : SureStep Flex의 반복성 변이계수는 4.0-7.3%였고, 중간정밀도 변이계수는 4.3-6.2%였다. 정확도는 75 mg/dL 미 만인 검체와 75 mg/dL 이상인 검체는 모두 참고법에 의한 혈당 값 차이가 각각 ±6 mg/dL, ±12.7% 범위 내에 분포하여 ISO- 15197 기준을 만족하였다. 농도범위 36-491 mg/dL에서 직선 성을 보였다. 또한, Error Grid 방법으로 분석한 결과, GEM Premier 4000 및 TBA-200FR 값과 비교한 모든 측정치는 임 상적으로 정확한 범위인 A영역에 포함되었다. 결론 : SureStep Flexx는 ISO1597 기준을 충족하는 신뢰성 있는 검사 값을 제공함으로써, 효과적인 당뇨병 관리에 도움을 줄 수 있을 것으로 사료된다.
Abstract
Background : We have evaluated the analytical performance of SureStep Flexx (Johnson and Johnson, USA) which can report the plasma equivalent glucose test results and be connected to the hospital information networks, following ISO15197 analytic procedure for glucometer for the first time. Methods : Adopting the guidelines of ISO15197, we measured the precision of ten glucometers from their repeatability and intermediate precision, and determined the accuracies of the glucometer, comparing to those of GEM Premier 4000 (Instrumentation Laboratory, USA). In addition, the guidelines of CLSI EP9-A2 and EP6-A were applied to correlate between data of glucometer and those of laboratory reference method by TBA-200FR (Toshiba Medical Systems, Japan) and to examine its linearity of glucose concentrations measured by SureStep Flexx. We used the clinical specimens and commercial control materials. Results : Repeatabilities and intermediate precisions of those glucometers were 4.0-7.3%, and 4.3-6.2%, respectively. When glucose levels are under 75 mg/dL, the difference between results of those meters and the reference values were within ±6 mg/dL. However when glucose levels are over 75mg/dL, those differences were within ±12.7%. These results were acceptable for the ISO15197 criteria in all glucose concentrations. The glucose concentrations showed the clinically relevant linearity in the range from 36 mg/dL to 491 mg/dL. Moreover, Error Grid Analysis showed that all glucose results were in ‘‘zone A’’, which means that these values were clinically accurate. Conclusions : This study showed that SureStep Flexx can provide reliable results for patients and clinicians to manage the diabetes mellitus, satisfying the ISO15197 criteria.
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