ARKRAY ADAMS HA-8180 HbA1c Analyzer의 수행능 평가
Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer
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초록
배경: HbA1c는 당뇨조절에 통상적으로 사용되어 왔다. 2010년 미국당뇨병협회에서는 HbA1c를 당뇨의 선별검사의 항목으로 추가시켰다. 최근 새롭게 개발된 ARKRAY ADAMDS HA-8180 HbA1c analyzer (ARKRAY KDK, Japan)가 소개되었다. 이에 본 연구에서는ARKRAY ADAMDS HA-8180 HbA1c analyzer를 이용한 HbA1c의측정 수행능을 평가하였다. 방법: CLSI EP5-A에 따라 Lyphochek Diabetes Control (Bio-Rad Laboratories, USA)을 사용하여 정밀도를 평가하였다. 2가지 농도(저농도 그리고 고농도)의 정도관리 물질을 20일에 걸쳐 하루에 2회씩 매 검사마다 반복 측정하였으며 평균, 총표준편차, 총변이계수, 검사 간 그리고 검사일 간 변이계수가 측정되었다. 총 150검체에 대해 ARKRAY ADAMDS HA-8180 HbA1c analyzer와 Variant II Turbo (Bio-Rad Laboratories, USA)의 HbA1c 측정값을 비교하여 상관성을 평가하였으며, CLSI EP9-A2에 따라 변이를 결정하였다. 또한 직선성과 검체 간 교차오염률을 평가하였다. 결과: ARKRAY ADAMDS HA-8180 HbA1c analyzer의 HbA1c 측정정밀도는 고농도에서의 총변이계수, 검사 간 변이계수, 검사일 간변이계수는 각각 0.7%, 0.0%, 0.3%였으며 저농도에서 총변이계수,검사 간 변이계수, 검사일 간 변이계수는 각각 0.5%, 0.3%, 0.2%로나타났다. 직선성은 3.1-19.3% 범위에서 R2 =0.99로 나타났다. Variant II Turbo와도 상관성은 매우 높았다(R2 =0.994). 검체 간 교차오염률은 0%로 나타났다. 결론: ARKRAY ADAMDS HA-8180 HbA1c analyzer는 우수한 정밀도, 직선성 및 검체 간 교차오염률을 나타냈다. 또한 NGSP 인증된Variant II Turbo 기기와 우수한 상관성을 나타내었다. 결론적으로,ARKRAY ADAMDS HA-8180 HbA1c analyzer는 HbA1c 측정에 있어신뢰할 수 있는 HPCL 장비로 당뇨병의 진단, 추적감시 그리고 위험도 측정에 있어 유용할 것이라고 생각한다.
Abstract
Background: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. Methods: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. Results: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range,3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. Conclusions: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.
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