Hitachi Clinical Analyzer 7180을 이용한 AutoLab HbA1c 시약의 분석능 평가
Evaluation of the AutoLab HbA1c Reagent by Using Hitachi Clinical Analyzer 7180
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배경: 헤모글로빈 A1c는 당뇨 환자의 혈당조절을 추적 관찰하는 데널리 사용되고 있으며, 다양한 방법들로 HbA1c를 측정하고 있다. 최근에 면역혼탁법을 기반으로 한 AutoLab HbA1c이 개발되었다. 본 연구에서 저자들은 생화학자동분석기(Hitachi Clinical Analyzer 7180)에서 AutoLab HbA1c 시약을 사용하여 평가하였다. 방법: Hitachi Clinical Analyzer 7180에서 AutoLab HbA1c 시약의정밀도, 직선성, 교차오염률, 검체의 안정성과 HPLC법인 Variant II Turbo와 상관성을 평가하였다. 결과: 검사 내 정밀도의 변이계수는 저농도와 고농도에서 0.8%와0.6%였고, 총 정밀도의 변이계수는 저농도와 고농도에서 1.5%와2.9%였다. 직선성은 4.3%와 12.4% 내에서 우수하였고, 상관성 검사에서 Variant II turbo와 AutoLab HbA1c의 상관계수는 0.9914로좋은 상관관계를 보였다. 교차오염률은 0%였다. 4°C에서 냉장 보관한 검체는 15일까지 안정하였다. 결론: Hitachi Clinical Analyzer 7180에서 AutoLab HbA1c 시약은좋은 정밀도, 직선성, 교차오염률과 Variant II turbo와 상관성을 보였다. 이 시약은 당뇨 환자의 진단과 치료 시 혈당 조절의 추적관찰에 사용할 수 있을 것이다.
Abstract
Background: Hemoglobin A1c (HbA1c) is a universally used parameter for monitoring glycemic control in diabetic patients. Various methods are used for the measurement of HbA1c levels. The AutoLab HbA1c reagent was recently developed for use in immunoturbidimetric assays for measurement of HbA1c levels. We evaluated the reliability of using the AutoLab HbA1c reagent with the Hitachi Clinical Analyzer 7180, an automated chemistry analyzer, for measuring HbA1c levels. Methods: We evaluated the precision, linearity, carryover rate, and stability of the samples analyzed using Hitachi clinical analyzer 7180 with the AutoLab HbA1c reagent and compared the results with those obtained with an HPLC method performed using the Variant II Turbo analyzer. Results: The CV values for within-run imprecision at low and high levels were 0.8% and 0.6%, respectively, and the CV values for between-run imprecision at low and high levels were 1.5% and 2.9%, respectively. The linearity of the results was good in the range of 4.3-12.3%, and comparison with the results obtained by Variant II Turbo showed an excellent correlation coefficient of 0.9914. The carryover rate was 0%, and the samples refrigerated at 4℃ for 15 days were found to be stable. Conclusions: In comparison with Variant II Turbo, Hitachi clinical analyzer 7180 with AutoLab HbA1c reagent showed good precision, linearity,and carryover rate. Hence, Hitachi clinical analyzer 7180 with AutoLab HbA1c reagent may be used for the diagnosis of diabetes and for monitoring blood glucose levels in diabetic patients.
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