자동화학분석기에서의 라텍스 면역비탁법의 Autolab HbA1c 평가
Evaluation of HbA1c Levels Via the Latex Immunoturbidimetric Method by Using Chemistry Autoanalyzer
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초록
배경: HbA1c의 측정은 최근 6-8주간의 혈당조절을 평가하고 당뇨를 진단하기 위해 사용되고 있다. 최근 라텍스 면역비탁법을 사용하는 HbA1c 측정법이 개발되어 분석 능력과 임상검사실에서의 유용성을 평가하였다. 방법: 2009년 4월부터 7월까지 TBA-200FR에 Autolab HbA1c을 장착하여 CLSI guideline (EP5-A2, EP6-P, EP9-A2)에 따라 직선성, 정밀도, 상관성을 평가하였다. 결과: Autolab HbA1c는 고농도(15.1%)와 저농도(3.1%)의 검체의 혼합에서 r2 = 0.9997의 높은 직선성을 보였다. 12.1%의 경우 검사 일내 정밀도와 검사 일간 정밀도의 표준편차는 각각 0.06, 0.12였고변이계수는 0.5%, 1.0%였다. 5.1%의 경우 각각 표준편차는 0.04,0.09이었고 변이계수는 0.8%, 1.6%이었다. 비교식은 Autolab HbA1c =1.0859×HPLC-0.6957이었다. 결론: 본 연구에서 Autolab HbA1c는 Tosoh G7과 비교하여 좋은 수행능력을 보였다. 문헌고찰에서 변이형 혈색소에 따른 간섭은 없는 것으로 알려졌다. Tosoh G7에 비해 결과획득시간은 지연되는단점이 있지만 Autolab HbA1c의 장점은 일반 화학분석기에 적용이가능하고 검체의 전처리가 필요없으며 증류수를 사용하여 자동적으로 용혈과정이 이루어진다는 점이다.
Abstract
Background: Measurement of HbA1c levels is widely used to diagnose diabetes mellitus and to evaluate and monitor plasma-glucose concentrations over 6-8 weeks. In this study, we evaluated the diagnostic performance of the newly developed latex immunoturbidimetric method by using Autolab HbA1c. Methods: We analyzed and compared the diagnostic performance of Autolab HbA1c with that of Toshiba 200FR between April 2009 and July 2009. According to guidelines (EP5-A2, EP6-P, EP9-A2) of the clinical and laboratory standards institute (CLSI), we compared linearity, precision and correlation of Autolab HbA1c with those of G7 (Tosoh Corp., Kyoto, Japan) by using high-performance liquid chromatography (HPLC) method. Results: Data obtained using Autolab HbA1c showed good linearity in mixtures of samples with low (3.1%) and high (15.1%) levels of HbA1c (r2 =0.9997). In the analysis of within-run precision of the samples with HbA1c levels of 5.1% and 12.1%, the SDs were 0.04 and 0.06 and covariances of these samples were 0.8% and 0.5%, respectively. In the Deming regression model, the regression equation was as follows: Autolab HbA1c = 1.0859×Tosoh HPLC-0.6957. Conclusions: In this study, Autolab HbA1c method showed better performance characteristics than Tosoh G7 did. In reference review, there was no interference of variant hemoglobin. The data acquisition time of Autolab HbA1c was lower than that of Tosoh G7. The advantages of Autolab HbA1c are that it can be used as an autoanlyzer in routine chemical analysis, it does not require pre-analytical treatment, and the samples are automatically treated with distilled water for hemolysis.
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