Norudia GA 시약의 당화알부민 검사 분석능 평가
Evaluation of the Analytical Performance of the Norudia GA Glycoalbumin Test
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초록
당뇨병의 진단과 모니터링에 사용되는 혈액 지표들은 공복 혈 당, 당화혈색소, 당화알부민, 프럭토 사민, 1,5-anhydro-D-glucitol 등이 있는데, 당화알부민은 약 3주일의 반감기를 갖기에 상대적으 로 짧은 기간의 당 조절능 을 관찰하는데 유용하다. 본 연구에서는 Roche Modular E170 (Roche Diagnostics, Germany) 장비를 이용하여 Norudia GA (Sekisui Medical, Japan) 시약의 분 석성능 을 평 가하였다. 정밀도 와 직선성은 각각 CLSI 가이드라인 EP05-A3와 EP06-A에 따라 평가했으며, 상관성 평가 를 위해 CLSI 가이드라인 EP09-A3에 따라 121명을 대상으 로 Norudia GA와 Lucica GA-L (Asahi Kasei Pharma Corporation, Japan) 시약 측정결과 에 대해 Passing-Bablok 회귀분 석을 수행하였다. 참고구간은 120명의 건강 인을 대상으 로 CLSI 가이드라인 EP28-A3C에 따라 설정하였다. 반복 정밀도 와 검사실내정밀도의 변이계수 는 각각 0.9-2.5%와 2.6-4.5% 의 분포를 보였고 , 임상적으 로 의미 있는 범위(21.44-713.01 μmol/L) 에서 직선성이 확 인되었다. 상관성 평가 에서 Norudia GA와 Lucica GA-L 두 시약 간의 동 등 성이 있음 을 확 인하였으며, 참고구간은 11.2-17.5%로 설정하였다.
Abstract
Blood biomarkers for the diagnosis and monitoring of diabetes mellitus include fasting plasma glucose, HbA1c, glycoalbumin (GA), fructosamine, and 1,5-anhydro-D-glucitol levels. GA has a half-life of approximately three weeks, and its levels are useful for assessing short-term changes in glycemic control. Herein, we evaluated the performance of the Norudia GA assay kit (Sekisui Medical, Japan) using a Roche Modular E170 analyz er (Roche Diagnostics, Germany). We evaluated the precision and linearity of the assay in accordance with the Clinical and Laboratory Standards Institute (CLSI) EP05-A3 and EP06-A guidelines, respectively. A comparison of the Norudia GA and Lucica GA-L (Asahi Kasei Pharma Corporation, Japan) methods was performed by Passing-Bablok regression, using blood samples obtained from 121 patients, in accordance with the CLSI guideline EP09-A3. The reference interval for GA concentration was established based on 120 healthy individuals, according to CLSI guideline EP28-A3C. Repeatability (% CV) ranged from 0.9-2.5% and within-laboratory precision was 2.6-4.5% at three levels. Linearity was observed for GA concentration in the performance ranges used (21.4-713.0 μmol/L). In the equation for the correlation between Norudia GA and Lucica GA-L assay results, the slope and y-intercept were 1.014 (95% confidence interval: 1.000-1.045) and -0.017 (95% confidence interval: -0.444- 0.381), respectively. The reference interval was calculated to be 11.2-17.5%
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