Lab Med Online.  2021 Jan;11(1):55-59. 10.47429/lmo.2021.11.1.55.

Evaluation of the Analytical Performance of the Norudia GA Glycoalbumin Test

• Ha C
• Oh J
• Park HD

• KMID: 2525781
• DOI: http://doi.org/10.47429/lmo.2021.11.1.55

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 analyzer (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%.

Keyword

Diabetes mellitus; Glycoalbumin; Norudia GA; Performance

Figure

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  Fig. 1 Linearity of the Norudia GA assay for serum glycoalbumin measurement.

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  Fig. 2 Comparison of serum glycoalbumin values measured by Lucica GA-L and Norudia GA kits. (A) Scatter plot. (B) Difference plot.

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