Analytical Performances of an Enzymatic Assay for the Measurement of Glycated Albumin. (1st September 2016)

• Record Type: Journal Article
• Authors: Testa, Roberto; Guerra, Elena; Bonfigli, Anna Rita; Di Gaetano, Nicola; Santini, Gabriele; Ceriotti, Ferruccio
• Is Part Of: Journal of applied laboratory medicine. Volume 1:Number 2(2016)
• Page Start: 162
• Page End: 171
• Publication Date: 2016-09-01
• Subjects: Clinical chemistry -- Periodicals; Diagnosis, Laboratory -- Periodicals; 616.0756
• DOI: 10.1373/jalm.2016.020446
• Languages: English
• ISSNs: 2576-9456

Abstract

Abstract: Background: Short to intermediate integrated glycemic control is best determined by glycated albumin (GA). This assay is appropriate when interpretation of glycated hemoglobin (HbA1c ) is critical because of hemoglobinopathies, severe anemias, or other factors that affect red blood lifespan as hemodialysis. We evaluated a new assay based on the enzymatic quantification of GA by ketoamine oxidase and an albumin-specific protease. Methods: Limits of blank, detection, and quantification; precision; linearity; accuracy; interferences; correlation with HbA1c ; and serum vs plasma study have been evaluated on ILab ® systems. Results: Limit of blank, detection, and quantification for GA (g/L) were, respectively, 0.26, 0.36, and 1.15. Repeatability and within-device precision CVs were lower than 2.11%, 1.61%, and 1.56% for GA (g/L), albumin (g/L), and GA%, respectively. Linearity for GA (g/L) and GA% was 1.2–36.8 and 5.5–92.2, respectively. Highest deviation from linearity was <11% and recovery was higher than 90%. Accuracy against the certified ReCCS Japan Clinical Chemistry Reference Material (JCCRM) 611 was <1%. Classical interfering substances had no significant impact. Correlation of GA% between ILab ® Taurus and ADVIA system was y = 1.02[GA%]+0.25; R 2 = 0.994. No difference was found in the determination of GA% in serum vs plasma. Conclusions: GA enzymatic assay is a reliable, fully automated method allowing accurate and precise determination of GA in a routine laboratory.