Abstract

Background: The aim of our study was to assess the analytical performance of the Tosoh HLC-723G8 automated analyzer and to compare it with the Trinity Biotech Premier Hb9210 analyzer for the measurement of hemoglobin A1c (HbA1c).
Methods: A total of 101 patients with pre-diabetes or diabetes mellitus were included in the study. HbA1c was measured by both an ion-exchange high-performance liquid chromatography (IE-HPLC) method and a boronate affinity chromatography method. Statistical analysis was performed using Deming regression. Bland–Altman plots were used to calculate mean difference (bias).
Results: The CV% values of IE-HPLC and boronate affinity methods for within run and between days were lower than 2.0%. High correlation was found (y = 1.0045x + 0.2111; r = 0.9941) between the two methods. The method shows no interference from carbamylated hemoglobin.
Conclusions: Both systems showed acceptable performance and are suitable for clinical application in the analysis of HbA1c. However, laboratories should be aware of the limitations of their methods and the availability of more accurate and precise HbA1c determination methods.

DOI: 10.7754/Clin.Lab.2015.150742