Evaluation of the Tosoh G8 Analyzer and Comparison with the Trinity Biotech Premier Hb9210 Analyzer for the Measurement of HbA₁c

• Published in: Clinical laboratory (Heidelberg) Vol. 62; no. 3; p. 443
• Main Authors: Ucar, Fatma, Erden, Gonul, Ozdemir, Seyda, Yildiz, Zeynep, Arzuhal, Abdullah Ercan, Temel, Ismail
• Format: Journal Article
• Language: English
• Published: Germany 2016
• Subjects: Adult; Aged; Chromatography, Affinity; Chromatography, High Pressure Liquid; Chromatography, Ion Exchange; Female; Glycated Hemoglobin A - analysis; Hematologic Tests - instrumentation; Humans; Male; Middle Aged
• ISSN: 1433-6510
• DOI: 10.7754/Clin.Lab.2015.150742

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). 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). 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. 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.