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DOI: 10.48087/BJMS.2026.130215
Authors: Hichem BENGHEZEL, Mourad SADELAOUD
Affiliations: Laboratoire d’Analyses Médicales Sadelaoud Batna – Algérie.
Keywords: H100 Lifotronic, HbA1c, Hemoglobin fractions, Method comparison, versatility.
Abstract
Background: Glycated hemoglobin (HbA1c) is a key biomarker for the diagnosis and long-term monitoring of diabetes mellitus. However, its measurement may be affected by hemoglobin variants and quantitative abnormalities, highlighting the need for analytical methods that are both robust and informative. Ion-exchange HPLC systems provide reliable HbA1c measurement together with direct visualization of hemoglobin profiles. Objective: To evaluate the analytical performance and clinical relevance of the H100 Lifotronic system for HbA1c measurement and hemoglobin fraction analysis, in comparison with the Tosoh G11 (HPLC) and the Sebia MiniCAP (capillary electrophoresis). Methods: This was a cross-sectional analytical comparison study conducted under routine laboratory conditions. A total of 520 EDTA whole blood samples were analyzed for HbA1c comparison between the H100 and Tosoh G11 systems, according to CLSI EP09-A3 guidelines. A subgroup of 35 samples with hemoglobin variants (HbS, HbC) was evaluated separately. Comparison with the Sebia MiniCAP involved 54 samples for HbF, HbA₂, HbS, and HbC analysis. Correlation analysis, bias estimation, and regression analysis were performed. Results: The comparison between H100 and Tosoh G11 showed excellent agreement for HbA1c (r = 0.995), with a mean relative bias of approximately 2%, well below the ±3% clinical acceptability threshold. The bias was stable across the analytical range, with near-zero bias at higher HbA1c values. In samples with hemoglobin variants, correlation remained high (r = 0.962), with a mean relative bias of 2.98%. Comparison with the Sebia MiniCAP demonstrated almost perfect agreement for HbF (r ≈ 0.99). Overall agreement for HbA₂ was satisfactory, although expected discrepancies were observed in the presence of HbC, related to co-migration in capillary electrophoresis. HbS and HbC fractions were reliably identified by both techniques. Conclusion: The H100 Lifotronic system demonstrates strong analytical performance for HbA1c measurement, comparable to a reference HPLC analyzer, while offering integrated hemoglobin fraction analysis. This versatility, based on a single chromatographic platform, represents a significant clinical and organizational advantage, particularly in settings where diabetes and hemoglobinopathies coexist.