The Hemo One Autoanalyzer for Glycated Hemoglobin Assay

Abstract

Background: Glycated hemoglobin (HbA1c) is widely used as a clinical marker of long-term blood glucose concentration in patients with diabetes. The clinical laboratory plays a vital role in the diagnosis and management of diabetes. Many methods for the measurement of HbA1c have been developed based on different analytical principles, often causing discordant results. For this reason, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a reference method for HbA1c assay, namely, high-performance liquid chromatography–mass spectrometry/capillary electrophoresis (HPLC-MS/CE). Objective: In order to evaluate in parallel 2 different routine methods, namely, ion-exchange HPLC and immunoturbidimetry. Methods: For our comparison study, we used the Tosoh G8 HPLC analyzer and the Hemo One autoanalyzer system to test 100 blood specimens for HbA1c concentration, the values of which ranged from 4.3% (23.5 mmol/mol) to 14.7% (137 mmol/mol). Results: Concordance between HPLC and the immunoturbidimetric method revealed perfect agreement with a Kappa value of 0.828. Conclusions: Our results confirm the validity of the immunoturbidimetric method compared with the reference method. Our findings highlight that these 2 methods are equivalent for the diagnosis and therapeutic monitoring of diabetes.