Analytical performances of a new enzymatic assay for hemoglobin A1c

Background: HbA(1c) is considered the gold standard for the follow-up of diabetic patients and a new diagnostic tool for diabetes mellitus, which implies the availability of reliable assay methods. We have evaluated a new assay developed by Abbott Laboratories, based on the enzymatic quantification of HbA(1c), by a fructosyl dipeptide oxidase using Architect analyzers. Methods: Precision, linearity, correlation with a HPLC method, accuracy and potential impact interferences on HbA(1c) measurement have been evaluated. Results: Intra-day and between-day CVs were lower than 1.2% and linearity was excellent from 19 mmol/mol (3.9%) to 163 mmol/mol (17.1%). The results were well correlated with those obtained by the HPLC (Variant II device, kit NU - BioRad): HbA(1c) [Architect, mmol/mol] = 0.986 x HbA(1c) [Variant II, mmol/mol] + 0.713 (r = 0.998, n = 109). This method provided consistent results with IFCC titrated quality control samples. Classical interferences in HbA(1c), assays (i.e. labile HbA(1c), carbamylated hemoglobin, triglycerides or bilirubin) did not have an impact on HbA(1c) quantification by this method. Conclusion: This new enzymatic assay proved to be a robust and reliable method for HbA(1c), measurement suitable for routine practice in clinical chemistry laboratories. (C) 2014 Elsevier B.V. All rights reserved.