Evaluation of an Enzymatic Hemoglobin A1C Assay

Background: Different modalities have been designed for estimation of HbA1c, that include ion-exchange High Performance Liquid Chromatography (HPLC), immunoassay, enzymatic assays and capillary electrophoresis. Although based on different principles, these analytical processes have to exhibit robust performance so that an overall comparability of assay values can be ensured which are traceable to the available reference method. Objectives: Objective of the study was to evaluate HbA1c measurement on Abbott Alinity C system against ion exchange high performance liquid chromatography. Methods: We performed different experiments to evaluate measurement of HbA1c on Alinity C system by Abbott. These studies included accuracy, precision, linearity, carry over and method comparison in patients without any hemoglobin variants. Evaluation Protocol (EP) evaluator was used for data analysis. Results: All the experiments passed the minimum passing criteria. All the claims by the vendor were successfully verified with and addition that vendor claims 12-hour stability while our study showed a stability of 18 hours. In precision the coefficient of variance in our experiment showed better results. Conclusion: Alinity C system can be used reliably and efficiently for the assessment of HbA1c in patients without haemoglobin variants as our study did not include samples with variant hemoglobin.