Analytical evaluation of hemoglobin A1c dual kit assay on Bio-Rad Variant II: an automated HPLC hemoglobin analyzer for the management of diabetic patients

Objectives To evaluate the analytical performance of the Bio-Rad Variant II HbA1c dual kit assay. Design and methods Precision, carryover, linearity and analytical range were investigated. 139 patients’ HbA1c results analyzed by the Variant II were compared to the Variant I method. 49 blood samples analyzed by the Variant II at Toronto Medical Laboratories (TML) were compared to the Variant II at Hospital for Sick Children (HSC). Results Total imprecision was less than 2% for the Variant II assay. The method had a wide analytical range with no carryover. HbA1c results were not changed after switching back and forth from the beta thalassemia to HbA1c assay. The Variant II showed an average of 0.0027 negative bias compared to the Variant I method. There was an average of 0.0020 negative bias for HbA1c results on the Variant II at TML compared to the Variant II at HSC. Conclusion HbA1c analysis on the Variant II HbA1c dual kit is a relatively fast and reproducible method.