Analytical evaluation of the Bio-Rad Variant II automated HbA1C analyzer

Objectives: To evaluate the analytical performance of the Bio-Rad Variant II HbA1C analyzer (a completely automated system for the quantification of glycohemoglobin [HbA1C] in blood). Design and Methods: The analytical parameters of precision, linearity and analytical range were assessed and HbA1C results from the Variant II were compared to HbA1C results from the Bio-Rad Variant (a method certified by the National Glycohemoglobin Standardization Program). The effect of a variety of hemoglobin variants on HbA1C obtained on the system was investigated. Results: Total imprecision was less than 5% and the results compared well with those from an established method. The method has a wide analytical range with no carryover between specimens. Conclusion: The HbA1C method on the Variant II gives acceptable analytical performance.