Analytical evaluation of the Bio-Rad Variant II automated HbA1c analyzer

Objectives: To evaluate the analytical performance of the Bio-Rad Variant II HbA(IC) analyzer (a completely automated system for the quantification of glycohemoglobin [HbA(IC)] in blood). Design and Methods: The analytical parameters of precision, linearity and analytical range were assessed and HbA(IC) results from the Variant II were compared to HbA(IC) results from the Bio-Rad Variant (a method certified by the National Glycohemoglobin Standardization Program). The effect of a variety of hemoglobin variants on HbA(IC) 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 HbA(IC) method on the Variant II gives acceptable analytical performance. (C) 2001 The Canadian Society of Clinical Chemists. All rights reserved.