Analytical evaluation of hemoglobin A(1c) dual kit assay on Bio-Rad Variant II: an automated HPLC hemoglobin analyzer for the management of diabetic patients.
OBJECTIVE
To evaluate the analytical performance of the Bio-Rad Variant II HbA(1c) dual kit assay.


METHODS
Precision, carryover, linearity and analytical range were investigated. 139 patients' HbA(1c) 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. HbA(1c) results were not changed after switching back and forth from the beta thalassemia to HbA(1c) 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 HbA(1c) results on the Variant II at TML compared to the Variant II at HSC.


CONCLUSIONS
HbA(1c) analysis on the Variant II HbA(1c) dual kit is a relatively fast and reproducible method.
Moridani
Majid Y
MY
Toronto Medical Laboratories, St. Patrick Site, University Health Network, 222 St Patrick Street, M5T 1V4, Toronto, Ontario, Canada.
Verjee
Zul
Z
Allen
Lynn C
LC
D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results
D006442:Glycated Hemoglobin; D011933:Reagent Kits, Diagnostic