Analytical evaluation of the Bio-Rad variant II automated HbA(1C) analyzer.
OBJECTIVE
To evaluate the analytical performance of the Bio-Rad Variant II HbA(1C) analyzer (a completely automated system for the quantification of glycohemoglobin [HbA(1C)] in blood).


METHODS
The analytical parameters of precision, linearity and analytical range were assessed and HbA(1C) results from the Variant II were compared to HbA(1C) 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(1C) 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.


CONCLUSIONS
The HbA(1C) method on the Variant II gives acceptable analytical performance.
Higgins
T N
TN
Dynacare Kasper Medical Laboratories, T5V 1B4, Edmonton, Alberta, Canada. Higgins@dkml.com
Blakney
G B
GB
Dayton
J
J
D001331:Automation; D001774:Blood Chemical Analysis / Q000295:instrumentation; D002623:Chemistry Techniques, Analytical / Q000379:methods; D002851:Chromatography, High Pressure Liquid; D003920:Diabetes Mellitus / Q000097:blood; D005319:Fetal Hemoglobin / Q000032:analysis; D005612:Freeze Drying; D014644:Genetic Variation; D006442:Glycated Hemoglobin / Q000032:analysis*; D006446:Hemoglobin E / Q000032:analysis; D006448:Hemoglobin J / Q000032:analysis; D006455:Hemoglobins, Abnormal / Q000032:analysis; D006801:Humans; D012016:Reference Values; D012044:Regression Analysis; D015203:Reproducibility of Results; D013223:Statistics as Topic
D005319:Fetal Hemoglobin; D006442:Glycated Hemoglobin; D006446:Hemoglobin E; D006448:Hemoglobin J; D006455:Hemoglobins, Abnormal; C032001:hemoglobin D