Evaluation of the analytic performances of the new HPLC system HLC-723 G7 for the measurement of hemoglobin A1C

Objectives: The analytical performance of a new automated HPLC system, for the determination of HbA(1C) in blood (Tosoh HLC-723 G7), was studied. Design and methods: The study design included the evaluation of imprecision, linearity, interference and carryover. Comparison study was performed by comparing HbA(1C) results with those obtained from an established method (Bio-Rad Variant II). Results: Total imprecision was less than 1.34% and the results were linear up to 17.2% HbA(1C). The method showed a wide analytical range, and no carryover between specimens. Comparison study yielded, r = 0.989, Sy.x = 0.255, regression equation (y = 0.9895x-0.35); Bland-Altman plot showed a mean bias = - 0.43% HbA(1C) with confidence limits ranging from -0.48% to -0.38% HbA(1C). The presence of abnormal hemoglobin was clearly revealed, and no interference from labile HbA(1C) was apparent. Conclusion: The HLC-723 G7 instrument seems to be a reliable system for routine assay of HbA(1C). (C) 2003 The Canadian Society of Clinical Chemists. All rights reserved.