Evaluation of the analytic performances of the new HPLC system HLC-723 G7 for the measurement of hemoglobin A1c.
OBJECTIVE
The analytical performance of a new automated HPLC system, for the determination of HbA1C in blood (Tosoh HLC-723 G7), was studied.


METHODS
The study design included the evaluation of imprecision, linearity, interference and carryover. Comparison study was performed by comparing HbA1C 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% HbA1C. 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% HbA1C with confidence limits ranging from -0.48% to -0.38% HbA1C. The presence of abnormal hemoglobin was clearly revealed, and no interference from labile HbA1C was apparent.


CONCLUSIONS
The HLC-723 G7 instrument seems to be a reliable system for routine assay of HbA1C.
Terreni
Alessandro
A
Central Clinical Biochemistry Laboratory, Hospital of Careggi, viale Morgagni 85, 50139 Florence, Italy.
Paleari
Renata
R
Caldini
Anna
A
Ognibene
Agostino
A
Mosca
Andrea
A
Messeri
Gianni
G
D001663:Bilirubin / Q000097:blood; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation* / Q000379:methods* / Q000706:statistics & numerical data; D006442:Glycated Hemoglobin / Q000032:analysis*; D006455:Hemoglobins, Abnormal / Q000032:analysis; D006801:Humans; D014280:Triglycerides / Q000097:blood
D001663:Bilirubin; D006442:Glycated Hemoglobin; D006455:Hemoglobins, Abnormal; D014280:Triglycerides