Abstract

VERNA, Juan Antonio; VENTIMIGLIA, Fernando Daniel; BRUNO, Jorge José  and  D’AGOSTINO, Liliana Elena. Analytical performance of a chromatographic method for the quantitation of glycated hemoglobin. Acta bioquím. clín. latinoam. [online]. 2015, vol.49, n.3, pp.295-299. ISSN 0325-2957.

Measurement of glycated hemoglobin (HbA_1C) was proposed in 2010 by the American Diabetes Association (ADA) as diagnostic criteria for diabetes mellitus, being essential for control and monitoring of blood glucose in the follow-up. In this context, the laboratory must ensure compliance with international quality requirements so as to guarantee that the change in the result of HbA1C between two successive determinations of a patient shows a clinical variation and not an analytical variation. In this paper, the analytical performance of a chromatographic method was evaluated by processing control samples provided by the manufacturer. The coefficient of total variation, bias, total error, reference value for the change and significant clinical change to the critical point of 7.0% -NGSP were calculated. The method evaluated met all international quality requirements, which would measure the change in HbA1C concentration in two successive determinations of a patient, due to a change in clinical condition and not to the analytical variability.

Keywords : Glycated hemoglobin; HbA_1C; Chromatography; Diabetes diagnosis; Method; Analytical performance; Total error; Change reference value; Clinically significant change.