Resumen

UNGER, Gisela et al. Analytical performance evaluation of three methods for hemoglobin A_1c quantification. Acta bioquím. clín. latinoam. [online]. 2014, vol.48, n.2, pp.183-189. ISSN 0325-2957.

The laboratory must guarantee the accuracy of HbA1c results meeting the increasingly strict international analytical quality standards and assuring that an HbA_1c variation of 0.5 percentage points (%-NGSP) or more between two consecutive controls of a diabetic patient is due to a clinical variation and not to an analytical variation. In this paper, the analytical performance of three commercial methods for HbA_1c: Immunoturbidimetric, Chromatographic and Enzymatic Cation Exchange, were evaluated. For this purpose, commercial controls with assigned values traceable to the IFCC reference method for HbA_1c were processed. For each methodology, total Coefficient of Variation (CV%), Bias%, Total Error (TE%), Change Reference Value and Clinically Significant Change (CSC) at the critical point of HbA_1c 7.0%-NGSP were determined. Within the analytical conditions of this study, only the immunoturbidimetric method had an acceptable analytical performance, allowing attribute a change in 0.5%-NGSP to a significant clinical variation. Faced with international recommendations on the use of HbA1c on control and diagnosis of diabetes, the importance of choosing a method that meets the minimum analytical quality requirements to ensure the clinical utility of HbA_1c result is undeniable.

Palabras clave : Hemoglobin A_1c; Glycated hemoglobin; Analytical quality requirements; Methodology; Analytical performance; Change reference value; Diabetes diagnosis; Management of the diabetic patient.

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