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Revista Mexicana de Patología Clínica y Medicina de Laboratorio

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2019, Number 1

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Rev Mex Patol Clin Med Lab 2019; 66 (1)

Correlation among two methods for glycated hemoglobin determination in diabetic Mexican patients for glycemic control

Gastélum-Cano JM, García-Alcalá H, Rodríguez-Gallegos AB, Fragoso-Flores J, Vera-Balderas AM
Full text How to cite this article

Language: English
References: 35
Page: 13-19
PDF size: 252.10 Kb.


Key words:

Glycated hemoglobin, glycemic control, capillary electrophoresis, ion exchange chromatography, diabetes mellitus.

ABSTRACT

Glycated hemoglobin (HbA1c) is a molecule derived from the non-enzymatic union of glucose in the β chain of Hemoglobin (Hb) A of red blood cells proposed for the American Diabetes Association (ADA) as the best test to evaluate long term glycemic control. The precision in its determination is a very important issue. The objective of this study was to analyze correlation and to determine glycemic control classification concordance among two methods : Ion-Exchange High-performance Liquid Chromatography (IE-HPLC) and Capillary Electrophoresis (CE) using two commercial instruments. A total of 249 samples from diabetic patients (n) were tested for HbA1c by both methods. Results were analyzed by correlation, Bland-Altman scatter plots and calculating CE’s sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV and NPV) to identify glycemic control (HPLC HbA1c ‹ 7%). The correlation was statistically significant (r = 0.9906, p ‹ 0.0001), Kappa correlation 0.959 (p ‹ 0.05); Bland-Altman plot analysis showed high level of agreement. CE Sn, SP, PPV and NPV were respectively: 98%, 98, 99% and 97%. Considerable differences in glycemic control classification were not observed. CE in Capillarys 2FP seems to be a good alternative method for HbA1c measuring for glycemic control.


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Rev Mex Patol Clin Med Lab. 2019;66