Desempeño de un grupo de laboratorios mexicanos en la determinación de HbA1c

Abstract

In this study, we assessed the competency of Mexican labo- ratories for glicated hemoglobin (HbA1c) measurement, becoming the first study done in the country in order to es- tablish a permanent quality assurance scheme program for HbA1c. Forty-six laboratories participated in the study, which were classified by group according to methodology and equipment used. All laboratories received two pooled samples from fresh blood obtained from six non-diabetic male donors, for sample and six diabetic males, for sample B. An aliquot from each sample was prepared ac- cording to the reference method of the International Fede- ration of Clinical Chemistry and Laboratory Medicine (IFCC). The assigned value was obtained from the Europe- an Reference Laboratory (ERL) for Glico hemoglobin. All samples were analyzed in triplicate; to estimate the diffe- rences from the mean for HbA1c between methods and equipments, ANOVA test was used. Laboratory results showed a very heterogeneous situation. For sample A, we found a mean value of 5.78 + 1.89% and a coefficient of variation (CV) of 32.7%. For sample B, the mean was 9.10 + 2.4%, and CV of 26.4%. On the other hand, in some specific laboratories optimal results were found with a CV < 2.5%. Reference values of 5.52% and 9.23% were as- signed for sample A and B, respectively. We found differ- ences for the mean value of HbA1c between methods and equipments. This study demonstrated the need to contin- ue evaluating the competence of the clinical laboratories in Mexico with the aim to improve the quality of the services provides to the patient. RESUMEN