2007, Number 3
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Bioquimia 2007; 32 (3)
Performance of HbA1c determination in a group of Mexican laboratories
Rojano-Rodríguez E, Acosta-González RI, Bocanegra-Alonso A, Rivera-Sánchez G, Sierra-Amor RI
Language: Spanish
References: 31
Page: 91-99
PDF size: 255.79 Kb.
ABSTRACT
In this study, we assessed the competency of Mexican laboratories for glicated hemoglobin (HbA1c) measurement, becoming the first study done in the country in order to establish 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 “A”, and six diabetic males, for sample “B”. An aliquot from each sample was prepared according to the reference method of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The assigned value was obtained from the European Reference Laboratory (ERL) for Glico hemoglobin. All samples were analyzed in triplicate; to estimate the differences 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 assigned for sample A and B, respectively. We found differences for the mean value of HbA1c between methods and equipments. This study demonstrated the need to continue evaluating the competence of the clinical laboratories in Mexico with the aim to improve the quality of the services provides to the patient.
REFERENCES
Bunn HF, Haney DN, Kamin S, Gabbay KH, Gallop PM. The biosynthesis of human hemoglobin A1c, slow glycosilation of the hemoglobin in vivo. J Clin Invest. 1976; 57 1652-9.
The Diabetes Control and Complications Trial Research Group. Effect of long-term monitoring of glycosilated hemoglobine levels in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329: 977-86.
Gabbay KH, Hasty K, Breslow JL, Ellison RC, Bunn HF, Gallop PM. Glycosylated hemoglobins and long-term blood glucose control in diabetes mellitus. J Clin Endocrinol Metab. 1977; 44: 859-64.
UKPDS Group. UK Prospective Diabetes Study 17: A nine-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann Intern Med. 1996; 124: 136-45.
UK Prospective Diabetes Study Group (UKPDS). Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352: 837-53.
The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329: 977-86.
Finke A, Kobold U, Hoelzel W, Weycamp C, Jeppsson JO, Miedema K. Preparation of a candidate primary reference material for the international standardization of HbA1c determinations. Clin Chem Lab Med. 1998; 6: 299-308.
Weykamp CA, Penders TJ, Muskiet FAJ, van der Slik W. Evaluation of a reference material for glycated haemoglobin. Eur J Clin Chem Clin Biochem. 1996; 34: 67-72.
Kobolb U, Jeepson JO, Dülffer T, Finke A, Hoelzel W, Miedema K. Candidate reference methods for hemoglobin A1c based on peptide mapping. Clin Chem. 1997; 43: 1944-51.
Little RR, Rohlfing CL, Wiedmeyer HM, Myers GL, Sacks DB, Goldstein DE. The national glycohemoglobin standardization program: a five years progress report. Clin Chem. 2001; 47: 1985-92.
American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2007; 30(S1): S4-S41.
Hoelzel W, Miedema K. Development of a reference system for the international standardization of HbA1c /glycohemoglobin determinations. J Int Fed Clin Chem. 1996; 9: 62-7.
Jeepson O, Kobold U, Barr J, Finke A, Hoelzel W, Hoshino T, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002; 40: 78-89.
Weykamp CW, Miedema K, De Haan T, Doellman Cess JA. Carbamylated hemoglobin interference in glycohemoglobin assays. Clin Chem. 1999; 45: 438-40.
Bry L, Chen PL, Sacks DB. Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin. Clin Chem. 2001; 47: 153-63.
Nathan DM, Francis TB, Palmer JL. Effect of aspirin on determinations of glycosylated hemoglobin. Clin Chem. 1983; 29: 466-9.
Ceriello A, Giugliano D, Dello Russo P, Sgambato S, D’Onoffio F. Increased glycosylated haemoglobin A1 in opiate addicts: evidence for a hyperglycaemic effect of morphine. Diabetologia. 1982; 22: 379.
Hoberman HD, Chiodo SM. Elevation of the hemoglobin A1 fraction in alcoholism. Alcohol Clin Exp Res. 1982; 6: 260-6.
Pasare G, Fastbom J, Töring O, Vitanen M. Drug use and increased HbA1c levels in non-diabetic very elderly persons: the Kungsholmen project. Eur J Clin Pharmacol. 2004; 60: 121-6.
Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, et al. IFCC Working group on HbA1c standardization. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem. 2004; 50: 166-74.
Raymondo S, Piana A, Pintos C, et al. Interlaboratory evolution of glycated hemoglobin methods in Uruguay between years 2001 and 2004. Clin Chem. 2005; 51(S1): 6, A126.
Mazziotta D. Evaluación externa de la calidad en glucosa y HbA1c. Acta Bioquim Clin Latinoam. 2006; (S4): 32.
Ramón F, Alsina MJ, Álvarez V, Bosch M, Cava F, Cortés M, et al. VII Programa de Evaluación Externa de la Calidad de Bioquímica (glicohemoglobina) de la Sociedad Española de Bioquímica Clínica y Patología Molecular 2003. Química Clínica. 2004; 23: 206-8.
Mosca A, Peleari R. Standardizzazione dell’emoglobina glicata nell’ambito dello studio DAI. Ann Ist Super Sanità. 2003; 39: 145-51.
List of NGSP certified methods (Updated 5/07). Disponible en: URL: http://www.ngsp.org/prog/index.html acceso en mayo de 2007.
Rojano E, Acosta-González RI, Bocanegra-Alonso A, Sierra-Amor RI. Programa de evaluación externa de la calidad para HbA1c/desempeño de un grupo de laboratorios mexicanos: estudio preliminar. Bioquimia. 2007; 32(Supl A): 83.
Diario Oficial de la Federación. NOM-166-SSA1-1997. Para la organización y funcionamiento de los laboratorios clínicos. 13 de Enero de 2000. Disponible en: URL: http://www.economia-nom.gob.mx/. Acceso mayo 22 de 2007.
Mares-Amezquita S, Cedillo-Martínez MP, Vázquez-Juárez G, Sierra-Amor RI. Proceso de reconocimiento como proveedor de ensayos de aptitud en el área de química clínica del programa de evaluación externa de la calidad de la AMBC A.C. Bioquimia. 2006; 31(Supl A): 124.
Sacks DB. Carbohydrate. In: Burtis CA; Ashwood ER, ed. Tietz textbook of clinical chemistry. Philadelphia: WB Saunders Company 1999; p. 750-808.
Nordin G, Dybkær R. Recommendation for tem and measurement unit for ‘‘HbA1c’’. Clin Chem Lab Med. 2007; 45: 1081-2.
Panteghini M, Garry WJ. Implementation of haemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med. 2007; 45: 942-4.