Campuzano-Maya G, Latorre-Sierra G

Language: Spanish
References: 198
Page: 211-241
PDF size: 1453.48 Kb.

ABSTRACT

Humanity is facing a diabetes epidemic with uncontrolled progress. According to the World Health Organization, the world’s diabetic population has risen from 30 million in 1985, to 220 million in 2009, and is expected that by 2030 this figure will reach 336 million. Diabetes is defined as hyperglycemia that over the years is manifested by to multiple organ failure, being the primary cause of blindness, kidney failure and amputations in adults, and a major cause of heart disease and thrombosis. Since its discovery, hemoglobin A1C (HbA1c) has been the most accurate indicator for monitoring diabetic patients and due to its standardization in recent years, the American Diabetes Association (ADA) recently has incorporated it as the first diagnostic criteria for asymptomatic diabetes or when the disease is suspected. The ADA has defined three cutoff points for HbA1c: ≤ 5.6%, non-diabetic level; between 5,7% and 6,4%, pre-diabetic level; and ≥ 6,5%, compatible with the diagnosis of diabetes. Similarly, the ADA maintains as the goal in treated patients an HbA1c ≤ 7%. Furthermore, the ADA emphasizes on the need for these test to be made in a clinical laboratory with instruments and reagents certified by the NGSP (National Glycohemoglobin Standardization Program) and standardized according to the specifications of the DCCT (Diabetes Control and Complications Trial). The module analyzes clinical and epidemiological aspects of diabetes mellitus and historical aspects of the assay, the bases of glycation as a non-enzymatic biochemical phenomenon, the available methods, and the pre-analytical, analytical and post-analytic factors that could affect the assay, and that both the physician and the clinical laboratory should be aware when requesting or running a test, respectively.

REFERENCES

1. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009; 32: 1327-1334.

2. Standards of medical care in diabetes-2010. Diabetes Care 2010;33 Suppl 1: S11-61.

3. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993; 329: 977-986.

4. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998; 352: 837-853.

5. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412.

6. Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet 2010; 376: 124-136.

7. Gonen B, Rubenstein A, Rochman H, Tanega SP, Horwitz DL. Haemoglobin A1: An indicator of the metabolic control of diabetic patients. Lancet 1977; 2: 734-737.

8. Davis JE, McDonald JM, Jarett L. A high-performance liquid chromatography method for hemoglobin A1c. Diabetes 1978; 27: 102-107.

9. Beccaria L, Chiumello G, Gianazza E, Luppis B, Righetti PG. Hemoglobin A1C separation by isoelectric focusing. Am J Hematol 1978; 4: 367-374.

10. Poynard JP, Malgrange D, Couchot J, Caron J, Leutenegger M, Maquart FX, et al. Dosage par micromethode de l’hemoglobine A1c chez les diabetiques. Premiers resultats. Nouv Presse Med 1978; 7: 1648-1649.

11. Effect of intensive diabetes management on macrovascular events and risk factors in the Diabetes Control and Complications Trial. Am J Cardiol 1995; 75: 894-903.

12. Turner RC. The U.K. Prospective Diabetes Study. A review. Diabetes Care 1998; 21 Suppl 3: C35-38.

13. Standards of medical care for patients with diabetes mellitus. Diabetes Care 2000; 23 Suppl 1: S32-42.

14. Standards of medical care in diabetes. Diabetes Care 2005; 28 Suppl 1: S4-S36.

15. Standards of medical care in diabetes-2007. Diabetes Care 2007; 30 Suppl 1: S4-S41.

16. Standards of medical care in diabetes--2008. Diabetes Care 2008; 31 Suppl 1: S12-54.

17. Standards of medical care in diabetes--2009. Diabetes Care 2009; 32 Suppl 1: S13-61.

18. Harris SB, Lank CN. Recommendations from the Canadian Diabetes Association. 2003 guidelines for prevention and management of diabetes and related cardiovascular risk factors. Can Fam Physician 2004; 50: 425-433.

19. Bhattacharyya OK, Shah BR, Booth GL. Management of cardiovascular disease in patients with diabetes: the 2008 Canadian Diabetes Association guidelines. CMAJ 2008;179:920-926.

20. Holt RI, Jacklin PB, Round JA, Mugglestone MA, Hughes RG. Gestational diabetes mellitus: NICE for the U.S.? A comparison of the American Diabetes Association and the American College of Obstetricians and Gynecologists Guidelines With the U.K. National Institute for Health and clinical excellence guidelines: response to Simmons et al. Diabetes Care 2010; 33: e46- 47; author reply e48.

21. Nelson RG, Tuttle KR. The new KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and CKD. Blood Purif 2007; 25: 112-114.

22. Sheehy AM, Flood GE, Tuan WJ, Liou JI, Coursin DB, Smith MA. Analysis of guidelines for screening diabetes mellitus in an ambulatory population. Mayo Clin Proc 2010; 85: 27-35.

23. Ryden L, Standl E, Bartnik M, Van den Berghe G, Betteridge J, de Boer MJ, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007; 28: 88-136.

24. Asociación Latinoamericana de Diabetes. Guías ALAD de diagnóstico, control y tratamiento de la diabetes mellitus tipo 2 2007.

25. Dyck R, Osgood N, Lin TH, Gao A, Stang MR. Epidemiology of diabetes mellitus among First Nations and non-First Nations adults. CMAJ 2010; 182: 249-256.

26. Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, et al. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care 2009; 32: 287-294.

27. Li C, Ford ES, Zhao G, Mokdad AH. Prevalence of pre-diabetes and its association with clustering of cardiometabolic risk factors and hyperinsulinemia among U.S. adolescents: National Health and Nutrition Examination Survey 2005-2006. Diabetes Care 2009; 32: 342-347.

28. Ramlo-Halsted BA, Edelman SV. The natural history of type 2 diabetes. Implications for clinical practice. Prim Care 1999; 26: 771-789.

29. Diagnosis and classification of diabetes mellitus. Diabetes Care 2010; 33 Suppl 1: S62-69.

30. Smyth S, Heron A. Diabetes and obesity: the twin epidemics. Nature Medicine 2005; 12: 75-80.

31. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care 1998; 21: 1414-1431.

32. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27: 1047-1053.

33. Hildebrand P, Beglinger C. Nondispers ve infrared spectrometry: a new method for the detection of Helicobacter pylori infection with the 13C-urea breath test. Clin Infect Dis 1997; 25: 1003-1005.

34. http://www.idf.org/fact-sheet-impaired-glucosetolerance-igt.

35. Harris MI, Klein R, Welborn TA, Knuiman MW. Onset of NIDDM occurs at least 4-7 yr before clinical diagnosis. Diabetes Care 1992; 15: 815-819.

36. Young TK, Mustard CA. Undiagnosed diabetes: does it matter? CMAJ 2001; 164: 24-28.

37. Wee CC, Hamel MB, Huang A, Davis RB, Mittleman MA, McCarthy EP. Obesity and undiagnosed diabetes in the U.S. Diabetes Care 2008; 31: 1813-1815.

38. Hernandez-Mijares A, Sola-Izquierdo E, Ballester- Mecho F, Mari-Herrero MT, Gilabert- Moles JV, Gimeno-Clemente N, et al. Obesity and overweight prevalences in rural and urban populations in East Spain and its association with undiagnosed hypertension and Diabetes Mellitus: a cross-sectional population-based survey. BMC Res Notes 2009; 2: 151.

39. Sayer AA, Dennison EM, Syddall HE, Gilbody HJ, Phillips DI, Cooper C. Type 2 diabetes, muscle strength, and impaired physical function: the tip of the iceberg? Diabetes Care 2005; 28: 2541-2542.

40. Wraight PR, Lawrence SM, Campbell DA, Colman PG. Retrospective data for diabetic foot complications: only the tip of the iceberg? Intern Med J 2006; 36: 197-199.

41. Keegan MT, Goldberg ME, Torjman MC, Coursin DB. Perioperative and critical illness dysglycemia-- controlling the iceberg. J Diabetes Sci Technol 2009; 3: 1288-1291.

42. Andrade F. Estimating diabetes and diabetesfree life expectancy in Mexico and seven major cities in Latin America and the Caribbean. Rev Panam Salud Publica 2009; 26: 9-16.

43. Cowie CC, Rust KF, Byrd-Holt DD, Gregg EW, Ford ES, Geiss LS, et al. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in 1988-2006. Diabetes Care 2010; 33: 562-568.

44. Harris MI. Undiagnosed NIDDM: clinical and public health issues. Diabetes Care 1993; 16: 642-652.

45. Mooy JM, Grootenhuis PA, de Vries H, Valkenburg HA, Bouter LM, Kostense PJ, et al. Prevalence and determinants of glucose intolerance in a Dutch caucasian population. The Hoorn Study. Diabetes Care 1995; 18: 1270-1273.

46. Hadaegh F, Bozorgmanesh MR, Ghasemi A, Harati H, Saadat N, Azizi F. High prevalence of undiagnosed diabetes and abnormal glucose tolerance in the Iranian urban population: Tehran Lipid and Glucose Study. BMC Public Health 2008; 8: 176.

47. Cases A. Enfermedad macro y microvascular en la diabetes mellitus tipo 2. Nefrologia 2002; 22: 406-411.

48. King KD. Microvascular and macrovascular complications of diabetes mellitus. Am J Pharm Educ 2005; 69: 1-10.

49. Donaghue KC, Chiarelli F, Trotta D, Allgrove J, Dahl-Jorgensen K. Microvascular and macrovascular complications associated with diabetes in children and adolescents. Pediatr Diabetes 2009; 10 Suppl 12: 195-203.

50. Aiello LP, Gardner TW, King GL, Blankenship G, Cavallerano JD, Ferris FL, 3rd, et al. Diabetic retinopathy. Diabetes Care 1998; 21: 143-156.

51. Frank RN. Diabetic retinopathy. N Engl J Med 2004; 350: 48-58.

52. Remuzzi G, Schieppati A, Ruggenenti P. Clinical practice. Nephropathy in patients with type 2 diabetes. N Engl J Med 2002; 346: 1145-1151.

53. Shlipak M. Diabetic nephropathy. Clin Evid (Online) 2009; 2009.

54. Zelmanovitz T, Gerchman F, Balthazar AP, Thomazelli FC, Matos JD, Canani LH. Diabetic nephropathy. Diabetol Metab Syndr 2009; 1: 10.

55. Joseph AJ, Friedman EA. Diabetic nephropathy in the elderly. Clin Geriatr Med 2009; 25: 373-389.

56. Johannesson A, Larsson GU, Ramstrand N, Turkiewicz A, Wirehn AB, Atroshi I. Incidence of lower-limb amputation in the diabetic and nondiabetic general population: a 10-year population-based cohort study of initial unilateral and contralateral amputations and reamputations. Diabetes Care 2009; 32: 275-280.

57. Said G. Diabetic neuropathy-a review. Nat Clin Pract Neurol 2007; 3: 331-340.

58. Bloomgarden ZT. Diabetic neuropathy. Diabetes Care 2008; 31: 616-621.

59. Edwards JL, Vincent AM, Cheng HT, Feldman EL. Diabetic neuropathy: mechanisms to management. Pharmacol Ther 2008; 120: 1-34.

60. Vinik AI, Strotmeyer ES, Nakave AA, Patel CV. Diabetic neuropathy in older adults. Clin Geriatr Med 2008; 24: 407-435, v.

61. Mahmood D, Singh BK, Akhtar M. Diabetic neuropathy: therapies on the horizon. J Pharm Pharmacol 2009; 61: 1137-1145.

62. Bekler HI, Ertav A. Preclinical symptoms of the diabetic foot. J Am Podiatr Med Assoc 2009; 99: 114-120.

63. Wukich DK. Current concepts review: diabetic foot ulcers. Foot Ankle Int 2010; 31: 460-467.

64. Sanjeev Kumar G, Panda S, Surya Kumar S. The etiopathogenesis of the diabetic foot: an unrelenting epidemic. Int J Low Extrem Wounds 2010; 9: 127-131.

65. Adeniyi AF, Adeleye JO, Adeniyi CY. Diabetes, sexual dysfunction and therapeutic exercise: a 20 year review. Curr Diabetes Rev 2010; 6: 201-206.

66. Ziaei-Rad M, Vahdaninia M, Montazeri A. Sexual dysfunctions in patients with diabetes: a study from Iran. Reprod Biol Endocrinol 2010; 8: 50.

67. Lorenzi M. Glucose toxicity in the vascular complications of diabetes: the cellular perspective. Diabetes Metab Rev 1992; 8: 85-103.

68. Carnethon MR, Biggs ML, Barzilay J, Kuller LH, Mozaffarian D, Mukamal K, et al. Diabetes and coronary heart disease as risk factors for mortality in older adults. Am J Med 2010; 123: 556 e551-559.

69. Colwell JA. Vascular thrombosis in type II diabetes mellitus. Diabetes 1993; 42: 8-11.

70. Roberts JD, Oudit GY, Fitchett DH. Acute coronary thrombosis in a patient with diabetes and severe hyperglycemia. Can J Cardiol 2009; 25: e217-219.

71. Hu G, Sarti C, Jousilahti P, Peltonen M, Qiao Q, Antikainen R, et al. The impact of history of hypertension and type 2 diabetes at baseline on the incidence of stroke and stroke mortality. Stroke 2005; 36: 2538-2543.

72. Stern MP. Diabetes and cardiovascular disease. The “common soil” hypothesis. Diabetes 1995; 44: 369-374.

73. Fore WW. Noninsulin-dependent diabetes mellitus. The prevention of complications. Med Clin North Am 1995; 79: 287-298.

74. Jeppsson JO, 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.

75. Jenkins M, Ratnaike S. Capillary electrophoresis of hemoglobin. Clin Chem Lab Med 2003; 41: 747-754.

76. Saxena S, Mitchell P, Rochtchina E. Five-year incidence of cataract in older persons with diabetes and pre-diabetes. Ophthalmic Epidemiol 2004; 11: 271-277.

77. Koga M, Kasayama S. Clinical impact of glycated albumin as another glycemic control marker. Endocr J 2010.

78. Peterson KP, Pavlovich JG, Goldstein D, Little R, England J, Peterson CM. What is hemoglobin A1c? An analysis of glycated hemoglobins by electrospray ionization mass spectrometry. Clin Chem 1998; 44: 1951-1958.

79. Inaba M, Okuno S, Kumeda Y, Yamada S, Imanishi Y, Tabata T, et al. Glycated albumin is a better glycemic indicator than glycated hemoglobin values in hemodialysis patients with diabetes: effect of anemia and erythropoietin injection. J Am Soc Nephrol 2007; 18: 896-903.

80. Lu L, Pu LJ, Xu XW, Zhang Q, Zhang RY, Zhang JS, et al. Association of serum levels of glycated albumin, C-reactive protein and tumor necrosis factor-alpha with the severity of coronary artery disease and renal impairment in patients with type 2 diabetes mellitus. Clin Biochem 2007; 40: 810-816.

81. Armbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987; 33: 2153-2163.

82. Lim HS. Fructosamine and diabetes. Singapore Med J 1988; 29: 541, 543.

83. Youssef D, El Abbassi A, Jordan RM, Peiris AN. Fructosamine--an underutilized tool in diabetes management: case report and literature review. Tenn Med 2008; 101: 31-33.

84. Doery JC, Regan J, Healy D, Bishop S, Tippett C. Fructosamine in gestational diabetes. Am J Obstet Gynecol 1990; 162: 1635-1636.

85. Fitzgibbons JF, Koler RD, Jones RT. Red cell age-related changes of hemoglobins AIa+b and AIc in normal and diabetic subjects. J Clin Invest 1976; 58: 820-824.

86. Bunn HF, Haney DN, Kamin S, Gabbay KH, Gallop PM. The biosynthesis of human hemoglobin A1c. Slow glycosylation of hemoglobin in vivo. J Clin Invest 1976; 57: 1652-1659.

87. Tahara Y, Shima K. The response of GHb to stepwise plasma glucose change over time in diabetic patients. Diabetes Care 1993; 16: 1313-1314.

88. Tahara Y, Shima K. Kinetics of HbA1c, glycated albumin, and fructosamine and analysis of their weight functions against preceding plasma glucose level. Diabetes Care 1995; 18: 440-447.

89. Maillard LC. Condensation des acides aminés sur les sucres; formation de melanoidines par voie méthodique. CR Acad Sci Paris 1912; 154: 66-68.

90. Kunkel HG, Wallenius G. New hemoglobin in normal adult blood. Science 1955; 122: 288.

91. Allen DW, Schroeder, W. A., Balog, J. Observations on the chromatographic heterogeneity of normal adult and fetal human hemoglobin: A study of the effects of crystallization and chromatography on the heterogeneity and isoleucine content. Journal of the American Chemical Society 1958; 80: 1628-1634.

92. Huisman TH, Sydenstricker VP. Difference in gross structure of two electrophoretically identical ‘minor’ haemoglobin components. Nature 1962; 193: 489-491.

93. Huisman TH, Dozy AM. Studies on the heterogeneity of hemoglobin. V. Binding of hemoglobin with oxidized glutathione. J Lab Clin Med 1962; 60: 302-319.

94. Bookchin RM, Gallop PM. Structure of hemoglobin AIc: nature of the N-terminal beta chain blocking group. Biochem Biophys Res Commun 1968; 32: 86-93.

95. Rahbar S. An abnormal hemoglobin in red cells of diabetics Clinica Chimica Acta 1968; 22: 296-298.

96. Rahbar S, Blumenfeld O, Ranney HM. Studies of an unusual hemoglobin in patients with diabetes mellitus. Biochem Biophys Res Commun 1969; 36: 838-843.

97. Knowles HC, Jr. The problem of the relation of the control of diabetes to the development of vascular disease. Trans Am Clin Climatol Assoc 1964; 76: 142-147.

98. Trivelli LA, Ranney HM, Lai HT. Hemoglobin components in patients with diabetes mellitus. N Engl J Med 1971; 284: 353-357.

99. Campuzano-Maya G. Utilidad de la hemoglobina glicosilada en diabetes. Temas de Laboratorio 1982; 1: 2-6.

100. Boucher BJ, Burrin JM, Gould BJ, John PN, Lewis G, Owens C, et al. A collaborative study of the measurement of glycosylated haemoglobin by several methods in seven laboratories in the United Kingdom. Diabetologia 1983; 24: 265-271.

101. Little RR, Wiedmeyer HM, England JD, Wilke AL, Rohlfing CL, Wians FH, Jr., et al. Interlaboratory standardization of measurements of glycohemoglobins. Clin Chem 1992; 38: 2472-2478.

102. Weykamp CW, Penders TJ, Muskiet FA, van der Slik W. Evaluation of a reference material for glycated haemoglobin. Eur J Clin Chem Clin Biochem 1996; 34: 67-72.

103. Kobold U, Jeppsson JO, Dulffer T, Finke A, Hoelzel W, Miedema K. Candidate reference methods for hemoglobin A1c based on peptide mapping. Clin Chem 1997; 43: 1944-1951.

104. Finke A, Kobold U, Hoelzel W, Weykamp C, Miedema K, Jeppsson JO. Preparation of a candidate primary reference material for the international standardisation of HbA1c determinations. Clin Chem Lab Med 1998; 36: 299-308.

105. Hoelzel W, Miedema K. Development of a reference system for the international standardization of HbA1c/glycohemoglobin determinations. J Int Fed Clin Chem 1996; 9: 62-64, 66-67.

106. Weykamp C, John WG, Mosca A, Hoshino T, Little R, Jeppsson JO, et al. The IFCC Reference Measurement System for HbA1c: a 6-year progress report. Clin Chem 2008; 54: 240-248.

107. Consensus statement on the worldwide standardization of the hemoglobin A1C measurement: the American Diabetes Association, European Association for the Study of Diabetes, International Federation of Clinical Chemistry and Laboratory Medicine, and the International Diabetes Federation. Diabetes Care 2007; 30: 2399-2400.

108. Hanas R, John G. 2010 consensus statement on the worldwide standardization of the hemoglobin a1c measurement. Clin Chem 2010; 56: 1362-1364.

109. Hanas R, John G. 2010 Consensus statement on the worldwide standardization of the hemoglobin A(1c) measurement. Clin Chem Lab Med 2010; 48: 775-776.

110. Hanas R, John G. 2010 consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Diabet Med 2010; 27: 737-738.

111. Hanas R, John G. 2010 consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Pediatr Diabetes 2010; 11: 209-211.

112. Hanas R, John G. 2010 consensus statement on the worldwide standardization of the hemoglobin A1C measurement. Diabetes Care 2010; 33: 1903-1904.

113. Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ. Translating the A1C assay into estimated average glucose values. Diabetes Care 2008; 31: 1473-1478.

114. Weykamp C, John WG, Mosca A. A review of the challenge in measuring hemoglobin A1c. J Diabetes Sci Technol 2009; 3: 439-445.

115. Borg R, Kuenen JC, Carstensen B, Zheng H, Nathan DM, Heine RJ, et al. Associations between features of glucose exposure and A1C: the A1C-Derived Average Glucose (ADAG) study. Diabetes 2010; 59: 1585-1590.

116. Goodall I. HbA1c standardisation destination-- global IFCC Standardisation. How, why, where and when--a tortuous pathway from kit manufacturers, via inter-laboratory lyophilized and whole blood comparisons to designated national comparison schemes. Clin Biochem Rev 2005; 26: 5-19.

117. John WG, Mosca A, Weykamp C, Goodall I. HbA1c standardisation: history, science and politics. Clin Biochem Rev 2007; 28: 163-168.

118. Weykamp CW, Penders TJ, Miedema K, Muskiet FA, van der Slik W. Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods. Clin Chem 1995; 41: 82-86.

119. A desktop guide to Type 1 (insulin-dependent) diabetes mellitus. European Diabetes Policy Group 1998. Diabet Med 1999; 16: 253-266.

120. A desktop guide to Type 2 diabetes mellitus. European Diabetes Policy Group 1999. Diabet Med 1999; 16: 716-730.

121. International Diabetes Federation. Clinical Guidelines Task Force. Global guideline for Type 2 diabetes. Brussels, 2005.

122. Camargo JL, Zelmanovitz T, Paggi A, Friedman R, Gross JL. Accuracy of conversion formulae for estimation of glycohaemoglobin. Scand J Clin Lab Invest 1998; 58: 521-528.

123. List of NGSP certified methods. Disponible en: http://www.ngsp.org/prog/index.html, accesado en junio de 2010.

124. John WG, Braconnier F, Miedema K, Aulesa C, Piras G. Evaluation of the Menarini-Arkray HA 8140 hemoglobin A1c analyzer. Clin Chem 1997; 43: 968-975.

125. Gibb I, Parnham A, Fonfrede M, Lecock F. Multicenter evaluation of Tosoh glycohemoglobin analyzer. Clin Chem 1999; 45: 1833-1841.

126. Higgins TN, Blakney GB, Dayton J. Analytical evaluation of the Bio-Rad variant II automated HbA(1C) analyzer. Clin Biochem 2001; 34: 361-365.

127. Little RR, Rohlfing CL, Wiedmeyer HM, Myers GL, Sacks DB, Goldstein DE. The National Glycohemoglobin Standardization Program: a five-year progress report. Clin Chem 2001; 47: 1985-1992.

128. Klenk DC, Hermanson GT, Krohn RI, Fujimoto EK, Mallia AK, Smith PK, et al. Determination of glycosylated hemoglobin by affinity chromatography: comparison with colorimetric and ion-exchange methods, and effects of common interferences. Clin Chem 1982; 28: 2088-2094.

129. Little RR, Vesper H, Rohlfing CL, Ospina M, Safar-Pour S, Roberts WL. Validation by a mass spectrometric reference method of use of boronate affinity chromatography to measure glycohemoglobin in the presence of hemoglobin S and C traits. Clin Chem 2005; 51: 264-265.

130. Little RR, Roberts WL. A review of variant hemoglobins interfering with hemoglobin A1c measurement. J Diabetes Sci Technol 2009; 3: 446-451.

131. Wilson DH, Bogacz JP, Forsythe CM, Turk PJ, Lane TL, Gates RC, et al. Fully automated assay of glycohemoglobin with the Abbott IMx analyzer: novel approaches for separation and detection. Clin Chem 1993; 39: 2090-2097.

132. John WG, Edwards R, Price CP. Laboratory evaluation of the DCA 2000 clinic HbA1c immunoassay analyser. Ann Clin Biochem 1994; 31 ( Pt 4): 367-370.

133. Sakurabayashi I, Watano T, Yonehara S, Ishimaru K, Hirai K, Komori T, et al. New enzymatic assay for glycohemoglobin. Clin Chem 2003; 49: 269-274.

134. National Glycohemoglobin Standardization Program Protocol. Disponible en: http://www.ngsp. org/prog/protocol/prot.html, accesado en junio 2010.

135. European Reference Laboratory. Disponible en: http://www.euroreflab.com, accesado en junio 2010.

136. Bruns DE. Standardization, calibration, and the care of diabetic patients. Clin Chem 1992; 38: 2363-2364.

137. Narayanan S. The preanalytic phase. An important component of laboratory medicine. Am J Clin Pathol 2000; 113: 429-452.

138. Lippi G, Fostini R, Guidi GC. Quality improvement in laboratory medicine: extra-analytical issues. Clin Lab Med 2008; 28: 285-294, vii.

139. Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002; 48: 436-472.

140. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002; 48: 691-698.

141. Valenstein PN, Sirota RL. Identification errors in pathology and laboratory medicine. Clin Lab Med 2004; 24: 979-996, vii.

142. Herman WH, Fajans SS. Hemoglobin A1c for the diagnosis of diabetes: practical considerations. Pol Arch Med Wewn 2010; 120: 37-40.

143. Wiener K, Roberts NB. Age does not influence levels of HbA1c in normal subject. QJM 1999; 92: 169-173.

144. Nuttall FQ. Effect of age on the percentage of hemoglobin A1c and the percentage of total glycohemoglobin in non-diabetic persons. J Lab Clin Med 1999; 134: 451-453.

145. Rohlfing C, Wiedmeyer HM, Little R, Grotz VL, Tennill A, England J, et al. Biological variation of glycohemoglobin. Clin Chem 2002; 48: 1116-1118.

146. Kim C, Bullard KM, Herman WH, Beckles GL. Association between iron deficiency and A1C levels among adults without diabetes in the National Health and Nutrition Examination Survey, 1999-2006. Diabetes Care 2010; 33: 780-785.

147. Coban E, Ozdogan M, Timuragaoglu A. Effect of iron deficiency anemia on the levels of hemoglobin A1c in nondiabetic patients. Acta Haematol 2004; 112: 126-128.

148. Bry L, Chen PC, Sacks DB. Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin. Clin Chem 2001; 47: 153-163.

149. Schnedl WJ, Lahousen T, Lang T, Lipp RW, Yonehara S, Fukunaga S, et al. Determination of glycated hemoglobin in clinically silent hemoglobin variants. Diabetes Metab Res Rev 2004; 20: 460-465.

150. Moridani MY, Verjee Z, Allen LC. Analytical evaluation of hemoglobin A(1c) dual kit assay on Bio-Rad Variant II: an automated HPLC hemoglobin analyzer for the management of diabetic patients. Clin Biochem 2003; 36: 317-320.

151. Liew CF, Cheah JS. Hereditary spherocytosis, a pitfall in the assessment of glycaemic control. Singapore Med J 2003; 44: 94-97.

152. Panzer S, Kronik G, Lechner K, Bettelheim P, Neumann E, Dudczak R. Glycosylated hemoglobins (GHb): an index of red cell survival. Blood 1982; 59: 1348-1350.

153. Rohlfing CL, Connolly SM, England JD, Hanson SE, Moellering CM, Bachelder JR, et al. The effect of elevated fetal hemoglobin on hemoglobin A1c results: five common hemoglobin A1c methods compared with the IFCC reference method. Am J Clin Pathol 2008; 129: 811-814.

154. Karsegard J, Wicky J, Mensi N, Caulfield A, Philippe J. Spurious glycohemoglobin values associated with hydroxyurea treatment. Diabetes Care 1997; 20: 1211-1212.

155. Albright ES, Ovalle F, Bell DS. Artificially low hemoglobin A1c caused by use of dapsone. Endocr Pract 2002; 8: 370-372.

156. Ceriello A, Giugliano D, Dello Russo P, Sgambato S, D’Onofrio F. Increased glycosylated haemoglobin A1 in opiate addicts: evidence for a hyperglycaemic effect of morphine. Diabetologia 1982; 22: 379.

157. Nathan DM, Francis TB, Palmer JL. Effect of aspirin on determinations of glycosylated hemoglobin. Clin Chem 1983; 29: 466-469.

158. Davie SJ, Gould BJ, Yudkin JS. Effect of vitamin C on glycosylation of proteins. Diabetes 1992; 41: 167-173.

159. Camargo JL, Felisberto M, Gross JL. Effect of pre-analytical variables on glycohemoglobin measurements in routine clinical care. Clin Biochem 2004; 37: 836-839.

160. Selvaraj N, Bobby Z, Sathiyapriya V. Effect of lipid peroxides and antioxidants on glycation of hemoglobin: an in vitro study on human erythrocytes. Clin Chim Acta 2006; 366: 190-195.

161. Camargo JL, Stifft J, Gross JL. The effect of aspirin and vitamins C and E on HbA1c assays. Clin Chim Acta 2006; 372: 206-209.

162. Camargo JL, Gross JL. [Glycohemoglobin (GHb): clinical and analytical aspects]. Arq Bras Endocrinol Metabol 2004; 48: 451-463.

163. Robertson M. Artificially low HbA1c associated with treatment with ribavirin. BMJ 2008; 336:505.

164. Garrib A, Griffiths W, Eldridge P, Hatton R, Worsley A, Crook M. Artifactually low glycated haemoglobin in a patient with severe hypertriglyceridaemia. J Clin Pathol 2003; 56: 394-395.

165. Tarim O, Kucukerdogan A, Gunay U, Eralp O, Ercan I. Effects of iron deficiency anemia on hemoglobin A1c in type 1 diabetes mellitus. Pediatr Int 1999; 41: 357-362.

166. Hashimoto K, Noguchi S, Morimoto Y, Hamada S, Wasada K, Imai S, et al. A1C but not serum glycated albumin is elevated in late pregnancy owing to iron deficiency. Diabetes Care 2008; 31: 1945-1948.

167. Proto G, De Marchi S, Cecchin E. Glycosylated hemoglobin in chronic alcoholics. Drug Alcohol Depend 1983; 12: 299-302.

168. Ng JM, Jennings PE, Laboi P, Jayagopal V. Erythropoetin treatment significantly alters measured glycated haemoglobin (HbA1c). Diabet Med 2008; 25: 239-240.

169. Passare G, Fastbom J, Torring O, Viitanen M. Drug use and increased HbA1c levels in nondiabetic very elderly persons: the Kungsholmen project. Eur J Clin Pharmacol 2004; 60: 121-126.

170. De Boer MJ, Miedema K, Casparie AF. Glycosylated haemoglobin in renal failure. Diabetologia 1980; 18: 437-440.

171. Selvaraj N, Bobby Z, Sridhar MG. Increased glycation of hemoglobin in chronic renal failure: [corrected] potential role of oxidative stress. Arch Med Res 2008; 39: 277-284.

172. Blincko S, Anzetse J, Edwards R. Measurement of glycated haemoglobin in whole blood by a novel fluorescence quenching assay. Ann Clin Biochem 2000; 37 ( Pt 4): 492-497.

173. Hoberman HD, Chiodo SM. Elevation of the hemoglobin A1 fraction in alcoholism. Alcohol Clin Exp Res 1982; 6: 260-266.

174. Stevens VJ, Fantl WJ, Newman CB, Sims RV, Cerami A, Peterson CM. Acetaldehyde adducts with hemoglobin. J Clin Invest 1981; 67: 361-369.

175. Koskinen LK, Korpela MM, Lahtela JT, Laippala PJ, Pikkarainen PH, Koivula TA. Effect of acetaldehyde and acetylsalicylic acid on HbA1c chromatography in the FPLC method with Mono S cation exchanger. Clin Chim Acta 1998; 275: 53-61.

176. McCready F, Cundy T. Effects of splenectomy for hereditary spherocytosis on glycated haemoglobin in a woman with Type 2 diabetes. Diabet Med 2009; 26: 570-571.

177. Weykamp CW, Penders TJ, Siebelder CW, Muskiet FA, van der Slik W. Interference of carbamylated and acetylated hemoglobins in assays of glycohemoglobin by HPLC, electrophoresis, affinity chromatography, and enzyme immunoassay. Clin Chem 1993; 39: 138-142.

178. Weykamp CW, Miedema K, de Haan T, Doelman CJ. Carbamylated hemoglobin interference in glycohemoglobin assays. Clin Chem 1999; 45: 438-440.

179. Fajans SS, Conn JW. The early recognition of diabetes mellitus. Ann N Y Acad Sci 1959; 82: 208-218.

180. Rushforth NB, Bennett PH, Steinberg AG, Burch TA, Miller M. Diabetes in the Pima Indians. Evidence of bimodality in glucose tolerance distributions. Diabetes 1971; 20: 756-765.

181. Rushforth NB, Bennett PH, Steinberg AG, Miller M. Comparison of the value of the two- and one-hour glucose levels of the oral GTT in the diagnosis of diabetes in Pima Indians. Diabetes 1975;24:538-546.

182. Bennett PH, Rushforth NB, Miller M, Le- Compte PM. Epidemiologic studies of diabetes in the Pima Indians. Recent Prog Horm Res 1976;32:333-376.

183. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. National Diabetes Data Group. Diabetes 1979; 28: 1039-1057.

184. Kramer CK, Araneta MR, Barrett-Connor E. A1C and diabetes diagnosis: The Rancho Bernardo Study. Diabetes Care 2010; 33: 101-103.

185. Lenters-Westra E, Slingerland RJ. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Clin Chem 2010; 56: 44-52.

186. Delaronde S. Barriers to A1C testing among a managed care population. Diabetes Educ 2005; 31: 235-239.

187. Agus MS, Alexander JL, Wolfsdorf JI. Utility of immediate hemoglobin A1c in children with type I diabetes mellitus. Pediatr Diabetes 2010.

188. Sacks DB. Global harmonization of hemoglobin A1c. Clin Chem 2005; 51: 681-683.

189. Aldasouqi SA, Gossain VV. Hemoglobin A1c: past, present and future. Ann Saudi Med 2008; 28: 411-419.

190. Kilpatrick ES. Haemoglobin A1c in the diagnosis and monitoring of diabetes mellitus. J Clin Pathol 2008; 61: 977-982.

191. Saudek CD, Brick JC. The clinical use of hemoglobin A1c. J Diabetes Sci Technol 2009; 3: 629-634.

192. Pozzilli P, Leslie RD, Chan J, De Fronzo R, Monnier L, Raz I, et al. The A1C and ABCD of glycaemia management in type 2 diabetes: a physician’s personalized approach. Diabetes Metab Res Rev 2010; 26: 239-244.

193. Matsushita K, Blecker S, Pazin-Filho A, Bertoni A, Chang PP, Coresh J, et al. The Association of Hemoglobin A1c with Incident Heart Failure among Persons without Diabetes: The Atherosclerosis Risk in Communities (ARIC) Study. Diabetes 2010.

194. Kalyani RR, Saudek CD, Brancati FL, Selvin E. Association of diabetes, comorbidities, and A1C with functional disability in older adults: results from the National Health and Nutrition Examination Survey (NHANES), 1999-2006. Diabetes Care 2010; 33: 1055-1060.

195. Sikaris K. The correlation of hemoglobin A1c to blood glucose. J Diabetes Sci Technol 2009; 3: 429-438.

196. Nakagami T, Tajima N, Oizumi T, Karasawa S, Wada K, Kameda W, et al. Hemoglobin A1c in predicting progression to diabetes. Diabetes Res Clin Pract 2010; 87: 126-131.

197. Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events. A metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care 1999; 22: 233-240.

198. Dluhy RG, McMahon GT. Intensive glycemic control in the ACCORD and ADVANCE trials. N Engl J Med 2008; 358: 2630-2633.