medigraphic.com
ISSN 0185-6014 (Print)
Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio

2006, Number 3

<< Back Next >>

Rev Mex Patol Clin Med Lab 2006; 53 (3)

National Program of Glycohemoglobin Standardization

Terrés-Speziale AM

Language: Spanish
References: 46
Page: 157-165
PDF size: 163.64 Kb.


ABSTRACT

Background: In three multicentric international studies that were carried out in the United States (DCCT), England (UKPDS) and Japan (Kumamoto) it was clearly demonstrated that the risk for the development and the progression of the chronic complications of diabetes mellitus is closely related to the degree glycemic control, that can be reliably evaluated through glycohemoglobin HbA1c determinations quarterly. A new disposition of the health board in New York City —where old ones, Afro Americans, Hispanics, and the members of some other ethnic groups are severely affected—, entered in effect on January of 2006 forcing the clinical laboratories to inform the results into HbA1c to the Health Department of the City, as an effective method to monitor the DM epidemic, using only certified National Glycohemoglobin Standardization Program (NGSP) methods. Goal: To review the antecedents, foundations, structure and implications of NGSP in order to orient Clinical Laboratory Professionals on the procedure selection and use of methods for the determination of HbA1c. Method: This it is a revision work that was developed during the second trimester of year 2006, when we led ourselves to review, to study and to discuss basic the bibliographical information of available documents. Results: For the epidemiological monitoring of DM, the use of methods certified by NGSP is demanded. The intention of this program is standardize GHB test procedures so that clinical laboratory results may be comparable to DCCT where the correlation of hyperglucemia with the chronic complications risk was settled. Since many methods for the determination of the GHB are available, standardization in the industry is necessary for the diagnosis, also inter laboratories proficiency testing is recommended. Recent studies have demonstrated the necessity, the advantages and the viability to carry out methodological standardization for GHB analysis. Traceability towards the chromatographic reference method is required. Reference method is preferred because it allows to detect and to quantify the presence of hemoglobinopathies. Discussion: It is desirable that the laboratories use only certified methods for HbA1c. It is also desirable that all the laboratories that perform the test HbA1c participate on Proficiency Testing such as the CAP scheme that has been running since 1996 using whole blood as preferred specimen. The therapeutical goal for patient control is a level of 6 to 7 percent. With respect to any type of method for testing, results are required to disclose the report as the percent of HbA1c.


REFERENCES

  1. Terrés Speziale AM. Glicemia. Límites de referencia biocronológicos y niveles de decisión clínica. Rev Mex Patol Clin 1999: 46: 133-143.

  2. Terrés Speziale A. Confiabilidad y aplicabilidad de los nuevos criterios internacionales para el diagnóstico de DM. Rev Mex Patol Clin 2002; 49 (4): 212-220.

  3. Terrés Speziale AM. Evaluación de tres estudios internacionales para comparar el impacto del tratamiento intensificado vs el manejo convencional de pacientes con DM tipo 1 y 2. DM Hoy 2003; (4) 1: 1010-1016.

  4. American DM Association. Direct and indirect costs or DM in the United States in 1992. Alexandria, VA: American DM Association, 1993; 27.

  5. Rubin RJ, Altman WM, Mendelson DN. Health care expenditures for people with DM, 1992. J Clin Endocrinol Metab 1994; 78: 809A-F.

  6. National DM Data Group. DM in America. 2nd ed. National Institutes of Health, National Institute of DM and Digestive and Kidney Diseases, NIH Publication No. 95-1468, 1995.

  7. Harris MI. Summary. Chapter I in DM in America, National DM Data Group. NIH Publication No. 95-1468, 1995.

  8. Canahuati Rock L, Terrés Speziale AM. Aterogénesis y glicosilación de las proteínas en DM. Rev Mex Patol Clin 1996; 43: 67-79.

  9. Steinbrook R. Diabetes Surveillance in New York State. NEJM 2006; 354: 545-554.

  10. DCCT Research Group. The effect of intensive treatment of DM on the development and progression of long-term complications in insulin-dependent DM. N Engl J Med 1993; 329: 977-986.

  11. Little RR, England JD, Wiedmeyer HM et al. Interlaboratory standardization of glycated hemoglobin determinations. Clin Chem 1986; 32: 358-360.

  12. Little RR, Wiedmeyer HM, England JD et al. Interlaboratory comparison of glycated hemoglobin results: College of American Pathologists (CAP) survey data. Clin Chem 1991; 37: 1725-1729.

  13. Bodor G, Little R, Garrett N et al. Standardization of glycated hemoglobin determinations in the clinical laboratory: three years experience. Clin Chem 1992; 38: 2414-2418.

  14. Little RR, Wiedmeyer HM, England JD et al. Interlaboratory standardization of measurements of glycated hemoglobin. Clin Chem 1992; 38: 2472-2478.

  15. Feichtner M, Ramp J, England B et al. Affinity binding assay of glycated hemoglobin by two-dimensional centrifugation referenced to hemoglobin A1c. Clin Chem 1992; 38: 2372-2379.

  16. Weykamp CW, Penders TJ, Frits AJ et al. Effect of calibration on dispersion of glycated hemoglobin values as determined by 111 laboratories using 21 methods. Clin Chem 1994; 40: 138-144.

  17. Goldstein DE, Little RR, England JD et al. Methods for quantitating glycosylated hemoglobins: high performance liquid chromatography and thiobarbituric acid colorimetry. In: Clarke WL, Larner J, Pohl SL (eds). Methods in DM Research. Vol 2. Clinical Methods. New York: John Wiley, 1986; 475-504.

  18. DCCT Research Group. Feasibility of centralized measurements of glycated in the DM control and complications trial: A multicenter study. Clin Chem 1987; 33: 2267-2271.

  19. NCCLS. Development of designated comparison methods for analytes in the clinical laboratory. Proposed Guideline. NCCLS publication NRSCL6-P2. 2nd ed. Villanova, PA: NCCLS, 1993.

  20. Myers GL et al. Standardization of lipid and lipoprotein measurement. In: Rifai N, Warnick GR (eds). Laboratory measurements of lipids, lipoproteins and apolipoproteins. Washington, DC: AACC Press, 1994; 177-205.

  21. NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. NCCLS document EP5-A2. 2nd ed. Wayne, Pennsylvania: NCCLS, 2004.

  22. Bland JM, Altman DD. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; i: 307-310.

  23. DCCT: DM Control and Complications Trial or DCCT: New Engl J Med 1993; 329: 977-986

  24. DCCT: Analysis of the DCCT glucose profile data. DM Care 2002; 25: 275-278.

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

  26. Frank EL, Moulton L, Little RR, Wiedmeyer HM, Rohlfing C, Roberts WL. Effects of Hemoglobin C and S Traits on Seven glycated hemoglobin Methods. Clin Chem 2000; 46: 864-867.

  27. Roberts WL, Barun KD, Brown D, Hanbury CM, Hoyer JD, John WG, Lambert TL, Lundell RB, Rohlfing C, Little RR. Hemoglobin C and S trait on eight glycated hemoglobin methods. Clin Chem 2002; 48: 383-385.

  28. Weykamp CW, Martina WV, van der Dijs F, Penders TJ, van der S lik W, Muskiet F. Hemoglobins S and C: Reference values for glycated hemoglobin in heterozygous, double-heterozygotes and homozygous subjects, as established by 13 methods. Clin Chim Acta 1994; 231: 161-171.

  29. Blakney G, Higgins TN, Holmes DJ. Comparison of hemoglobin A1c results by two different methods on patients with structural hemoglobin variants. Clin Biochem 1998; 31: 619-626.

  30. Roberts WL, Frank EL, Moulton L, Papadea C, Noffsinger J, Ou C. Effects of nine hemoglobin variants on five glycated hemoglobin methods. Clin Chem 2000; 46: 569-572.

  31. Musalmah M, Normah J, Mohamad WBW, Salwah ON, Fatah HA, Zahari NAN. Effect of hemoglobin E on glycosylated hemoglobin determinations using different commercial kits. Med J Malaysia 2000; 55: 352-356.

  32. Higgins TN, Blakney GB, Dayton J. Analytical evaluation of the Bio-Rad Variant II automated HbA1c analyzer. Clin Biochem 2001; 34: 361-365.

  33. Little R, Mathew AS, Tennill AL, Rohlfing CL, Goldstein DG. Measurement of glycated hemoglobin (GHB) in patients with chronic renal failure (CRF): Are ion-exchange HPLC results really invalid? (abstract). Clin Chem 1997; 43 (suppl 1): S136.

  34. Weykamp CW, Miedema K, de Haan T, Doleman C. Carbamylated hemoglobin interference in glycated hemoglobin assays. Clin Chem 1999; 45: 438-440.

  35. Little RR, Tennill AL, Rohlfing C, Wiedmeyer H, Khanna R, Goel S, Aggrawal A, Madsen R, Goldstein DE. Can glycohemoglobin (GHB) be used to assess glycemic control in patients with chronic renal failure? Clin Chem, 2002; 48:784-786.

  36. Chevenne D, Fonfrede M, Ducrocq R, Chauffert M, Trivin F. Uremia and HbA1c measured by high-performance liquid chromatography. Diab Care 1998; 21: 463-464.

  37. Hansen KW, Wrlandsen E, Helleberg K, Danielsen H. Uremia and HbA1c. Diabetes Care 1997; 20: 1341-1342.

  38. Chachou A, Randoux, Millart H, Chanard J, Gillery P. Influence of in vivo hemoglobin carbamylation on HbA1c measurements by various methods. Clin Chem Lab Med 2000; 38: 321-326.

  39. Thoma J, Stirn F, Kutter D. Influence of Urea on HbA1c-determinations by Menarini HA 8140 and on the difference between immunoturbidimetric and HPLC HbA1c results. Clin Lab 2000; 46: 261-268.

  40. Holbrook I. Measurement of HbA1c by high-performance liquid chromatography in patients with renal failure. Ann Clin Biochem 1999; 36: 238-239.

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

  42. Ceriello A, Giugliano D, Quatraro A, Donzella C, Dipalo G, Lefebvre PJ. Vitamin E reduction of protein glycosylation in diabetes. New prospect for prevention of diabetic complications? Diabetes Care 1991; 14: 68-72.

  43. 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.

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

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

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




2020     |     www.medigraphic.com