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TEST ITEMS

THE GENERATION DIAGNOSTIC SYSTEM

HbA1c

Glycated protein is formed post-translationally through the slow, nonenzymatic reaction between glucose and amino groups on proteins. HbA1c is a clinically useful index of mean glycemia during the preceding 120 days, the average life span of erythrocytes. Carefully controlled studies have documented a close relationship between the concentrations of HbA1c and mean glycemia. HbA1c is considered as a more reliable parameter in monitoring glycemia over the glycemic reading with the conventional glucometer.

References

  • 1. Goldstein DE,Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM. Tests of glycemia in diabetes. Diabetes Care 1995; 18:896-909.
  • 2. Bunn HF. Nonenzymatic glycosylation of protein: relevance to diabetes. Am J Med 1981; 70:325-30.
  • 3. Jovanovic L, Peterson CM. The clinical utility of glycosylated hemoglobin. Am J Med 1981; 70:331-8.
  • 4. Nathan DM, Singer DE, Hurxthal K, Goodson JD. The clinical information value of the glycosylated hemoglobin assay. N Engl J Med 1984; 310:341-6.
  • 5. Goldstein DE, Little RR, Wiedmeyer HM, England JD, McKenzie EM. Glycated hemoglobin: methodologies and clinical applications. Clin Chem 1986; 32:B64-70.
  • 6. Goldstein DE, Little RR, England JD, Wiedemeyer H-M, McKenzie E. Methods of glycosylated hemoglobins: high performance liquid chromatography and thiobarbituric acid colorimetric methods. In: Clarke WL, Larner J, Pohl SL, eds. Methods in diabetes research, Vol. 2. New York: John Wiley, 1986:475-504.
  • 7. Tahara Y, Shima K. The response of GHb to stepwise plasma glucose change over time in diabetic patients. Diabetes Care 1993; 16:1313-4.
  • 8. Svendsen PA, Lauritzen T, Soegaard U, Nerup J. Glycosylated haemoglobin and steady-state mean blood glucose concentration in type 1 (insulin-dependent) diabetes. Diabetologia 1982; 23:403-5.
  • 9. Cefalu WT, Wang ZQ, Bell-Farrow A, Kiger FD, Izlar C. Glycohemoglobin measured by automated affinity HPLC correlates with both short-term and long-term antecedent glycemia. Clin Chem 1994; 40:1317-21.
  • 10. Singer DE, Coley CM, Samet JH, Nathan DM. Tests of glycemia in diabetes mellitus. Their use in establishing a diagnosis and in treatment. Ann Intern Med 1989; 110:125-37.
  • 11. Molnar GD. Clinical evaluation of metabolic control in diabetes. Diabetes 1978; 27:216-25.
  • 12. UK Prospective Diabetes Study. Reduction in HbA1c with basal insulin supplement, sulfonylurea or biguanide therapy in maturity-onset diabetes. Diabetes 1985; 34:793-8.
  • 13. Baker JR, Johnson RN, Scott DJ. Serum fructosamine concentrations in patients with type II (non-insulin-dependent) diabetes mellitus during changes in management. BMJ (Clin Res Ed) 1984; 288:1484-6.
  • 14. 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; 18:440-7.
  • 15. Brooks DE, Devine DV, Harris PC, et al. RAMP(TM): A rapid, quantitative whole blood immunochromatographic platform for point of care testing. Clin Chem 1999; 45:1676-1678.

ichroma™

Compatible Device ichroma™ I/II
Detection Range 4~15% (68.3~383.8mg/dl)
Sample Type Whole Blood
CV <10%
Comparability 0.986
Reaction Time 12Min

AFIAS

Compatible Device AFIAS-1/6
Detection Range 4~15% (68.3~383.8mg/dl)
Sample Type Whole Blood
CV <10%
Comparability 0.993
Reaction Time 10Min

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