Comparison of Hemoglobin A1c assay performance on two different commercial systems
Introduction: Glycated hemoglobin (HbA1c) is formed by non-enzymatic binding of glucose to the free amino group of the N-terminal end of the ß-chain of hemoglobin A. HbA1c is representative of the mean blood glucose level over three months. The aim of the study was to evaluate the Hemoglobin A1c immunoturbidimetric assay performance on two different commercial systems.
Methods: We evaluated the precision and trueness for determination of HbA1c in whole blood. Concentrations of total hemoglobin and HbA1c were evaluated on Dimension Xpand (Siemens) and Cobas 501 (Roche) analyzers. HbA1c was measured in a latex agglutination inhibition test. Commercial controls Liquichek Diabetes Control Level 1 and Liquichek Diabetes Control Level 2 (Bio Rad) at two levels were used for quality control. Analytical validation of HbA1c included: within-run imprecision, between-day imprecision, inaccuracy and comparison determination on the human samples on 2 systems: Dimension Xpand and Cobas 501 analyzers.
Results: Within-run imprecision on the commercially controls for Level 1 is 4.5% and Level 2 is 3.2% between-day imprecision on commercially controls is 6.1% Level 1 and 5.1% Level 2 for respectively inac- curacy on commercially controls for Level 1 is 1.8% and Level 2 is 4.8%. Method comparison on human samples shows the correlation coefficient of 0.99.
Conclusion: The presented results of the analytical evaluation methods for the determination of HbA1c showed an acceptable accuracy and precision.
2. Topić E. Guidelines and recommendations for testing in diagnosis of diabetes mellitus: The role of HBA1c. Biochemia Medica 2014; 24(Suppl1):S17-S20.
3. Kilpatrick ES, Bloomgarden Z, Zimmet P. Is hemoglobin A1c a step forward for diagnosing of diabetes. BMJ 2009; 339:1288-90.
4. Sack DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus. Diabetes Care 2011; 34:61-99.
5. Nathan DM, Balkau B, Bonora E, Borch-Johnsen K, Buse JB, Colagiuri S. et al. International Expert Committee Report on the role of the HbA1c assay in the diagnosis of diabetes, Diabetes Care 2009; 32:1327-34.
6. Higgin T. HbA1c- An analyte of increasing importance. Clin Biochem 2012;45:1038-45.
7. Mandal Š, Ćaušević A, Malenica M, Hadžidedić Š. Age and gender related differences in free fatty acid levels in patients with type 2 diabetes mellitus. Journal of Health Sciences 2012; 11:184-191.
8. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2011; 34:S11-S61.
9. Bucala R, Cerami A, Vlassara H. Advanced glycosylation end products in diabetic complications.Diabetes Rev 1995; 3: 258-68.
10. Jusupović F, Avdić D, Mahmutović J, Rudić A, Pašalić A, Branković S, Berić A, Mačak A. The presence of risk factors for diabetes mellitus type 2 in patients of family practice medicine. Journal of Health Sciences 2011; 1:23-28.
11. Nordin G. HbA1c analyzing-challengers for the laboratory. Biochemia Medica 2014;24(Suppl 1):S21-S21.
12. Miller M, Šimundić A, Štefanović M, Ferene D. A model for results comparison on two different biochemistry analyzers in laboratory accredited according to the ISO 15 189. Biochemia Medica 2009:287-93.
13. Plebani M. Laboratory errors: Haw to improve pre- and post- analytical phases. Biochem. Med. 2007; 15, 5-9.
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