Comparison of Hemoglobin A1c assay performance on two different commercial systems

Authors

  • Jozo Ćorić Department of Clinical Chemistry, Clinical Center of Sarajevo University, Sarajevo
  • Elma Kučukalić Department of Clinical Chemistry, Clinical Center of Sarajevo University, Sarajevo
  • Berina Hasanefendic
  • Aleksandar Bodulović Department of Clinical Chemistry, Clinical Center of Sarajevo University, Sarajevo
  • Jasminka Mujic
  • Mirsad Panjeta Department of Clinical Chemistry, Clinical Center of Sarajevo University, Sarajevo

DOI:

https://doi.org/10.17532/jhsci.2015.233

Keywords:

hemoglobin HbA1c, diabetes mellitus, Dimension XPanda analyzer

Abstract

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.


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Published

16.04.2015

Issue

Section

Research articles

How to Cite

1.
Comparison of Hemoglobin A1c assay performance on two different commercial systems. JHSCI [Internet]. 2015 Apr. 16 [cited 2024 May 24];5(1):11-4. Available from: https://www.jhsci.ba/ojs/index.php/jhsci/article/view/380