The Analytical Performances of Four Different Glycated Hemoglobin Methods
Genc S*, Gurdol F, Kanmaz-Ozer M , Ince N , Ozcelik F and Omer B
Istanbul University, Istanbul Faculty of Medicine, Department of Biochemistry, Capa, Istanbul, Turkey
- *Corresponding Author:
- Sema Genc
Istanbul University, Istanbul Faculty of Medicine
Department of Biochemistry
Capa, Istanbul, Turkey
Tel: +90 212 6214756
E-mail: [email protected]
Received date: June 06, 2014; Accepted date: June 26, 2014; Published date: June 28, 2014
Citation: Genc S, Gurdol F, Kanmaz-Ozer M, Ince N, Ozcelik F, et al. (2014) The Analytical Performances of Four Different Glycated Hemoglobin Methods. Med chem 4:501-505. doi: 10.4172/2161-0444.1000185
Copyright: © 2014 Genc S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Objectives: The analytical performances of the Sebia capillary electrophoresis (CE), Roche turbidimetric inhibition immunoassay (TINIA), Tosoh G8 cation-exchange high-performance liquid chromatography (HPLC) and Premier boronate affinity chromatography methods were evaluated. Capillary electrophoresis (CE) was accepted as a comparative method.
Design and Methods: This study comprised randomly chosen 224 whole blood samples from the diabetic and non-diabetic patients. HbA1c level was quantified using four methods as follows: Roche TINIA, Premier Hb9210 boronate affinity chromatography, Tosoh G8 cation-exchange HPLC and Sebia CE. The analytical performances of the methods were evaluated with imprecion, bias estimation and comparison studies.
Results: The results of all precision studies CV% were under 2.0%. The accepted goals for imprecision are 2.8% (IFCC) and <2.0% (NGSP). Analysis using Spearman test showed good correlation between CE and all three evaluated methods (r=0.99, p=0.001; r=0.98, p=0.001; and r=0.98, p=0.001, respectively). The comparison of the methods with CE was performed using Deming Regression analysis and revealed good agreement between CE and all methods. Although the HPLC method showed a linear relation with CE, it differed significantly from the comparative method because of its confidence interval did not contain 0.
Conclusion: All methods revealed acceptable precision and good accuracy. TINIA and boronate affinity chromatography methods showed good agreement and correlation with the comparative method (CE), whereas a significant difference was obtained between the mean levels of HPLC and CE.