औषधीय रसायन शास्त्र

The Analytical Performances of Four Different Glycated Hemoglobin Methods

Abstract

Genc S, Gurdol F, Kanmaz-Ozer M, Ince N, Ozcelik F and Omer B

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.