engleski

An automated immunoturbidimetric (Tina-quant HbA1c II) assay for HbA1c determination

The aim of the study was to adapt an immunoassay (TINA-QUANT HBA1c, Roche Diagnostics, Mannheim) for the in vitro determination of hemoglobin A1c in whole blood on autoanalyzer Olympus AU 600, (Olympus Optical Co., Tokyo, Japan). Venous blood samples from diabetic patients are collected into vacutainer tubes K3EDTA containing. HBA1c determination is based on the turbidimetric inhibition immunoassay principle (TINIA), utilizing an antibody specific for the glycated aminoterminus of the hemoglobin beta-chain. Total hemoglobin concentration was determined in the second channel. Final result was calculated automatically. Calibration of the procedure was performed using internal HBA1c reference material. Imprecision within-run (on three different HbA1c concentrations), imprecision between-run (on triplicate for two control hemolysate measured ten days), and accuracy (with control material, and by comparison with ion- exchange low pressure liquid chromatography method, n=50) were assessed. Within-run and between-run imprecision CV was 0.88%-1.97% and 1.73%-4.34%, respectively. Results of the comparison study showed no statistical difference according to Passing & Bablok regression analysis (y=0.899x+1.16 ; r=0.989). Calibration of the assay was stable for at least 5 weeks, if the same lot of reagents was used. Refrigerated samples remained stable for HBA1c analysis for 7 days. Stability of the hemolysate was 3 hours at room temperature. Results of the study indicate that the automated immunoturbidimetric procedure adapted for Olympus AU600 autoanalyzer provides a precise and accurate determination of HBA1c.

HBA1c; immunoassay methods; Olympus AU600

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