engleski

An automated immunoturbidimetric assay for HbA1c determination

The aim of this study was to adapt a light-scattering competitive immunoassay for hemoglobin A1c (Unimate HbA1c, Roche Diagnostic Products, Hoffmann-La Roche, Basle, Switzerland) to an automated clinical chemistry analyzer (Olympus AU600, Olympus Optical Co, Tokyo, Japan). After hemolysis combined with enzymatic cleavage, hemoglobin A1c (HbA1c) and total hemoglobin were determined by immunoassay and colorimetry, respectively, and final result calculated as a percentage from the two measured parameters ratio. The within- and between-run imprecision of the automated immunoturbidimetric procedure (expressed as C.V.) ranged between 3.13% and 4.59%, and 3.73% and 4.80%, respectively, at the HbA1c levels of 4.1, 7.2 and 12.1%. The adapted procedure gave highly comparable results to the ion-exchange chromatography (Mono S column, Pharmacia, Uppsala, Sweden) in a wide range of HbA1c values (r=0.998, n=117). Regression analysis data showed that neither slope (0.988) nor intercept (0.099) were significantly different from the respective target values (1.0 and 0.0) within 95% confidence limits. In vitro experiments showed no significant influence of either Schiff base or a decreasing hematocrit on the assay results. Results from this study indicate that the automated immunoassay provides a precise, accurate and rapid tool for the routine determination of HbA1c.

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