Evaluation of the AutoLab HbA1c Reagent by Using Hitachi Clinical Analyzer 7180

ABSTRACT

BACKGROUND: Hemoglobin A1c (HbA1c) is a universally used parameter for monitoring glycemic control in diabetic patients. Various methods are used for the measurement of HbA1c levels. The AutoLab HbA1c reagent was recently developed for use in immunoturbidimetric assays for measurement of HbA1c levels. We evaluated the reliability of using the AutoLab HbA1c reagent with the Hitachi Clinical Analyzer 7180, an automated chemistry analyzer, for measuring HbA1c levels. METHODS: We evaluated the precision, linearity, carryover rate, and stability of the samples analyzed using Hitachi clinical analyzer 7180 with the AutoLab HbA1c reagent and compared the results with those obtained with an HPLC method performed using the Variant II Turbo analyzer. RESULTS: The CV values for within-run imprecision at low and high levels were 0.8% and 0.6%, respectively, and the CV values for between-run imprecision at low and high levels were 1.5% and 2.9%, respectively. The linearity of the results was good in the range of 4.3-12.3%, and comparison with the results obtained by Variant II Turbo showed an excellent correlation coefficient of 0.9914. The carryover rate was 0%, and the samples refrigerated at 4degrees C for 15 days were found to be stable. CONCLUSIONS: In comparison with Variant II Turbo, Hitachi clinical analyzer 7180 with AutoLab HbA1c reagent showed good precision, linearity, and carryover rate. Hence, Hitachi clinical analyzer 7180 with AutoLab HbA1c reagent may be used for the diagnosis of diabetes and for monitoring blood glucose levels in diabetic patients.