Lab Med Online.  2012 Apr;2(2):74-79.

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

• Park SH
• Seo YH
• Ahn JY
• Kim KH
• Jung JH
• Park PW

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.

Keyword

AutoLab; HbA1c; Immunoassay

MeSH Terms

Blood Glucose
Chromatography, High Pressure Liquid
Hemoglobins
Humans
Immunoassay
Blood Glucose
Hemoglobins

Figure

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  Fig. 1 Linearity of HbA1c values using Hitachi clinical analyzer 7180 with AutoLab HbA1c.

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  Fig. 2 Comparison of HbA1c levels measured by Variant II turbo and Hitachi clinical analyzer 7180 with AutoLab HbA1c.

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  Fig. 3 Stability of whole blood sample obtained using an EDTA tube at 4℃ and room temperature.

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