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KMID : 0985420100320020217
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Laboratory Medicine and Quality Assurance
2010 Volume.32 No. 2 p.217 ~ p.223
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Performance Evaluation of HbA1c Test on the Toshiba 200FR NEO Using AutoLab HbA1c Reagent
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Kim Taek-Su
Kim Sun-Tae
Chang Ho-Eun
Song Sang-Hoon
Kim Jin-Q
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Abstract
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Background: Hemoglobin A1c (HbA1c) is widely used for the monitoring of glycemic control in diabetes mellitus patients. Various methods are applied for the determination of HbA1c levels. Recently, a novel National Glycohemoglobin Standardization Program (NGSP)-certificated reagent (AutoLab HbA1c, IVD-LAB, Korea) was introduced for use in an automated chemistry analyzer. We evaluated the analytical performance of this immunoturbidimetry reagent and compared it with the ion-exchange high performance liquid chromatography (Variant II Turbo, Bio-Rad Laboratories, Inc., USA) and immunoassay (Cobas Integra 800, Roche Diagnostics, Germany) methods.
Methods: Toshiba 200FR NEO (Toshiba Medical Systems Co., Japan) with the AutoLab reagent was evaluated for precision, linearity, carryover and compared with Cobas Integra and Variant II Turbo.
Results: Coefficients of variation (CVs) of within-run imprecision for low and high level were 1.8% and 0.7%, respectively. CVs of within-laboratory imprecision for low and high level were 2.4% and 1.0%, respectively. The linearity was excellent with R2 = 0.99 in the range of 3.05-15.50%. It was well correlated with Variant II Turbo (R=0.9904) and Cobas Integra 800 (R=0.9992). The carryover rate was 0.4%.
Conclusions: The Toshiba 200FR NEO with the AutoLab reagent showed excellent precision and linearity and minimal carryover rate. It was well correlated with the other widely used methodological instruments. It may be used for the diagnosis and the treatment monitoring of diabetes.
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KEYWORD
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Hemoglobin A1c (HbA1c), Diabetes, Immunoturbidimetry, Automated chemistry analyzer
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