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KMID : 0985420120340010019
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Laboratory Medicine and Quality Assurance
2012 Volume.34 No. 1 p.19 ~ p.23
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Evaluation of Bio-Rad D-10 HbA1c Autoanalyzer
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Lee Jong-Han
Park Chul-Hee
Kim Moon-Jung
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Abstract
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Background: Hemoglobin A1c (HbA1c) is a useful marker for the diagnosis and monitoring of diabetes, which has resulted in an increasing dependency on HbA1c levels for diagnosing diabetes in small- and medium-sized hospitals. We evaluated a high performance liquid chromatography (HPLC) based HbA1c autoanalyzer Bio-Rad D-10 (Bio-Rad Laboratories, USA) by comparing the analysis results with that by Tosoh HLC-723 G7 (Tosoh Corporation, Japan).
Methods: The Bio-Rad D-10 autoanalyzer was evaluated for its precision, linearity, and carryover. The analysis time and correlation were evaluated and compared with those by Tosoh HLC-723 G7 autoanalyzer.
Results: Bio-Rad D-10 showed within-run, between-day, and total precision of less than 1.3% coefficient of variation (CV) and excellent linearity between HbA1c in the range of 3.2%-21% (coefficient of determination, R2 = 0.998). The sample- to-sample carryover was 0.57%. The results obtained by using Bio-Rad D-10 showed good correlation (r = 0.997; P < 0.001) with those by Tosoh HLC-723 G7; however, the analysis time using Bio-Rad D-10 was about 2.3 times per 10 samples and 2.5 times per 20 samples than those using Tosoh HLC-723 G7.
Conclusions: Bio-Rad D-10 showed good performance in assaying HbA1c. Bio-Rad D-10 autoanalyzer would be suitable for use in laboratories with small to medium amount of samples to be analyzed, but its initial analyzing time was longer than that by Tosoh HLC-723 G7.
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KEYWORD
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Hemoglobin A1c (HbA1c), Bio-Rad D-10, Tosoh HLC-723 G7
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