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KMID : 1100820240140010001
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Laboratory Medicine Online
2024 Volume.14 No. 1 p.1 ~ p.7
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Analytical Performance Evaluation of the ARKRAY ADAMS A1c HA-8190V Analyzer
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Shin Woo-Jin
Kim Sung-Min
Lee Ji-Kyo
Lee Kyung-Hoon
Song Sang-Hoon
Lee Joon-Hee
Song Jung-Han
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Abstract
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Background: Hemoglobin A1c is an important marker used in the diagnosis and treatment monitoring of diabetes mellitus, which is an increasingly significant health problem in South Korea. We evaluated the analytical performance of the HPLC-based ADAMS HA-8190V (ARKRAY, Japan) HbA1c analyzer.
Methods: The precision, linearity, and carryover of the HA-8190V device were evaluated. Using 120 residual samples, comparative analysis between the HA-8190V and HLC-723 G11 (Tosoh, Japan) devices was conducted. Accuracy was evaluated using commutable samples with known HbA1c concentrations measured using an International Federation of Clinical Chemistry reference measurement procedure. Interference by common Korean Hb variants was evaluated with 21 known Hb variant samples.
Results: The repeatability (%CV) for the low- and high-level controls was 0.5% and 0.4%, respectively, while the within-laboratory precision was 1.0% and 0.9%, respectively. For linearity, the coefficient of determination was 0.9988, with excellent linearity in a range of 3.0?20.2%. No significant carryover was observed. HbA1c concentrations measured by HA-8190V showed good correlation (r=0.997) with the G11. Percentage biases at medical decision levels (5.7% and 6.5%) were within the allowable range. The HA-8190V showed the least interference from Hb variants compared to other instruments in standard mode.
Conclusions: HA-8190V showed reliable analytical performance with good precision, linearity, and minimal carryover. Furthermore, HA-8190V showed good correlation with the G11 and was least affected by Hb variants compared to other commercial analyzers. Hence, HA-8190V can be utilized in clinical laboratories to accurately measure HbA1c for the diagnosis and treatment monitoring of diabetes mellitus.
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KEYWORD
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HbA1c, Analytical performance, Hb Variant, Accuracy, ARKRAY ADAMS A1c HA-8190V, Linearity, Precision
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