Performance Evaluation of the ARKRAY ADAMS A1c HA-8180

Eun-Hyung Yoo; Byung-In Kim; Hyun-Jung Cho

doi:10.3343/lmo.2014.4.3.164

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Yoo, Kim, and Cho: Performance Evaluation of the ARKRAY ADAMS A1c HA-8180

Short Communication

Clinical Chemistry

Laboratory Medicine Online 2014; 4(3): 164-167.

Published online: 1 July 2014

DOI: https://doi.org/10.3343/lmo.2014.4.3.164

Performance Evaluation of the ARKRAY ADAMS A1c HA-8180

Eun-Hyung Yoo, M.D., Byung-In Kim, M.T., Hyun-Jung Cho, M.D.

Department of Laboratory Medicine, Konyang University Hospital, College of Medicine, Konyang University, Daejeon, Korea.

Corresponding author: Hyun-Jung Cho. Department of Laboratory Medicine, Konyang University Hospital, 158 Gwangeodong-ro, Seo-gu, Daejeon 371-713, Korea. Tel: +82-42-600-9273, Fax: +82-42-600-9272, hjchomd@kyuh.ac.kr

Received 5 March 2013 Revised 12 July 2013 Accepted 22 July 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The hemoglobin A1c (Hb A1c) test is widely used to diagnose diabetes mellitus and monitor glycemic control in patients with diabetes. We evaluated the performance of the ARKRAY ADAMS A1c HA-8180 (ARKRAY KDK, Japan), an automated, HPLC-based Hb A1c analyzer. The ARKRAY ADAMS A1c HA-8180 was evaluated for its linearity and precision and compared to the HLC-723 G7 (Tosoh Corporation, Japan), according to the Clinical and Laboratory Standards Institute's guidelines. The coefficients of variation (CVs) for within-run precision at low and high levels were 0.6% and 0.3%, respectively, and the total CVs at low and high levels were 0.8% and 0.6%, respectively. The coefficient of determination (R²) was 0.9975, with linearity in the range of 3.0-18.5%. A comparison between the ARKRAY ADAMS A1c HA-8180 and HLC-723 G7 revealed a good correlation (r=0.9955) in the range of 4.8-14.6%. The runtime was 57 s per sample. The ARKRAY ADAMS A1c HA-8180 showed good analytical performance and high throughput. Therefore, it is suitable for routine use for clinical measurements of Hb A1c.

Keywords: Hemoglobin A1c (Hb A1c), HPLC, ADAMS A1c HA-8180, Diabetes mellitus

Figures and Tables

Fig. 1

Linearity of Hb A1c values using the ARKRAY ADAMS A1c HA-8180.

Fig. 2

Comparison of Hb A1c levels measured by the HLC-723 G7 and ARKRAY ADAMS A1c HA-8180. (A) Scatter plot with linear fit (r=0.9955). (B) Difference plot showing the mean bias (0.06%) and the limits of agreement between the HLC-723 G7 and ARKRAY ADAMS A1c HA-8180.

Table 1

Precision in Hb A1c measurements with the ARKRAY ADAMS A1c HA-8180

Notes

This article is available from http://www.labmedonline.org

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