Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer

Jinsook Lim; Ji-Myung Kim; Sun Hoe Koo; Kye Chul Kwon

doi:10.3343/lmo.2012.2.3.126

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Lim, Kim, Koo, and Kwon: Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer

Original Article

Clinical Chemistry

Laboratory Medicine Online

Laboratory Medicine Online 2012; 2(3): 126-130.

Published online: 1 July 2012

DOI: https://doi.org/10.3343/lmo.2012.2.3.126

Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA_1c Analyzer

Jinsook Lim, M.D., Ji-Myung Kim, M.D., Sun Hoe Koo, M.D., Kye Chul Kwon, M.D.

Department of Laboratory Medicine, Chungnam National University Hospital, Daejeon, Korea.

Corresponding author: Kye Chul Kwon, M.D. Department of Laboratory Medicine, Chungnam National University Hospital, 640 Daesa-dong, Jung-gu, Daejeon 301-721, Korea. Tel: +82-42-280-7799, Fax: +82-42-257-5365, kckwon@cnu.ac.kr

Received 20 October 2011 Revised 29 February 2012 Accepted 29 February 2012

(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

Background

Hemoglobin (Hb)-A_1c is routinely used for the management of diabetes. In 2010, HbA_1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA_1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA_1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer.

Methods

According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA_1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated.

Results

Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R²) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA_1c analyzer and Variant II Turbo (R²=0.994). The carry over rate was 0.0%.

Conclusions

The ARKRAY ADAMS HA-8180 HbA_1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA_1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA_1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.

Keywords: Hemoglobin A_1c (HbA_1c), High-performance chromatography (HPLC), Diabetes

Figures and Tables

Fig. 1

Comparison of HbA_1c levels assayed by Variant II Turbo and ARKRAY ADAMS HA-8180 HbA_1c analyzer. (A) Scattered plot with ordinary linear fit (blue line). (B) Bland-Altman difference plot. (C) Bland-Altman % difference plot.

Fig. 2

Linearity of HbA_1c values using ARKRAY ADAMDS HA-8180 HbA_1c analyzer.

Table 1

Precision of HbA_1c measurement of ARKRAY ADAMDS HA-8180

Notes

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

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