Evaluation of HbA1c Levels Via the Latex Immunoturbidimetric Method by Using Chemistry Autoanalyzer

Yongjun Jo; So-young Lee; Hae-il Park; YeongSic Kim; Jehoon Lee; Yonggoo Kim; Kyungja Han

doi:10.3343/lmo.2012.2.1.2

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Jo, Lee, Park, Kim, Lee, Kim, and Han: Evaluation of HbA1c Levels Via the Latex Immunoturbidimetric Method by Using Chemistry Autoanalyzer

Original Article

Clinical Chemistry

Laboratory Medicine Online

Laboratory Medicine Online 2012; 2(1): 10-14.

Published online: 1 January 2012

DOI: https://doi.org/10.3343/lmo.2012.2.1.2

Evaluation of HbA_1c Levels Via the Latex Immunoturbidimetric Method by Using Chemistry Autoanalyzer

Yongjun Jo, M.D., So-young Lee, M.D., Hae-il Park, M.D., YeongSic Kim, M.D., Jehoon Lee, M.D., Yonggoo Kim, M.D., Kyungja Han, M.D.

Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Corresponding author: Jehoon Lee, M.D. Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea Yeouido St. Mary's Hospital, 62 Yeouido-dong, Yeongdeungpo-gu, Seoul 150-713, Korea. Tel: +82-2-3779-1297, Fax: +82-2-3779-2285, lyejh@catholic.ac.kr

Received 10 December 2010 Revised 8 August 2011 Accepted 9 August 2011

(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

Measurement of HbA1c levels is widely used to diagnose diabetes mellitus and to evaluate and monitor plasma-glucose concentrations over 6-8 weeks. In this study, we evaluated the diagnostic performance of the newly developed latex immunoturbidimetric method by using Autolab HbA_1c.

Methods

We analyzed and compared the diagnostic performance of Autolab HbA_1c with that of Toshiba 200FR between April 2009 and July 2009. According to guidelines (EP5-A2, EP6-P, EP9-A2) of the clinical and laboratory standards institute (CLSI), we compared linearity, precision and correlation of Autolab HbA_1c with those of G7 (Tosoh Corp., Kyoto, Japan) by using high-performance liquid chromatography (HPLC) method.

Results

Data obtained using Autolab HbA_1c showed good linearity in mixtures of samples with low (3.1%) and high (15.1%) levels of HbA_1c (r² = 0.9997). In the analysis of within-run precision of the samples with HbA_1c levels of 5.1% and 12.1%, the SDs were 0.04 and 0.06 and covariances of these samples were 0.8% and 0.5%, respectively. In the Deming regression model, the regression equation was as follows: Autolab HbA_1c = 1.0859×Tosoh HPLC-0.6957.

Conclusions

In this study, Autolab HbA_1c method showed better performance characteristics than Tosoh G7 did. In reference review, there was no interference of variant hemoglobin. The data acquisition time of Autolab HbA_1c was lower than that of Tosoh G7. The advantages of Autolab HbA_1c are that it can be used as an autoanlyzer in routine chemical analysis, it does not require pre-analytical treatment, and the samples are automatically treated with distilled water for hemolysis.

Keywords: HbA_1c, Immunoturbidimetric method, HPLC

Figures and Tables

Fig. 1

Linearity of HbA_1c values as measured by Autolab HbA_1c.

Fig. 2

Deming regression plot of Tosoh G7 vs. Autolab HbA_1c.

Fig. 3

Difference plot between Autolab HbA_1c and Tosoh G7.

Fig. 4

Changes in HbA_1c levels with the length of time after the samples were mixed.

Notes

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

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