Lab Med Online.  2012 Jan;2(1):10-14. 10.3343/lmo.2012.2.1.2.

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

Affiliations
  • 1Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. lyejh@catholic.ac.kr

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 HbA1c.
METHODS
We analyzed and compared the diagnostic performance of Autolab HbA1c 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 HbA1c with those of G7 (Tosoh Corp., Kyoto, Japan) by using high-performance liquid chromatography (HPLC) method.
RESULTS
Data obtained using Autolab HbA1c showed good linearity in mixtures of samples with low (3.1%) and high (15.1%) levels of HbA1c (r2 = 0.9997). In the analysis of within-run precision of the samples with HbA1c 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 HbA1c = 1.0859xTosoh HPLC-0.6957.
CONCLUSIONS
In this study, Autolab HbA1c 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 HbA1c was lower than that of Tosoh G7. The advantages of Autolab HbA1c 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.

Keyword

HbA1c; Immunoturbidimetric method; HPLC

MeSH Terms

Chromatography, High Pressure Liquid
Chromatography, Liquid
Diabetes Mellitus
Hemoglobins
Hemolysis
Latex
Organothiophosphorus Compounds
Water
Hemoglobins
Latex
Organothiophosphorus Compounds
Water

Figure

  • Fig. 1 Linearity of HbA1c values as measured by Autolab HbA1c.

  • Fig. 2 Deming regression plot of Tosoh G7 vs. Autolab HbA1c.

  • Fig. 3 Difference plot between Autolab HbA1c and Tosoh G7.

  • Fig. 4 Changes in HbA1c levels with the length of time after the samples were mixed.


Cited by  1 articles

Evaluation of Analytical Performance of an Automated Glycated Hemoglobin Analyzer, HLC-723 G11
Yoo Na Chung, Seung Gyu Yun, Yunjung Cho
Lab Med Online. 2020;10(1):46-51.    doi: 10.3343/lmo.2020.10.1.46.


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