• Laboratory Medicine Online
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• v.2 no.1
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• pp.10-14
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• 2012

Background: Measurement of HbA_1c 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.