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Yoo Na Chung, M.D., Seung Gyu Yun, M.D.
, Yunjung Cho, M.D.
, Yunjung Cho, M.D.
Abstract
Background
Glycated hemoglobin (HbA1c) is a key biomarker for the monitoring of glycemic balance in patients with diabetes. The aim of this study was to evaluate the performance of a new system, the Tosoh HLC-723 G11 analyzer (Tosoh Corporation, Japan), compared to that of two routine diagnostic testing systems, Tosoh G8 (Tosoh Corporation) and Capillarys 2 Flex Piercing (Sebia, France).
Methods
Tosoh G11 was evaluated for precision, linearity, and carry-over, according to the Clinical and Laboratory Standard Institute's guidelines. Test results from clinical samples were compared between Tosoh G11 and the routine testing systems, Tosoh G8 and Capillarys 2 Flex Piercing.
Results
With respect to the precision of Tosoh G11, the test results for low- and high-concentration controls showed a coefficient of variation of less than 1.1%. Furthermore, the new device exhibited good linearity for HbA1c values ranging from 3.4% to 18.8%, and carry-over was not observed. HbA1c results for Tosoh G11 (N=143) correlated well with those for Tosoh G8 (r=0.9971) and Capillarys 2 Flex Piercing (r=0.9918).
Conclusions
Tosoh G11 demonstrated reliable analytical performance with good precision and linearity, and no carry-over results. In addition, its results were comparable to those of the existing instruments. Thus, the results of this evaluation suggest that Tosoh G11 is suitable for the routine diagnostic testing of HbA1c levels in clinical chemistry laboratories.
Figures and Tables
Fig. 1
Linearity of Tosoh HLC-723 G11 analyzer (Y=0.9768X+0.001182, R=0.999). The Solid line represents linear regression of the measured values and the dotted line is an equality line.
Fig. 2
Comparison of HbA1c values measured by the Tosoh HLC-723 G11 analyzer (tested instrument), Tosoh HLC-723 G8 analyzer (comparative instrument) and Capillarys 2 Flex Piercing (comparative instrument). A Passing and Bablok regression plot for Tosoh G11 and Sebia capillarys 2 (A) and for Tosoh G11 and Tosoh G8 (B). Bland- Altman difference plot for Tosoh G11 and Sebia capillarys 2 (C) and for Tosoh G11 and Tosoh G8 (D).
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