HbA1c 측정을 위한 HLC-723 G11 장비의 분석적 성능 평가

초록

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.

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