HbA1c 측정을 위한 HLC-723 G11 장비의 분석적 성능 평가
Evaluation of Analytical Performance of an Automated Glycated Hemoglobin Analyzer, HLC-723 G11
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초록
배경: 헤모글로빈 당화혈색소는 당뇨의 진단과 치료 및 추적 관찰 에 유용한 지표로서 표준화된 검사법에 의한 정확한 검사 결과가 필수적이다. 본 연구에서는 고성능 엑체크로마토그래피법(HPLC) 을 이용하여 당화혈색소를 측정하는 장비인 Tosoh HLC-723 G11 analyzer (Tosoh Corporation, Japan)의 분석 성능을 평가하고자 하였다. 방법: Clinical Laboratory Standard Institute (CLSI)의 지침을 참고 하여 Tosoh G11의 정밀도, 직선성 및 검체 간 교차오염률을 평가 하였다. 그리고 임상검체를 이용하여 기존 장비인 Tosoh G8 (Tosoh Corporation)과 Capillarys 2 Flex Piercing (Sebia, France)과의 상관 성을 평가하였다. 결과: Tosoh G11을 사용한 당화혈색소 측정의 검사 간 변이계수 와 검사일간 변이계수는 모두 1.1% 미만이었다. 직선성은 당화혈색소 3.4-18.8% 범위에서 우수하였고 검체 간 교차 오염률은 관찰되 지 않았다. Tosoh G11의 Tosoh G8과 Capillarys 2 Flex Piercing과 의 상관성 평가(N=143)에서 상관계수는 각각 0.9971, 0.9918로 우 수한 상관성을 보여주었다. 결론: Tosoh G11은 우수한 정밀도와 직선성 및 비교방법과의 비교 에서 우수한 상관성을 보여주었다. 따라서 Tosoh G11은 검사실에 서 당뇨병의 진단과 치료 및 당뇨 합병증의 예방을 위한 추적 관찰 에 유용하게 사용될 수 있을 것으로 생각된다.
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.
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