항뮬러관 호르몬검사 시약 Elecsys AMH plus의 성능 및 비오틴 간섭평가
Performance and Biotin Interference Evaluation of the Elecsys AMH plus for Measuring Anti-Mullerian Hormone
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배경: Elecsys AMH plus (Roche Diagnostics GmbH, Mannheim, Germany)는 항뮬러관 호르몬 검사를 위한 새로운 시약으로 기존시약 Elecsys AMH (Roche Diagnostics GmbH, Mannheim)의 혈중비오틴의 간섭 현상을 보완하였다. 본 연구는 Elecsys AMH plus의수행능과 기존 시약과의 상관성을 평가하고자 하였다. 방법: CLSI 지침에 따라 Elecsys AMH plus의 정밀도, 직선성, 측정한계를 평가하였고 기존 시약과의 상관성 및 비오틴 간섭효과를비교 분석하였다. 결과: 시약의 정밀도는 저농도와 고농도 모두에서 5% 이내였으며적절한 직선성을 보였다. 제조사에서 제시한 검출한계 값도 검증되었다. 상관성 평가 결과, 저농도에서 백분율 바이어스가 관찰되었으나 상관계수 0.975 이상으로 우수한 상관성을 보였다. Elecsys AMH plus는 기존 시약에 비해 비오틴 간섭영향이 적었으며 500 ng/mL의 비오틴 농도에서도 5% 미만 변화율 보였다. 결론: Elecsys AMH plus의 정밀도, 직선성, 측정한계, 상관성, 그리고 비오틴 간섭효과 평가에서 우수한 결과를 보여 AMH 측정에서기존 시약의 대체제로 적합할 것으로 판단된다.
Abstract
Background: This study aimed to evaluate the performance of Elecsys AMH plus (Roche Diagnostics GmbH, Mannheim, Germany), an improved version of the reagent used for measuring anti-Mullerian hormone, compared to its predecessor, Elecsys AMH (Roche Diagnostics GmbH). Methods: The precision, linearity, and limit of detection were assessed according to the CLSI (Clinical and Laboratory Standards Institute) guidelines. Method comparison and biotin interference evaluations were also conducted. Results: Our results demonstrated that Elecsys AMH plus exhibited precision within 5% for both low and high concentrations, maintained linearity within the analytical measuring intervals, was verified for the detection limit established by the manufacturer, and demonstrated excellent correlation with Elecsys AMH (correlation coefficient >0.975). Furthermore, Elecsys AMH plus exhibited enhanced resistance to biotin interference, with a change rate of under 5% even at a biotin concentration of 500 ng/mL. Conclusions: Elecsys AMH plus demonstrated excellent performance in terms of precision, linearity, detection limit, and biotin interference resistance.
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