새로운 ARCHITECT AFP Assay의 분석능 평가
Analytical Performance of New ARCHITECT AFP Assay: Comparison with the Current Assay
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초록
알파태아단백(AFP)은 간세포암의 진단과 감시에 흔히 사용된다. 이전에 사용하던 ARCHITECT AFP (List number 7K67) 시약은 그측정 범위가 0–350 ng/mL여서 200–350 ng/mL 사이의 검체는 희석이 필요하다. 새로운 ARCHITECT AFP (8100/3P36) 시약은 그측정 범위가 2,000 ng/mL로 확대되었다. 이 연구의 목적은 이전의시약과 새로운 시약의 비교평가이며 새로운 시약의 분석능 또한평가하였다. 비교평가 결과 우수한 상관성을 보였으며 정밀도 검사에서도 우수한 결과를 보였다. 새로운 ARCHITECT AFP 시약은그 측정 범위가 넓어 희석에 필요한 수고를 줄일 수 있으며 우수한분석능을 가지고 있으므로 이전의 시약을 대체하기에 충분한 것으로 사료된다.
Abstract
Alpha-fetoprotein (AFP) is frequently used for hepatocellular carcinoma (HCC) diagnosis and surveillance. Although the current ARCHITECT AFP (List number 7K67) assay range is 0–350 ng/mL, all samples with test results between 200 and 350 ng/mL must be diluted and retested until their levels are <200 ng/mL. A new ARCHITECT AFP (8100/3P36) assay with a dynamic range of up to 2000 ng/mL has been introduced. The aim of this study was to perform a method comparison between the current ARCHITECT AFP assay and the new assay. The precision study showed excellent results for both high and low controls. There was a positive correlation between the two assay systems and clinical samples. The new ARCHITECT AFP assay with a wide assay range demonstrated good analytical performance. Therefore, the current ARCHITECT AFP assay could be replaced by the new assay, which is more convenient and minimizes manual labor.
참고문헌 (16)
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