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KMID : 1100820180080020062
Laboratory Medicine Online
2018 Volume.8 No. 2 p.62 ~ p.65
Analytical Performance of New ARCHITECT AFP Assay: Comparison with the Current Assay
Woo Kwang-Sook

An Gyu-Dae
Lim Hyeon-Ho
Han Jin-Yeong
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.
KEYWORD
Alpha-fetoprotein, ARCHITECT AFP assay, Analytical performance
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