Lab Med Online.  2018 Apr;8(2):62-65. 10.3343/lmo.2018.8.2.62.

Analytical Performance of New ARCHITECT AFP Assay: Comparison with the Current Assay

Affiliations
  • 1Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea. jyhan@dau.ac.kr

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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