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

• Woo KS
• An GD
• Lim HH
• Han JY

• KMID: 2407564
• DOI: http://doi.org/10.3343/lmo.2018.8.2.62

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

MeSH Terms

alpha-Fetoproteins
Carcinoma, Hepatocellular
Diagnosis
Methods
alpha-Fetoproteins

Figure

• 

  Fig. 1 Linearity analysis of new ARCHITECT AFP assay. The new AFP assay showed good linearity for the expected values (y=1.0021x–22.253, r2=0.9994).

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  Fig. 2 Comparison of new and current ARCHITECT AFP assay in patients (A) and healthy individuals (B). There was excellent correlation between the results of the new and current assays in both patients (r=0.8522, P<0.0001) and healthy individuals (r=0.9574, P<0.0001).

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