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Clinical Advantage of Highly Sensitive On-Chip Immunoassay for Fucosylated Fraction of Alpha-Fetoprotein in Patients with Hepatocellular Carcinoma

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Abstract

Background

Alpha-fetoprotein (AFP) has been widely used as a diagnostic master for hepatocellular carcinoma (HCC), and the fucosylated fraction of AFP (AFP-L3) has been reported to be a specific marker for HCC. However, AFP-L3 has not always been reliable in cases with low serum AFP concentrations. Recently, a novel automated immunoassay for AFP-L3, the micro-total analysis system (μ-TAS), has been developed.

Aim

The aim of this study is to evaluate the clinical usefulness of μ-TAS AFP-L3.

Methods

Serum AFP-L3 was measured in 295 patients with HCC and in 350 with benign liver diseases. The diagnostic accuracy of μ-TAS AFP-L3 was compared with that of the conventional assay (liquid-phase binding assay; LiBASys). The relationship between μ-TAS AFP-L3 and clinical features was investigated.

Results

When the cutoff value was set at 7%, the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of μ-TAS AFP-L3 were 60.0%, 90.3%, 76.4%, 83.9%, and 72.8%, respectively. Its sensitivity was particularly good (41.1%) in HCC subgroups with lower AFP concentrations (<20 ng/ml). The positivity rates for μ-TAS AFP-L3 were higher at each tumor stage than those of LiBASys AFP-L3 (μ-TAS/LiBASys: stage I, 44.2%/16.3%; stage II, 52.9%/37.5%; stage III, 66.4%/44.5%; stage IV, 82.8%/65.5%).

Conclusions

μ-TAS AFP-L3 is more sensitive for discriminating HCC than the conventional LiBASys AFP-L3, particularly in subgroups with lower AFP concentrations and early-stage HCC.

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Acknowledgments

This study was supported in part by a Grant-in-Aid (20390205), Japan Society for the Promotion Science, and a Grant-in-Aid from Health, Labor, and Welfare, Japan.

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Niigata University Graduate School of Medical and Dental Sciences, 757 Asahimachi Dori-1-Bancho, Chuo-ku, Niigata, 951-8520, Japan

    Yasushi Tamura, Masato Igarashi, Hirokazu Kawai, Takeshi Suda & Yutaka Aoyagi

  2. Diagnostic Division, Wako Pure Chemical Industries Ltd., Osaka, Japan

    Shinji Satomura

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  1. Yasushi Tamura
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  2. Masato Igarashi
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  3. Hirokazu Kawai
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  6. Yutaka Aoyagi
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Correspondence to Yasushi Tamura.

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Tamura, Y., Igarashi, M., Kawai, H. et al. Clinical Advantage of Highly Sensitive On-Chip Immunoassay for Fucosylated Fraction of Alpha-Fetoprotein in Patients with Hepatocellular Carcinoma. Dig Dis Sci 55, 3576–3583 (2010). https://doi.org/10.1007/s10620-010-1222-5

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  • DOI: https://doi.org/10.1007/s10620-010-1222-5

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