title: Clinical advantage of highly sensitive on-chip immunoassay for fucosylated fraction of alpha-fetoprotein in patients with hepatocellular carcinoma.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: 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. ytamura@med.niigata-u.ac.jp
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Tamura
authors.forename: Masato
authors.initials: M
authors.lastname: Igarashi
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Kawai
authors.forename: Takeshi
authors.initials: T
authors.lastname: Suda
authors.forename: Shinji
authors.initials: S
authors.lastname: Satomura
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Aoyagi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis* / Q000401:mortality / Q000473:pathology; D019075:Electrophoresis, Capillary; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D037121:Plant Lectins; D011379:Prognosis; D012372:ROC Curve; D012680:Sensitivity and Specificity; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: C097353:AFP protein, human; D037121:Plant Lectins; D000509:alpha-Fetoproteins
references.citation: J Hepatol. 1999 Jan;30(1):125-30
references.pmid: 9927159
references.citation: Am J Gastroenterol. 1999 Oct;94(10):3028-33
references.pmid: 10520864
references.citation: Cancer. 1988 Feb 15;61(4):769-74
references.pmid: 2448024
references.citation: J Clin Gastroenterol. 2001 Mar;32(3):240-4
references.pmid: 11246354
references.citation: Anal Biochem. 2009 May 15;388(2):306-11
references.pmid: 19250915
references.citation: Am J Gastroenterol. 1998 Dec;93(12):2452-6
references.pmid: 9860408
references.citation: Cancer Res. 1993 Nov 15;53(22):5419-23
references.pmid: 7693340
references.citation: J Gastroenterol Hepatol. 2001 Dec;16(12):1378-83
references.pmid: 11851836
references.citation: J Gastroenterol. 2003;38(3):207-15
references.pmid: 12673442
references.citation: Cancer. 1998 Nov 15;83(10):2076-82
references.pmid: 9827711
references.citation: Am J Clin Pathol. 1999 Jun;111(6):811-6
references.pmid: 10361518
references.citation: Electrophoresis. 2008 Apr;29(7):1399-406
references.pmid: 18384019
references.citation: J Gastroenterol. 2007 Dec;42(12):962-8
references.pmid: 18085353
references.citation: Hepatology. 2006 Dec;44(6):1518-27
references.pmid: 17133456
references.citation: Cancer. 1970 May;25(5):1091-8
references.pmid: 5443731
references.citation: Anal Chem. 1998 Mar 1;70(5):954-7
references.pmid: 9511471
references.citation: Hepatol Res. 2007 Nov;37(11):914-22
references.pmid: 17610501
references.citation: Hepatology. 1993 Jan;17(1):50-2
references.pmid: 7678576
references.citation: Cancer Res. 1968 Jul;28(7):1344-50
references.pmid: 4174340