title: Sensitive measurement of serum abnormal prothrombin (PIVKA-II) as a marker of hepatocellular carcinoma.
abstract: OBJECTIVE
  The usefulness of abnormal prothrombin (PIVKA-II) for diagnosis of small HCC has been limited by its low sensitivity, despite a high specificity.
  
  
  METHODS
  The serum concentration of PIVKA-II was determined by using a new sensitive enzyme immunoassay (EIA) kit in patients with hepatocellular carcinoma (HCC), liver cirrhosis (LC), or chronic hepatitis (CH) and normal controls (NC). alpha-Fetoprotein (AFP) was simultaneously determined in same patients.
  
  
  RESULTS
  This kit has made it possible to detect low concentrations of PIVKA-II in the NC. The serum PIVKA-II concentration (mean +/- SE) was 15.7 +/- 1.1 mAu/ml, 16.1 +/- 2.0 mAu/ml, 26.3 +/- 7.2 mAu/ml and 5420.3 +/- 3960.0 mAu/ml in NC, CH, LC and HCC, respectively. Among 106 patients with HCC, 74 patients (69.8%) were positive for PIVKA-II (> or = 40 mAu/ml), while only 9 patients out of 68 patients with LC were positive (13.2%) and only 2 out of 90 patients with CH were positive (2.2%). No significant correlation was observed between AFP and PIVKA-II levels. With combined assay of AFP and PIVKA-II, the positive rate for HCC was increased to 78.3%. Among 14 patients with HCC < 20 mm in diameter. 7 were positive for PIVKA-II, and 6 out of 10 patients with HCC between 20 and 30 mm in diameter were positive for PIVKA-II. There was a correlation between tumor size and the PIVKA-II level.
  
  
  CONCLUSIONS
  Determination of PIVKA-II by this new EIA kit could be useful for the diagnosis of HCC, especially combined with determination of AFP.
authors.affiliation: Department of Medicine, Osaka Koseinenkin Hospital, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Tanaka
authors.forename: T
authors.initials: T
authors.lastname: Kashiwagi
authors.forename: H
authors.initials: H
authors.lastname: Tsutsumi
authors.forename: M
authors.initials: M
authors.lastname: Nagasawa
authors.forename: T
authors.initials: T
authors.lastname: Toyama
authors.forename: S
authors.initials: S
authors.lastname: Ozaki
authors.forename: M
authors.initials: M
authors.lastname: Naito
authors.forename: K
authors.initials: K
authors.lastname: Ishibashi
authors.forename: M
authors.initials: M
authors.lastname: Azuma
mesh_terms: D015415:Biomarkers; D014408:Biomarkers, Tumor / Q000097:blood*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis*; D005260:Female; D006521:Hepatitis, Chronic / Q000097:blood; D006801:Humans; D007124:Immunoenzyme Techniques; D008103:Liver Cirrhosis / Q000097:blood; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis*; D008297:Male; D011498:Protein Precursors / Q000032:analysis*; D011516:Prothrombin / Q000032:analysis*; D000509:alpha-Fetoproteins / Q000032:analysis
chemical_list: D015415:Biomarkers; D014408:Biomarkers, Tumor; D011498:Protein Precursors; D000509:alpha-Fetoproteins; C008208:acarboxyprothrombin; D011516:Prothrombin