title: Evaluation of clinical usefulness of second-generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is an important etiologic agent for chronic liver diseases.
  
  
  METHODS
  The aim of this study was to evaluate the clinical usefulness of second-generation HCV core antigen assay by comparing the results of the assay with those of the COBAS AMPLICOR HCV MONITOR version 2.0 (COBAS v2.0).
  
  
  RESULTS
  HCV core antigen was detectable by this assay in 142/149 (95.3%) of serotype 1 (3821+/-322 fmol/l; mean+/-SD), in 56/58 (96.6%) of serotype 2 (2589+/-449 fmol/l), and in 6/6 (100%) of serotypes 1+2 (1240+/-548 fmol/l). The HCV core antigen levels measured by this assay correlated well with the HCV RNA levels by COBAS v2.0 (r=0.848, P<0.0001). In relation to the outcome of interferon monotherapy, the pretreatment HCV core antigen levels of sustained and non-sustained virological responders were 659+/-189 and 4904+/-376 fmol/l in serotype 1, 1993+/-740 and 3145+/-519 fmol/l in serotype 2. The cutoff values with the best accuracy for HCV core Ag levels to discriminate between sustained and non-sustained virological response were 699 fmol/l for serotype 1 and 292 fmol/l for serotype 2, respectively, by receiver operating characteristic curve analysis.
  
  
  CONCLUSIONS
  This new assay was considered to be useful in evaluating the HCV levels in patients with chronic hepatitis C.
authors.affiliation: Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan. yokosukao@faculty.chiba-u.jp
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokosuka
authors.forename: Shigenobu
authors.initials: S
authors.lastname: Kawai
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Kenichi
authors.initials: K
authors.lastname: Fukai
authors.forename: Fumio
authors.initials: F
authors.lastname: Imazeki
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kanda
authors.forename: Motohisa
authors.initials: M
authors.lastname: Tada
authors.forename: Rintarou
authors.initials: R
authors.lastname: Mikata
authors.forename: Akira
authors.initials: A
authors.lastname: Hata
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Saisho
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D018936:Hepatitis C Antigens / Q000097:blood*; D019698:Hepatitis C, Chronic / Q000821:virology*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins / Q000097:blood*; D019562:Viral Load
chemical_list: D018936:Hepatitis C Antigens; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins