Evaluation of clinical usefulness of second-generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0.
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.
Yokosuka
Osamu
O
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan. yokosukao@faculty.chiba-u.jp
Kawai
Shigenobu
S
Suzuki
Yoichi
Y
Fukai
Kenichi
K
Imazeki
Fumio
F
Kanda
Tatsuo
T
Tada
Motohisa
M
Mikata
Rintarou
R
Hata
Akira
A
Saisho
Hiromitsu
H
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
D018936:Hepatitis C Antigens; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins