title: [Evaluation of ARCHITECT HCV core antigen assay].
abstract: BACKGROUND
  Hepatitis C virus (HCV) core antigen (Ag) levels are known to be well correlating with HCV RNA levels, and may be used as an alternative marker of HCV replication for monitoring the response to HCV treatment. However, the low sensitivity of HCV core Ag assay has been an obstacle for clinical use. In this study, recently developed ARCHITECT HCV Ag assay (Abbott Laboratories, USA) was evaluated for analytical performance and clinical usefulness.
  
  
  METHODS
  A total of 109 sera from HCV infected patients including various genotypes of HCV (1b, 2, 2a/2c, 2b, and 3a) and 20 sera from healthy donors were used for evaluating the sensitivity, precision, and linearity of the HCV core Ag assay. The cross reactivity with HIV, hepatitis B virus and myeloma proteins (N=5, each) and correlation with HCV RNA PCR assay were also evaluated.
  
  
  RESULTS
  The sensitivity of the HCV core Ag assay was 97.2% (106/109) and there were no false positive results and cross reactivity. The within-run, between-run and between-day CVs were 3.0%, 2.5% and 3.0%, respectively. The levels of HCV core antigen showed a good correlation with those of HCV RNA quantification (r=0.940). The HCV Ag assay showed an excellent linearity in the range from 0.63 to 17,114 fmol/L (r=0.999).
  
  
  CONCLUSIONS
  The ARCHITECT HCV Ag assay was good in sensitivity, precision, and linearity and its results well correlated with HCV RNA levels. This assay could be used as a good marker of viral replication for monitoring the therapy response in chronically HCV infected patients.
authors.affiliation: Department of Laboratory Medicine, Pusan National University School of Medicine, Pusan National University Hospital, Busan, Korea.
authors.forename: Dual
authors.initials: D
authors.lastname: Song
authors.forename: Jeong Eun
authors.initials: JE
authors.lastname: Kang
authors.forename: Shine Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Hwang
authors.forename: Hyung Hoi
authors.initials: HH
authors.lastname: Kim
authors.forename: Eun Yup
authors.initials: EY
authors.lastname: Lee
authors.forename: Han Chul
authors.initials: HC
authors.lastname: Son
mesh_terms: D003429:Cross Reactions; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology*; D018963:Hepatitis Antigens / Q000097:blood*; D006801:Humans; D008163:Luminescent Measurements / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014758:Viral Core Proteins / Q000097:blood*
chemical_list: D018963:Hepatitis Antigens; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins