title: Performance of ARCHITECT HCV core antigen test with specimens from US plasma donors and injecting drug users.
abstract: BACKGROUND
  Hepatitis C virus (HCV) core antigen is a serological marker of current HCV infection.
  
  
  OBJECTIVE
  The aim of this study was mainly to evaluate the performance characteristics of the ARCHITECT HCV core antigen assay with specimens from US plasma donors and injecting drug users.
  
  
  METHODS
  A total of 551 serum and plasma samples with known anti-HCV and HCV RNA status were tested for HCV core antigen using the Abbott ARCHITECT HCV core antigen test.
  
  
  RESULTS
  HCV core antigen was detectable in 100% of US plasma donor samples collected during the pre-seroconversion phase of infection (anti-HCV negative/HCV RNA positive). Overall sensitivity of the HCV core antigen assay was 88.9-94.3% in samples collected after seroconversion. The correlation between HCV core antigen and HCV RNA titers was 0.959.
  
  
  CONCLUSIONS
  HCV core antigen testing may be reliably used to identify current HCV infection.
authors: Centers for Disease Control and Prevention, Division of Viral Hepatitis, Atlanta, GA, USA.
authors: Tonya
authors: T
authors: Mixson-Hayden
authors: Abbott Laboratories, Abbott Park, IL, USA.
authors: George J
authors: GJ
authors: Dawson
authors: Centers for Disease Control and Prevention, Division of Viral Hepatitis, Atlanta, GA, USA.
authors: Eyasu
authors: E
authors: Teshale
authors: Centers for Disease Control and Prevention, Division of Viral Hepatitis, Atlanta, GA, USA.
authors: Thao
authors: T
authors: Le
authors: Abbott Laboratories, Abbott Park, IL, USA.
authors: Kevin
authors: K
authors: Cheng
authors: Centers for Disease Control and Prevention, Division of Viral Hepatitis, Atlanta, GA, USA.
authors: Jan
authors: J
authors: Drobeniuc
authors: Centers for Disease Control and Prevention, Division of Viral Hepatitis, Atlanta, GA, USA.
authors: John
authors: J
authors: Ward
authors: Centers for Disease Control and Prevention, Division of Viral Hepatitis, Atlanta, GA, USA. Electronic address: skamili@cdc.gov.
authors: Saleem
authors: S
authors: Kamili
mesh_terms: D000956:Antigens, Viral / Q000097:blood*; D001782:Blood Donors; D003955:Diagnostic Tests, Routine / Q000379:methods*; D055030:Drug Users; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008403:Mass Screening / Q000379:methods*; D010949:Plasma / Q000821:virology*; D012680:Sensitivity and Specificity; D015819:Substance Abuse, Intravenous / Q000150:complications*; D014481:United States; D014758:Viral Core Proteins / Q000097:blood*
chemical_list: D000956:Antigens, Viral; D014758:Viral Core Proteins; C069130:nucleocapsid protein, Hepatitis C virus
keywords: HCV RNA; HCV core antigen; HCV screening