title: Detection of HCV core antigen in human serum and plasma with an automated chemiluminescent immunoassay.
abstract: BACKGROUND
  Currently, the detection of HCV infection in blood donors relies on the ability of immunoassays to detect circulating HCV antibodies. However, a significant delay exists between the time of infection and the development of antibodies. This delay (window period) can last up to 70 days. The introduction of NAT for the detection of HCV RNA has reduced this window period dramatically. However, NAT is labor intensive, prone to contamination, and expensive as compared with standard serologic tests.
  
  
  METHODS
  An automated, microparticle-based chemiluminescent assay for the detection of HCV core antigen in human serum and plasma was developed. The specificity and sensitivity of this prototype assay were evaluated by testing a population of normal blood donors and commercially available seroconversion panels.
  
  
  RESULTS
  The HCV core antigen assay exhibited a 99.9-percent specificity by detecting a single repeatably reactive sample out of 1004 normal donors tested. Assay sensitivity was determined by comparing the HCV core antigen detection rate with the antibody seroconversion profile and the rate of HCV RNA detection. Among 15 seroconversion panels examined, core antigen was detected in 69 of 70 antibody-negative and/or RNA-positive samples for a sensitivity relative to NAT of 98.6 percent.
  
  
  CONCLUSIONS
  These data indicate that the automated, microparticle-based chemiluminescent HCV core antigen assay can reduce the window period for detection of potentially infected blood donors by 32.7 days, and it represents a viable alternative to HCV RNA testing.
authors.affiliation: Experimental Biology Research, Abbott Laboratories, North Chicago, Illinois 60064-6269, USA. scott.muerhoff@abbott.com
authors.forename: A Scott
authors.initials: AS
authors.lastname: Muerhoff
authors.forename: Lily
authors.initials: L
authors.lastname: Jiang
authors.forename: Dinesh O
authors.initials: DO
authors.lastname: Shah
authors.forename: Robin A
authors.initials: RA
authors.lastname: Gutierrez
authors.forename: Jigisha
authors.initials: J
authors.lastname: Patel
authors.forename: Cynthia
authors.initials: C
authors.lastname: Garolis
authors.forename: Charles R
authors.initials: CR
authors.lastname: Kyrk
authors.forename: Gregor
authors.initials: G
authors.lastname: Leckie
authors.forename: Andrea
authors.initials: A
authors.lastname: Frank
authors.forename: James L
authors.initials: JL
authors.lastname: Stewart
authors.forename: George J
authors.initials: GJ
authors.lastname: Dawson
mesh_terms: D000911:Antibodies, Monoclonal; D001322:Autoanalysis; D001782:Blood Donors; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis / Q000517:prevention & control / Q000635:transmission; D018937:Hepatitis C Antibodies / Q000097:blood; D018936:Hepatitis C Antigens / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements; D012367:RNA, Viral / Q000097:blood; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D000911:Antibodies, Monoclonal; D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D012367:RNA, Viral