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Improved Detection of Antibodies to Hepatitis C Virus Using a Second Generation Elisa

  • Stephen Lee
  • John McHutchinson
  • Brian Francis
  • Robert DiNello
  • Alan Polito
  • Stella Quan
  • Mitchell Nelles
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 312)

Abstract

A screening assay for the detection of antibodies to hepatitis C virus (HCV); ORTHOTM HCV ELISA Test System, Second Generation, was compared with the currently licensed c100-3 based test (ORTHOTM HCV ELISA Test System). The second generation ELISA differs from the c100-3 based assay in that it detects circulating antibodies to both structural (nucleocapsid) and non-structural (NS3/NS4) HCV proteins. Specimens tested consisted of a cohort of 35 patients diagnosed with non-A, non-B hepatitis (NANBH) and 3971 presumably healthy volunteer blood donors. Second generation ELISA demonstrated significantly greater clinical sensitivity in patients with acute phase NANBH (80% vs. 60%) as well as chronic disease (88% vs. 72%). Additional specimens reactive only in second generation ELISA, demonstrated reactivity to HCV antigens c33c and/or c22-3 in supplemental testing by the Chiron HCV RIBA tm Assay System. The second generation ELISA also detected additional RIBA reactive volunteer blood donors (0.18% of the population tested) that were nonreactive in first generation ELISA. This data indicated that second generation ELISA would detect approximately 2 additional antiHCV reactive donors per 1,000 screened. Specificities obtained with this low risk population were 99.6% for first generation and 99.7% for second generation ELISA.

Keywords

Volunteer Blood Donor NANB Hepatitis Generation ELISA ELISA Test System Chronic NANB Hepatitis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 1992

Authors and Affiliations

  • Stephen Lee
    • 1
  • John McHutchinson
    • 2
  • Brian Francis
    • 1
  • Robert DiNello
    • 3
  • Alan Polito
    • 3
  • Stella Quan
    • 3
  • Mitchell Nelles
    • 1
  1. 1.Ortho Diagnostic Systems, Inc.RaritanUSA
  2. 2.Division of GI and Liver DiseaseUniversity of Southern CaliforniaLos AngelesUSA
  3. 3.Chiron CorporationEmeryvilleUSA

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