title: Comparison of two anti-hepatitis C virus enzyme-linked immunosorbent assays.
abstract: BACKGROUND
  Third-generation anti-hepatitis C virus (HCV) enzyme-linked immunosorbent assays (ELISA) are now implemented in most laboratories in Europe, but have not yet been fully implemented in the United States.
  
  
  METHODS
  Two ELISAs (Ortho 3.0 and Ortho 2.0, Ortho Diagnostics, Raritan, NJ) were compared by tests on various serum panels: A) blood donor samples (n = 530) that tested positive in first- or second-generation anti-HCV ELISA; B) samples from persons with chronic non-A, non-B hepatitis (n = 185); C) samples from multiply transfused patients (n = 79); D) samples from patients on hemodialysis (n = 473); and E) samples from Dutch random blood donors (n = 2153).
  
  
  RESULTS
  In panels A, B, and C, 247 (100%) of 247 polymerase chain reaction (PCR)-positive and 278 (100%) of 278 second-generation recombinant immunoblot assay (RIBA-2)-positive specimens were detected by Ortho 2.0 and 3.0 (sensitivity, 100%). In the sera of panel D, used to represent a group of patients with a high risk for HCV, no additional positives were found by Ortho 3.0. In panel E, of 2153 blood donor samples, 2 (0.1%) were positive in Ortho 2.0 and 8 (0.4%) in Ortho 3.0. Two samples that were positive in both Ortho 2.0 and 3.0 were also positive in RIBA-2; one was positive on PCR. From the 6 remaining Ortho 3.0-positive (Ortho 2.0-negative) samples, 1 was positive in RIBA-2 (isolated anti-c100) and 3 were positive in third-generation RIBA (1/3 isolated anti-c100, 2/3 isolated NS5). All 6 samples were PCR negative. In first-time donors, no difference in specificity was found.
  
  
  CONCLUSIONS
  The sensitivity and specificity of the Ortho 3.0 ELISA are comparable to those of the Ortho 2.0 ELISA.
authors.affiliation: Red Cross Blood Bank Amsterdam, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Vrielink
authors.forename: H L
authors.initials: HL
authors.lastname: Zaaijer
authors.forename: H W
authors.initials: HW
authors.lastname: Reesink
authors.forename: P N
authors.initials: PN
authors.lastname: Lelie
authors.forename: C L
authors.initials: CL
authors.lastname: van der Poel
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D016174:Hepacivirus / Q000302:isolation & purification*; D006801:Humans; D012680:Sensitivity and Specificity