Improved detection of antibodies to hepatitis C virus using a second generation ELISA.
A screening assay for the detection of antibodies to hepatitis C virus (HCV); ORTHO HCV ELISA Test System, Second Generation, was compared with the currently licensed c100-3 based test (ORTHO 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 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 anti-HCV 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.
Lee
S
S
Ortho Diagnostic Systems, Inc., Raritan, NJ.
McHutchinson
J
J
Francis
B
B
DiNello
R
R
Polito
A
A
Quan
S
S
Nelles
M
M
D001782:Blood Donors; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D016174:Hepacivirus / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood*; D006526:Hepatitis C / Q000097:blood / Q000382:microbiology / Q000635:transmission; D018937:Hepatitis C Antibodies; D006801:Humans; D012680:Sensitivity and Specificity
D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies