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Comparison of two anti‐hepatitis C virus enzyme‐linked immunosorbent assays
Author(s) -
Vrielink H.,
Zaaijer H. L.,
Lelie P. N.,
Poel C. L.
Publication year - 1995
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1046/j.1537-2995.1995.35795357885.x
Subject(s) - virology , medicine , hepatitis c virus , enzyme , virus , immunology , biology , biochemistry
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. STUDY DESIGN AND 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. CONCLUSION: The sensitivity and specificity of the Ortho 3.0 ELISA are comparable to those of the Ortho 2.0 ELISA.