Premium
Performance of three generations of anti‐hepatitis C virus enzyme‐ linked immunosorbent assays in donors and patients
Author(s) -
Vrielink Hans,
Reesink Henk W.,
Burg Peter J.M.,
Zaaijer Hans L.,
Cuypers H. Theo M.,
Lelie P. Nico,
Poel Cees L.
Publication year - 1997
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.1537-2995.1997.37897424409.x
Subject(s) - seroconversion , antibody , virology , medicine , hepatitis c virus , recombinant dna , population , serology , polymerase chain reaction , viral disease , immunoassay , virus , immunology , biology , gene , biochemistry , environmental health
BACKGROUND: Prevention of posttransfusion non‐A,non‐B hepatitis in recipients of blood components improved considerably with the introduction of the second‐generation of hepatitis C virus (HCV) antibody tests. In 1993, third‐generation HCV antibody assays were introduced in Europe. STUDY DESIGN AND METHODS: The performance of three generations of anti‐HCV enzyme‐linked immunosorbent assay (ELISA) (ELISA‐1, −2, −3) was compared in routine blood donor screening (99,394 donations were tested with ELISA‐1, 167,999 donations with ELISA‐2, and 262,090 donations with ELISA‐3) and in serial samples from nine patients with documented acute posttransfusion HCV infection. RESULTS: Eight (0.01%) repeat donors, previously negative in ELISA‐1, were found positive in ELISA‐2 and were confirmed as positive in second‐generation recombinant immunoblot assay and/or cDNA polymerase chain reaction. In the donor population, no difference in the sensitivity of ELISA‐2 and ‐ 3 was observed. The specificity of the three generations of ELISAs was comparable (99.8, 99.7, and 99.7%). In seroconversion samples, ELISA‐2 and −3 detected HCV antibodies at the same time in seven patients, but in two patients, ELISA‐3 found HCV antibodies, respectively, 63 and 77 days earlier than ELISA‐2 did. In the seroconversion samples, ELISA‐2 and −3 were significantly more sensitive than second‐ and third‐ generation recombinant immunoblot assays. CONCLUSION: ELISA‐3 did not detect more HCV‐infected individuals in a donor population that previously tested negative in ELISA‐2, but it did detect HCV antibodies earlier in some patients with acute HCV infection. ELISA‐2 and −3 were significantly more sensitive than second‐ and third‐generation recombinant immunoblot assays.