Get access

Performance of three generations of anti-hepatitis C virus enzyme- linked immunosorbent assays in donors and patients

Authors

  • Hans Vrielink MD, PhD,

    Search for more papers by this author
    • Hans Vrielink, MD, PhD, Senior Scientist, Red Cross Blood Bank Amsterdam, Postbox 9137, Plesmanlaan 125, 1006 AC Amsterdam, the Netherlands. [Reprint requests]

  • Henk W. Reesink MD, PhD,

    Search for more papers by this author
    • Henk W. Reesink, MD, PhD, Medical Director, Red Cross Blood Bank Amsterdam.

  • Peter J.M. van den Burg MD, PhD,

    Search for more papers by this author
    • Peter J.M. van den Burg, MD, PhD, Senior Scientist, Red Cross Blood Bank Amsterdam.

  • Hans L. Zaaijer MD, PhD,

    Search for more papers by this author
    • Hans L. Zaaijer, MD, PhD, Senior Scientist, Viral Serology, Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam, the Netherlands.

  • H. Theo M. Cuypers PhD,

    Search for more papers by this author
    • H. Theo M. Cuypers, PhD, Senior Scientist, Viral Serology, Central Laboratory of the Netherlands Red Cross Blood Transfusion Service.

  • P. Nico Lelie PhD, Head,

    Search for more papers by this author
    • P. Nico Lelie, PhD, Head, Viral Serology, Central Laboratory of the Netherlands Red Cross Blood Transfusion Service.

  • Cees L. van der Poel MD, PhD

    Search for more papers by this author
    • Cees L. van der Poel, MD, PhD, Senior Scientist, Red Cross Blood Bank Amsterdam; current address: Red Cross Blood Bank Utrecht, Utrecht, the Netherlands.


Abstract

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.

Ancillary