title: Assays for antibodies to human interferon-alpha: the need for standardization.
abstract: Since the first reported occurrence of anti-interferon (IFN) antibodies in 1981, the reported incidence of antibody production has differed enormously. In some clinical trials of human IFN preparations, no patients developed antibodies, whereas other studies reported an incidence of more than 80%. In patients with hepatitis C, the reported incidence varies from 7% to 61%. One of the factors contributing to the variability of the results is the lack of a standard assay system to measure antibodies to IFNs. In 1994, a Concerted Action funded by the European Commission started to coordinate studies into the immunogenicity of recombinant DNA-derived pharmaceuticals. These studies aimed to examine whether antibodies could interfere with the efficacy of treatment and also studied the long-term effects on cytokines produced by the patients themselves. Only when a well-calibrated and standardized assay is available, however, will it be possible to define the biologically relevant titer of antibody. Assays for both binding and neutralizing antibodies are discussed here.
authors.affiliation: Diagnostic Center SSDZ, Delft, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Schellekens
authors.forename: J C
authors.initials: JC
authors.lastname: Ryff
authors.forename: P H
authors.initials: PH
authors.lastname: van der Meide
mesh_terms: D000937:Antigen-Antibody Reactions; D001323:Autoantibodies / Q000032:analysis*; D006801:Humans; D007158:Immunologic Techniques / Q000592:standards; D016898:Interferon-alpha / Q000276:immunology*; D011994:Recombinant Proteins / Q000276:immunology
chemical_list: D001323:Autoantibodies; D016898:Interferon-alpha; D011994:Recombinant Proteins