Schellekens H, Ryff J C, van der Meide P H
Diagnostic Center SSDZ, Delft, The Netherlands.
J Interferon Cytokine Res. 1997 Jul;17 Suppl 1:S5-8.
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.
自1981年首次报道出现抗干扰素（IFN）抗体以来，报道的抗体产生发生率差异极大。在一些人干扰素制剂的临床试验中，没有患者产生抗体，而其他研究报道的发生率超过80%。在丙型肝炎患者中，报道的发生率从7%到61%不等。导致结果差异的因素之一是缺乏用于检测抗干扰素抗体的标准检测系统。1994年，由欧盟委员会资助的一项联合行动开始协调对重组DNA衍生药物免疫原性的研究。这些研究旨在检查抗体是否会干扰治疗效果，并研究对患者自身产生的细胞因子的长期影响。然而，只有当有一个经过良好校准和标准化的检测方法时，才有可能确定生物学相关的抗体滴度。本文讨论了结合抗体和中和抗体的检测方法。
