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    • 4. 发明授权
    • Process for the preparation of immunogens or diagnostic reagents, and immunogens or diagnostic reagents thereby obtainable
    • 用于制备免疫原或诊断试剂的方法,以及由此获得的免疫原或诊断试剂
    • US06541210B1
    • 2003-04-01
    • US09441992
    • 1999-11-18
    • Franco FeliciAlessandra LuzzagoPaolo MonaciAlfredo NicosiaRiccardo Cortese
    • Franco FeliciAlessandra LuzzagoPaolo MonaciAlfredo NicosiaRiccardo Cortese
    • G01N3353
    • C40B40/02A61K39/00C07K14/005C07K14/4713C07K16/32C07K2319/40C07K2319/735C12N15/1037C12N2730/10122C12N2770/24222Y10S436/811
    • A process for the preparation of immunogens or diagnostic reagents that mimic an antigen or a pathogenic organism specific to a disease, essentially characterized by the following operations: identification of at least one antibody that reacts with the antigen or pathogenic organism specific to the disease; construction of phage libraries which display on the surface of the capsid oligopeptides, expressed from random sequence oligonucleotidic inserts introduced into a gene coding for a phage capsid protein using genetic manipulation techniques (for example, using a plasmid engineered for the purposes of the invention, the genetic map of which is shown in the figure); selection of the phages that display on the surfaces of the capsid antigenic oligopeptides recognized by said antibody; optional use of the selected phages and/or fragments thereof and/or their derivatives for the formulation of diagnostic kits for the specific pathogenic agent, or in general for the disease, including immunological disorders typical of so-called autoimmune diseases, with known or unknown etiology and/or pathogenesis; optional use of the selected phages and/or fragments thereof and/or their derivatives to induce a tolerance of the phenomena of hypersensitivity and/or allergy to compounds and/or natural or synthetic preparations; optional immunization of an organism by means of the selected phages and/or fragments thereof and/or their derivatives; and optional verification of the presence, in the serum of the immunized organism, of antibodies that recognize the above antigen or organism specific to the disease.
    • 一种制备模拟抗原或疾病特异性的致病生物的免疫原或诊断试剂的方法,其基本特征在于以下操作:鉴定与该疾病特异性的抗原或致病生物反应的至少一种抗体; 在使用遗传操作技术(例如,使用为本发明的目的而工程设计的质粒)的引入到编码噬菌体衣壳蛋白的基因中的随机序列寡核苷酸插入物表达的衣壳寡肽的表面上显示的噬菌体文库的构建 遗传图谱如图所示); 选择在所述抗体识别的衣壳抗原寡肽的表面上显示的噬菌体; 任选使用所选择的噬菌体和/或其片段和/或其衍生物用于制备用于特定病原体的诊断试剂盒,或一般用于该疾病,包括典型的所谓自身免疫性疾病的免疫学疾病,具有已知或未知的 病因和/或发病机制; 任选使用所选择的噬菌体和/或其片段和/或其衍生物以诱导对化合物和/或天然或合成制剂的过敏和/或过敏现象的耐受性; 通过所选择的噬菌体和/或其片段和/或其衍生物任选地免疫生物体; 并且可选地验证在免疫生物体的血清中存在识别上述对该疾病特异性的抗原或生物体的抗体。