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    • 10. 发明公开
    • SOLUBLE AND IMMUNOREACTIVE VARIANTS OF HTLV CAPSID ANTIGEN P24
    • LÖSLICHE免疫缺陷型变态反应型HTLV-KAPSID-ANTIGENS P24
    • EP3110831A2
    • 2017-01-04
    • EP15706804.0
    • 2015-02-26
    • Roche Diagnostics GmbHF. Hoffmann-La Roche AG
    • FAATZ, ElkeMUENCH, PeterSCHOLZ, Christian
    • C07K14/005G01N33/569
    • G01N33/56988C07K14/005C07K2319/35C12N2740/14022C12N2740/14031C12N2740/14051G01N33/56983G01N2333/15G01N2469/20
    • The invention concerns soluble and antigenic HTLV p24 variants that are fused to chaperones and their use in diagnostic applications such as immunoassays for detecting antibodies against HTLV-I or HTLV-II in an isolated biological sample. In particular, the invention relates to a soluble HTLV-I or HTLV-II p24 antigen comprising a fragment of at least 25 amino acids of SEQ ID NOs. 1 or 4 (HTLV-1) or SEQ ID NOs. 5 or 8 (HTLV-II), wherein the HTLV p24 antigen is fused to a chaperone. Moreover, the invention covers recombinant DNA molecules encoding these HTLV-I and -II fusion antigens as well as their recombinant production using expression vectors and host cells transformed with such expression vectors. In addition, the invention focusses on compositions of these HTLV p24 antigens with HTLV gp21 antigen and on an immunoassay method for detection of HTLV antibodies using the antigens of the invention. Also the use of HTLV p24 antigens in an in vitro diagnostic assay as well as a reagent kit for detection of anti-HTLV-antibodies comprising said HTLV antigens is encompassed.
    • 本发明涉及与分子伴侣融合的可溶性和抗原性HTLV p24变体及其在诊断应用中的用途,例如用于检测分离的生物样品中针对HTLV-1或HTLV-II的抗体的免疫测定。 特别地,本发明涉及包含SEQ ID NOs至少25个氨基酸的片段的可溶性HTLV-1或HTLV-II p24抗原。 1或4(HTLV-1)或SEQ ID NO。 5或8(HTLV-II),其中HTLV p24抗原与伴侣融合。 此外,本发明涵盖了编码这些HTLV-1和-II融合抗原的重组DNA分子以及使用表达载体和用这些表达载体转化的宿主细胞的重组生产。 此外,本发明集中于这些HTLV p24抗原与HTLV gp21抗原的组合物和使用本发明的抗原检测HTLV抗体的免疫测定方法。 还包括在体外诊断测定中使用HTLV p24抗原以及用于检测包含所述HTLV抗原的抗HTLV抗体的试剂盒。