公开(公告)号：US10830771B2

公开(公告)日：2020-11-10

申请号：US15766239

申请日：2016-10-06

申请人： FUJIREBIO INC. ,  SEKISUI MEDICAL CO., LTD.

发明人： Yoshiyuki Kitamura ,  Katsumi Aoyagi

IPC分类号： G01N33/573 ,  G01N33/53 ,  C07K16/36 ,  C07K16/40 ,  C12N15/02

摘要： Disclosed is a means of enabling the construction of a more accurate PIVKA-II immunoassay system using monoclonal antibodies against human prothrombin. The PIVKA-II assay method according to the present invention comprises measuring PIVKA-II in a sample by an immunoassay using an anti-PIVKA-II antibody or an antigen-binding fragment thereof which specifically binds to PIVKA-II and a mixture of a first anti-prothrombin antibody or an antigen-binding fragment thereof which recognizes hydrophilic PIVKA-II molecules and a second anti-prothrombin antibody or an antigen-binding fragment thereof which recognizes hydrophobic PIVKA-II molecules.

公开(公告)号：US10539559B2

公开(公告)日：2020-01-21

申请号：US14420122

申请日：2013-08-06

申请人： FUJIREBIO INC. ,  SEKISUI MEDICAL CO., Ltd.

发明人： Kentaro Yamaguchi ,  Katsumi Aoyagi ,  Azusa Terao

IPC分类号： G01N33/543 ,  G01N33/86 ,  C07K14/745 ,  G01N33/574

摘要： Disclosed are a PIVKA-II measurement method that achieves better serum-plasma correlation than conventional methods, and a reagent and a kit therefor. The PIVKA-II measurement method according to the present invention comprises measuring PIVKA-II in a sample by an immunoassay using a mixture of an anti-F1 antibody that specifically binds to prothrombin fragment F1 or an antigen-binding fragment thereof and an anti-F2 antibody that specifically binds to prothrombin fragment F2 or an antigen-binding fragment thereof; and an anti-PIVKA-II antibody that specifically binds to PIVKA-II or an antigen-binding fragment thereof.

公开(公告)号：US11454632B2

公开(公告)日：2022-09-27

申请号：US16768419

申请日：2018-11-22

申请人： FUJIREBIO INC.

发明人： Chiharu Ohue ,  Kumiko Iida ,  Katsumi Aoyagi ,  Shintaro Yagi

IPC分类号： G01N33/576 ,  G01N33/563 ,  G01N33/53

摘要： Disclosed is a highly sensitive assay method and assay kit for HBsAg, which do not require treatment with a strong acid or alkali in the sample pretreatment, and which is less susceptible to influences by the autoantibodies. The assay method for hepatitis B virus s antigen in a sample separated from a living body includes: a pretreatment step of mixing a sample with a pretreatment reagent containing a reducing agent, to reduce hepatitis B virus s antigen; and an immunoassay step of subjecting the pretreated sample to an immunoassay of hepatitis B virus s antigen using at least one antibody or antigen-binding fragment thereof capable of antigen-antibody reaction with a reduced peptide composed of the amino acids at positions 98 to 179 of hepatitis B virus s antigen.

公开(公告)号：US20150219638A1

公开(公告)日：2015-08-06

申请号：US14420122

申请日：2013-08-06

申请人： FUJIREBIO INC. ,  EIDIA Co., Ltd.

发明人： Kentaro Yamaguchi ,  Katsumi Aoyagi ,  Azusa Terao

IPC分类号： G01N33/543

CPC分类号： G01N33/54306 ,  C07K14/745 ,  G01N33/57438 ,  G01N33/86 ,  G01N2333/745

摘要： Disclosed are a PIVKA-II measurement method that achieves better serum-plasma correlation than conventional methods, and a reagent and a kit therefor. The PIVKA-II measurement method according to the present invention comprises measuring PIVKA-II in a sample by an immunoassay using a mixture of an anti-F1 antibody that specifically binds to prothrombin fragment F1 or an antigen-binding fragment thereof and an anti-F2 antibody that specifically binds to prothrombin fragment F2 or an antigen-binding fragment thereof; and an anti-PIVKA-II antibody that specifically binds to PIVKA-II or an antigen-binding fragment thereof.

摘要翻译： 公开了PIVKA-II测定方法，其比常规方法获得更好的血浆 - 血浆相关性，以及试剂和试剂盒。 根据本发明的PIVKA-II测量方法包括使用特异性结合凝血酶原片段F1或其抗原结合片段的抗-F1抗体和抗F2的混合物通过免疫测定在样品中测量PIVKA-II 特异性结合凝血酶原片段F2或其抗原结合片段的抗体; 和与PIVKA-II或其抗原结合片段特异性结合的抗PIVKA-II抗体。