公开(公告)号：US11567079B2

公开(公告)日：2023-01-31

申请号：US16577175

申请日：2019-09-20

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Christian Scholz ,  Peter Muench

IPC: C07K14/005 ,  C07K14/15 ,  G01N33/569

Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be 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 either the N- or the C-terminal domain of p24 and lacking the other domain. 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 focuses 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.

公开(公告)号：US11312750B2

公开(公告)日：2022-04-26

申请号：US16663417

申请日：2019-10-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Mario Gloeck ,  Peter Muench ,  Alexander Riedel ,  Christian Scholz ,  Gloria Tabares

IPC: C07K14/005 ,  C07K14/18 ,  C12N7/00 ,  G01N33/569

Abstract: The disclosure concerns a polypeptide suitable for detecting antibodies against Zika virus in an isolated biological sample having a Zika virus NS1 wing domain specific amino acid sequence and variants thereof, wherein no further Zika virus specific amino acid sequences are present in the polypeptide. This polypeptide does not immunologically cross-react with antibodies raised against structurally related antigens from tick-borne encephalitis virus, Dengue virus 1-4, West Nile virus, yellow fever virus or Japanese encephalitis virus, but immunologically reacts with antibodies raised against full length Zika virus NS1 antigen. Also disclosed is a method of producing a soluble and immunoreactive Zika virus NS1 polypeptide as well as methods and kits for detecting antibodies specific for Zika virus in an isolated sample.

公开(公告)号：US20170269068A1

公开(公告)日：2017-09-21

申请号：US15614856

申请日：2017-06-06

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Michael Gerg ,  Hans-Peter Josel ,  Christian Vogl

IPC: G01N33/537 ,  G01N33/82 ,  C07K16/26 ,  G01N33/541

CPC classification number: G01N33/537 ,  C07K16/26 ,  G01N33/541 ,  G01N33/82

Abstract: The present invention concerns an in vitro method for measurement of 25-hydroxyvitamin D, wherein the potentially interfering compound 24,25-dihydroxyvitamin D3 is blocked by a binding agent specifically binding to 24,25-dihydroxyvitamin D3 and not binding to 25-hydroxyvitamin D.

公开(公告)号：US20170184591A1

公开(公告)日：2017-06-29

申请号：US15246607

申请日：2016-08-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Christian Scholz ,  Peter Muench

IPC: G01N33/569 ,  C07K14/005

CPC classification number: G01N33/56988 ,  C07K14/005 ,  C07K2319/35 ,  C12N2740/14022 ,  C12N2740/14031 ,  C12N2740/14051 ,  G01N33/56983 ,  G01N2333/15 ,  G01N2469/20

Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be 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 either the N- or the C-terminal domain of p24 and lacking the other domain. 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 focuses 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.

公开(公告)号：US09316642B2

公开(公告)日：2016-04-19

申请号：US14335022

申请日：2014-07-18

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Peter Schaarschmidt ,  Urban Schmitt ,  Christian Scholz

IPC: A61K39/02 ,  A61K39/00 ,  G01N33/53 ,  G01N33/571 ,  C07K14/20

CPC classification number: G01N33/571 ,  C07K14/20 ,  C07K2319/00 ,  G01N2333/20 ,  G01N2469/20

Abstract: The invention concerns soluble variants of Treponema pallidum antigen 47 (TpN47 antigen) comprising at least domain B, or at least domains A and B, optionally domain D of the complete TpN47 protein molecule with the proviso that all antigens lack domain C (amino acid residues 224 to 351) of TpN47. The Tpn47 antigens can be fused to a chaperone. Moreover, the invention covers DNA encoding the antigens, a method of producing these antigens as well as the use of these antigens in an immunodiagnostic assay for the detection of antibodies against Treponema pallidum in an isolated sample.

Abstract translation: 本发明涉及包含至少结构域B或者至少结构域A和B，完全TpN47蛋白质分子的任选结构域D的梅毒螺旋体抗原47（TpN47抗原）的可溶性变体，条件是所有抗原缺失结构域C（氨基酸残基 224〜351）TpN47。 Tpn47抗原可以融合到伴侣。 此外，本发明涵盖编码抗原的DNA，制备这些抗原的方法以及在免疫诊断测定中使用这些抗原来检测分离样品中针对梅毒螺旋体的抗体。

公开(公告)号：US20150132859A1

公开(公告)日：2015-05-14

申请号：US14334773

申请日：2014-07-18

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Peter Schaarschmidt ,  Urban Schmitt ,  Christian Scholz

IPC: G01N33/68 ,  C07K14/245 ,  C07K14/28

CPC classification number: G01N33/6854 ,  C07K14/245 ,  C07K14/28 ,  C07K2319/35 ,  G01N33/5306 ,  G01N33/571 ,  G01N2333/20 ,  G01N2333/28 ,  G01N2469/20 ,  G01N2800/26

Abstract: The invention relates to a method for detecting antibodies against the TpN17 antigen of Treponema pallidum in an isolated sample wherein a peptide sequence of Vibrio cholerae lipoprotein 15 (VcLp15) or a partial sequence thereof is used as a reagent for reduction of interference, i.e. for minimizing false positive results. In addition the invention relates to fusion polypeptides comprising a VcLp15 peptide sequence and a chaperone, to their use as an additive in an immunoassay for said reduction of interferences and for minimizing false positive results and to a reagent kit for detecting antibodies against Treponema pallidum antigens in an isolated sample comprising a TpN17 antigen and said VcLp15-chaperone fusion polypeptide.

Abstract translation: 本发明涉及在分离的样品中检测针对梅毒螺旋体的TpN17抗原的抗体的方法，其中使用霍乱弧菌脂蛋白15（VcLp15）或其部分序列的肽序列作为减少干扰的试剂，即最小化 假阳性结果。 此外，本发明涉及包含VcLp15肽序列和伴侣的融合多肽，用于在用于所述减少干扰和最小化假阳性结果的免疫测定中作为添加剂，以及用于检测针对梅毒螺旋体抗原的抗体的试剂盒 包含TpN17抗原和所述VcLp15伴侣融合多肽的分离样品。

公开(公告)号：US11319351B2

公开(公告)日：2022-05-03

申请号：US16663457

申请日：2019-10-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Alexander Riedel ,  Christian Scholz ,  Peter Muench ,  Gloria Tabares ,  Mario Gloeck ,  Silke Luebcke ,  Juliane Benz

IPC: C07K14/005 ,  C07K14/18 ,  C12N7/00 ,  G01N33/569

Abstract: The disclosure relates to a polypeptide suitable for detecting antibodies against a flavivirus in an isolated biological sample having a flavivirus NS1 wing domain specific amino acid sequence, wherein no amino acid sequences from the NS1 ß-ladder domain of said flavivirus are present in the polypeptide. In an embodiment, the flavivirus is selected from Zika virus (ZIKV), West-Nile virus (WNV), Dengue virus types 1-4 (DENV1-4), tick-borne encephalitis virus (TBEV), yellow fever virus (YFV) and Japanese encephalitis virus (JEV). Also disclosed is a method for producing said flaviviral NS1 wing domain specific polypeptides, a method for detecting antibodies specific for a first flavivirus species, the use of said flaviviral NS1 wing domain specific polypeptides for detecting antibodies as well as a reagent kit for detecting said flavivirus antibodies that has a flavivirus NS1 wing domain polypeptide.

公开(公告)号：US20200048313A1

公开(公告)日：2020-02-13

申请号：US16663457

申请日：2019-10-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Alexander Riedel ,  Christian Scholz ,  Peter Muench ,  Gloria Tabares ,  Mario Gloeck ,  Silke Luebcke ,  Juliane Benz

IPC: C07K14/18 ,  G01N33/569 ,  C12N7/00

Abstract: The disclosure relates to a polypeptide suitable for detecting antibodies against a flavivirus in an isolated biological sample having a flavivirus NS1 wing domain specific amino acid sequence, wherein no amino acid sequences from the NS1 ß-ladder domain of said flavivirus are present in the polypeptide. In an embodiment, the flavivirus is selected from Zika virus (ZIKV), West-Nile virus (WNV), Dengue virus types 1-4 (DENV1-4), tick-borne encephalitis virus (TBEV), yellow fever virus (YFV) and Japanese encephalitis virus (JEV). Also disclosed is a method for producing said flaviviral NS1 wing domain specific polypeptides, a method for detecting antibodies specific for a first flavivirus species, the use of said flaviviral NS1 wing domain specific polypeptides for detecting antibodies as well as a reagent kit for detecting said flavivirus antibodies that has a flavivirus NS1 wing domain polypeptide.

公开(公告)号：US20200048312A1

公开(公告)日：2020-02-13

申请号：US16663417

申请日：2019-10-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Mario Gloeck ,  Peter Muench ,  Alexander Riedel ,  Christian Scholz ,  Gloria Tabares

IPC: C07K14/005 ,  G01N33/569

Abstract: The disclosure concerns a polypeptide suitable for detecting antibodies against Zika virus in an isolated biological sample having a Zika virus NS1 wing domain specific amino acid sequence and variants thereof, wherein no further Zika virus specific amino acid sequences are present in the polypeptide. This polypeptide does not immunologically cross-react with antibodies raised against structurally related antigens from tick-borne encephalitis virus, Dengue virus 1-4, West Nile virus, yellow fever virus or Japanese encephalitis virus, but immunologically reacts with antibodies raised against full length Zika virus NS1 antigen. Also disclosed is a method of producing a soluble and immunoreactive Zika virus NS1 polypeptide as well as methods and kits for detecting antibodies specific for Zika virus in an isolated sample.

公开(公告)号：US10466242B2

公开(公告)日：2019-11-05

申请号：US15246607

申请日：2016-08-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Elke Faatz ,  Christian Scholz ,  Peter Muench

IPC: A61K39/12 ,  G01N33/569 ,  C07K14/005

Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be 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 either the N- or the C-terminal domain of p24 and lacking the other domain. 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 focuses 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.