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.

公开(公告)号：US20170261498A1

公开(公告)日：2017-09-14

申请号：US14640263

申请日：2015-03-06

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Hartmut Duefel ,  Alexander Riedel ,  Peter Schaarschmidt ,  Urban Schmitt ,  Christian Scholz

IPC: G01N33/53 ,  C07K14/245 ,  C12N9/90

CPC classification number: G01N33/5306 ,  C07K14/245 ,  C07K2319/35 ,  C07K2319/735 ,  C12N9/90 ,  C12Y502/01008

Abstract: The invention concerns a fusion polypeptide comprising several molecules of folding helper polypeptides, comprising one multimerization domain, in particular Skp, and at least one molecule of SlyD or SlpA, wherein no further target polypeptide sequences are fused to said fusion polypeptide. The invention further concerns an immunoassay and the use of said fusion polypeptide in an immunoassay for reduction of interferences or minimizing false positive results or for stabilizing proteinaceous assay reagents. Further the invention concerns a reagent kit for use in an immunoassay comprising said fusion polypeptide.

公开(公告)号：US20170248597A1

公开(公告)日：2017-08-31

申请号：US15587842

申请日：2017-05-05

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Peter Muench ,  Dieter Roessler ,  Christian Scholz ,  Barbara Upmeier ,  Toralf Zarnt

IPC: G01N33/569 ,  C07K14/44 ,  G01N33/564

CPC classification number: G01N33/56905 ,  A61K39/005 ,  C07K14/44 ,  G01N33/564 ,  G01N2333/44 ,  G01N2469/20 ,  G01N2800/26

Abstract: The present invention concerns a composition of polypeptides suitable for detecting antibodies against Trypanosoma cruzi (T. cruzi) in an isolated biological sample consisting of three polypeptides 1F8, JL7 and Cruzipain. A method of producing a soluble and immunoreactive composition of polypeptides suitable for detecting antibodies against T. cruzi using said composition of polypeptides is also part of the invention. Moreover, the invention concerns a method for detecting antibodies specific for T. cruzi in an isolated sample wherein a composition of said T. cruzi polypeptides is used as well as a reagent kit comprising said composition of T. cruzi polypeptides.