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    SOLUBLE AND IMMUNOREACTIVE VARIANTS OF HTLV CAPSID ANTIGEN P24
    13.
    发明申请
    SOLUBLE AND IMMUNOREACTIVE VARIANTS OF HTLV CAPSID ANTIGEN P24 审中-公开

    公开(公告)号：US20200033342A1

    公开(公告)日：2020-01-30

    申请号：US16577175

    申请日：2019-09-20

    Applicant: Roche Diagnostics Operations, Inc.

    Inventor： Elke Faatz ,  Christian Scholz ,  Peter Muench

    IPC: 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.

    Analytical test management system and method
    14.
    发明授权
    Analytical test management system and method 有权

    公开(公告)号：US10101349B2

    公开(公告)日：2018-10-16

    申请号：US15249834

    申请日：2016-08-29

    Applicant: Roche Diagnostics Operations, Inc.

    Inventor： Sascha Martin Antoni ,  Martin Burri ,  Werner Doeppen ,  Bernhard Eckert ,  Elke Faatz ,  Barbara Upmeier ,  Andreas Woeste ,  Dieter Roessler ,  Elena Pfaffenrot

    IPC: G01N35/00 ,  G01N35/10 ,  G05B19/042

    Abstract: A test management system is presented. The system comprises an analyzer to perform tests a sample according to a first set of instructions, a manager module connected to the analyzer, and a first order interface connected to the manager module. The manager module directs activity of the analyzer according to a second set of instructions. The first order interface receives an order for a first analytical test and a second analytical test and transmits the order to the manager module. If the order is for the first analytical test, the test manager module forwards the order directly to the analyzer and the sample is analyzed by the analyzer according to the first set of instructions. If the order is for the second analytical test, the manager module handles the order according to the second set of instructions and generates and transmits secondary test requests to the analyzer.

    SOLUBLE IMMUNOREACTIVE TREPONEMA PALLIDUM TpN47 ANTIGENS
    15.
    发明申请
    SOLUBLE IMMUNOREACTIVE TREPONEMA PALLIDUM TpN47 ANTIGENS 有权
    可溶性免疫反应性TREPONEMA PALLIDUM TpN47抗原

    公开(公告)号：US20150079604A1

    公开(公告)日：2015-03-19

    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: 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蛋白质分子的任选区域D的梅毒螺旋体抗原47（TpN47抗原）的可溶性变体，条件是所有抗原都缺乏结构域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。

    SOLUBLE AND IMMUNOREACTIVE FLAVIVRAL NS1 POLYPEPTIDES
    17.
    发明申请
    SOLUBLE AND IMMUNOREACTIVE FLAVIVRAL NS1 POLYPEPTIDES 有权

    公开(公告)号：US20220220158A1

    公开(公告)日：2022-07-14

    申请号：US17705704

    申请日：2022-03-28

    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 ,  C12N7/00 ,  G01N33/569 ,  C07K14/005

    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 β-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.

    Automatic analyzer
    18.
    发明授权
    Automatic analyzer 有权

    公开(公告)号：US11215627B2

    公开(公告)日：2022-01-04

    申请号：US15756431

    申请日：2016-07-01

    Applicant: HITACHI HIGH-TECHNOLOGIES CORPORATION ,  ROCHE DIAGNOSTICS OPERATIONS, INC.

    Inventor： Kenta Imai ,  Toshiharu Suzuki ,  Shigeki Matsubara ,  Takayuki Sugime ,  Shunsuke Sasaki ,  Elke Faatz ,  Beatus Ofenloch-Haehnle

    IPC: G01N35/10 ,  G01N35/00

    Abstract: In conventional automatic analyzers, there have been instances where, when a plurality of associated items are analyzed as a set item, there is high variation in the analysis data obtained using the set item, leading to a need for improvement of analysis precision. The present invention comprises performing, in mutual association, a set of preparation steps to carry out until it is time to analyze an unknown sample, the set of preparation steps including a pre-preparation step in which stirring, etc., is performed when an analysis reagent kit is mounted on the analyzer, and a step for correcting a standard curve in which correction samples that correspond to analysis items are used. This makes it possible to perform analysis after the preparation states of a plurality of analysis reagent kits are collected as needed, enabling high-precision analysis of a set item.

    ANALYTICAL TEST MANAGEMENT SYSTEM AND METHOD
    20.
    发明申请
    ANALYTICAL TEST MANAGEMENT SYSTEM AND METHOD 审中-公开
    分析测试管理系统与方法

    公开(公告)号：US20170067922A1

    公开(公告)日：2017-03-09

    申请号：US15249834

    申请日：2016-08-29

    Applicant: Roche Diagnostics Operations, Inc.

    Inventor： Sascha Martin Antoni ,  Martin Burri ,  Werner Doeppen ,  Bernhard Eckert ,  Elke Faatz ,  Barbara Upmeier ,  Andreas Woeste ,  Dieter Roessler ,  Elena Pfaffenrot

    IPC: G01N35/00 ,  G01N35/10

    CPC classification number: G01N35/0092 ,  G01N35/00613 ,  G01N35/00712 ,  G01N35/00871 ,  G01N35/0095 ,  G01N35/1072 ,  G01N2035/00326 ,  G01N2035/00881 ,  G01N2035/0091 ,  G01N2035/1032 ,  G05B19/042 ,  G05B2219/32258 ,  Y02P90/20

    Abstract: A test management system is presented. The system comprises an analyzer to perform tests a sample according to a first set of instructions, a manager module connected to the analyzer, and a first order interface connected to the manager module. The manager module directs activity of the analyzer according to a second set of instructions. The first order interface receives an order for a first analytical test and a second analytical test and transmits the order to the manager module. If the order is for the first analytical test, the test manager module forwards the order directly to the analyzer and the sample is analyzed by the analyzer according to the first set of instructions. If the order is for the second analytical test, the manager module handles the order according to the second set of instructions and generates and transmits secondary test requests to the analyzer.

    Abstract translation: 提出了一个测试管理系统。 该系统包括分析器，用于根据第一组指令执行样本测试，连接到分析器的管理器模块以及连接到管理器模块的第一阶接口。 管理器模块根据第二组指令指示分析仪的活动。 第一订单接口接收第一分析测试和第二分析测试的订单，并将该订单发送给管理器模块。 如果订单是第一次分析测试，则测试管理器模块将订单直接转发到分析仪，并且分析仪根据第一组指令对样品进行分析。 如果订单用于第二次分析测试，则管理器模块根据第二组指令处理订单，并生成并传送二次测试请求给分析仪。

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