公开(公告)号：US20190086413A1

公开(公告)日：2019-03-21

申请号：US16204681

申请日：2018-11-29

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Barbara Upmeier ,  Toralf Zarnt ,  Manfred Ginter ,  Ralf Bollhagen

IPC: G01N33/576 ,  G01N33/84

Abstract: The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject with the steps of (a) contacting the sample with a surfactant comprising a cationic detergent; (b) contacting the sample with a binding compound; and (c) detecting a core polypeptide of the HCV in the sample; wherein step a) is immediately followed by step b). The present disclosure further relates to a method for pre-processing a sample from a subject for detection of an HCV core polypeptide, involving (a) contacting the sample with a surfactant comprising a cationic detergent and, optionally, with an agent inducing a pH shift, immediately followed by (b) contacting the sample with a binding compound. Moreover, the present disclosure further relates to uses, devices, and analytical systems related to aforesaid methods.

公开(公告)号：US20160145281A1

公开(公告)日：2016-05-26

申请号：US14867074

申请日：2015-09-28

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Robert Cysewski ,  Luisa de Cola ,  Jesus Miguel Fernandez Hernandez ,  Hans-Peter Josel ,  Eloisa Lopez-Calle ,  Toralf Zarnt

IPC: C07F15/00 ,  G01N21/76 ,  G01N33/58

CPC classification number: C07F15/0033 ,  G01N21/76 ,  G01N33/533 ,  G01N33/582 ,  G01N2458/30

Abstract: Novel iridium-based Ir(III) luminescent complexes, conjugates comprising these complexes as a label and their application, for example in the electrochemiluminescence based detection of an analyte.

公开(公告)号：US11320423B2

公开(公告)日：2022-05-03

申请号：US15995572

申请日：2018-06-01

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Barbara Upmeier ,  Toralf Zarnt ,  Dieter Roessler ,  Johannes Polz

IPC: G01N31/00 ,  G01N33/53 ,  G01N33/541 ,  G01N33/543 ,  G01N21/64 ,  G01N21/78 ,  G01N33/531 ,  G01N33/538 ,  G01N33/569 ,  G01N33/576

Abstract: Disclosed is an immunoassay method for detecting an analyte such as an antigen or an antibody in an isolated sample suspected to contain the analyte by incubating the sample with a plurality of binding partners, one of which carries a detectable label, wherein a label-specific binding partner is added that does not carry a label but binds to the detectable label. The method is applicable for a large variety of analytes and has proven particularly useful for analyte antibodies of the IgG and IgM class present in samples due to infections by pathogens. Also disclosed is a reagent kit useful for the method comprising at least two analyte-specific binding partners one of which carries a detectable label and a label-specific binding partner that binds to said detectable label but itself does not carry a detectable label.

公开(公告)号：US20200148726A1

公开(公告)日：2020-05-14

申请号：US16751609

申请日：2020-01-24

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Barbara Upmeier ,  Ralf Bollhagen ,  Toralf Zarnt

IPC: C07K14/005 ,  G01N33/576

Abstract: The disclosure relates to a multi-epitope fusion protein as well as to its use as calibrator and/or control in an in vitro diagnostics immunoassay for detecting HCV core antigen. The multi-epitope fusion protein has two to six different non-overlapping linear peptides present in the amino acid sequence of hepatitis C virus (HCV) core protein, wherein each of the peptides is separated from the other peptides by a spacer consisting of a non-HCV amino acid sequence and having a chaperone amino acid sequence. No further HCV specific amino acid sequences are present in the polypeptide. A further aspect relates to a reagent kit for detecting HCV core antigen containing said multi-epitope fusion protein as calibrator or control or both.

公开(公告)号：US20190086412A1

公开(公告)日：2019-03-21

申请号：US16204580

申请日：2018-11-29

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Ralf Bollhagen ,  Barbara Upmeier ,  Toralf Zarnt ,  Peter Muench ,  Manfred Ginter

IPC: G01N33/576 ,  G01N33/53

Abstract: The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject involving (a) contacting said sample with a base and with a surfactant having a cationic detergent, and (b) detecting a core polypeptide of the HCV in the sample. The present invention further relates to a method for pre-processing a sample from a subject for detection of HCV, involving contacting the sample with a base and with a surfactant having a cationic detergent; and to a pre-processing reagent for detecting HCV in a sample, having a base and a surfactant including a cationic detergent, wherein the surfactant also has a nonionic detergent. Moreover, the present disclosure further relates to kits, uses, and devices related to the methods disclosed.

公开(公告)号：US10228370B2

公开(公告)日：2019-03-12

申请号：US15587907

申请日：2017-05-05

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Dieter Roessler ,  Barbara Upmeier ,  Toralf Zarnt

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

Abstract: The invention concerns variants of JL7 antigens that are suitable for detecting antibodies against Trypanosoma cruzi (causing Chagas disease) in an isolated biological sample. These antigens comprise a JL7 specific amino acid sequence, said JL7 specific sequence consisting of two copies of SEQ ID NO. 2, wherein each of said two copies has an amino acid identity of at least 90% to SEQ ID NO.2 and wherein no further Trypanosoma cruzi specific amino acid sequences are present in said polypeptide. The invention also concerns a composition of polypeptides useful for the detection of antibodies against Trypanosoma cruzi that comprises the above characterized JL7 antigen along with at least one of T. cruzi polypeptides 1F8, Cruzipain, KMP-11 and PAR-2. Moreover, it relates to a method for producing JL7 antigen as well as to diagnostic methods for detecting T. cruzi antibodies using the JL7 polypeptide. In addition, the invention concerns a reagent kit comprising said JL7 polypeptides or composition of Trypanosoma cruzi polypeptides.

公开(公告)号：US20180172680A1

公开(公告)日：2018-06-21

申请号：US15899003

申请日：2018-02-19

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Toralf Zarnt ,  Dieter Heindl ,  Alfons Nichtl ,  Frank Sicherl-Birk

IPC: G01N33/543

Abstract: Disclosed is a method for measurement of an analyte in a microparticle-based analyte-specific binding assay, wherein the microparticles are coated with the first partner of a binding pair, the method involving mixing the coated microparticles, an analyte-specific binding agent conjugated to the second partner of the binding pair, and a sample suspected of containing or containing the analyte, wherein the second partner of the binding pair is bound to the analyte-specific binding agent via a linker having from 12 to 30 ethylene glycol units (PEG 12 to 30), thereby binding the analyte via the conjugated analyte-specific binding agent to the coated microparticles, separating the microparticles having the analyte bound via the binding pair and the analyte-specific binding agent from the mixture and measuring the analyte bound to the microparticles.

公开(公告)号：US11327077B2

公开(公告)日：2022-05-10

申请号：US16204681

申请日：2018-11-29

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Barbara Upmeier ,  Toralf Zarnt ,  Manfred Ginter ,  Ralf Bollhagen

IPC: G01N33/576 ,  G01N33/84

Abstract: The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject with the steps of (a) contacting the sample with a surfactant comprising a cationic detergent; (b) contacting the sample with a binding compound; and (c) detecting a core polypeptide of the HCV in the sample; wherein step a) is immediately followed by step b). The present disclosure further relates to a method for pre-processing a sample from a subject for detection of an HCV core polypeptide, involving (a) contacting the sample with a surfactant comprising a cationic detergent and, optionally, with an agent inducing a pH shift, immediately followed by (b) contacting the sample with a binding compound. Moreover, the present disclosure further relates to uses, devices, and analytical systems related to aforesaid methods.

公开(公告)号：US11150247B2

公开(公告)日：2021-10-19

申请号：US16204580

申请日：2018-11-29

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Ralf Bollhagen ,  Barbara Upmeier ,  Toralf Zarnt ,  Peter Muench ,  Manfred Ginter

IPC: G01N33/576 ,  G01N33/53

Abstract: The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject involving (a) contacting said sample with a base and with a surfactant having a cationic detergent, and (b) detecting a core polypeptide of the HCV in the sample. The present invention further relates to a method for pre-processing a sample from a subject for detection of HCV, involving contacting the sample with a base and with a surfactant having a cationic detergent; and to a pre-processing reagent for detecting HCV in a sample, having a base and a surfactant including a cationic detergent, wherein the surfactant also has a nonionic detergent. Moreover, the present disclosure further relates to kits, uses, and devices related to the methods disclosed.

公开(公告)号：US11099180B2

公开(公告)日：2021-08-24

申请号：US16528710

申请日：2019-08-01

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Ralf Bollhagen ,  Barbara Upmeier ,  Werner Naser ,  Toralf Zarnt

IPC: G01N33/53 ,  G01N33/543 ,  G01N33/576

Abstract: The disclosure concerns a method and kits for measurement of an analyte in a microparticle-based analyte-specific binding assay. In the assay, the microparticles are coated with the first partner of a binding pair, mixing the coated microparticles and at least two analyte-specific binding agents, each conjugated to the second partner of the binding pair, and a sample suspected of containing the analyte. The second partner of the binding pair is bound to each of the analyte-specific binding agents via a linker comprising from 12 to 30 ethylene glycol units (PEG 12 to 30), thereby binding the analyte via the conjugated analyte-specific binding agents to the coated microparticles. The method also entails separating the microparticles having the analyte bound via the binding pair and the analyte-specific binding agent from the mixture and measuring the analyte bound to the microparticles.