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：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：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.

公开(公告)号：US11078241B2

公开(公告)日：2021-08-03

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.