公开(公告)号：US20240142441A1

公开(公告)日：2024-05-02

申请号：US18541708

申请日：2023-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Regina Baranowski ,  Dieter Heindl ,  Nikolaus-Peter Stengele ,  Christian Wellner

IPC: G01N33/543 ,  G01R33/09

CPC classification number: G01N33/54306 ,  G01R33/098

Abstract: The present invention concerns the field of diagnostics. In particular, it relates to a method for determining an analyte suspected to be present in a sample comprising contacting said sample with a sensor element comprising an anchor layer which is present on a solid support, a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer, a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, said second binding agent comprising at least one magnetic label, and a magnetic tunnel junction in functional proximity to the second binding agent which generates a signal elicited in proximity to the at least one magnetic label of the second binding agent, for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent and detecting the formation the complex of first binding agent, analyte and second binding agent based on an altered signal which is generated by the magnetic tunnel junction whereby the analyte is determined. The present invention, further, relates to a device and a kit for determining an analyte suspected to be present in a sample and to the use of said device for determining an analyte suspected to be present in a sample.

公开(公告)号：US20240133878A1

公开(公告)日：2024-04-25

申请号：US18541476

申请日：2023-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Nikolaus-Peter Stengele

IPC: G01N33/544 ,  G01N33/543

CPC classification number: G01N33/544 ,  G01N33/54386

Abstract: The present invention relates to diagnostic test and technology. In particular, the present invention relates to a method for determining an analyte suspected to be present in a sample comprising contacting said sample with a sensor element comprising i) an anchor layer which is present on a solid support, ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label, and iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent and detecting the formation of the complex of first binding agent, analyte and second binding agent whereby the analyte is determined. Moreover, provided is a device for determining an analyte suspected to be present in a sample and the use thereof for determining an analyte suspected to be present in a sample in said sample. Moreover, the present invention contemplates a kit for determining an analyte suspected to be present in a sample.

公开(公告)号：US20240230637A9

公开(公告)日：2024-07-11

申请号：US18541476

申请日：2023-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Nikolaus-Peter Stengele

IPC: G01N33/544 ,  G01N33/543

CPC classification number: G01N33/544 ,  G01N33/54386

Abstract: The present invention relates to diagnostic test and technology. In particular, the present invention relates to a method for determining an analyte suspected to be present in a sample comprising contacting said sample with a sensor element comprising i) an anchor layer which is present on a solid support, ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label, and iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent and detecting the formation of the complex of first binding agent, analyte and second binding agent whereby the analyte is determined. Moreover, provided is a device for determining an analyte suspected to be present in a sample and the use thereof for determining an analyte suspected to be present in a sample in said sample. Moreover, the present invention contemplates a kit for determining an analyte suspected to be present in a sample.

公开(公告)号：US20240142447A1

公开(公告)日：2024-05-02

申请号：US18541343

申请日：2023-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Nikolaus-Peter Stengele

IPC: G01N33/543

CPC classification number: G01N33/54393

Abstract: The present invention relates to diagnostic test and technology. In particular, the present invention relates to a method for determining an analyte suspected to be present in a sample comprising (a) contacting said sample with (i) a first binding agent which is capable of specifically binding to the analyte and which is immobilized on a solid support and (ii) a second binding agent which is capable of specifically binding to the analyte and which is capable of reversibly binding at least one detectable label, wherein said first and/or second binding agent is linked to an linking agent which is capable of covalently binding the at least one reversibly bound detectable label to the solid support when the first and second binding agents are in physical proximity, for a time and under conditions which allow specific binding of the analyte to the first and the second binding agent such that an complex of first binding agent, analyte and second binding agent is formed, and which allow for covalently binding the at least one detectable label to the solid support, and (b) removing the complex of first binding agent, analyte and second binding agent from the solid support such that the solid support having covalently bound the at least one detectable label remains, and (c) detecting the at least one covalently bound detectable label on the solid support whereby the analyte is determined. The present invention also relates to a device for determining an analyte suspected to be present in a sample, to the use of the device of the invention for determining an analyte suspected to be present in a sample in said sample, and to a kit for determining an analyte suspected to be present in a sample.

公开(公告)号：US20240118271A1

公开(公告)日：2024-04-11

申请号：US18541875

申请日：2023-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Regina Baranowski ,  Dieter Heindl ,  Nikolaus-Peter Stengele ,  Christian Wellner

IPC: G01N33/543

CPC classification number: G01N33/54326 ,  G01N2446/60

Abstract: The present invention relates to diagnostic test and technology. In particular, the present invention relates to a method for determining an analyte suspected to be present in a sample comprising contacting said sample with a sensor element comprising an anchor layer which is present on a solid support, a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one magnetic label, wherein said at least one magnetic label is located within the anchor layer, a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, and a magnetic tunnel junction in functional proximity to the second binding agent which generates a signal elicited in proximity to the at least one magnetic label of the first binding agent, for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent and detecting the formation the complex of first binding agent, analyte and second binding agent based on the signal which is generated by the magnetic tunnel junction whereby the analyte is determined. Moreover, provided is a device for determining an analyte suspected to be present in a sample and the use thereof for determining an analyte suspected to be present in a sample in said sample. Moreover, the present invention contemplates a kit for determining an analyte suspected to be present in a sample.