# US 2022/0034874 A1 · Extended range immunoassay devices with immunosensor and magnetic immunosensor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2022/0034874 A1 - Document ID: US20220034874A1 - Status: Published application - Kind: A1 - Application number: 17/451,029 - Filed: 2021-10-15 - Published: 2022-02-03 - Earliest claimed: 2016-12-09 - Assignees: Abbott Point of Care Inc. - Applicants: Abbott Point of Care Inc. - Inventors: Jing Hua Hu; Antii Leo Oskari Virtanen; John Wilfrid Bezaire; Eric Edward Potter; James T.K. Smith; Cary James Miller; John Lewis Emerson Campbell; Adam Roger Moss - Web page: https://patentgrep.com/patent/US20220034874A1 ## CPC - G01N 33/54326: {Magnetic particles} - B01L 3/502761: {specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads or physically stretching molecules} - G01N 27/3273: {Devices therefor, e.g. test element readers, circuitry (details not specific to biochemical electrodes G01N33/4875)} - G01N 33/50: Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing (measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q) - G01N 33/5306: {Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding} - G01N 33/536: with immune complex formed in liquid phase - G01N 33/543: with an insoluble carrier for immobilising immunochemicals - G01N 33/54306: {Solid-phase reaction mechanisms} - G01N 33/54366: {Apparatus specially adapted for solid-phase testing} - G01N 33/5438: {Electrodes} - G01N 33/6887: {from muscle, cartilage or connective tissue} - G01R 33/1269: {of molecules labeled with magnetic beads (magnetic particles for bio assay G01N33/54326)} - B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept - B01L 2300/043: Hinged closures - B01L 2300/048: enabling gas exchange, e.g. vents - B01L 2300/0636: Integrated biosensor, microarrays - B01L 2300/0645: Electrodes - B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions - B01L 2400/043: magnetic forces - B01L 2400/0481: squeezing of channels or chambers - B01L 2400/0487: fluid pressure, pneumatics - G01N 27/3276: {being a hybridisation with immobilised receptors (using a FET type sensor G01N27/4145; concerning the hybridisation C12Q1/68)} - G01N 27/745: {for detecting magnetic beads used in biochemical assays (concerning the assays G01N33/54326; sensors therefor G01R33/1269; automatic analysers therefor G01N35/0098)} - G01N 2800/325: Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12) ## Abstract The present invention relates to systems and methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device includes a housing, a heterogeneous surface capture immunosensor within the housing and configured to generate a first signal indicative of the concentration of the analyte in an upper concentration range, and a homogeneous magnetic bead capture immunosensor within the housing and configured to generate a second signal indicative of the concentration of the analyte in a lower concentration range. ## Claims ### Claim 1 A sensor chip comprising: a non-conductive substrate; a first sensor for an analyte; and a second sensor for the analyte, wherein the non-conductive substrate is planar, and comprises a top surface and a bottom surface, the top surface forming a base for the first sensor and the second sensor, wherein the first sensor is a heterogeneous surface capture immunosensor comprising a conductive layer deposited on the non-conductive substrate, and a capture biomolecule immobilized on or near at least a portion the conductive layer, and wherein the second sensor is a homogeneous magnetic bead capture immunosensor comprising a second microelectrode, and a magnetic element. ### Claim 2 (depends on 1) The sensor chip of claim 1, wherein the first sensor and the second sensor are spaced at least 0.3 mm apart on the non-conductive substrate. ### Claim 3 (depends on 1) The sensor chip of claim 1, wherein the capture biomolecule is coated onto microspheres deposited on the at least the portion of the conductive layer. ### Claim 4 (depends on 1) The sensor chip of claim 1, wherein the capture biomolecule is an antibody. ### Claim 5 (depends on 4) The sensor chip of claim 4, wherein the antibody is an anti-troponin I (TnI) antibody or an anti-cardiac troponin I (cTnI) antibody. ### Claim 6 (depends on 1) The sensor chip of claim 1, wherein the at least the portion of the conductive layer is surrounded by a containment structure. ### Claim 7 (depends on 1) The sensor chip of claim 1, wherein the magnetic element is a magnetic layer positioned on the top surface of the non-conductive substrate, positioned on the bottom surface of the non-conductive substrate, or embedded into the non-conductive substrate. ### Claim 8 (depends on 1) The sensor chip of claim 1, wherein the top surface further comprises a region comprising a biomolecule specific for the analyte and conjugated to an enzyme. ### Claim 9 (depends on 1) The sensor chip of claim 1, wherein the top surface further comprises a region coated with magnetic beads coated with capture biomolecule for the analyte. ### Claim 10 A sensing device for detecting an analyte in a fluid sample, comprising, a housing comprising an opening for receiving the fluid sample, and, a conduit in fluidic communication with the opening and comprising a first sensor for the analyte, a second sensor for the analyte, and a magnetic element located at or below the second sensor for the analyte, wherein the first sensor is a heterogeneous surface capture immunosensor comprising a conductive layer deposited on the non-conductive substrate, and a capture biomolecule immobilized on or near at least a portion the conductive layer, and wherein the second sensor is a homogeneous magnetic bead capture immunosensor comprising a second microelectrode, and a magnetic element. ### Claim 11 (depends on 10) The sensing device of claim 10, wherein the first sensor and the second sensor are spaced at least 0.3 mm apart in the conduit. ### Claim 12 (depends on 10) The sensing device of claim 10, wherein the magnetic element is located in the conduit below the second sensor. ### Claim 13 (depends on 12) The sensing device of claim 12, wherein the magnetic element is located in a trench in the housing. ### Claim 14 (depends on 10) The sensing device of claim 10, wherein the magnetic element is located on a sensor chip comprising the second sensor. ### Claim 15 (depends on 10) The sensing device of claim 10, wherein the capture biomolecule is an antibody. ### Claim 16 (depends on 15) The sensing device of claim 15, wherein the antibody is an anti-troponin I (TnI) antibody or an anti-cardiac troponin I (cTnI) antibody. ### Claim 17 (depends on 10) A system for detecting the analyte in the fluid sample, comprising: the sensing device of claim 10; and, an analyzer comprising a port with an electrical contact for the analyzer. ### Claim 18 A method of determining a concentration of an analyte in a fluid sample, comprising: dissolving a signal antibody in a fluid sample, wherein the signal antibody is specific for the analyte and is conjugated to an enzyme; allowing a first complex of the signal antibody and the analyte to form; dissolving in a fluid sample magnetic beads coated with first capture antibodies specific for the analyte; allowing a second complex of the first complex and the first capture antibodies coated on the magnetic beads to form; allowing a third complex of the first complex and second capture antibodies specific for the analyte to form, where in the second capture antibodies are immobilized on a surface of a first sensor, attracting the second complex to a second sensor by a magnetic field localized around the second sensor; applying a fluid comprising a substrate for the enzyme to the first sensor and the second sensor; detecting by the first sensor a first signal from a reaction of the substrate with the third complex, wherein the first signal is indicative of a first concentration of the analyte in a first concentration range; detecting by the second sensor a second signal from a reaction the substrate with the second complex attracted by the magnetic field to the second sensor, wherein the second signal is indicative of a second concentration of the analyte in a second concentration range. ### Claim 19 (depends on 18) The method of claim 18, further comprising, using computer processing circuitry and computer readable and executable computer instructions stored on a computer memory, calculating concentration of the analyte in the fluid sample based on the first concentration and the second concentration. ### Claim 20 (depends on 18) The method of claim 18, wherein the analyte is troponin I (TnI) or anti-cardiac troponin I (cTnI).