# US 10,799,861 B2 · Biochemical-immunological hybrid biosensor and sensor system including the same

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- Number: US 10,799,861 B2
- Document ID: US10799861B2
- Status: Granted
- Kind: B2
- Application number: 15/820,719
- Filed: 2017-11-22
- Published: 2018-05-24
- Granted: 2020-10-13
- Earliest claimed: 2016-11-24
- Assignees: Korea University Research and Business Foundation, Sejong Campus
- Applicants: Korea University Research and Business Foundation, Sejong Campus
- Inventors: Se-Hwan Paek
- Web page: https://patentgrep.com/patent/US10799861B2

## CPC

- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- C12Y 113/12004: Lactate 2-monooxygenase (1.13.12.4)
- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- G01N 33/54388: {based on lateral flow}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/74: involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors}
- H04N 23/12: with one sensor only
- H04N 23/55: Optical parts specially adapted for electronic image sensors; Mounting thereof
- H04N 23/56: provided with illuminating means
- B01L 2300/0654: Lenses; Optical fibres
- B01L 2300/069: Absorbents; Gels to retain a fluid
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0819: Microarrays; Biochips
- B01L 2300/0825: Test strips
- B01L 2300/0887: Laminated structure
- B01L 2400/0406: capillary forces
- C12Q 1/26: involving oxidoreductase
- G01N 2333/4737: C-reactive protein
- G01N 2333/585: Calcitonins
- G01N 2333/90241: acting on single donors with incorporation of molecular oxygen, i.e. oxygenases (1.13)
- G01N 2333/908: acting on hydrogen peroxide as acceptor (1.11)
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- C12Y: ENZYMES
- 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)
- H04N: PICTORIAL COMMUNICATION, e.g. TELEVISION
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Disclosed is a biochemical-immunological hybrid biosensor. The biochemical-immunological hybrid biosensor includes a reaction strip in the form of a porous membrane through which a sample moves by capillary action. The reaction strip can simultaneously measure heterogeneous multiple biomarkers through both a biochemical analysis and an immunoassay in an independent manner based on membrane chromatography to diagnose a particular disease.

## Claims

### Claim 1

A biochemical-immunological hybrid biosensor comprising a reaction strip in the form of a porous membrane through which a sample moves by capillary action wherein the reaction strip comprises: a sample transfer pad having a predetermined length and along which the sample is transferred from one end to the other in the lengthwise direction; a sample addition pad absorbing the sample loaded from the outside; a conjugate pad comprising detection antibodies specifically binding to protein markers in the sample and a tracer generating color signals for immunoreactions with the protein markers, and connecting one end of the sample transfer pad to the sample addition pad; one or more immunoreaction zones, formed on the sample transfer pad, comprising capture antibodies specifically binding to the protein markers; at least one biochemical reaction zone comprising a chromogenic substrate generating a color signal for a biochemical reaction and at least one enzyme producing a product reacting with the chromogenic substrate from a biochemical marker in the sample which is received from at least one of the sample transfer pad, the sample addition pad, and the conjugate pad, and where a biochemical reaction occurs independently from the reactions in the immunoreaction zones; a sample absorption pad arranged at the other end of the sample transfer pad to absorb the sample transferred along the sample transfer pad; and at least one biochemical reaction pad extending outward from at least one of the sample transfer pad, the sample addition pad, and the conjugate pad, and the biochemical reaction zone is arranged on one side of the biochemical reaction pad,
wherein the detection antibodies are conjugated with the tracer,
wherein some of the sample are transferred to the sample transfer pad through the conjugate pad, and some of the sample are transferred to the biochemical reaction pad,
wherein the protein markers bound the detection antibodies conjugated with the tracer generating color signals are bound to the capture antibodies, so that the color signals for immunoreactions are generated in the immunoreaction zones,
wherein the biochemical marker in the sample reacts with the enzyme and the chromogenic substrate, so that the color signal for the biochemical reaction is generated in the biochemical reaction zone.

### Claim 2 (depends on 1)

The biochemical-immunological hybrid biosensor according to claim 1, wherein the biochemical reaction zone is provided in plurality.

### Claim 3 (depends on 1)

The biochemical-immunological hybrid biosensor according to claim 1, wherein the conjugate pad is disposed on one end of the sample transfer pad, the sample addition pad is disposed on the conjugate pad, and the sample absorption pad is disposed on the other end of the sample transfer pad.

### Claim 4 (depends on 1)

The biochemical-immunological hybrid biosensor according to claim 1, wherein the number of the immunoreaction zones is equal to or greater than 2, and the capture antibodies bind to the protein markers in a one-to-one relationship in the immunoreaction zones.

### Claim 5 (depends on 1)

The biochemical-immunological hybrid biosensor according to claim 1, wherein the protein markers are C-reactive protein (CRP) and procalcitonin (PCT), the biochemical marker is lactate, the enzyme is an enzyme complex of lactate oxidase (LOX) and horseradish peroxidase (HRP), the chromogenic substrate is potassium iodide, and the hybrid biosensor diagnoses sepsis.

### Claim 6 (depends on 1)

The biochemical-immunological hybrid biosensor according to claim 1, further comprising a substrate addition pad disposed adjacent to one lateral side of the sample transfer pad to supply a substrate loaded from the outside and a substrate absorption pad disposed adjacent to the other lateral side of the sample transfer pad to absorb the substrate transferred across the sample transfer pad.

### Claim 7 (depends on 1)

The biochemical-immunological hybrid biosensor according to claim 1, further comprising a cartridge having an accommodation space in which the reaction strip is arranged, a detection window through which the immunoreaction zone and the biochemical reaction zone are exposed, and a sample injection port through which the sample is loaded into the sample addition pad.

### Claim 8 (depends on 1)

A sensor system comprising: the biochemical-immunological hybrid biosensor according to claim 1; a smart device in which a camera capable of capturing color signals from the immunoreaction zones or a color signal from the biochemical reaction zone as an image is accommodated; and a smart device holder having a slot into which the biochemical-immunological hybrid biosensor is inserted and adapted to hold the smart device.

### Claim 9 (depends on 8)

The sensor system according to claim 8, further comprising a light source arranged in the smart device holder to emit light.

### Claim 10 (depends on 8)

The sensor system according to claim 8, wherein the captured image of the color signals is converted into digital data by an application on the smart device.

### Claim 11 (depends on 8)

The sensor system according to claim 8, further comprising a focusing lens arranged between the camera and the immunoreaction zone or the biochemical reaction zone to control the focal distance of the camera.