# US 2022/0034883 A1 · Method for measuring viral antigen in sample, antibody set, and reagent kit

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- Number: US 2022/0034883 A1
- Document ID: US20220034883A1
- Status: Published application
- Kind: A1
- Application number: 17/387,409
- Filed: 2021-07-28
- Published: 2022-02-03
- Earliest claimed: 2020-07-29
- Assignees: Sysmex Corporation
- Applicants: Sysmex Corporation
- Inventors: Keiko HIGUCHI; Naoki NISHIYAMA; Megumi GOTO; Nobuyuki IDE
- Web page: https://patentgrep.com/patent/US20220034883A1

## CPC

- G01N 33/56983: {Viruses}
- G01N 33/54326: {Magnetic particles}
- G01N 33/563: involving antibody fragments
- G01N 2333/165: Coronaviridae, e.g. avian infectious bronchitis virus
- G01N 2469/10: Detection of antigens from microorganism in sample from host
- 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)

## Abstract

Disclosed is a method for measuring a viral antigen using a capture antibody and a detection antibody, the method comprising forming a sandwich immune complex that contains the capture antibody, the viral antigen and the detection antibody, the capture antibody comprising a heavy chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 1, CDR2 comprising amino acid sequence of SEQ ID NO: 2 and CDR3 comprising amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 4, CDR2 comprising amino acid sequence of SEQ ID NO: 5 and CDR3 comprising amino acid sequence of SEQ ID NO: 6, and the detection antibody comprising a heavy chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 7, CDR2 comprising amino acid sequence of SEQ ID NO: 8 and CDR3 comprising amino acid sequence of SEQ ID NO: 9, and a light chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 10, CDR2 comprising amino acid sequence of SEQ ID NO: 11 and CDR3 comprising amino acid sequence of SEQ ID NO: 12.

## Claims

### Claim 1

A method for measuring a viral antigen in a sample by using a capture antibody and a detection antibody, the method comprising
forming a sandwich immune complex that contains the capture antibody, the viral antigen and the detection antibody,
the capture antibody comprising a heavy chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 1, CDR2 comprising amino acid sequence of SEQ ID NO: 2 and CDR3 comprising amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 4, CDR2 comprising amino acid sequence of SEQ ID NO: 5 and CDR3 comprising amino acid sequence of SEQ ID NO: 6, and
the detection antibody comprising a heavy chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 7, CDR2 comprising amino acid sequence of SEQ ID NO: 8 and CDR3 comprising amino acid sequence of SEQ ID NO: 9, and a light chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 10, CDR2 comprising amino acid sequence of SEQ ID NO: 11 and CDR3 comprising amino acid sequence of SEQ ID NO: 12.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the capture antibody and the detection antibody form the sandwich immune complex with a nucleoprotein of SARS-CoV or SARS-CoV-2, but do not form the sandwich immune complex with a nucleoprotein of MERS-CoV, and viral antigens of HCoV-OC43, HCoV-NL63 and HCoV-229.

### Claim 3 (depends on 1)

The method according to claim 1, wherein
the capture antibody comprises the heavy chain variable region comprising amino acid sequence of SEQ ID NO: 13, and the light chain variable region comprising amino acid sequence of SEQ ID NO: 14, and
the detection antibody comprises the heavy chain variable region comprising amino acid sequence of SEQ ID NO: 15, and the light chain variable region comprising amino acid sequence of SEQ ID NO: 16.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the capture antibody is IgG, reduced IgG, Fab, Fab′, F(ab′)2, Fv, scFv, diabody or triabody.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the detection antibody is IgG, reduced IgG, Fab, Fab′, F(ab′)2, Fv, scFv, diabody or triabody.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the sample is a biological sample.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the viral antigen is a nucleoprotein of SARS-CoV or SARS-CoV-2.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the capture antibody is immobilized on a solid phase.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the solid phase is a magnetic particle or a microplate.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the detection antibody is labeled with a labeling substance.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the labeling substance is at least one enzyme selected from the group consisting of alkaline phosphatase, peroxidase, (3-galactosidase, glucosidase, polyphenol oxidase, tyrosinase, acid phosphatase and luciferase.

### Claim 12

An antibody set for measuring a viral antigen in a sample by an immunological measurement method,
the antibody comprising a capture antibody and a detection antibody that form a sandwich immune complex with the viral antigen in the immunological measurement method,
the capture antibody comprising a heavy chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 1, CDR2 comprising amino acid sequence of SEQ ID NO: 2 and CDR3 comprising amino acid sequence of SEQ ID NO: 3; and a light chain variable region that comprises CDR1 comprising the amino acid sequence of SEQ ID NO: 4, CDR2 comprising the amino acid sequence of SEQ ID NO: 5 and CDR3 comprising the amino acid sequence of SEQ ID NO: 6, and
the detection antibody comprises a heavy chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 7, CDR2 comprising amino acid sequence of SEQ ID NO: 8 and CDR3 comprising amino acid sequence of SEQ ID NO: 9; and a light chain variable region that comprises CDR1 comprising amino acid sequence of SEQ ID NO: 10, CDR2 comprising amino sequence of SEQ ID NO: 11 and CDR3 comprising amino acid sequence of SEQ ID NO: 12.

### Claim 13 (depends on 12)

A reagent kit comprising the capture antibody and the detection antibody described in claim 12.

### Claim 14 (depends on 13)

The reagent kit according to claim 13, comprising a first reagent and a second reagent, the first reagent comprising the capture antibody and the second reagent comprising the detection antibody.

### Claim 15 (depends on 13)

The reagent kit according to claim 13, wherein the capture antibody is immobilized on a solid phase.

### Claim 16 (depends on 15)

The reagent kit according to claim 15, wherein the solid phase is a magnetic particle or a microplate.

### Claim 17 (depends on 13)

The reagent kit according to claim 13, wherein the detection antibody is labeled with a labeling substance.

### Claim 18 (depends on 17)

The reagent kit according to claim 17, wherein the labeling substance is at least one enzyme selected from the group consisting of alkaline phosphatase, peroxidase, β-galactosidase, glucosidase, polyphenol oxidase, tyrosinase, acid phosphatase and luciferase.

### Claim 19 (depends on 18)

The reagent kit according to claim 18, further comprising a substrate for the enzyme.