# US 10,871,493 B2 · Assay for the diagnosis of peanut allergy

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- Number: US 10,871,493 B2
- Document ID: US10871493B2
- Status: Granted
- Kind: B2
- Application number: 15/898,074
- Filed: 2018-02-15
- Published: 2018-08-16
- Granted: 2020-12-22
- Earliest claimed: 2017-02-15
- Assignees: EUROIMMUN Medizinische Labordiagnostika AG
- Applicants: Euroimmun Medizinische Labordiagnostika AG
- Inventors: Waltraud Suer; Stefanie Rohwer; Bettina Brix; Alf Weimann
- Web page: https://patentgrep.com/patent/US10871493B2

## CPC

- G01N 33/6854: {Immunoglobulins}
- A61K 39/35: Allergens
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 14/415: from plants
- A61K 2039/577: {tolerising response}
- C07K 2319/00: Fusion polypeptide
- G01N 2800/24: Immunology or allergic disorders
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

A diagnostically useful carrier has a polypeptide for specifically capturing an antibody to Ara h 7 isotype 7.0201 in a sample from a subject. A method includes detecting in a sample from a subject the presence or absence of an antibody to Ara h 7 isotype 7.0201. A pharmaceutical composition includes Ara h 7 isotype 7.0201 or a variant thereof.

## Claims

### Claim 1

A diagnostically useful carrier, comprising:
a polypeptide comprising SEQ ID NO: 8 for specifically capturing an antibody to Ara h 7 isotype 7.0201 in a sample from a subject, wherein the antibody to Ara h 7 isotype 7.0201 binds to a sequence of SEQ ID NO: 6 that comprises SEQ ID NO: 8, and
a carrier, which is at least one member selected from the group consisting of a bead, a test strip, a microtiter plate, a microarray, a solid polymer derived from cellulose, a line blot, a dot blot, a glass surface, a slide, and a biochip,
wherein the polypeptide is immobilized on the diagnostically useful carrier.

### Claim 2 (depends on 1)

The diagnostically useful carrier according to claim 1, further comprising:
a polypeptide for specifically capturing an antibody to at least one further antigen selected from the group consisting of Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9, Ara h 8, and Ara h 5.

### Claim 3 (depends on 1)

A method, comprising:
obtaining a sample from a subject; and
detecting, in the sample, the presence of an antibody to Ara h 7 isotype 7.0201 that binds to a sequence of SEQ ID NO: 6 that comprises SEQ ID NO: 8 by
contacting the sample with the diagnostically useful carrier according to claim 1, or
contacting the sample with a diagnostically useful carrier comprising an immobilized antibody capable of binding to the antibody to Ara h 7 isotype 7.0201 and with a polypeptide for specifically binding to the antibody to Ara h 7 isotype 7.0201, wherein. the polypeptide comprises a member selected from the group consisting of SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9 and SEQ ID NO: 10; and
detecting binding between the polypeptide of the diagnostically useful carrier and the antibody to Ara h 7 isotype 7.0201.

### Claim 4 (depends on 3)

The method according to claim 3, further comprising:
detecting, in a sample from a subject, the presence of an antibody to at least one further antigen.

### Claim 5 (depends on 3)

The method according to claim 3, wherein
the presence or absence of the antibody to Ara h 7 isotype 7.0201 and the presence of an antibody to at least one further antigen are detected simultaneously.

### Claim 6 (depends on 3)

The method according to claim 3, wherein
the presence or absence of the antibody to Ara h 7 isotype 7.0201 and the presence of an antibody to at least one further antigen are detected in spatially separate binding reactions.

### Claim 7 (depends on 3)

The method according to claim 3, wherein
the presence of the antibody Ara h 7 isotype 7.0201 and the presence of an antibody to at least one further antigen are detected in a one-pot reaction.

### Claim 8 (depends on 3)

The method according to claim 3, wherein
the presence or absence of the antibody to Ara h 7 isotype 7.0201, and the presence of an antibody to at least one of Ara h 2 and Ara h 6, are detected simultaneously.

### Claim 9 (depends on 5)

The method according to claim 5, wherein
the immobilized antibody is an IgE antibody.

### Claim 10 (depends on 5)

The method according to claim 5, wherein the immobilized antibody binding to the antibody to Ara h 7 isotype 7.0201 is an antibody that recognizes IgE, IgG, or IgA class antibodies.

### Claim 11 (depends on 5)

The method according to claim 5, wherein the antibody to Ara h 7 isotype 7.0201 binds to the amino acid sequence selected from the group consisting of SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10.

### Claim 12 (depends on 1)

The carrier according to claim 1, wherein
the antibody to isotype 7.0201 is an antibody monospecific to Ara h 7.

### Claim 13 (depends on 1)

A method of making a kit, the method comprising:
adding the diagnostically useful carrier according to claim 1 to a container, said container comprising:
a device for receiving a bodily fluid sample from a subject.

### Claim 14 (depends on 1)

The diagnostically useful carrier according to claim 1, wherein
the antibody to Ara h 7 isotype 7.0201 is an antibody to SEQ ID NO: 6; or
the antibody to Ara h 7 isotype 7.0201 is an antibody to at least one member selected from the group consisting of SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10; or
the antibody to Ara h 7 isotype 7.0201 is an antibody to SEQ ID NO: 8.

### Claim 15 (depends on 1)

The diagnostically useful carrier according to claim 1, further comprising:
a polypeptide for specifically capturing an antibody to at least one further antigen selected from the group consisting of Ara h 2, Ara h 6, Ara h 1, Ara h 3, and Ara h 9.

### Claim 16 (depends on 1)

The diagnostically useful carrier according to claim 1,
wherein the carrier is at least one member selected from the group consisting of a microtiter plate and a line blot.

### Claim 17 (depends on 1)

The diagnostically useful carrier according to claim 1, wherein
the antibody to Ara h 7 isotype 7.0201 is at least one member selected from the group consisting of IgA, IgG, and IgE; or
the antibody to Ara h 7 isotype 7.0201 is at least one member selected from the group consisting of IgG and IgE; or
the antibody to Ara h 7 isotype 7.0201 is at least one member selected from the group consisting of IgG1, IgG4, and IgE.

### Claim 18

A vaccine, comprising:
a polypeptide comprising a sequence of SEQ ID NO: 6 that comprises SEQ ID NO: 8, an adjuvant, and at least one diluent, at least one glidant, and/or at least one filling agent.

### Claim 19 (depends on 11)

The vaccine according to claim 11, wherein
the diluent is at least one member selected from the group consisting of starch, lactose, microcrystalline cellulose, and dicalcium phosphate.

### Claim 20

A kit, comprising:
a diagnostically useful carrier, and
a labelled antigen that is recognized by an antibody to Ara h 7 isotype 7.0201, wherein the labelled antigen is selected from the group consisting of a sequence of SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10;
wherein the diagnostically useful carrier comprises:
a carrier having an immobilized antibody that recognizes and immobilizes IgE, IgG, or IgA class antibodies, wherein the IgE, IgG, or IgA class antibodies comprise the antibody to Ara h 7 isotype 7.0201, and
said carrier selected from the group consisting of a bead, a test strip, a microtiter plate, a microarray, a solid polymer derived from cellulose, a line blot, a dot blot, a glass surface, a slide, a biochip, and a membrane.

### Claim 21 (depends on 20)

The kit according to claim 20, wherein the kit comprises one or more selected from the group consisting of a sample dilution buffer, a washing buffer, a positive control, a negative control, and a standard solution for preparing a calibration curve.

### Claim 22 (depends on 20)

The kit according to claim 20, wherein the labelled antigen comprises a label selected from the group consisting of a fluorescent label, a radioactive label, a chemiluminescent label.

### Claim 23 (depends on 20)

The kit of claim 20, wherein the antibody to Ara h 7 isotype 7.0201 binds to a sequence of SEQ ID NO: 6.