# US 8,540,994 B2 · H5 subtype-specific binding proteins useful for H5 avian influenza diagnosis and surveillance

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- Number: US 8,540,994 B2
- Document ID: US8540994B2
- Status: Granted
- Kind: B2
- Application number: 12/599,616
- Filed: 2007-05-11
- Published: 2011-01-06
- Granted: 2013-09-24
- Earliest claimed: 2007-05-11
- Assignees: Temasek Life Sciences Laboratory Limited
- Applicants: Yuen Fern Ho; Qing Yun Du; Fang He; Jimmy Hwei-Sing Kwang
- Inventors: Yuen Fern Ho; Qing Yun Du; Fang He; Jimmy Hwei-Sing Kwang
- Web page: https://patentgrep.com/patent/US8540994B2

## CPC

- G01N 33/56983: {Viruses}
- A61P 31/16: for influenza or rhinoviruses
- C07K 16/108: Orthomyxoviridae (F), e.g. influenza virus
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- G01N 2333/11: Orthomyxoviridae, e.g. influenza virus
- 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)
- 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

The invention provides monoclonal antibodies and related binding proteins that bind specifically to the envelope glycoprotein of H5 subtypes of avian influenza virus (“AIV”). The monoclonal antibodies and related binding proteins are useful for the detection of H5 subtypes of AIV, including the pathogenic H5N1 subtypes. Virus may be detected in formalin preserved, paraffin embedded specimens as well as frozen specimens and biological fluids. Accordingly, the invention provides for the diagnosis and surveillance of dangerous viral infections.

## Claims

### Claim 1

An isolated monoclonal antibody 6B8 as produced by hybridoma 6B8 which is deposited with the American Type Culture Collection with Accession Number PTA-8246.

### Claim 2

A method for detecting H5 subtype avian influenza virus in a biological specimen which comprises contacting the biological specimen with monoclonal antibody 6B8, as produced by hybridoma 6B8 which is deposited with the American Type Culture Collection with Accession Number PTA-8246 and detecting binding of said monoclonal antibody.

### Claim 3 (depends on 2)

The method of claim 2, which further comprises contacting the biological specimen with a detector binding protein that specifically binds to the envelope glycoprotein of the H5 subtype of avian influenza virus, wherein the monoclonal antibody 6B8 is a capture binding protein and the detector binding protein contains or is conjugated to a detectable element.

### Claim 4 (depends on 3)

The method of claim 3, wherein the detector binding protein is a monoclonal antibody.

### Claim 5 (depends on 3)

The method of claim 3, wherein the detector monoclonal antibody 6B8 is immobilized onto a solid surface.

### Claim 6 (depends on 3)

The method of claim 3, wherein the binding protein contains a radioactive atom, is conjugated to a fluorescent molecule, or is conjugated to an enzyme.

### Claim 7

A kit for detecting H5 subtype avian influenza virus in a biological specimen which comprises
monoclonal antibody 6B8, as produced by hybridoma 6B8 which is deposited with the American Type Culture Collection with Accession Number PTA-8246;
together with reagents for the detection of binding of said monoclonal antibody 6B8 to an envelope glycoprotein of said H5 subtype avian influenza virus.

### Claim 8 (depends on 7)

The kit of claim 7, which further comprises a detector binding protein that specifically binds to the envelope glycoprotein of the H5 subtype of avian influenza virus, wherein the monoclonal antibody 6B8 is a capture binding protein and the detector binding protein contains or is conjugated to a detectable element.

### Claim 9 (depends on 8)

The kit of claim 8, wherein the detector binding protein is a monoclonal antibody.

### Claim 10 (depends on 8)

The kit of claim 8, wherein the monoclonal antibody 6B8 is immobilized onto a solid surface.

### Claim 11 (depends on 8)

The kit of claim 8, wherein the detector binding protein contains a radioactive atom, is conjugated to a fluorescent molecule, or is conjugated to an enzyme.