# US 2013/0157255 A1 · Method for simultaneously detecting an antigen of, and an antibody against, an infectious microorganism

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- Number: US 2013/0157255 A1
- Document ID: US20130157255A1
- Status: Published application
- Kind: A1
- Application number: 13/435,325
- Filed: 2012-03-30
- Published: 2013-06-20
- Earliest claimed: 2002-05-10
- Assignees: Bio-Rad Innovations
- Inventors: François RIEUNIER; Muriel Feyssaguet; Stéphanie Henriot; Nadine Lambert
- Web page: https://patentgrep.com/patent/US20130157255A1

## CPC

- C07K 14/1833: {Hepatitis C; Hepatitis NANB}
- C07K 14/005: from viruses
- C07K 14/161: {gag-pol, e.g. p55, p24/25, p17/18, p7, p6, p66/68, p51/52, p31/34, p32, p40}
- C07K 16/118: Hepatitis C virus; GB virus C [GBV-C]
- C07K 16/42: against immunoglobulins
- G01N 33/569: for microorganisms, e.g. protozoa, bacteria, viruses
- G01N 33/56983: {Viruses}
- G01N 33/56988: {HIV or HTLV}
- G01N 33/5767: {non-A, non-B hepatitis}
- C07K 2317/32: specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
- C12N 2740/16122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/16222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2770/24222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- G01N 2333/16: HIV-1, HIV-2
- G01N 2333/18: Togaviridae; Flaviviridae
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention relates to a method for detecting, in vitro, an infection with a microorganism, such as the hepatitis C virus, in a biological sample, by simultaneously detecting an antigen of this microorganism and the antibodies against this same antigen, and also to the reagents and kits implementing this method.

## Claims

### Claim at position 1

1-55. (canceled)

### Claim 56

A kit which is of use for detecting an infection with human immunodeficiency virus (HIV) in a biological sample, comprising:
a capture or detection antigen which comprises an antigenic fragment of a protein of HIV, said fragment comprising at least one destroyed epitope, while at the same time conserving the ability to bind the antibodies directed against HIV possibly present in the biological sample;
a capture or detection antibody directed against said epitope, which is intact, of said protein of HIV.

### Claim 57 (depends on 56)

The kit as claimed in claim 56, the HIV being an HIV-1 and/or an HIV-2.

### Claim 58 (depends on 56)

The kit as claimed in claim 56, in which the antibody is an antibody for capturing the HIV antigen present in the biological sample.

### Claim 59 (depends on 56)

The kit as claimed in claim 56, in which the antibody recognizes an epitope of sequence QASQEVKNWMTETLL (SEQ ID NO: 24).

### Claim 60 (depends on 45)

The kit as claimed in claim 45 further comprising, besides the capture antigen, means of detecting the anti-HIV antibodies present in the biological sample, the detecting means forming complexes with the capture antigen.

### Claim 61 (depends on 49)

The kit as claimed in claim 49, wherein the detecting means is a labeled anti-immunoglobulin or anti-isotype antibody.

### Claim 62 (depends on 56)

The kit as claimed in claim 56, wherein the capture antibody and the capture antigen are present in a form immobilized on a solid phase.

### Claim 63 (depends on 56)

The kit as claimed in claim 56, comprising:
a) the capture antigen which comprises an antigenic fragment of a protein of an HIV, the fragment comprising at least one destroyed epitope, while at the same time conserving the ability to bind the anti-HIV antibodies possibly present in a biological sample;
b) a capture antibody directed against one of the epitopes, which are intact, of the HIV protein;
said capture antigen and the capture antibody being immobilized on a solid phase;
c1) a labeled detection antibody directed against another of the epitopes, which are intact, of the HIV protein;
c2) and/or optionally a labeled detection antigen which is an antigenic fragment of an HIV protein, the fragment comprising at least one destroyed epitope, while at the same time conserving the ability to bind the anti-HIV antibodies possibly present in a biological sample.

### Claim 64 (depends on 52)

The kit as claimed in claim 52, in which the capture antigen comprises an antigenic fragment of the gag protein of HIV, in which at least one epitope site has been destroyed.

### Claim 65 (depends on 56)

The kit as claimed in claim 56, in which the capture antigen comprises a fragment of the gag protein of HIV, at least one epitope site of which fragment has been destroyed, and the antibody recognizes the epitope site, which is intact, of the gag protein.

### Claim 66 (depends on 56)

The kit as claimed in claim 56, also comprising at least one detergent of the nonionic type.

### Claim 67 (depends on 66)

The kit as claimed in claim 66, wherein the at least one detergent is NP40.
