Anti-T. cruzi antibodies and methods of use

• US 10,215,754 B2
• Filed: 10/06/2016
• Issued: 02/26/2019
• Est. Priority Date: 12/27/2007
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Brophy, Susan E., Hawksworth, David J., Shah, Dinesh O., Siegel, Robert W., Tieman, Bryan C., Tu, Bailin, Tyner, Joan D., Ziemann, Robert N.
• Primary Examiner(s): Duffy, Patricia
• Application Number:
  US15/287,605
• Publication Number:
  US 20170023568A1
• Time in Patent Office: 873 Days
• Field of Search: None
• CPC Class Codes: C07K 16/20 from protozoa
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/56 variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/92 Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
• CPC Class Codes: G01N 2333/44 from protozoa
• CPC Class Codes: G01N 2469/10 Detection of antigens from microorganism in sample from host
• CPC Class Codes: G01N 2469/20 Detection of antibodies in sample from host which are directed against antigens from microorganisms
• CPC Class Codes: G01N 2496/00 Reference solutions for assays of biological material
• CPC Class Codes: G01N 33/56905 Protozoa
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present disclosure is directed to reagents and methods of using the reagents to detect epitopes of Trypanosoma cruzi.

Claims

1. An immunodiagnostic reagent comprising a monoclonal antibody that specifically binds to a diagnostically relevant region of a T cruzi FP10 polypeptide, or an antigen binding fragment thereof, which monoclonal antibody comprises a variable light chain region (V_L) amino acid sequence of SEQ ID NO:

18 and a variable heavy chain region (V_H) amino acid sequence of SEQ ID NO;

20.

4. A method of purifying a T cruzi FP10 polypeptide comprising the amino acid sequence of SEQ ID NO:

6, which method comprises;

(a) contacting a sample suspected of containing a T cruzi FP10 polypeptide with the immunodiagnostic reagent according to claim 1 under conditions that allow formation of antibody;

antigen complexes;

(b) isolating the antibody;

antigen complexes formed; and

(c) separating the antigen from the antibody.

5. The immunodiagnostic reagent of claim 1, which comprises an antigen-binding fragment of the monoclonal antibody selected from a Fab fragment, a Fab′

fragment, a Fab′

-SH fragment, a F(ab′

)2 fragment, an Fv fragment, a diabody, and a single-chain Fv (scFv) molecule.

2. A monoclonal antibody that specifically binds to diagnostically relevant region of a T cruzi FP10 polypeptide, or an antigen-binding fragment thereof, which monoclonal antibody comprises a variable light chain region (V_L) amino acid sequence of SEQ ID NO:

18 and a variable heavy chain region (V_H) amino acid sequence of SEQ ID NO;

20.

6. The monoclonal antibody of claim 2, which comprises an antigen-binding fragment of the monoclonal antibody selected from a Fab fragment, a Fab′

fragment, a Fab′

-SH fragment, a F(ab′

)2 fragment, an Fv fragment, a diabody, and a single-chain Fv (scFv) molecule.

3. A cell line that expresses a chimeric antibody that specifically binds to a diagnostically relevant region of a T cruzi FP10 polypeptide, wherein said cell line is deposited with the American Type Tissue Collection and identified by patent deposit designation selected PTA-8140.