Anti-;antibodies and methods of use

• US 9,073,984 B2
• Filed: 01/19/2012
• Issued: 07/07/2015
• Est. Priority Date: 12/27/2007
• Status: Active Grant

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• 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 ANN
• Application Number:
  US13/353,678
• Publication Number:
  US 20120122125A1
• Time in Patent Office: 1,265 Days
• Field of Search: None
• US Class Current: 1/1
• 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 an isolated, monoclonal antibody that specifically binds to a diagnostically relevant region of a T. cruzi polypeptide, wherein said monoclonal antibody comprises a variable light (V_L) region comprising an amino acid sequence as set forth in SEQ ID NO:

14 and a variable heavy (V_H) region comprising an amino acid sequence as set forth in SEQ ID NO;

16.

2. The immunodiagnostic reagent according to claim 1, wherein said monoclonal antibody is

an antibody that specifically binds to an epitope comprised by an amino acid sequence as set forth in SEQ ID NO.:

4.

9. A method of detecting a T. cruzi antigen comprising the steps of:

(a) contacting a test sample suspected of containing a T. cruzi antigen with the immunodiagnostic reagent of claim 1 under conditions that allow formation of antibody;

antigen complexes; and

(b) detecting presence of any antibody;

antigen complexes formed, presence of said complexes indicating presence of said T. cruzi antigen.

10. A method of detecting a T. cruzi antigen comprising the steps of:

(a) contacting a test sample suspected of containing a T. cruzi antigen with the immunodiagnostic reagent of claim 1 under conditions that allow formation of antibody;

antigen complexes; and

(b) contacting said antibody;

antigen complexes with a conjugate comprising an antibody attached to a detectable label, for a time and under conditions sufficient for said antibody of said conjugate to bind to said antigen of said antibody;

antigen complexes and to allow for formation of antibody;

antigen;

conjugate complexes; and

(c) detecting a signal generated by said label, wherein presence of said signal indicates detection of said T. cruzi antigen.

11. A diagnostic kit for the detection of T. cruzi antigen comprising said immunodiagnostic reagent of claim 1.

3. An isolated, monoclonal antibody comprising a variable light (V_L) region comprising an amino acid sequence as set forth in SEQ ID NO:

14 and a variable heavy (V_H) region comprising an amino acid sequence as set forth in SEQ ID NO;

16.

4. The isolated, monoclonal antibody of claim 3, wherein said monoclonal antibody is

an antibody that specifically binds to an epitope comprised by an amino acid sequence as set forth in SEQ ID NO.:

4.

5. An isolated antibody expressed by a cell line deposited with the American Type Tissue Collection and identified by patent deposit designation PTA-8138.

6. An isolated antibody expressed by a cell line deposited with the American Type Tissue Collection and identified by patent deposit designation PTA-8137.

7. An isolated polypeptide comprising a portion of a monoclonal antibody which binds to a diagnostically relevant region of a T. cruzi polypeptide, wherein said monoclonal antibody comprises

a variable light (V_L) region comprising an amino acid sequence as set forth in SEQ ID NO.:

14 and a variable heavy (V_H) region comprising an amino acid sequence as set forth in SEQ ID NO.;

16.

8. A cell line that expresses a monoclonal antibody that specifically binds to a diagnostically relevant region of a T. cruzi polypeptide, wherein said cell line is PTA-8137 or PTA-8138.