Anti-;antibodies and methods of use

• US 9,482,667 B2
• Filed: 04/14/2015
• Issued: 11/01/2016
• 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 ANN
• Application Number:
  US14/686,351
• Publication Number:
  US 20150212083A1
• Time in Patent Office: 567 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.:

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

12.

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

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

2.

8. A method for 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 according to claim 1 under conditions that allow formation of antibody;

antigen complexes; and

(b) detecting any antibody;

antigen complexes formed as indicating the presence of said T. cruzi antigen.

9. The method of claim 8, wherein the immunodiagnostic reagent comprises a detectable label.

10. The method of claim 8, wherein the antibody:

antigen complexes is contacted with a secondary antibody or fragment thereof, wherein the secondary antibody or fragment thereof comprises a detectable label.

11. A method for detecting a T. cruzi antibody comprising the steps of:

(a) contacting a test sample suspected of containing a T. cruzi antibody with one or more T. cruzi antigens specific for the T. cruzi antibody under conditions that allow formation of antigen;

antibody complexes; and

(b) detecting any antigen;

antibody complexes formed as indicating the presence of said T. cruzi antigens,

wherein the immunodiagnostic reagent according to claim 1 is used in said method as a positive control or standardization reagent.

12. A diagnostic kit for the detection of T. cruzi comprising the immunodiagnostic reagent of claim 1.

3. An isolated monoclonal antibody that specifically binds to a diagnostically relevant region of a T. cruzi polypeptide, the isolated monoclonal antibody comprising a variable light (V_L) region comprising an amino acid sequence as set forth in SEQ ID NO.:

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

12.

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

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

2.

5. The isolated antibody of claim 3, wherein said isolated antibody is expressed by a cell line deposited with the American Type Tissue Collection and identified by patent deposit designation PTA-8136.

6. The isolated antibody of claim 3, wherein said isolated antibody is expressed by a cell line deposited with the American Type Tissue Collection and identified by patent deposit designation PTA-8139.

7. A cell line that expresses an antibody that specifically binds to a diagnostically relevant region of a T. cruzi polypeptide, wherein said cell line is deposited with the American Type Tissue Collection and identified by patent deposit designation PTA-8136.

13. An isolated polypeptide comprising a portion of a 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.:

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

12.