HCV core lipid binding domain monoclonal antibodies

• US 9,371,374 B2
• Filed: 12/23/2013
• Issued: 06/21/2016
• Est. Priority Date: 03/14/2013
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Ziemann, Robert, Ahlberg, April, Hawksworth, David, Tieman, Bryan, Muerhoff, A. Scott, Marohnic, Christopher, Otis, Kathy
• Primary Examiner(s): Boesen, Agnieszka
• Application Number:
  US14/138,991
• Publication Number:
  US 20140272931A1
• Time in Patent Office: 911 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: C07K 16/109 Hepatitis C virus; Hepatitis G virus
• CPC Class Codes: C07K 2317/34 Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• 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 2333/186 Hepatitis C; Hepatitis NANB
• CPC Class Codes: G01N 2469/10 Detection of antigens from microorganism in sample from host
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/5767 non-A, non-B hepatitis

Abstract

The present invention relates to monoclonal antibodies for the detection of HCV antigen. More specifically, the invention describes antibodies against HCV core antigen lipid binding domain and immunoassay methods, kits and compositions for use in detecting HCV infection.

Claims

1. A monoclonal antibody that is specifically immunoreactive with the lipid binding domain of HCV core antigen, wherein said monoclonal antibody has a heavy chain variable domain of SEQ ID NO:

6; and

a light chain of SEQ ID NO;

306.

2. An immunoassay reagent comprising a monoclonal antibody of claim 1 wherein said antibody is labeled with a detectable label.

3. An immunoassay reagent comprising a monoclonal antibody of claim 1 wherein said antibody is bound to a solid phase.

4. The immunoassay reagent of claim 2 further comprising an additional antibody against an HCV antigen.

5. The immunoassay reagent of claim 4 wherein said additional antibody is an additional anti-core antibody.

6. An immunoassay for the detection of HCV in a test sample, said immunoassay comprising:

(i) contacting a test sample suspected of containing HCV with a first antibody directed against HCV core antigen to form a complex between said first antibody and antigen located within said test sample;

(ii) contacting said complex formed in step (i) with an antibody of claim 5, to form a complex between said antibody and antigen in the complex formed in step (i) wherein said antibody is detectably labeled and

(iii) detecting the labeled of the complex formed in step (ii).

7. The immunoassay of claim 6, wherein said first antibody is directed to the DNA binding domain of HCV core antigen.

8. The immunoassay of claim 6 wherein said antibody of step (ii) is labeled with a fluorescent label.

9. The immunoassay of claim 8 wherein said label is acridinium.

10. The immunoassay of claim 6 wherein said antibody of step (i) is bound to a solid phase.

11. The immunoassay of claim 6 wherein said antibody of step (i) comprises a monoclonal antibody that is specifically immunoreactive with the lipid binding domain of HCV core antigen and that is distinct from the antibody of step (ii).

12. The immunoassay of claim 6 wherein said antibody of step (i) comprises a monoclonal antibody that is specifically immunoreactive with the lipid binding domain of HCV core antigen and that is the same as the antibody of step (ii).

13. The immunoassay method of claim 6, wherein the test sample was obtained from a patient and the method further comprises diagnosing, prognosticating, or assessing the efficacy of a therapeutic/prophylactic treatment of the patient, wherein, if the method further comprises assessing the efficacy of a therapeutic/prophylactic treatment of the patent, the method optionally further comprises modifying the therapeutic/prophylactic treatment of the patient as needed to improve efficacy.

14. The immunoassay method of claim 13, wherein the method is adapted for use in an automated system or a semi-automated system.

15. A kit comprising the immunodiagnostic reagent of claim 1 and instructions for the use of the immunodiagnostic reagent in the immunoassay for detection HCV in a test sample.

16. The immunoassay reagent of claim 3 further comprising an additional antibody against an HCV antigen.