Method of diagnosis and kit therefor

• US 7,785,773 B1
• Filed: 11/22/2006
• Issued: 08/31/2010
• Est. Priority Date: 11/23/2005
• Status: Active Grant

• Current Assignee: Nanjing Biopoint Diagnostic Technology Company Limited
• Original Assignee: Hepgenics Pty., Ltd. (Rent.com.au Ltd.)
• Inventors: Garcia, Mary Louise, Howard, Teresa Sylvia, Anders, Katherine, Healy, Anne, Anderson, David Andrew
• Primary Examiner(s): Mosher; Mary E
• Assistant Examiner(s): SNYDER, STUART
• Application Number:
  US11/604,169
• Time in Patent Office: 1,378 Days
• Field of Search: None
• US Class Current: 435/5
• CPC Class Codes: C12N 2770/32411 Hepatovirus, i.e. hepatitis A virus
• CPC Class Codes: G01N 33/5768 Hepatitis A
• CPC Class Codes: G01N 33/6857 Antibody fragments
• 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

This invention is directed to diagnostic methods detecting the presence of an antibody to a virus in a sample from a subject and kits for using the methods.

Claims

1. A kit for diagnosing or monitoring an infection with a virus by detecting the presence of an IgM antibody to the virus in a test sample from a subject, wherein the kit comprises:

a) an immunographic device comprising a porous membrane operably connected to a sample portion, a test portion comprising an IgM antibody binding agent, and optionally a control portion; and

further comprising a sucker portion, a virus portion and a conjugate portion; and

b) instructions for using the immunographic device to detect the presence of the antibody to the virus in the test sample.

2. A kit of claim 1 wherein the virus portion comprises a viral particle of the virus and the conjugate portion comprises a detection marker.

3. The kit of claim 2 wherein the IgM antibody binding agent is an antibody or an antibody binding fragment thereof.

4. The kit of claim 3 wherein the antibody or fragment is an anti-species antibody or antigen binding fragment thereof.

5. The kit of claim 3 wherein the antibody or fragment binds to the IgM antibody.

6. The kit of claim 2 wherein the detection marker comprises a visually detectable reporter molecule.

7. The kit of claim 6 wherein the detection marker is selected from a colloidal metal, colloidal metal oxide particle, colloidal non-metal particle, a dye and/or coloured latex.

8. The kit of claim 2, 6 or 7 wherein the detection marker is directly or indirectly bound to a virus binding agent.

9. The kit of claim 8 wherein the virus binding agent is an antibody or antigen binding fragment thereof that binds to the viral particle.

10. The kit of claim 9 wherein the antibody or fragment in the conjugate portion and the antibody to the virus in the sample recognize the same epitope on the viral particle.

11. The kit of claim 2 wherein the viral particle is a hepatitis A virus (HAV) viral particle.

12. The kit of claim 9 wherein the antibody or fragment in the conjugate portion is an anti-HAV antibody.

13. The kit of claim 10 wherein the epitope is an immunodominant epitope.

14. The kit of claim 2 wherein the antibody binding agent is bound to the test portion of the device using an adhesive peptide having the sequence WGWQWGPW (SEQ ID NO:

1).

15. The kit of claim 14 wherein the antibody binding agent is conjugated to the adhesive peptide.

16. The kit of claim 2 wherein the viral particle in the virus portion is an inactivated viral particle.

17. The kit of claim 1 wherein the sucker portion, virus portion and conjugate portion are adapted to be operably connected to the porous membrane before use and/or when in use.

18. The kit of claim 11 wherein the antibody or fragment in the conjugate portion is an anti-HAV antibody.

19. The kit of claim 1 wherein the virus is a hepatitis A virus viral particle, a hepatitis B viral particle, a hepatitis C viral particle, a hepatitis D viral particle or a hepatitis E viral particle.