DETECTING HEPATITIS B VIRUS

• US 20090098531A1
• Filed: 09/11/2008
• Published: 04/16/2009
• Est. Priority Date: 09/13/2007
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Coleman, Paul F., Ali, Akhtar X.
• Application Number:
  US12/209,054
• Publication Number:
  US 20090098531A1
• Time in Patent Office: Days
• US Class Current: 435/5
• CPC Class Codes: C12Q 1/706 for hepatitis
• CPC Class Codes: G01N 33/5764 Hepatitis B surface antigen

Abstract

This invention is related to methods for detecting hepatitis B virus by determining the level of hepatitis B virus surface antigen protein. This invention is also related to methods for detecting mutant hepatitis B virus surface antigen protein and kits for detecting hepatitis B virus.

Claims

1. A method for detecting hepatitis B in a test sample, comprising:

(a) providing a test sample; and

(b) contacting said test sample with a first antibody for a time and under conditions sufficient to form middle hepatitis B surface protein (M-HBsAg)/first antibody complexes, presence of said complexes indicating detection of hepatitis B present said sample.

2. The method of claim 1, wherein amino acids 1-55 of M-HBsAg comprise an epitope recognized by the first antibody.

3. The method of claim 2, wherein the first antibody does not cross-react with small hepatitis B surface protein (S-HBsAg).

4. The method of claim 1, further comprising the step of contacting said test sample with a second antibody for a time and under conditions sufficient to form small hepatitis B surface protein (S-HBsAg)/second antibody complexes, presence of said complexes indicating detection of hepatitis B present in said test sample.

5. The method of claim 4, wherein amino acids 100-160 of S-HBsAg comprise an epitope recognized by the second antibody.

6. A method for detecting a mutant S-HBsAg in a test sample comprising:

(a) providing a test sample;

(b) contacting said test sample with a first antibody for a time and under conditions sufficient to form middle hepatitis B surface protein (M-HBsAg)/first antibody complexes;

(c) contacting said test sample with a second antibody for a time and under conditions sufficient to form small hepatitis B surface protein (S-HBsAg)/second antibody complexes; and

(d) comparing level of M-HBsAg/first antibody complexes to level of S-HBsAg/second antibody complexes, wherein a reduced level of S-HBsAg/second antibody complexes to M-HBsAg/first antibody complexes indicates detection of a mutant S-HBsAg in the test sample.

7. The method of claim 6, wherein amino acids 1-55 of M-HBsAg comprise an epitope recognized by the first antibody.

8. The method of claim 6, wherein the first antibody does not cross-react with small hepatitis B surface protein (S-HBsAg).

9. The method of claim 6, wherein amino acids 100-160 of S-HBsAg comprise an epitope recognized by the second antibody.

10. A method for detecting a mutant S-HBsAg in a test sample, comprising:

(a) providing a test sample;

(b) contacting said test sample with a first antibody for a time and under conditions sufficient to form small hepatitis B surface protein (S-HBsAg)/antibody complex

wherein a reduced level of S-HBsAg/antibody complex in comparison to a control indicates detection of a mutant S-HBsAg in the test sample.

11. The method of claim 10, wherein said first antibody does not cross-react with mutant small hepatitis B surface protein (S-HBsAg).

12. The method of claim 10, further comprising the steps of

(a) contacting said test sample with a second antibody for a time and under conditions sufficient to form a small hepatitis B surface protein (S-HBs-Ag)/second antibody complex;

and

(b) comparing the level of S-HBsAg/first antibody complex to level of S-HBs/second antibody complex,

wherein a difference in the ratio of the level of S-HBsAg detected by the first antibody to the level of S-HBsAg detected by the second antibody as compared to a predetermined ratio may indicate detection of mutant S-HBsAg in the test sample.

13. A kit for detecting hepatitis B comprising:

(a) at least one antibody that binds to M-HBsAg; and

(b) at least one antibody that binds to S-HBsAg.

14. The kit of claim 13, wherein amino acids 1-55 of M-HBsAg comprise an epitope recognized by the at least one antibody of (a).

15. The kit of claim 13, wherein the at least one antibody does not cross-react with S-HBsAg.

16. The kit of claim 13, wherein amino acids 100-160 of S-HBsAg comprise an epitope recognized by the at least one antibody of (b).

17. The kit of claim 13, further comprising instructions for said detection of said hepatitis B.