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Last Updated: March 28, 2024

Claims for Patent: 6,153,392


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Summary for Patent: 6,153,392
Title: Devices and methods comprising an HBcAg from hepatitis B virus
Abstract:A complex comprised of the HBcAg and an albumin or an unprocessed structural protein from a positive stranded RNA virus. Pursuant to such complexing, the antigenicity of the HBcAg is enhanced when compared to HBcAg alone, in terms of both or either affinity or specificity. This complexed HBcAg can be recognized by the immune system, which produces antibodies that have a high specificity and affinity for the complexed HBcAg, although such antibodies typically do also bind the uncomplexed antigen to a lower specificity and affinity. Also, methods and devices using the same.
Inventor(s): Liao; Jaw-Ching (Taipei, TW), Wang; Cheng-Nan (Tapei, TW)
Assignee: Bionova Corporation (San Francisco, CA)
Application Number:09/115,350
Patent Claims:1. An assay for the detection of an antibody against an HBcAg or an independent core-like antigen-adjacent protein of a positive stranded RNA virus in a sample, comprising:

(a) providing an HBcAg complexed with a protein selected from the group consisting of a serum albumin and a core-like antigen-adjacent protein of a positive stranded RNA virus, to provide an HBcAg-protein complex, and providing an independent core-like antigen-adjacent protein of a positive stranded RNA virus complexed to a protein, to provide an independent core-like antigen-adjacent protein complex;

(b) contacting the HBcAg-protein complex and the independent core-like antigen-adjacent protein complex with the sample under conditions suitable and for a time sufficient for the HBcAg-protein complex and the independent core-like antigen-adjacent protein complex to bind to one or more antibodies against the HBcAg or the independent core-like antigen-adjacent protein present in the sample, thereby providing one or more antibody-bound complexes; and

(c) detecting the one or more antibody-bound complexes, and therefrom determining whether the sample contains an antibody against HBcAg or the independent core-like antigen-adjacent protein.

2. The assay of claim 1 wherein the step of detecting allows the differentiation between different antibody-bound complexes.

3. The assay of claim 1 or 2 wherein the step of providing comprises providing at least two independent core-like antigen-adjacent proteins, at least two of which are from different positive-stranded RNA viruses, and wherein the step of contacting is performed under conditions suitable and for a time sufficient for each of the HBcAg and the at least two independent core-like antigen-adjacent proteins to bind to one or more antibodies specific therefor, thereby providing one or more antibody-bound complexes.

4. The assay of claim 1 or 2 wherein the step of providing comprises providing at least three independent core-like antigen-adjacent proteins, at least three of which are from different positive-stranded RNA viruses, and wherein the step of contacting is performed under conditions suitable and for a time sufficient for each of the HBcAg and the at least three independent core-like antigen-adjacent proteins to bind to one or more antibodies specific therefor, thereby providing one or more antibody-bound complexes.

5. The assay of claim 1 or 2 wherein the positive stranded RNA virus is selected from the group consisting of Togaviridae, Coronaviridae, Retroviridae, Picornaviridae, Caliciviridae and Flaviviridae.

6. The assay of claim 1 or 2 wherein the positive-stranded RNA virus is selected from the group consisting of hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Human T-cell Leukemia virus (HTLV).

7. The assay of claim 3 wherein the two different positive-stranded RNA viruses are selected from the group consisting of hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Human T-cell Leukemia virus (HTLV).

8. The assay of claim 4 wherein the three different positive-stranded RNA viruses are hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Human T-cell Leukemia virus (HTLV).

9. The assay of claim 1 or 2 wherein the assay is selected from the group consisting of a countercurrent immuno-electrophoresis (CIEP) assay, a radioimmunoassay, a western blot assay, a radioimmunoprecipitation, an enzyme-linked immuno-sorbent assay (ELISA), a dot blot assay, an inhibition or competition assay, a sandwich assay, an immunostick (dip-stick) assay, a simultaneous assay, an immunochromatographic assay, an immunofiltration assay, a latex bead agglutination assay, an immunofluorescent assay, a biosensor assay, and a low-light detection assay.

10. A composition comprising two or more different antigens capable of binding to an antibody against an HBcAg or an antibody against an independent core-like antigen of a positive stranded RNA virus, the composition comprising a) an isolated HBcAg complexed with a protein selected from the group consisting of a serum albumin and a core-like antigen-adjacent protein of a positive stranded RNA virus and b) an independent core-like antigen-adjacent protein of a positive stranded RNA virus complexed to a protein, to provide an isolated HBcAg-protein complex and an independent core-like antigen-adjacent protein complex.

11. The composition of claim 10 wherein the composition comprises at least two of the independent core-like antigen-adjacent proteins, at least two of which are from different positive-stranded RNA viruses.

12. The composition of claim 10 wherein the composition comprises at least three of the independent core-like antigen-adjacent proteins, at least three of which are from different positive-stranded RNA viruses.

13. The composition of any one of claims 10 to 12 wherein the positive stranded RNA virus is selected from the group consisting of Togaviridae, Coronaviridae, Retroviridae, Picornaviridae, Caliciviridae and Flaviviridae.

14. The composition of any one of claims 10 to 12 wherein the positive-stranded RNA virus is selected from the group consisting of hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Human T-cell leukemia virus (HTLV).

15. The composition of claim 14 wherein the two different positive-stranded RNA viruses are selected from the group consisting of hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Human T-cell Leukemia virus (HTLV).

16. The composition of claim 14 wherein the three positive-stranded RNA viruses are hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Human T-cell Leukemia virus (HTLV).

17. The composition of any one of claims 10 to 12 wherein the core-like antigen-adjacent protein is produced by a suitable prokaryotic host cell.

18. The composition of any one of claims 10 to 12 wherein the core-like antigen-adjacent protein is produced by a eukaryotic host cell that is unable to process the core-like antigen-adjacent protein.

19. The composition of any one of claims 10 to 12 wherein the serum albumin is selected from the group consisting of human serum albumin, .alpha.-fetoprotein, bovine serum albumin, fetal bovine serum albumin, new born bovine serum albumin and mouse serum albumin.

20. The composition of claim 19 wherein the serum albumin is human serum albumin.

21. A kit for the detection of an HBcAg, comprising:

(a) an HBcAg-protein complex comprised of the HBcAg complexed with a core-like antigen-adjacent protein of a positive stranded RNA virus; and

(b) one or both of a reagent or a device for detecting an antibody bound to the complex.

22. The kit of claim 21 wherein the composition further comprises an independent core-like antigen of a positive stranded RNA virus complexed to a protein.

23. The kit of claim 22 wherein the composition further comprises at least two of the independent core-like antigen-adjacent proteins, at least two of which are from different positive-stranded RNA viruses.

24. The kit of claim 23 wherein the composition comprises at least three of the independent core-like antigen-adjacent proteins, at least three of which are from different positive-stranded RNA viruses.

Details for Patent 6,153,392

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2017-07-30
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2017-07-30
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2017-07-30
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2017-07-30
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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