Antibodies, diagnostic systems and methods for assaying SV40 HBxAg
AssigneeThe Scripps Research Institute
InventorAnn M. Moriarty
Life of this patent
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Abstract
Antibodies that immunoreact with the hepatitis B virus HBxAg antigen and with HBxAg polypeptides, as well as diagnostic system and methods for assaying for the presence of HBxAg and anti-HBxAg antibodies in a body sample are disclosed.
Claims10
A receptor molecule that includes an antibody combining site that specifically binds both with HBxAg and with an antigenic synthetic polypeptide selected from the group of polypeptides represented by the formulae:
- (i) Gln-Leu-Asp-Pro-Ala-Arg-Asp-Val-Leu-Cys-Leu-Arg-Pro-Val-Gly;
- (ii) Ser-Ala-Val-Pro-Thr-Asp-His-Gly-Ala-His-Leu-Ser-Leu-Arg-Gly-Leu-Pro-Val-Cy s;
- and
- (iii) Met-Glu-Thr-Thr-Val-Asn-Ala-His-Gln-Ile-Leu-Pro-Lys-Val-Leu-His-Lys-Arg-Th r-Leu-Gly,
- wherein said receptor molecule consists of an antibody, a substantially whole antibody, a Fab fragment, or a (Fab').sub.2 fragment, and wherein said antibody combining site does not specifically bind an antigenic synthetic polypeptide represented by the formula:
- (iv) Leu-Ser-Ala-Met-Ser-Thr-Thr-Asp-Leu-Glu-Ala-Tyr-Phe-Lys-Asp-Cys;
- (v) Cys-Leu-Phe-Lys-Asp-Trp-Glu-Glu-Leu-Gly-Glu-Glu-Ile-Arg-Leu-Lys-Val;
- or
- (vi) Ala-Pro-Ala-Pro-Cys-Asn-Phe-Phe-Thr-Ser-Ala.
A diagnostic assay system for determining the presence of HBxAg in a body sample, said system having at least one container of a first reagent, said first reagent comprising receptor molecules consisting of antibodies, substantially whole antibodies, Fab fragments, (Fab').sub.2 fragments or a combination thereof, that include an antibody combining site that specifically binds both with HBxAg and with an antigenic synthetic polypeptide selected from the group of polypeptides represented by the formulae:
- (i) Gln-Leu-Asp-Pro-Ala-Arg-Asp-Val-Leu-Cys-Leu-Arg-Pro-Val-Gly;
- (ii) Ser-Ala-Val-Pro-Thr-Asp-His-Gly-Ala-His-Leu-Ser-Leu-Arg-Gly-Leu-Pro-Val-Cy s;
- and
- (iii) Met-Glu-Thr-Thr-Val-Asn-Ala-His-Gln-Ile-Leu-Pro-Lys-Val-Leu-His-Lys-Arg-Th r-Leu-Gly;
- but said antibody combining site does not specifically bind an antigenic synthetic polypeptide represented by the formula:
- (iv) Leu-Ser-Ala-Met-Ser-Thr-Thr-Asp-Leu-Glu-Ala-Tyr-Phe-Lys-Asp-Cys;
- (v) Cys-Leu-Phe-Lys-Asp-Trp-Glu-Glu-Leu-Gly-Glu-Glu-Ile-Arg-Leu-Lys-Val;
- or
- (vi) Ala-Pro-Ala-Pro-Cys-Asn-Phe-Phe-Thr-Ser-Ala;
- wherein said system further includes an indicating means for signalling immunoreaction between said receptor molecules and said antigenic synthetic polypeptides or HBxAg.
A method of assaying for the presence of HBxAg or a polypeptide portion thereof in a body sample comprising the steps of:
- (a) admixing said body sample with receptor molecules consisting of antibodies, substantially whole antibodies, Fab fragments, (Fab').sub.2 fragments, or a combination thereof to form an immunoreaction admixture, wherein said receptor molecules include an antibody combining site that specifically binds both with HBxAg and with an antigenic synthetic polypeptide selected from the group of polypeptides represented by the formulae:
- (i) Gln-Leu-Asp-Pro-Ala-Arg-Asp-Val-Leu-Cys-Leu-Arg-Pro-Val-Gly;
- (ii) Ser-Ala-Val-Pro-Thr-Asp-His-Gly-Ala-His-Leu-Ser-Leu-Arg-Gly-Leu-Pro-Val-Cy s;
- and
- (iii) Met-Glu-Thr-Thr-Val-Asn-Ala-His-Gln-Ile-Leu-Pro-Lys-Val-Leu-His-Lys-Arg-Th r-Leu-Gly;
- but said antibody combining site does not specifically bind with an antigenic synthetic polypeptide represented by the formula:
- (iv) Leu-Ser-Ala-Met-Ser-Thr-Thr-Asp-Leu-Glu-Ala-Tyr-Phe-Lys-Asp-Cys;
- (v) Cys-Leu-Phe-Lys-Asp-Trp-Glu-Glu-Leu-Gly-Glu-Glu-Ile-Arg-Leu-Lys-Val;
- or
- (vi) Ala-Pro-Ala-Pro-Cys-Asn-Phe-Phe-Thr-Ser-Ala;
- (b) maintaining said admixture for a time period sufficient to form an immunoreaction product;
- and
- (c) determining the presence of immunoreaction product formed in step (b), and thereby determining the presence of HBxAg or a polypeptide portion thereof in the body sample, wherein said polypeptide portion has an amino acid sequence corresponding to one or more antigenic determinants of HBxAg.
Dependencies are inferred from the claim text.