Materials and methods for assay of anti-hepatitis C virus (HCV) antibodies
First Claim
1. An immunodiagnostic reagent consisting essentially of(a) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO:
- 2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 and(b) an isolated or purified polypeptide consisting essentially of (i) an epitope that is immunoreactive with an antibody that specifically binds to the NS3 region of HCV and (ii) an epitope that is immunoreactive with an antibody that specifically binds to the core region of HCV, wherein the isolated or purified polypeptide consists essentially of the contiguous amino acids 2-267 and 270-419 of SEQ ID NO;
4,wherein (a) and (b) are co-coated on the same microparticles in a ratio of about 1;
2 and concentration of (a) is at least about 40 μ
g/mL and the concentration of (b) is at least about 80 μ
g/mL.
1 Assignment
0 Petitions
Accused Products
Abstract
A polypeptide comprising the contiguous amino acids 1-198 of SEQ ID NO: 2; a polypeptide, which comprises a contiguous amino acid sequence that is at least about 95% identical to the contiguous amino acids 1-198 of SEQ ID NO: 2, an epitope that is immunoreactive with an antibody that specifically binds to the core protein of hepatitis C virus (HCV), and an epitope that is immunoreactive with an antibody that specifically binds to the NS4 region of HCV; a nucleic acid encoding such a polypeptide; a host cell comprising such a nucleic acid; an immunodiagnostic reagent comprising such a polypeptide; a kit comprising such an immunodiagnostic reagent; and a method of determining the presence, amount, or concentration of anti-HCV antibodies in a test sample.
43 Citations
7 Claims
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1. An immunodiagnostic reagent consisting essentially of
(a) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO: - 2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 and(b) an isolated or purified polypeptide consisting essentially of (i) an epitope that is immunoreactive with an antibody that specifically binds to the NS3 region of HCV and (ii) an epitope that is immunoreactive with an antibody that specifically binds to the core region of HCV, wherein the isolated or purified polypeptide consists essentially of the contiguous amino acids 2-267 and 270-419 of SEQ ID NO;
4,wherein (a) and (b) are co-coated on the same microparticles in a ratio of about 1;
2 and concentration of (a) is at least about 40 μ
g/mL and the concentration of (b) is at least about 80 μ
g/mL. - View Dependent Claims (2)
- 2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
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3. A method of determining the presence, amount, or concentration of anti-HCV antibodies in a test sample, which method comprises assaying the test sample for anti-HCV antibodies by an assay:
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(i) employing; (i′
) an immunodiagnostic reagent comprising at least one pair of first specific binding partners selected from the group consisting of(1) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO;
2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 and an isolated or purified polypeptide comprising an epitope that is immunoreactive with an antibody that specifically binds to the NS3 region of HCV,(2) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO;
2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 and an isolated or purified polypeptide comprising the contiguous amino acids 2-267 of SEQ ID NO;
4,(3) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO;
2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 and an isolated or purified polypeptide comprising an epitope that is immunoreactive with an antibody that specifically binds to the NS3 region of HCV and an epitope that is immunoreactive with an antibody that specifically binds to the core region of HCV, and(4) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO;
2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 and an isolated or purified polypeptide comprising the contiguous amino acids 2-267 and 270-419 of SEQ ID NO;
4, and(ii′
) at least one detectable label, and(ii) comprising; comparing a signal generated by the detectable label as a direct or indirect indication of the presence, amount or concentration of anti-HCV antibodies in the test sample to a signal generated as a direct or indirect indication of the presence, amount or concentration of anti-HCV antibodies in a control or calibrator, which is optionally part of a series of calibrators in which each of the calibrators differs from the other calibrators in the series by the concentration of anti-HCV antibodies, whereupon the presence, amount or concentration of anti-HCV antibodies in the test sample is determined, wherein the polypeptides of which the immunodiagnostic reagent is comprised are co-coated on the same microparticles in a ratio of about 1;
2 and the concentration of the isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO;
2 or a contiguous amino acid sequence that is at least about 95% identical to the contiguous amino acids 1-198 of SEQ ID NO;
2 is at least about 40 μ
g/mL and the concentration of the other isolated or purified polypeptide is at least about 80 μ
g/mL. - View Dependent Claims (4, 5, 6, 7)
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Specification