Methods for the simultaneous detection of HCV antigens and HCV antibodies
AssigneeAbbott Laboratories
InventorsDinesh O. Shah, George J. Dawson, A. Scott Muerhoff, Lily Jiang, Robin A. Gutierrez, Thomas P. Leary, Suresh Desai, James L. Stewart
Life of this patent
Estimating the term…
Abstract
The subject invention relates to methods for the simultaneous detection of Hepatitis C Virus (HCV) antigens as well as antibodies produced in response to HCV antigens. Furthermore, the subject invention allows one to detect antigens in the early, acute stage of infection, even prior to the development of antibodies, thereby allowing for early detection of infected blood and blood products, thus improving the safety of the blood supply.
Claims22
A method of simultaneously detecting at least one Hepatitis C Virus (HCV) antigen and at least one HCV antibody in a test sample comprising the steps of:
- a) contacting said test sample with:
- 1) at least one HCV viral antigen or portion thereof coated on a solid phase, for a time and under conditions sufficient for the formation of antibody/antigen complexes and 2) at least one antibody to HCV or portion thereof coated on said solid phase, for a time and under conditions sufficient for the formation of antigen/antibody complexes;
- b) detecting said antibody/antigen complexes, presence of said complexes indicating presence of HCV antigen in said test sample;
- and
- c) detecting said antigen/antibody complexes, presence of said complexes indicating presence of HCV antibody in said test sample.
A method for simultaneously detecting the presence of at least one HCV antigen and at least one HCV antibody in a test sample comprising the steps of:
- a) contacting said test sample with:
- 1) at least one HCV viral antigen or portion thereof coated on a solid phase, for a time and under conditions sufficient for the formation of antibody/antigen complexes and 2) at least one HCV antibody or portion thereof coated on said solid phase, for a time and under conditions sufficient for the formation of antigen/antibody complexes;
- b) adding a conjugate to the resulting antibody/antigen complexes for a time and under conditions sufficient to allow said conjugate to bind to the bound antibody in (a)(1), wherein said conjugate comprises a second antibody attached to a chemiluminescent compound capable of generating a detectable signal and simultaneously adding a second conjugate to the resulting antigen/antibody complexes for a time and under conditions sufficient to allow said conjugate to bind to the bound antigen in (a)(2), wherein said conjugate comprises a third antibody attached to said chemiluminescent compound capable of generating a detectable signal;
- and
- c) detecting said generated signal, presence of said signal indicating presence of at least one antigen in said test sample selected from the group consisting of HCV antigen and HCV antibody.
A kit comprising:
- a) a container containing at least one HCV antigen coated on a solid phase;
- and
- b) a container containing at least one HCV antibody coated on a solid phase.
A kit comprising:
- a container containing:
- 1) at least one HCV antigen coated on a solid phase and 2) at least one HCV antibody, coated on said solid phase.
A method of detecting at least one HCV antigen in a test sample comprising the steps of:
- a) contacting said test sample with at least one HCV antibody coated on a solid phase, for a time and under conditions sufficient for the formation of antibody/antigen complexes;
- and
- b) detecting the presence of antibody/antigen complexes, presence of said complexes indicating presence of said at least one HCV antigen in said test sample.
A method of detecting at least one HCV antigen in a test sample comprising the steps of:
- a) contacting said test sample with at least one HCV antibody coated on a solid phase, for a time and under conditions sufficient for the formation of antibody/antigen complexes;
- b) adding a conjugate to the resulting antibody/antigen complexes for a time and under conditions sufficient to allow said conjugate to bind to the bound at least one antibody, wherein said conjugate comprises a second antibody attached to a chemiluminescent compound capable of generating a detectable signal;
- and
- c) detecting said signal generated by said chemiluminescent compound, a signal generated by said chemiluminescent compound indicating the presence of at least one HCV antigen in said test sample.
A recombinant protein comprising an amino acid sequence selected from the group consisting of SEQ ID NO:
- 6, SEQ ID NO:
- 8, SEQ ID NO:
- 12, SEQ ID NO:
- 16, and conservative amino acid substitutions thereof.
A recombinant protein comprising an amino acid sequence encoded by a nucleotide sequence selected from the group consisting of, for example, SEQ ID NO:
- 5, SEQ ID NO:
- 7, SEQ ID NO:
- 11 and SEQ ID NO:
- 15.
A vector or construct comprising a nucleotide sequence selected from the group consisting of SEQ ID NO:
- 5, SEQ ID NO:
- 7, SEQ ID NO:
- 11 and SEQ ID NO:
- 15.
An immunoassay which simultaneously detects at least one HCV antigen and at least one HCV antibody in a test sample.
Dependencies are inferred from the claim text.