Reagents for HCV antigen-antibody combination assays

Patent metadata

Field	Value
Publication number	US-10041946-B2
Application number	US-201815879547-A
Country	US
Kind code	B2
Filing date	Jan 25, 2018
Priority date	May 20, 2009
Publication date	Aug 7, 2018
Grant date	Aug 7, 2018

Abstract

The present invention is directed to combination immunoassays, reagents and kits for simultaneous detection of HCV antigens and anti-HCV antibodies in a sample. The combination immunoassays of the present invention employ a non-ionic detergent that effectively exposes or releases the HCV core antigen from virions in a sample without interfering with the performance of other reagents such as the capture of anti-HCV antibodies by recombinant HCV antigens.

First claim

What is claimed is:

1. A kit for simultaneously detecting HCV antigens and antibodies in a sample, comprising a non-ionic detergent comprising an N-alkyl-N,N-dimethyl-amine oxide, a first pair of a capture antigen and a detection antigen, a first pair of a capture antibody and a conjugate antibody, wherein said capture antigen and said detection antigen comprise a first peptide fragment of a first HCV protein, said capture antibody and said conjugate antibody specifically bind to a second HCV protein, and said detection antigen and said conjugate antibody comprise one and same signal generating means.

2. The kit of claim 1 , wherein said N-alkyl-N,N-dimethyl-amine oxide is characterized by the formula, CH3-(CH2)n-N + —(CH3)20 − , wherein n falls in the range of 9 to 13.

3. The kit of claim 2 , wherein said N-alkyl-N,N-dimethyl-amine oxide is Lauryldimethylamine N-oxide (LDAO).

4. The kit of claim 1 , wherein said first HCV protein and said second HCV protein are independently selected from the group consisting of the core antigen, E 1, E2, NS2, NS3, NS4, and NS5.

5. The kit of claim 1 , wherein said first HCV protein and said second HCV protein are the same, and said capture antibody and said conjugate antibody bind to a region of said second HCV protein outside of said first peptide fragment.

6. The kit of claim 5 , wherein said first HCV protein and said second HCV protein are both the HCV core antigen.

7. The kit of claim 1 , further comprising a second pair of a capture antigen and a detection antigen is provided, wherein said capture antigen and said detection antigen of the second pair comprise a second peptide fragment of an HCV protein, wherein said second peptide fragment is different from said first peptide fragment.

8. The kit of claim 7 , wherein said first peptide fragment and said second peptide fragment are derived from different HCV proteins.

9. The kit of claim 8 , wherein at least one of said first peptide fragment or said second peptide fragment is a fragment of the HCV core antigen.

10. The kit of claim 1 , wherein said capture antibody in said first pair comprises two or more antibodies.

11. The kit of claim 1 , further comprising a second pair of a capture antibody and a conjugate antibody, wherein said capture antibody and said conjugate antibody in said second pair specifically bind to said second HCV protein or a different HCV protein.

12. The kit of claim 1 , wherein said capture antigen and said capture antibody are attached to a solid phase.

Assignees

• Ortho Clinical Diagnostics Inc
• Ortho Clinical Diagnostics Inc

Inventors

• Zheng Jian
• Yang Jianping

Classifications

• G01N2469/20

  Detection of antibodies in sample from host which are directed against antigens from microorganisms · CPC title

• G01N2333/186

  Hepatitis C; Hepatitis NANB · CPC title

• G01N2469/10

  Detection of antigens from microorganism in sample from host · CPC title

• G01N33/5306

  Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding · CPC title

• G01N33/56983 Primary

  Viruses · CPC title