Provided herein are, inter alia, antibodies, antigen-binding antibody fragments, cells, polynucleotides, compositions, kits, and methods relating to the detection of HBV protein X (HBx), e.g., in vitro and in vivo. Included are antibodies and fragments thereof that bind HBx, as well as kits, cells, and compositions comprising such antibodies and fragments.

The present invention relates to epitope peptides (or mutants thereof) for treating hepatitis B virus infection, recombinant proteins comprising such epitope peptides (or mutants thereof) and carrier proteins, and uses of such epitope peptides (or mutants thereof) and recombinant proteins. The present invention also relates to antibodies against such epitope peptides, cell lines producing said antibodies, and uses thereof. Furthermore, the present invention relates to vaccines or pharmaceutical compositions for treating or alleviating one or more symptoms associated with hepatitis B virus infection, which comprise the recombinant proteins or antibodies according to the invention, respectively.

Disclosed is a method for producing an antibody reagent for detecting a test substance in a sample by an immune complex transfer method. The method comprises the steps of: bringing an antibody solution comprising a labeled antibody capable of binding to the test substance into contact with a solid phase used in the immune complex transfer method; and separating the solid phase and the antibody solution to prepare the antibody reagent from the antibody solution.

The present invention relates to a kit of in vitro quantifying large surface protein of hepatitis B virus (LHBS). The kit includes monoclonal antibodies having respective binding specificity for specific regions of LHBS, thereby increasing sensitivity and dynamic breadth of detecting LHBS in a biological sample. Moreover, the invention also provides a biomarker set corresponding to the specific regions of LHBS, and the biomarker set can be specifically recognized by the monoclonal antibodies, for non-invasively analyzing phases of HBV infection and hepatoma prognosis in a biological sample. Furthermore, the invention also provides a set of monoclonal antibodies for predicting, diagnosing or treating a chronic liver disease via those biomarkers in a subject in need thereof.

This disclosure provides a multimeric hepatitis B virus (HBV) protein binding molecule, e.g., a dimeric IgA or a pentameric or hexameric IgM binding molecule, comprising at least two bivalent binding units, or variants or fragments thereof, each comprising at least two antibody heavy chain constant regions or fragments thereof, wherein each heavy chain constant region or fragment thereof is associated with an HBV antigen binding domain. The disclosure also provides compositions comprising the multimeric binding molecules, polynucleotides encoding the multimeric binding molecules, and methods to make and use the multimeric binding molecules.

In the field of Hepatitis B virus (HBV) detection, disclosed are a method for detecting HBcAg by means of using a double antibody sandwich method, and an antibody and kit for detecting HBcAg; also included is a monoclonal antibody that can be used in the immunological detection of HBcAg in a tissue or cell sample.

The invention principally relates to a method of detecting a disease agent in blood, comprising: (i) creating a sample infra-red spectrum representative of the blood, with one or more spectral components, each having a wavenumber and absorbance value; (ii) providing a reference database of spectral models, each model having one or more database spectral components of a wavenumber and an absorbance value, wherein the database spectral components identify disease agents; (iii) determining whether one or more database spectral components corresponds to one or more sample spectral components; and (iv) compiling a list of corresponding database components identified.

The present invention relates to compositions and methods for the prevention, treatment, and diagnosis of Hepatitis B virus (HBV) infection, and discloses peptides, polypeptides, and polynucleotides that can be used to stimulate a CTL response against HBV infection. The peptide and/or proteins of the invention may be used as a therapeutic drug to stimulate the immune system to recognize and eliminate HBV infection in infected cells or as a vaccine for the prevention of disease.

Provided are a kit for measuring a titer of a human antibody, a humanized antibody, or a human Fc-fusion protein in human plasma or serum, and a method for measuring a titer of a human Fc-containing protein in human plasma or serum using the same, and more specifically, a kit for measuring a titer of human Fc-containing protein in human plasma or serum, the kit including a diluent for sample, a diluent for conjugate, and a cleansing solution and being used in analysis through an indirect enzyme-linked immunosorbent assay (indirect ELISA), and a method for measuring a titer of human Fc-containing protein in human plasma or serum using the same.

The present invention relates to a recombinant HBV cccDNA comprising HBV genome or the fragment or variant thereof and a site-hybrid insert, a method to generate said recombinant HBV cccDNA, a method for establishment of an in vitro or in vivo cccDNA based model for persistently hepatitis B virus replication by using the recombinant HBV cccDNA of the present invention, and a method for anti-HBV drug evaluation.