The present invention relates to a polypeptide and a nucleic acid encoding the polypeptide for use in a method of detecting the presence of hepatitis D virus (HDV) and/or of diagnosing an HDV infection and/or of monitoring the treatment of an HDV infection. The present invention further relates to an in vitro method, an immunographic test device as well as a kit. In particular, the present invention relates to a point of care diagnostic for HDV infections.

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 a simultaneous analysis method for a target using a plurality of metal nano-tags and, more particularly, to a simultaneous analysis method for a target using a plurality of metal nano-tags, wherein the method fuses a nano-particle technology on the basis of an antigen-antibody reaction, which is a conventional biological immune response, and simultaneously diagnoses a plurality of target materials by using a plurality of antigen-antibody reactions and a plurality of metal nano-tags, thereby enhancing diagnostic effect.

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.

Presently disclosed is a method of modulating Hepatitis B virus (HBV) replication, by contacting the cell with at least one agent that modulates at least one factor from a specified group consisting of SNAI2, SOX7 and other factors, the screening of said agent and use thereof in a medicament for treating HBV infection or disease or condition associated with a HBV infection in a subject. In one preferred embodiment, the agent is one peptide derived from SOX7 or SNAI2 or stapled peptides thereof. As a separate invention, a method of identifying at least one factor that modulates replication of a virus is also disclosed.

The present invention provides a method of identifying a viral-host junction sequence from a subject with a hepatocellular carcinoma caused by chronic infection of hepatitis B virus. The viral-host junction sequence has a length of less than 200 bps and comprises a hepatitis B viral genome sequence and a host genome sequence.

The disclosed embodiments concern non-invasive methods, and apparatus, and systems for identifying infections. The methods are predicated on identifying discriminating peptides present on a peptide array, which are differentially bound by the different mixtures of antibodies present in samples from subjects consequent to an infection relative to binding of mixtures of antibodies present in reference subjects.

Disclosed herein is a novel use of C-type lectin 18 (CLEC18) in disease prognosis. According to embodiments of the present disclosure, the mRNA or protein level of CLEC18 may serve as an indicator for diagnosing hepatitis B virus (HBV) infection, hepatitis B e antigen (HBeAg) loss and seroconversion, and/or liver fibrosis.

The disclosure concerns a method and kits for measurement of an analyte in a microparticle-based analyte-specific binding assay. In the assay, the microparticles are coated with the first partner of a binding pair, mixing the coated microparticles and at least two analyte-specific binding agents, each conjugated to the second partner of the binding pair, and a sample suspected of containing the analyte. The second partner of the binding pair is bound to each of the analyte-specific binding agents via a linker comprising from 12 to 30 ethylene glycol units (PEG 12 to 30), thereby binding the analyte via the conjugated analyte-specific binding agents to the coated microparticles. The method also entails separating the microparticles having the analyte bound via the binding pair and the analyte-specific binding agent from the mixture and measuring the analyte bound to the microparticles.

The present invention relates to the identification of a profile of antibodies in an individual with chronic hepatitis B (CHB) wherein the existence of this profile is indicative that the individual will achieve or has achieved a functional cure (FC). The present invention further identifies an epitope profile or profile on Hepatitis B virus surface antigen (HBsAg) which represents targets for antibodies which enable a level of clearance to be achieved to reach a functional cure for CHB. Level of occupancy of the epitope profile is indicative that a functional cure will or will not be achieved.