The present invention relates to measurement of immunological parameters as a means to predict time-to-viral clearance in patients with chronic Hepatitis C Virus (HCV) infection under direct acting antiviral (DAA) therapy. The present invention provides a principle and methods for stratifying individuals into suitable treatment groups and personalized methods of treatment for such individuals.

The disclosure relates to a multi-epitope fusion protein as well as to its use as calibrator and/or control in an in vitro diagnostics immunoassay for detecting HCV core antigen. The multi-epitope fusion protein has two to six different non-overlapping linear peptides present in the amino acid sequence of hepatitis C virus (HCV) core protein, wherein each of the peptides is separated from the other peptides by a spacer consisting of a non-HCV amino acid sequence and having a chaperone amino acid sequence. No further HCV specific amino acid sequences are present in the polypeptide. A further aspect relates to a reagent kit for detecting HCV core antigen containing said multi-epitope fusion protein as calibrator or control or both.

The present disclosure provides detection methods employing HCV core lipid binding domain and DNA binding domain monoclonal antibodies. In certain embodiments, the lipid binding domain monoclonal antibody recognizes an epitope in amino acids 141 to 161 of HCV core protein.

A method for detecting whether glucose metabolism is abnormal comprises: detecting GPx2 gene expression, GPx2 protein expression or the activity of GPx2 protein in a test body, and making comparisons with GPx2 expression amount of a normal individual, when the GPx2 expression of the individual is significantly lower than that of the normal individual, indicating that the carbohydrate metabolism of the individual is in an abnormal state. Applications of GPx2 in the preparation of a medical composition for the treatment and prevention of type II diabetes.

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.

The present disclosure provides detection methods employing HCV core lipid binding domain and DNA binding domain monoclonal antibodies or antibody fragments. In certain embodiments, the lipid binding domain monoclonal antibody or antibody fragment recognizes an epitope in amino acids 141 to 161 of HCV core protein and the DNA binding domain antibody or antibody fragment recognizes an epitope in amino acids 95-123 (e.g., in amino acids 99-117) of HCV core protein.

Hepatitis E virus (HEV) is responsible for over 50% of acute viral hepatitis cases worldwide. The inventors have now identified the precise sequence of infectious particle-associated ORF2 capsid protein. Strikingly, their analyses revealed that in infected patients, HEV produces three forms of the ORF2 capsid protein: ORF2i, ORF2g and ORF2c. The ORF2i protein is associated with infectious particles whereas ORF2g and ORF2c proteins are massively produced glycoproteins that are not associated with infectious particles and are the major antigens present in HEV-infected patient sera. Accordingly, the ORF2i and ORF2g proteins are thus the subject matter of the present invention as well as antibodies specific for the proteins and diagnostic assays (e.g. ELISA) for the diagnosis of Hepatitis E virus infection.

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 disclosure relates to hepatitis C virus (HCV) core and minicore-binding molecules and nucleic acid sequences encoding such molecules. In particular embodiments, the present invention provides HCV core and minicore-binding molecules (e.g., monoclonal antibodies or antibody fragments) with particular light chain and/or heavy chain CDRs (e.g., selected from SEQ ID NOS: 2-4 and 6-8) and methods for using such molecules to detect the presence of HCV core proteins (e.g., mature p21 core protein or minicore proteins) in a sample.

The invention relates to the field of diagnosis and treatment of cirrhosis and liver fibrosis. Specifically, the invention relates to the use of Golgi protein 73 (GP73) and a substance of detecting the level of Golgi protein 73 (GP73) for preparing the products for screening, auxiliarily diagnosing liver diseases or auxiliarily determining the prognosis of liver diseases. The invention proves that Golgi protein 73 (GP73) can be used as a novel marker of cirrhosis, and has diagnostic value especially for cirrhosis resulting from non-hepatitis B virus infection, but has no diagnostic value for primary hepatocellular carcinoma.