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.

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.

A novel serological target marker GP73 used for diagnosing and identifying a simple fatty liver and steatohepatitis in populations with fatty liver and a detection application method thereof. The serological target marker GP73 and the application thereof can replace golden standard liver puncture to identify and diagnose the simple fatty liver and steatohepatitis in populations with fatty liver, reduce the detection pain of a patient, and have an extremely high clinical application value in clinically identifying and diagnosing the simple fatty liver and steatohepatitis in the populations with fatty liver and assisting the treatment of the simple fatty liver and steatohepatitis.

Hepatitis F 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 arc 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 present disclosure provides methods, kits, and compositions for detecting subject anti-HCV antibodies in a sample using NS3 capture peptides. In certain embodiments, at least two NS3 helicase (NS3h) capture peptides and at least two conjugate peptides (e.g., NS3h conjugate peptides) are employed together, which allows for a broad dynamic range of subject antibody detection in a one-step type assay. In other embodiments, methods are provided of detecting NS3-specific subject antibodies without the use of a reducing agent. In some embodiments, NS3-specific subject antibodies are detected with a double shot of NS3 conjugate peptide (e.g., conjugate peptide added to a sample both before and after washing).

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 present disclosure provides methods, kits, and compositions for detecting subject anti-HCV antibodies in a sample using NS3 capture peptides. In certain embodiments, at least two NS3 helicase (NS3h) capture peptides and at least two conjugate peptides (e.g., NS3h conjugate peptides) are employed together, which allows for a broad dynamic range of subject antibody detection in a one-step type assay. In other embodiments, methods are provided of detecting NS3-specific subject antibodies without the use of a reducing agent. In some embodiments, NS3-specific subject antibodies are detected with a double shot of NS3 conjugate peptide (e.g., conjugate peptide added to a sample both before and after washing).

Modified hepatitis C virus polypeptides are described. The polypeptides include the HCV NS4a domain and modified NS3 domain. The polypeptides retain conformational epitopes. HCV immunoassays including the polypeptides are also described.

The present invention relates generally to a method for determining or diagnosing the presence or absence, or the risk of development, or the therapy control of autoimmune hepatitis in a subject, in particular, in mammals. In addition, the present invention relates to test kits for use in the diagnosis or the determination of the presence or absence, or the risk of development or the therapy control of autoimmune hepatitis in a subject. In particular, the present invention relates to a method wherein the presence or absence of antibodies against the huntingtin interacting protein 1 related protein (HIP1 R) or against immunoreactive peptides derived therefrom are analyzed, the presence of said antibodies is indicative for the presence, or the risk of development or for therapy control of autoimmune hepatitis of said subject. Further, the present invention relates to the use of the HIP1 R or an immunoreactive peptide derived therefrom in the diagnosis, the risk assessment or therapy control of hepatitis diseases by determining the presence of antibodies, in particular, autoantibodies against said HIP1 R or immunoreactive peptide derived therefrom, this is particularly helpful for differential diagnosis of autoimmune hepatitis.

A novel serological target marker GP73 used for diagnosing and identifying a simple fatty liver and steatohepatitis in populations with fatty liver and a detection application method thereof. The serological target marker GP73 and the application thereof can replace golden standard liver puncture to identify and diagnose the simple fatty liver and steatohepatitis in populations with fatty liver, reduce the detection pain of a patient, and have an extremely high clinical application value in clinically identifying and diagnosing the simple fatty liver and steatohepatitis in the populations with fatty liver and assisting the treatment of the simple fatty liver and steatohepatitis.