Compositions and processes are provided for the robust detection of hepatitis C virus in a sample. Compositions include amino acid sequences of HCV core region including or exclusive to residues 14-31 or 50-90 of the HCV core protein. Also provided are processes of detecting HCV in a sample whereby the provided peptides are optionally used alone or in conjunction with antibodies that do not recognize the peptides so that detection is independent of seroconversion in a subject. Using the compositions and processes, HCV can be detected in a sample prior to or following seroconversion leading to robust HCV detection and diagnosis.

The present invention provides a composition comprising hepatitis C virus (HCV) Envelope 2 (E2) glycoprotein, wherein the HCV E2 is substantially monomer depleted HCV E2. Also provide are methods of inducing an HCV immune response.

The application concerns means for predicting whether a subject infected with one or more HCVs has a high probability of responding to an anti-HCV treatment which will comprise the administration of interferon and of ribavirin or whether, in contrast, that subject has a high probability of not responding to that anti-HCV treatment. The means of the invention in particular involve assaying the levels of expression of selected genes, said selected genes being: at least one gene from among MBL2, LGALS3BP and IL8, and at least one gene from among G1P2, CCL21 and CXCL10, and optionally, at least one gene from among AFP, CRP, CXCL11, CXCL6, CXCL9, FGF7, MDK, MMP2, SFN, TGFB2 and VEGFD.

Hepatitis C virus replication at extrahepatic sites has been suggested; however, complete viral replication has only been confirmed in hepatocytes. Here we show that human adipogenic DLK-1.sup.+ stem cells (hADSC) freshly isolated from HCV-infected individuals contained viral transcripts, replication intermediates and viral antigens in vivo, and viral transcripts increased in supernatants upon prolonged ex vivo culture. Furthermore, naive hADSC isolated from HCV () individuals support complete replication of clinical isolates in vitro, and the infection is donor-nonspecific for cells and cross-genotypic for viruses. Viral infection/replication is mediated through CD81, LDL-R, SR-B1, EGFR, Apolipoprotein E, occludin, claudin-1, NPC1L1 and diacylglycerol acetyltransferase-1, and can be inhibited by anti-viral drugs. In addition, the physical properties of hADSC-propagated viral particles resemble clinical isolates more than JFH1/HCVcc, and viruses propagated by in vitro infected hADSC are infectious to primary human hepatocytes. Therefore, hADSC are an in vivo HCV reservoir and represent a novel venue of clinical virus-host interaction. hADSC can also be exploited as a physiologically relevant primary cell culture system to propagate clinical isolates.

A method and test system for detecting the presence of an analyte in a sample comprising a binding region and a detecting region, where the binding region contains a plurality of magnetic beads attached to a plurality of first capture molecules that bind to an analyte of interest in the sample, and a plurality of second capture molecules having a detectable label attached thereto, where the second capture molecules bind to the analyte of interest to form a complex, where the complexes are moved through at least one liquefied aliphatic partition via a magnetic field into the detecting region that having a detection composition allows for detection and, optionally, for signal quantification.

A method of preparing extracellularly assembled higher order antigen from a native lower order antigen the method comprising the following steps: (i) contacting lower order antigen with a solution comprising a reducing agent for a time and under 5 conditions sufficient to reduce one or more native cysteines; and (ii) removing or diluting the reducing agent or contacting the reduced lower order antigen with an oxidising agent, to elicit assembly of lower order antigen from (i) into an assembled higher order antigen; wherein at least 10% of the lower order antigen is converted to higher order antigen in step (ii) and whereby the assembled higher order antigen 10 displays at least reduced binding to non-neutralizing antibodies compared to the lower order antigen and retains binding to at least one neutralizing antibody. A method of producing a vaccine composition comprising following the steps of the method and then mixing the assembled higher order antigen with a pharmaceutically or physiologically acceptable diluent, carrier or adjuvant. A composition comprising a 15 higher order extracellularly assembled antigen, wherein the assembled antigen displays at least reduced binding to a non-neutralizing antibody compared to a native control higher order antigen. Use of the assembled higher order antigen to stimulate an immune response or for the detection and/or isolation of an immune cell such as a B-cell specific for the antigen.

The present invention generally relates to combination immunoassays, reagents and kits for simultaneous detection of HCV antigens and anti-HCV antibodies in a test sample.

The present disclosure relates to polypeptides, including fusions thereof, nucleic acids, vectors, host cells, immunodiagnostic reagents, kits, and immunoassays for use detecting the presence of HCV antibodies. More specifically, the present invention describes specific NS3 antigens that can be used for the detection of anti-HCV antibodies.

Novel epitope regions on hepatitis C virus E1E2 glycoprotein that induce a neutralizing antibody response in vivo are identified. Cross-neutralizing monoclonal antibodies that bind specifically to the epitopes are disclosed.

An anti-hepatitis C virus E2 protein antibody or antigen-binding antibody fragment thereof has infection inhibiting activity against hepatitis C virus (HCV). An anti-hepatitis C virus E2 protein antibody or antigen-binding antibody fragment thereof includes a certain variable region, which have infection inhibiting activity against hepatitis C virus (HCV) and exhibits an escape mutant emergence suppressive property.