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.

A kit for quantitatively detecting HBsAg and a method for quantitatively detecting an HBsAg content in a sample containing HBsAg. The kit comprises a first antibody specifically binding to HBsAg and a reagent composition. The reagent composition comprises tris(2-carboxyethyl)phosphine hydrochloride (TCEP) and urea.

A kit for quantitatively detecting HBsAg and a method for quantitatively detecting an HBsAg content in a sample containing HBsAg. The kit comprises a first antibody specifically binding to HBsAg and a reagent composition. The reagent composition comprises tris(2-carboxyethyl)phosphine hydrochloride (TCEP) and urea.

Systems, apparatuses, and methods are described herein for disease detection using an analyte-agnostic approach. Such systems, apparatuses, and methods can include using an array with hydrogels disposed on a substrate, where the hydrogels include one or more polymerized monomers and one or more photoinitiators or photocleavage products thereof. One or more samples including one or more unlabeled analytes can be contacted with an array of polymers. The samples disposed on the array can be incubated for a first predetermined period of time, and heated at a predetermined temperature for a second predetermined period of time. An imaging device (e.g., flatbed scanner) can be used to measure an amount of one or more colorimetric or luminescence signals produced by the array after the incubating and heating. A neural network trained using the samples can then be used to predict a diagnostic or disease class for the sample.

Exemplary embodiments of the present invention relate to rapidly and easily test initial liver disease and more particularly to a monoclonal antibody for α1-acid glycoprotein, a diagnosis kit for tracking progressive chronic hepatitis and liver fibrosis in an initial phase of liver disease by measuring the concentration of asialo-α1-acid glycoprotein (AsAGP) as a hepatocyte injury marker in a sample using the antibody, and a use thereof. Further, embodiments of the present invention provide a kit for specifically determining the degree of progressive chronic hepatitis and hepatic fibrosis from a blood sample and an immunochromatography strip, comprising a HRP-RCA II (Ricinus communis agglutinin II) conjugate or a Gold-RCA II conjugate specifically binding to asialo α-1 acid glycoprotein.

An examination system that recognizes a glycosylated antigen in Dane particles of hepatitis B virus (HBV) and a neutralizing antibody that recognizes the glycosylated antigen and that exhibits an infection-inhibiting activity. It was elucidated that Dane particles are associated with specific glycan structures, and this enabled the construction of a new detection system for infectious, i.e., nucleic acid-containing, hepatitis B virus particles and the provision of a neutralizing antibody that recognizes a glycosylated antigen and that exhibits an infection-inhibiting activity.

Disclosed is a novel method showing a higher detection sensitivity for hepatitis B virus genotype D than those of known methods. A method of immunoassay of hepatitis B virus core-related antigen uses, as an antibody to be used for the immunoassay, a monoclonal antibody that specifically binds to at least one kind of core-related antigen of hepatitis B virus genotype D, or an antigen-binding fragment thereof, wherein an epitope of the monoclonal antibody or the antigen-binding fragment thereof is a region included in the amino acid sequence from position 31 to 48 of SEQ ID NO:3.

The invention relates to mutations and alterations in the inflammatory pathway, including IL-18BP and IL-10RB mutations, that are associated with the development of fulminant viral hepatitis following viral infection, such as following hepatitis virus infection. The invention relates to methods for treating or ameliorating viral hepatitis comprising administering IL-18BP, IL-18 antagonist, IFNγ antagonist or inhibitor, and/or IL-10RB or an IL-10 antagonist.

The present invention relates to a method for diagnosis, prediction and/or prognosis of an active autoimmune pathology in a subject, comprising detecting the co-expression of PD-1 and CD38 proteins at the surface of T lymphocytes in a biological sample from the subject.

The present invention also relates to a use of the pool of PD-1 (Programmed cell death 1) and CD38 protein as biomarkers for diagnosis, prediction and/or prognosis of an active autoimmune pathology in a subject.

The present invention further relates to a test device for detecting the co-expression of PD-1 and CD38 in a sample from a subject, comprising: (i) optionally means for obtaining a sample from the subject, and (ii) means for detecting the co-expression of PD-1 and CD38 at the surface of the T lymphocytes in said sample, and (iii) means for determining the frequency of co-expression of PD-1 and CD38 in the sample

Methods for diagnosing non-alcoholic steatohepatitis (NASH) and NASH with or without advanced liver fibrosis in a subject are provided, such methods including the detection of levels of a variety of biomarkers diagnostic of NASH versus simple steatosis and NASH with advanced liver fibrosis versus NASH without advanced liver fibrosis. The invention also provides methods treating NASH (e.g., NASH with or without advanced liver fibrosis) by administering a biomarker or an agent that modulates a biomarker of NASH or fibrosis. Compositions in the form of kits and panels of reagents for detecting the biomarkers of the invention are also provided.