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.

Provided herein are compositions, systems, and methods for assessing and monitory disease stage and phases, predicting likelihood of disease progression, and predicting and monitoring responses to disease therapies (e.g., in HBV infection).

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.

Disclosed is a highly sensitive assay method and assay kit for HBsAg, which do not require treatment with a strong acid or alkali in the sample pretreatment, and which is less susceptible to influences by the autoantibodies. The assay method for hepatitis B virus s antigen in a sample separated from a living body includes: a pretreatment step of mixing a sample with a pretreatment reagent containing a reducing agent, to reduce hepatitis B virus s antigen; and an immunoassay step of subjecting the pretreated sample to an immunoassay of hepatitis B virus s antigen using at least one antibody or antigen-binding fragment thereof capable of antigen-antibody reaction with a reduced peptide composed of the amino acids at positions 98 to 179 of hepatitis B virus s antigen.

In the invention described here, the approach is to formulate an edible vaccine based on N-terminal yeast surface display expression platform that producing S.cerevisiae EBY100/pYD5-preS2/S(adw) and S.cerevisiae EBY100/pYD5-preS2/S(adr) for protecting and treating human against hepatitis B virus (HBV) infection, suggesting that yeast surface display expression system expressing HBsAg antigen has potential as a prophylactic treatment for HBV in human via oral vaccination. The technology developed in this patent application can also be used to produce edible (oral) vaccines for preventing and treating other infectious diseases in human.

An immunoassay apparatus may include: a sample dispenser part that dispenses a sample into a first reaction container; a reagent dispenser part that dispenses, into the first reaction container: a solid-phase reagent containing a solid-phase carrier; a labeled reagent; and a releasing reagent that releases, from the solid-phase carrier, an immune complex including a target substance and a labeled substance; a measurement part that measures a signal based on the labeled substance in the immune complex in a second reaction container; a container supply part that stores a plurality of reaction containers; a transfer part that transfers the first reaction container so that the sample dispenser part and the reagent dispenser part perform a dispensing operation to the first reaction container, and that transfers the second reaction container so that the immune complex dispended from the first reaction container is dispensed into the second container.

The present invention pertains to a method for detecting HBsAg with which it is possible to detect HBsAg with high sensitivity even when blood (whole blood) is used as a sample. A sample is provided on a metal film on the surface of which there is immobilized a binding substance (e.g., an antibody) capable of specifically binding to hepatitis B surface antigens, and hepatitis B surface antigens included in the sample are bound by the binding substance. The hepatitis B surface antigens are also labeled by a fluorescent substance. Fluorescence, which is emitted from the fluorescent substance when the metal film is irradiated with excitation light so that surface plasmon resonance is produced in the metal film, is detected.

An immunoassay apparatus may include: a sample dispenser part that dispenses a sample into a first reaction container; a reagent dispenser part that dispenses, into the first reaction container,: a solid-phase reagent containing a solid-phase carrier; a labeled reagent; and a releasing reagent that releases, from the solid-phase carrier, an immune complex including a target substance and a labeled substance; a measurement part that measures a signal based on the labeled substance in the immune complex in a second reaction container; a container supply part that stores a plurality of reaction containers; a transfer part that transfers the first reaction container so that the sample dispenser part and the reagent dispenser part perform a dispensing operation to the first reaction container, and that transfers the second reaction container so that the immune complex dispended from the first reaction container is dispensed into the second container.

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.

In the invention described here, the approach is to formulate an edible vaccine based on N-terminal yeast surface display expression platform that producing S.cerevisiae EBY100/pYD5-preS2/S(adw) and S.cerevisiae EBY100/pYD5-preS2/S(adr) for protecting and treating human against hepatitis B virus (HBV) infection, suggesting that yeast surface display expression system expressing HBsAg antigen has potential as a prophylactic treatment for HBV in human via oral vaccination. The technology developed in this patent application can also be used to produce edible (oral) vaccines for preventing and treating other infectious diseases in human.