The present invention relates to a pretreatment method of a sample for detecting HBs antigen, which is a surface antigen of the hepatitis B virus, and a method for detecting HBs antigen utilizing the pretreatment method. The present invention also relates to a pretreatment reagent kit for detecting HBs antigen.

Disclosed is a liquid-sealed cartridge in which a liquid is transferred by a centrifugal force generated when the liquid-sealed cartridge is rotated around a rotation shaft, including: a liquid storage portion configured to store the liquid therein; a seal having an outer peripheral portion connected to the liquid storage portion, the seal being configured to seal the liquid storage portion; a flow path connected to the liquid storage portion via the seal, through which the liquid in the liquid storage portion is transferred by the centrifugal force in a direction away from the rotation shaft, wherein, when the seal receives a pressing force, the seal is inclined in a pressing direction, with one portion of the outer peripheral portion thereof remaining connected with the liquid storage portion, and the other portion of the outer peripheral portion being separated from the liquid storage portion.

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.

A method of detecting pre-S.sub.2 deletion mutant LHBS is disclosed herein. The method comprises incubating a biological sample with a first antibody to captured HBS proteins; detecting the LHBS and WT LHBS bound to the immobilized first antibody, respectively; and calculating the amount of the pre-S.sub.2 deletion mutant LHBS protein by subtracting the amount of the WT LHBS protein from that of the LHBS protein. Advantageously, by the method described herein, the amount of the pre-S.sub.2 deletion mutant LHBS, a potential high-risk marker for HCC incidence in chronic HBV carriers and recurrence in HCC patients after hepatectomy surgery, in a biological sample may be easily calculated without mutual influence between the WT and pre-S mutant LHBS while reducing the labor-intensive process for cloning each gene product before analysis.

A HBS-specific antibody, a LHBS-specific antibody, a WT LHBS-specific antibody, an immunoassay kit comprising the antibodies, and a method of detecting pre-S.sub.2 deletion mutant LHBS using the immunoassay kit are disclosed herein. The method comprises incubating a biological sample with a first antibody to captured HBS proteins; detecting the LHBS and WT LHBS bound to the immobilized first antibody, respectively; and calculating the amount of the pre-S.sub.2 deletion mutant LHBS protein by subtracting the amount of the WT LHBS protein from that of the LHBS protein. Advantageously, by the method described herein, the amount of the pre-S.sub.2 deletion mutant LHBS, a potential high-risk marker for HCC incidence in chronic HBV carriers and recurrence in HCC patients after hepatectomy surgery, in a biological sample may be easily calculated without mutual influence between the WT and pre-S mutant LHBS while reducing the labor-intensive process for cloning each gene product before analysis.

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).

The present invention relates to the field of molecular virology and immunology, in particular to the field of hepatitis B virus (HBV) infection treatment. In particular, the present invention relates to an epitope peptide (or a variant thereof) capable of treating a hepatitis B virus infection, a recombinant protein comprising the epitope peptide (or a variant thereof) and a carrier protein, and an antibody (e.g. a nanobody) for the epitope peptide. The epitope peptide and antibody of the present invention can be used to prevent and/or treat HBV infection or a disease related to HBV infection (e.g. hepatitis B), for reducing the serum level of HBV DNA and/or HBsAg in a subject (e.g. a human), or for activating a subject (e.g. a chronic HBV infected person or a chronic hepatitis B patient) against HBV humoral immune response.

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).

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.