National Cheng-kung University

National Health Research Institutes

Yun-Ping Lee

Ih-Jen Su

Wenya Huang

Wen Ya Huang

Chia Jui Yen

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.

Kit of in vitro quantifying large surface protein of hepatitis B virus (HBV), biomarker set for analyzing phases of HBV infection and hepatoma prognosis, and set of monoclonal antibodies for predicting, diagnosing or treating chronic liver disease

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-Sdeletion 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-Sdeletion 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-Sdeletion 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.

Growing community of inventors

Tainan, Taiwan

Yun-Ping Lee