US 12,442,821 B2
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
Wen Ya Huang, Tainan (TW); Chia Jui Yen, Tainan (TW); and Yun-Ping Lee, Tainan (TW)
Assigned to NATIONAL CHENG KUNG UNIVERSITY, Tainan (TW)
Filed by NATIONAL CHENG KUNG UNIVERSITY, Tainan (TW)
Filed on Jun. 30, 2022, as Appl. No. 17/854,736.
Claims priority of provisional application 63/217,300, filed on Jul. 1, 2021.
Prior Publication US 2023/0018242 A1, Jan. 19, 2023
Int. Cl. G01N 33/576 (2006.01)
CPC G01N 33/5764 (2013.01) [G01N 2333/02 (2013.01)] 16 Claims
 
1. A kit of in vitro quantifying large surface protein of hepatitis B virus (LHBS) in a biological sample, comprising:
a blocking solution;
a set of monoclonal antibodies for detecting biomarkers in the biological sample, comprising:
a first monoclonal antibody immobilized in multiple discrete locations on a solid support and immersed in the blocking solution, wherein the first monoclonal antibody has a binding specificity for a first polypeptide listed as SEQ ID NO: 1 in a biological sample, and the first monoclonal antibody comprises heavy chain CDR 1 to 3 sequences consisting of SEQ ID NOs: 4 to 6 and light chain CDR 1 to 3 sequences consisting of SEQ ID NOs: 7 to 9; and
at least one of a second monoclonal antibody and a third monoclonal antibody, wherein the second monoclonal antibody and the third monoclonal antibody are respectively linked to a label, the second monoclonal antibody has a binding specificity for a second polypeptide listed as SEQ ID NO: 2 in the biological sample, and the third monoclonal antibody has a binding specificity for a third polypeptide listed as SEQ ID NO: 3 in the biological sample, the second monoclonal antibody comprises heavy chain CDR 1 to 3 sequences consisting of the sequences listed as SEQ ID NO: 10 to 12 and light chain CDR 1 to 3 sequences consisting of the sequences listed as SEQ ID NO: 13 to 15, and the third monoclonal antibody comprises heavy chain CDR 1 to 3 sequences consisting of the sequences listed as SEQ ID NO: 16 to 18 and light chain CDR 1 to 3 sequences consisting of the sequences listed as SEQ ID NO: 19 to 21; and
a detection reagent capable of reacting with the label and forming a detectable product.