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US 12,624,090 B2Granted
Method and antibody for detection of HBcAg
AssigneesXiamen Innodx Biotech Co., Ltd, Xiamen University
InventorsZimin Chen, Junhui Xiong, Jiaqi Liu, Shaojuan Wang, Shengxiang Ge, Quan Yuan, Liuwei Song, Xudong Sun
Life of this patent
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Abstract
In the field of Hepatitis B virus (HBV) detection, disclosed are a method for detecting HBcAg by means of using a double antibody sandwich method, and an antibody and kit for detecting HBcAg; also included is a monoclonal antibody that can be used in the immunological detection of HBcAg in a tissue or cell sample.
Claims19
A method for detecting the presence or level of HBcAg protein in a sample, comprising the steps of:
- (1) contacting the sample with a first antibody to form an antibody-antigen complex, wherein the first antibody is selected from an antibody or antigen-binding fragment thereof that specifically binds to positions 150-183 of HBcAg protein;
- (2) contacting the antibody-antigen complex with a second antibody to form an antibody-antigen-antibody complex, wherein the second antibody is selected from an antibody or antigen-binding fragment thereof that specifically binds to positions 141-154 of HBcAg protein;
- and
- (3) determining an amount of the antibody-antigen-antibody complex;
- wherein the first antibody is selected from the following antibodies or antigen-binding fragments thereof:
- (i) an antibody or an antigen-binding fragment thereof, which comprises:
- a heavy chain variable region (VH) comprising the following 3 complementarity determining regions (CDRs):
- HCDR1 having a sequence set forth in SEO ID NO:
- 3, HCDR2 having a sequence set forth in SEO ID NO:
- 4, and HCDR3 having a sequence set forth in SEO ID NO:
- 5;
- and, a light chain variable region (VL) comprising the following 3 complementarity determining regions (CDRs):
- LCDR1 having a sequence set forth in SEO ID NO:
- 6, LCDR2 having a sequence set forth in SEO ID NO:
- 7, and LCDR3 having a sequence set forth in SEO ID NO:
- 8;
- or,
- (ii) an antibody or an antigen-binding fragment thereof, which comprises:
- a heavy chain variable region (VH) comprising 3 CDRs contained in the VH set forth in SEO ID NO:
- 1;
- and a light chain variable region (VL) comprising 3 CDRs contained in the VL set forth in SEO ID NO:
- 2;
- wherein the 3 CDRs contained in the VH and the 3 CDRs contained in the VL are defined by the Kabat, Chothia or IMGT numbering system;
- or,
- (iii) an antibody or an antigen-binding fragment thereof, wherein the antibody is a monoclonal antibody produced by a hybridoma cell line 18B2-2 which is deposited in the China Center for Type Culture Collection (CCTCC) and has the deposit number of CCTCC NO. C2019303;
- and wherein the second antibody is selected from the following antibody or antigen-binding fragment thereof:
- (i) an antibody or an antigen-binding fragment thereof, comprising:
- a heavy chain variable region (VH) comprising the following 3 complementarity determining regions (CDRs):
- HCDR1 having a sequence set forth in SEO ID NO:
- 11, HCDR2 having a sequence set forth in SEO ID NO:
- 12, and HCDR3 having a sequence set forth in SEO ID NO:
- 13;
- and a light chain variable region (VL) comprising the following 3 complementarity determining regions (CDRs):
- LCDR1 having a sequence set forth in SEO ID NO:
- 14, LCDR2 having a sequence set forth in SEO ID NO:
- 15, and LCDR3 having a sequence set forth in SEO ID NO:
- 16;
- or,
- (ii) an antibody or antigen-binding fragment thereof, which comprises:
- a heavy chain variable region (VH) comprising 3 CDRs contained in the VH set forth in SEO ID NO:
- 9;
- and a light chain variable region (VL) comprising 3 CDRs contained in the VL set forth in SEO ID NO:
- 10;
- wherein the 3 CDRs contained in the VH and the 3 CDRs contained in the VL are defined by the Kabat, Chothia or IMGT numbering system;
- or,
- (iii) an antibody or antigen-binding fragment thereof, wherein the antibody is a monoclonal antibody produced by a hybridoma cell line 2A7 which is deposited in the China Center for Type Culture Collection (CCTCC) and has the deposit number of CCTCC NO. C2019302.
43 more elements
A monoclonal antibody or antigen-binding fragment thereof capable of specifically binding to HBcAg, wherein,
- (i) the monoclonal antibody or antigen-binding fragment thereof comprises:
- a heavy chain variable region (VH) comprising the following 3 complementarity determining regions (CDRs):
- HCDR1 having a sequence set forth in SEQ ID NO:
- 11, HCDR2 having a sequence set forth in SEQ ID NO:
- 12, and HCDR3 having a sequence set forth in SEQ ID NO:
- 13;
- and, a light chain variable region (VL) comprising the following 3 complementarity determining regions (CDRs):
- LCDR1 having a sequence set forth in SEQ ID NO:
- 14, LCDR2 having a sequence set forth in SEQ ID NO:
- 15, and LCDR3 having a sequence set forth in SEQ ID NO:
- 16;
- or,
- (ii) an antibody or antigen-binding fragment thereof, which comprises:
- a heavy chain variable region (VH) comprising 3 CDRs contained in a heavy chain variable region set forth in SEQ ID NO:
- 9;
- and, a light chain variable region (VL) comprising 3 CDRs contained in a light chain variable region set forth in SEQ ID NO:
- 10;
- wherein the 3 CDRs contained in the heavy chain variable region, and/or the 3 CDRs contained in the light chain variable region are defined by the Kabat, Chothia or IMGT numbering system;
- or,
- (iii) an antibody or antigen-binding fragment thereof, wherein the antibody is a monoclonal antibody produced by a hybridoma cell line 2A7 which is deposited in the China Center for Type Culture Collection (CCTCC) and has the deposit number of CCTCC NO. C2019302.
17 more elements
Dependencies are inferred from the claim text.