Monoclonal antibody against D-dimer and diagnosis agent for detecting D-dimer, crosslinked fibrin and its derivatives containing D-dimer by using the antibody

A diagnostic construct for detecting D-dimer and crosslinked fibrin comprising:

• (a) a first monoclonal antibody that binds to D-dimer and crosslinked fibrin, wherein the monoclonal antibody binds to a site comprising the amino acid sequence set forth in SEQ ID NO:
• 1 and
• (b) a second monoclonal antibody that binds to D-dimer and crosslinked fibrin, wherein the second monoclonal antibody binds to a site comprising the amino acid sequence set forth in SEQ ID NO:
• 2 and said antibodies form a sandwich having a D-dimer or crosslinked fibrin molecule as a target analyte to be detected;
• and
• (c) an optional substrate including a material for inducing color development by reacting with a marker.

A diagnostic construct for detecting D-dimer and crosslinked fibrin, comprising:

• (a) a first monoclonal antibody as a primary antibody that binds with a site on a beta-chain of the D-dimer and the crosslinked fibrin;
• (b) a second monoclonal antibody as a secondary antibody that binds with a site on an alpha-chain of D-dimer and crosslinked fibrin;
• and
• (c) a substrate or detector probe including a material for inducing color development by reacting with a marker.

A diagnostic method for detecting a rise in plasma concentration of D-dimer and crosslinked fibrin comprising:

• (a) applying a first monoclonal antibody that binds to a region of D-dimer or crosslinked fibrin molecule comprising an amino acid sequence set forth in SEQ ID NO:
• 1 to a sample obtained from a patient in need thereof,
• (b) applying a second monoclonal antibody that binds to a region of D-dimer or crosslinked fibrin molecule comprising amino acid sequence set forth in SEQ ID NO:
• 2 to said sample,
• (c) forming at least one immunocomplex between at least one of said antibodies and the D-dimer or crosslinked fibrin molecule as a target analyte,
• (d) quantitatively detecting the presence or absence of said target analyte using a detector probe which binds to the immunocomplex, wherein an increase in the quantitative detection of said probe signifies a rise in plasma concentration of the target analyte.