Pivka-ii measurement method, measurement reagent, and measurement kit

Abstract

Disclosed are a PIVKA-II measurement method that achieves better serum-plasma correlation than conventional methods, and a reagent and a kit therefor. The PIVKA-II measurement method according to the present invention comprises measuring PIVKA-II in a sample by an immunoassay using a mixture of an anti-F1 antibody that specifically binds to prothrombin fragment F1 or an antigen-binding fragment thereof and an anti-F2 antibody that specifically binds to prothrombin fragment F2 or an antigen-binding fragment thereof; and an anti-PIVKA-II antibody that specifically binds to PIVKA-II or an antigen-binding fragment thereof.

1 . A method for measuring PIVKA-II, comprising measuring PIVKA-II in a sample by carrying out an immunoassay using
 a mixture of an anti-F1 antibody that specifically binds to prothrombin fragment 1 or an antigen-binding fragment thereof, and an anti-F2 antibody that specifically binds to prothrombin fragment 2 or an antigen-binding fragment thereof; and   an anti-PIVKA-II antibody that specifically binds to PIVKA-II or an antigen-binding fragment thereof.   
     
     
         2 . The method according to  claim 1 , wherein said anti-F1 antibody is an antibody that recognizes an epitope in the F1 region and binds to PIVKA-II, and said anti-F2 antibody is an antibody that recognizes an epitope in the F2 region and binds to PIVKA-II. 
     
     
         3 . The method according to  claim 1  or  2 , wherein said anti-F1 antibody, said anti-F2 antibody, and said anti-PIVKA-II antibody are monoclonal antibodies. 
     
     
         4 . The method according to  claim 1 , wherein said immunoassay is carried out by a sandwich method using said mixture as a labeled antibody and said anti-PIVKA-II antibody or antigen-binding fragment thereof as an immobilized antibody. 
     
     
         5 . The method according to  claim 1 , wherein said mixture is a mixture containing said anti-F1 antibody and said anti-F2 antibody at a ratio of 1:0.2-2. 
     
     
         6 . The method according to  claim 1 , wherein said sample is serum or plasma.