Method for diagnosing acute coronary syndrome

Abstract

This invention concerns a bioaffinity assay for quantitative determination in a sample of free PAPP-A, defined as the pregnancy associated plasma protein A (PAPP-A) that is not complexed to the proform of major basic protein (proMBP), wherein free PAPP-A is determined either i) as a calculated difference between measured total PAPP-A and measured PAPP-A complexed to proMBP, or ii) by a direct bioaffinity assay measuring only free PAPP-A. Furthermore, the invention concerns a method for diagnosing an acute coronary syndrome in a person by using as marker either free PAPP-A as such or a ratio free PAPP-A/total PAPP-A, free PAPP-A/PAPP-A complexed to proMBP, or PAPP-A complexed to proMBP/total PAPP-A.

1 - 16 . (canceled) 
     
     
         17 . A bioaffinity assay for quantitative determination in a person's sample of free PAPP-A, defined as pregnancy associated plasma protein A (PAPP-A) that is not complexed to a proform of major basic protein (proMBP), wherein an amount of free PAPP-A present in said sample is determined by a direct bioaffinity assay measuring only free PAPP-A, by making PAPP-A complexed to proMBP non-capable of participating in a bioaffinity reaction in which said sample is exposed to a binder which binds total PAPP-A by blocking PAPP-A complexed to proMBP by the steps of
 exposing said sample to a first binder which binds to proMBP,   allowing said proMBP to bind to said first binder,   exposing said sample to a second binder which binds total PAPP-A, wherein the epitopes for said first binder and said second binder are located so close to each other that said first binder blocks said second binder from binding to its epitope in PAPP-A complexed to proMBP, and   detecting the bound PAPP-A,   
       wherein said first binder and said second binder are both independently either an antibody or an antibody fragment. 
     
     
         18 . A method for diagnosing persons suffering from an acute coronary syndrome or persons at risk of acute coronary syndrome, comprising
 comparing an amount of a marker present in a sample derived from said person to a reference amount of said marker,   diagnosing whether said person is at risk of acute coronary syndrome based on said comparison,   wherein said marker either consists of free PAPP-A, defined as pregnancy associated plasma protein A (PAPP-A) which is not complexed to a proform of major basic protein (proMBP), as such, or said marker consists of a ratio selected from the group consisting of free PAPP-A/total PAPP-A, free PAPP-A/PAPP-A complexed to proMBP, and PAPP-A complexed to proMBP/total PAPP-A.   
     
     
         19 . The method according to  claim 18 , wherein free PAPP-A is determined by a bioaffinity assay method for quantitative determination in a sample of free PAPP-A by a direct bioaffinity assay measuring only free PAPP-A by making PAPP-A complexed to proMBP non-capable of participating in a bioaffinity reaction in which said sample is exposed to a binder which binds total PAPP-A by blocking PAPP-A complexed to proMBP by the steps of
 exposing said sample to a first binder which binds to proMBP,   allowing said proMBP to bind to said first binder,   exposing said sample to a second binder which binds total PAPP-A, wherein the epitopes for said first binder and said second binder are located so close to each other that said first binder blocks said second binder from binding to its epitope in PAPP-A complexed to proMBP, and   detecting the bound PAPP-A,   
       wherein said first binder and said second binder are both independently either an antibody or an antibody fragment.