Method and Materials for Use in Diagnosing Viral Myocarditis

Abstract

The invention consists of assay methods, assay kits and antibodies for detecting the polypeptide fragments of dystrophin protein cleavage by enteroviral protease 2 A as a result of an enteroviral infection in the heart. The presence of dystrophin cleavage products in the myocytes or blood of a subject is diagnostic for enteroviral infection and myocarditis resulting therefrom.

1 . A method for detecting an enteroviral infection in a subject's heart, the method comprising in vivo imaging of myocytes for the presence of a dystrophin cleavage product therein, wherein the detection is performed as soon as 12 hours following a suspected infection by administering a diagnostically effective amount of detectably labeled dystrophin epitope-specific antibody or Fab fragment thereof into the subject's cardiovascular circulation or tissue, wherein binding of the antibody indicates that a dystrophin cleavage product resulting from an enteroviral infection is present in one or more of the myocytes. 
     
     
         2 . The method according to  claim 1 , wherein the dystrophin epitope-specific antibody is specific to a dystrophin cleavage product produced by enteroviral protease 2A cleavage of the rod domain of dystrophin. 
     
     
         3 . The method according to  claim 2 , wherein the rod domain encompasses a hinge segment of dystrophin. 
     
     
         4 . The method according to  claim 2 , wherein the dystrophin cleavage product is the 588 cleavage product. 
     
     
         5 . The method according to  claim 3 , wherein the dystrophin cleavage product is the 2434 cleavage product. 
     
     
         6 . The method according to  claim 1 , wherein the enteroviral infection is a Coxsackievirus infection. 
     
     
         7 . A kit for use in detecting an enteroviral infection in a subject's heart by in vivo imaging of myocytes for the presence of a dystrophin cleavage product therein, the kit comprising a diagnostically effective amount of detectably labeled dystrophin epitope specific antibody or Fab fragment thereof. 
     
     
         8 . The kit according to  claim 7 , wherein the dystrophin epitope-specific antibody is specific to a dystrophin cleavage product produced by enteroviral protease 2A cleavage of the rod domain of dystrophin. 
     
     
         9 . The kit according to  claim 8 , wherein the rod domain encompasses a hinge segment of dystrophin. 
     
     
         10 . The kit according to  claim 8 , wherein the dystrophin cleavage product is the 588 cleavage product. 
     
     
         11 . The kit according to  claim 9 , wherein the dystrophin cleavage product is the 2434 cleavage product. 
     
     
         12 . The kit according to  claim 7 , wherein the enteroviral infection is a Coxsackievirus infection. 
     
     
         13 . The kit according to  claim 7 , further comprising a carrier for the dystrophin epitope-specific antibody. 
     
     
         14 . The kit according to  claim 13 , wherein the carrier is a protein.