Diagnostic assay for trypanosoma cruzi infection

Abstract

A sensitive, multicomponent diagnostic test for infection with T. cruzi , the causative agent of Chagas disease, including methods of making and methods of use. Also provided is a method for screening T. cruzi polypeptides to identify antigenic polypeptides for inclusion as components of the diagnostic test, as well as compositions containing antigenic T. cruzi polypeptides.

1 - 23 . (canceled) 
     
     
         24 . A method for determining whether an infant has a  T. cruzi  infection, said method comprising:
 obtaining a biological sample from an infant born to a mother known to have or suspected of having a  T. cruzi  infection, wherein said biological sample is obtained later than about 3 months after birth of the infant;   contacting the infant's biological sample with a plurality of individually addressable antigenic  T. cruzi  polypeptides, or antigenic analogs or subunits thereof; and   evaluating the presence, absence, intensity or pattern of interaction of components of the biological sample with the antigenic  T. cruzi  polypeptides to determine whether the infant exhibits an antibody response that exceeds background levels.   
     
     
         25 . The method of  claim 24  further comprising:
 obtaining a biological sample from the infant's mother; 
 contacting the mother's biological sample with the plurality of individually addressable antigenic  T. cruzi  polypeptides, or antigenic analogs or subunits, thereof; and 
 comparing the presence, absence intensity or pattern of interaction of components of the infant's biological sample with the antigenic  T. cruzi  polypeptides, to determine whether the infant's antibody response differs from the mother's antibody response, wherein a difference in antibody responses indicates that the infant may have a  T. cruzi  infection. 
 
     
     
         26 . The method of  claim 24  wherein at least one polypeptide is selected from the polypeptides listed in Table 1, Table 2 or Table 4. 
     
     
         27 . The method of  claim 24  further comprising:
 obtaining an earlier biological sample from the infant shortly after birth; 
 contacting the infant's earlier biological sample with the plurality of individually addressable antigenic  T. cruzi  polypeptides, or antigenic analogs or subunits thereof; and 
 comparing the presence, absence, intensity or pattern of interaction of components of the infant's earlier biological sample with the antigenic  T. cruzi  polypeptides, to the presence, absence, intensity or pattern of interaction of components of the infant's later biological sample, or of the mother's biological sample, or both, with the antigenic  T. cruzi  polypeptides, to determine whether the infant's later antibody response differs from the mother's antibody response, wherein a difference in antibody responses indicates that the infant may have a  T. cruzi  infection. 
 
     
     
         28 . The method of  claim 24  wherein the biological sample comprises a body fluid comprising an antibody. 
     
     
         29 . The method of  claim 24  wherein the body fluid comprises blood, plasma or serum. 
     
     
         30 . The method of  claim 25  further comprising administering a therapeutic agent to the infant to treat a  T. cruzi  infection.