Methods and compositions for detection and diagnosis of infectious diseases

Abstract

Methods and compositions for the detection and diagnosis of infectious diseases are provided. In particular, efficient and sensitive methods and compositions for the detection of active mycobacterial disease are provided for distinguishing between individuals having active disease, and individuals who have been immunologically exposed, such as those infected with a mycobacterium but are without active disease, or those who have been vaccinated with BCG. The methods comprise topical application of antigen compositions for transdermal delivery.

1 - 20 . (canceled) 
     
     
         21 . A method of diagnosing infection with Mycobacterium tuberculosis in a patient with immune deficiency disease (AIDS):
 exposing the patient to a transdermal delivery device with an antigen composition applied to or impregnated on the transdermal delivery device wherein the antigen composition is an antigen derived from MPB64.   
     
     
         22 . The method of  claim 21 , wherein the antigen composition further comprises a surfactant. 
     
     
         23 . The method of  claim 22 , wherein the surfactant is a non-ionic surfactant. 
     
     
         24 . The method of  claim 23 , wherein the surfactant is polyoxyethylene sorbitan derivative. 
     
     
         25 . The method of  claim 24 , wherein the polyoxyethylene sorbitan derivative is polyoxyethylene sorbitan monooleate. 
     
     
         26 . The method of  claim 21 , wherein the transdermal device is medical tape, medical plaster, gauze, patch, adhesive solution, or a patch band. 
     
     
         27 . A method of monitoring effect of drug therapy in a patient infected with  Mycobacterium tuberculosis  comprising:
 exposing the patient to a transdermal delivery device with an antigen composition applied to or impregnated on the transdermal delivery device wherein the antigen composition is an antigen derived from MPB64.   
     
     
         28 . The method of  claim 27 , wherein the antigen composition further comprises a surfactant. 
     
     
         29 . The method of  claim 28 , wherein the surfactant is a non-ionic surfactant. 
     
     
         30 . The method of  claim 29 , wherein the surfactant is a polyoxyethylene derivative. 
     
     
         31 . The method of  claim 30 , wherein the polyoxyethylene sorbitan derivative is polyoxyethylene sorbitan monooleate. 
     
     
         32 . The method of  claim 27 , wherein the transdermal device is medical tape, medical plaster, gauze, patch, adhesive solution, or a patch band.