Diagnosis of autoimmune disease

Abstract

The present invention provides methods and compositions useful in the diagnosis and management of autoimmune diseases. In particular, the present invention provides improved methods and compositions for the diagnosis and management of Graves' disease. The methods of the present invention avoid the need for radioactivity and are much simpler, economical, and rapid than methods traditionally used for the diagnosis of Graves' disease.

1 . A method for determining the presence of thyroid-stimulating antibodies in a test sample, comprising: 
 a) providing: 
 i) a test sample suspected of containing thyroid-stimulating antibodies,  
 ii) cultured cells contained within a testing means, wherein said cultured cells are CHO-R cells, and  
 iii) polyethylene glycol;  
   b) exposing said test sample to said cultured cells and said polyethylene glycol under conditions such that said thyroid-stimulating antibodies are detectable; and    c) observing for the presence of detectable thyroid-stimulating antibodies.    
     
     
         2 . (canceled)  
     
     
         3 . The method of  claim 1 , wherein said observing is conducted using a luminometer.  
     
     
         4 . The method of  claim 1 , wherein said observing is conducted using cyclic adenosine monophosphate measurements.  
     
     
         5 . The method of  claim 1 , wherein said CHO-R cells are cultured in Growth Medium.  
     
     
         6 . The method of  claim 1 , wherein said CHO-R cells are cultured in Stimulation Medium.  
     
     
         7 . The method of  claim 5 , wherein said cultured cells are exposed to said Growth Medium prior to exposure of said test sample.  
     
     
         8 . The method of  claim 6 , wherein said cultured cells are exposed to said Stimulation Medium after exposure to said test sample.  
     
     
         9 . The method of  claim 8 , wherein said Stimulation Medium comprises said polyethylene glycol.  
     
     
         10 . A method for determining the presence of thyroid-stimulating antibodies in a test sample, comprising: 
 a) providing: 
 i) a test sample suspected of containing thyroid-stimulating antibodies,  
 ii) cultured CHO-R cells contained within a testing means, and  
 iii) polyethylene glycol;  
   b) exposing said test sample to said cultured cells and said polyethylene glycol under conditions such that said thyroid-stimulating antibodies are detectable; and    c) observing for the presence of detectable thyroid-stimulating antibodies, wherein said observing utilizes a luminometer.    
     
     
         11 . The method of  claim 10 , wherein said CHO-R cells are cultured in Growth Medium.  
     
     
         12 . The method of  claim 10 , wherein said CHO-R cells are cultured in Stimulation Medium.  
     
     
         13 . The method of  claim 11 , wherein said cultured cells are exposed to said Growth Medium prior to exposure of said test sample.  
     
     
         14 . The method of  claim 12 , wherein said cultured cells are exposed to said Stimulation Medium after exposure to said test sample.  
     
     
         15 . The method of  claim 14 , wherein said Stimulation Medium comprises said polyethylene glycol.  
     
     
         16 . A method for determining the presence of thyroid-stimulating antibodies in a test sample, comprising: 
 a) providing: 
 i) a test sample suspected of containing thyroid-stimulating antibodies,  
 ii) cultured CHO-R cells contained within a testing means,  
 iii) Growth Medium, and  
 iv) Stimulation Medium, wherein said Stimulation Medium comprises polyethylene glycol;  
   b) exposing said cultured cells to said Growth Medium to produce grown cells;    c) exposing said test sample to said grown cells and said Stimulation Medium under conditions such that said thyroid-stimulating antibodies are detectable; and    d) observing for the presence of detectable thyroid-stimulating antibodies, wherein said observing utilizes a luminometer.    
     
     
         17 . (canceled)  
     
     
         18 . The method of  claim 16 , wherein said observing further comprises measuring the cyclic adenosine monophosphate concentration.