Device for detecting misfolded proteins and methods of use thereof

Abstract

The present invention relates to diagnostic devices as well as methods of using these devices for detecting proteins of interest associated with diseases or disorders in mammals. In particular, the proteins of interest may be misfolded proteins associated with certain misfolded-protein disorders in mammals including those mammals suspected of or at risk of having such disorders.

What is claimed is: 
     
         1 . A method of detecting of at least one protein in a biological sample of a mammal, comprising:
 a) applying a biological sample of said mammal to said sample receiving material of said diagnostic device of  claim 1  for a time and under conditions sufficient to allow said at least one protein to bind to said detection reagent; and   b) detecting presence of detection reagent on the capillary bed, wherein presence of detection reagent on the capillary bed indicates presence of said at least one protein present in said biological sample.   
     
     
         2 . The method of  claim 1 , wherein said mammal is suspected of having a protein-misfolding disorder or at risk of having a protein-misfolding disorder. 
     
     
         3 . The method of  claim 2 , wherein said at least one protein is selected from the group consisting of a misfolded protein, an aggregated protein, a supramolecular aggregated protein, a fragment of a misfolded protein, a fragment of an aggregated protein, a fragment of a supramolecular aggregated protein, mixtures thereof, and fragments of said mixtures. 
     
     
         4 . The method of  claim 3 , wherein said misfolded protein is selected from the group consisting of alpha-1 antitrypsin (SerpinA1), ceruloplasmin, heavy-chain IgG, light-chain IgG, interferon-inducible protein 6-16 (IF16-6,G1P3), albumin, and fragments thereof. 
     
     
         5 . The method of  claim 2 , wherein said protein-misfolding disorder is selected from the group consisting of preeclampsia, Alzheimer's disease, prion disease and Parkinson's disease. 
     
     
         6 . The method of  claim 5 , wherein said preeclampsia is selected from the group consisting of mild preeclampsia, severe preeclampsia, atypical preeclampsia, hemodialysis-elevated liver enzyme-low platelet count (HELLP) syndrome and eclampsia. 
     
     
         7 . The method of  claim 2 , wherein said biological sample is selected from the group consisting of urine, blood, saliva, tissue, interstitial fluid, serum, plasma, cerebrospinal fluid, amniotic fluid and an extracted substance. 
     
     
         8 . The method of  claim 2 , wherein said mammal is pregnant. 
     
     
         9 . The method of  claim 8 , wherein said pregnant mammal is selected from the group consisting of a human, a primate and a genetically-engineered mammal. 
     
     
         10 . The method of  claim 9 , wherein said mammal is human. 
     
     
         11 . The method of  claim 10 , wherein said human is approximately 8 to 42 weeks pregnant. 
     
     
         12 . The method of  claim 2 , wherein said mammal is postpartum. 
     
     
         13 . The method of  claim 3 , wherein said at least one protein may be detected by visualization in order to obtain a qualitative result or a semi-quantitative result or detected by measurement in order to obtain a semi-quantitative or a quantitative result.