Device and methods for the immunological identification of cerebrospinal fluid

Abstract

The present disclosure relates to detection of the presence or absence of cerebrospinal fluid (CSF) in a sample by the detection of one or more antigens that are enriched in CSF compared to their levels in other bodily fluids. The devices and methods are suitable for the detection of the presence or absence of cerebrospinal fluid in samples of mixed bodily fluids from a wide variety of human populations crossing ethnicity, age, gender, health status and genetic variability.

1 . A method for detecting the presence or absence of cerebrospinal fluid (CSF) in a sample, comprising:
 (a) obtaining a sample suspected of containing CSF from a subject;   (b) applying said sample to an assay for detection of the presence or absence of CSF in said sample, wherein said assay comprises:   a sample application region,   a sample labeling region comprising a first binding partner to at least one CSF-enriched protein,   a sample detection region comprising a second binding partner to said at least one CSF-enriched protein,   wherein, when said sample contains CSF, said assay displays a detectable reaction in said sample detection region and presence of said detectable reaction indicates presence of CSF in said sample.   
     
     
         2 . The method of  claim 1 , wherein presence of CSF in said sample is indicative of a head, neck or spinal injury in said subject. 
     
     
         3 . The method of  claim 1 , wherein said first binding partner is a polyclonal or monoclonal antibody. 
     
     
         4 . A method of detecting the presence or absence of CSF in a sample, comprising:
 (a) obtaining a sample suspected of containing CSF from a subject; and   (b) applying said sample to an assay,   
       wherein detection of a post-translational modification of at least one CSF-enriched protein in said sample is indicative of CSF in said sample. 
     
     
         5 . The method of  claim 4 , wherein said assay is selected from the group consisting of a lateral flow assay, a Western Blot, an enzyme-linked immunosorbent assay and a immunoprecipitation assay. 
     
     
         6 . The method of  claim 4 , wherein presence of CSF in said sample is indicative of a head, neck or spinal injury in said subject. 
     
     
         7 . The method of  claim 4 , wherein said post-translational modification is selected from the group consisting of phosphorylation, glycosylation, sumoylation, ubiquitination, lipidation, nitrosylation, acetylation and neddylation. 
     
     
         8 . The method of  claim 7 , wherein said post-translational modification is glycosylation. 
     
     
         9 . The method of  claim 4 , wherein said at least one CSF-enriched protein comprises SEQ ID NO:13. 
     
     
         10 . The method of  claim 7 , wherein said post-translation modification is phosphorylation. 
     
     
         11 . The method of  claim 10 , wherein said phosphorylation is a serine/threonine phosphorylation or a tyrosine phosphorylation. 
     
     
         12 . The method of  claim 4 , wherein said at least one CSF-enriched protein is angiotensinogen. 
     
     
         13 . A method for detecting the presence or absence of cerebrospinal fluid (CSF) in a sample, comprising the steps of:
 (a) obtaining a sample suspected of containing CSF from said subject;   (b) contacting said sample with: 1) a first antibody which binds to a first epitope on a CSF-enriched protein and 2) a second antibody which binds to a second epitope on said CSF-enriched protein, for a time and under conditions suitable for formation of first epitope of said CSF-enriched protein/first antibody/second epitope of said CSF-enriched protein/second antibody complexes, wherein detection of said complexes is indicative of presence of CSF in said sample.   
     
     
         14 . The method of  claim 13 , wherein said first epitope and said second epitope are phosphorylated. 
     
     
         15 . The method of  claim 13 , wherein said CSF-enriched protein is angiotensinogen.