Use of GFAP for identification of intracerebral hemorrhage

Abstract

The present invention relates to the use of glial fibrillary acidic protein (GFAP) as a diagnostic marker for intracerebral hemorrhage. The invention especially relates to methods for the early detection of intracerebral hemorrhage. Such early and rapid detection can be performed rapidly e.g. by a test strip format assay. GFAP can be used as a stand-alone marker or in combination with one or more other markers.

1 . A method for assessing a subject suffering from a stroke to distinguish between an ischemic stroke and an intracerebral hemorrhagic stroke, the method comprising: 
 obtaining a test sample from the subject within 6 hours after onset of the stroke, and    screening the test sample for presence of glial fibrillary acidic protein, wherein the detection of glial fibrillary acidic protein in the test sample is diagnostic of an intracerebral hemorrhage.    
     
     
         2 . The method of  claim 1  wherein the test sample is selected from the group consisting of whole blood, serum, and plasma.  
     
     
         3 . The method of  claim 2  wherein the screening step comprises detecting glial fibrillary acidic protein by an immunoassay.  
     
     
         4 . The method of  claim 3  wherein the immunoassay is conducted using a test strip.  
     
     
         5 . The method of  claim 4  wherein the lower limit of detection of the test strip is 3 pg/ml.  
     
     
         6 . The method of  claim 3  wherein the immunoassay is a quantitative immunoassay.  
     
     
         7 . The method of  claim 3  wherein the test sample is further analyzed for presence of a marker indicative for ischemic stroke, wherein the absence of the marker for ischemic stroke is used to further rule out ischemic stroke.  
     
     
         8 . A method for assessing the severity of an intracerebral hemorrhage, the method comprising: 
 measuring an amount of glial fibrillary acidic protein present in a test sample obtained from a subject, wherein the amount of glial fibrillary acidic protein measured in the test sample relates to the severity of intracerebral hemorrhage.    
     
     
         9 . The method of  claim 8 , wherein the test sample is selected from the group consisting of whole blood, serum, and plasma.  
     
     
         10 . The method of  claim 8  wherein the test sample is whole blood.  
     
     
         11 . A test strip for detecting the presence of glial fibrillary acidic protein in a test sample from a subject, the test strip comprising: 
 a first antibody that specifically binds to glial fibrillary acidic protein, the antibody being directly or indirectly bound to a solid phase, and    a second antibody that specifically binds to a glial fibrillary acidic protein epitope separate from the epitope of the first antibody, wherein the second antibody is labeled with a detectable marker.    
     
     
         12 . The test strip of  claim 11  wherein the strip has a lower limit of detection of 3 pg/ml.  
     
     
         13 . A kit for detecting glial fibrillary acidic protein in a sample, the kit comprising: 
 one or more reagents for determining the presence of glial fibrillary acidic protein, and    instructions for using the reagents in an assay to detect the glial fibrillary acidic protein.    
     
     
         14 . The kit of  claim 13  wherein the kit comprises a test strip for detecting the presence of glial fibrillary acidic protein in a test sample from a subject, the test strip comprising: 
 a first antibody that specifically binds to glial fibrillary acidic protein, the antibody being labeled with a detectable marker, and    a second antibody that specifically binds to a glial fibrillary acidic protein epitope separate from the epitope of the first antibody, wherein the second antibody is bound to a solid phase.    
     
     
         15 . The kit of  claim 14  wherein the assay has a lower limit of detection of 3 pg/ml.  
     
     
         16 . The kit of  claim 14  further comprising a positive control sample and a negative control sample, wherein the positive control sample comprises a predetermined amount of glial fibrillary acidic protein.