Diagnostic method for urinary tract infection

Abstract

It has been demonstrated that the urinary level of HBP increases in individuals that have a urinary tract infection. Accordingly, the urinary level of HBP in an individual can be used to determine whether or not an individual has a urinary tract infection.

1 - 14 . (canceled) 
     
     
         15 . A method of identifying whether an individual has a urinary tract infection (UTI), comprising:
 measuring the level of Heparin Binding Protein (HBP, CAP37, Azuricidin) in a urine sample obtained from an individual by;   (i) contacting the sample with an antibody which binds specifically to HBP; and   (ii) quantitating the amount of antibody-HBP complex to measure the HBP level in the urine sample; and   detecting the presence of UTI in the individual at about 93% Sensitivity or greater and at about 90% Specificity or greater based on the measured HBP level in the urine sample.   
     
     
         16 . The method of  claim 15 , wherein the individual is a mammal. 
     
     
         17 . The method of  claim 16 , wherein the mammal is a human. 
     
     
         18 . The method of  claim 17 , wherein the detecting of UTI at about 93% Sensitivity or greater and at about 90% Specificity or greater is determined by a Receiver Operating Characteristic (ROC). 
     
     
         19 . The method of  claim 17 , wherein the 93.3% Sensitivity and the 90.3% Specificity for detecting UTI is a threshold value of about 32 ng/ml in the urine sample. 
     
     
         20 . The method of  claim 15 , wherein the binding of the antibody to HBP is measured by enzyme linked immunosorbent assay (ELISA). 
     
     
         21 . The method of  claim 15 , wherein the binding of the antibody to HBP is measured using a dipstick assay. 
     
     
         22 . The method of  claim 15 , wherein the urinary tract infection is lower urinary tract infection or pyelonephritis. 
     
     
         23 . The method of  claim 15 , further comprising determining the white blood cell count or the level of IL6 in a urine sample from the individual, or conducting the nitrite test on a urine sample from the individual.