Molecular markers for urinary tract infections

Abstract

The invention relates to an in vitro method for determining procalcitonin levels in plasma and urine as a diagnostic marker to identify patients with urinary tract infections, in vitro methods to perform said determination, a kit for the diagnosis of patients with urinary tract infections, and the usefulness of procalcitonin in the diagnosis urinary tract infections.

1 . In vitro method for diagnosis and/or monitoring of urinary tract infections comprising a step in which procalcitonin concentration is determined in a patient's urine sample. 
     
     
         2 - 9 . (canceled) 
     
     
         10 . A kit for in vitro diagnosis and/or monitoring of urinary tract infections, comprising aliquots of the reagents needed for determining procalcitonin concentration in a urine sample and, optionally, in a plasma sample. 
     
     
         11 . The kit according to  claim 10  comprising one or more aliquots of a primary antibody specific for the procalcitonin. 
     
     
         12 . The kit of  claim 11 , wherein said primary antibody is an antibody directly labeled with a compound selected from the group consisting of: hydroxycoumarin, aminocoumarin, methoxycoumarin, Europium, Samarium, FITC, Cy3, Cy5, Cy2, Cy7, XL665. 
     
     
         13 . The kit of  claim 12  further comprising one or more aliquots of a secondary antibody labeled with a compound selected from the group consisting of: hydroxycoumarin, aminocoumarin, methoxycoumarin, Europium, Samarium, FITC, Cy3, Cy5, Cy2, Cy7, XL665. 
     
     
         14 . The kit of  claim 10 , wherein said reagents comprise one or more aliquots of buffer solutions and/or one or more aliquots of binding solutions and/or one or more aliquots of reagents for detecting labeled antibodies. 
     
     
         15 . The kit of  claim 10 , further comprising one or more aliquots of a negative control and/or one or more aliquots of a positive control. 
     
     
         16 . The kit of  claim 15 , wherein said negative control is a urine sample with a procalcitonin concentration lower than 0.05 ng/ml and said positive control is a urine sample with a procalcitonin concentration greater than 0.3 ng/ml. 
     
     
         17 - 18 . (canceled) 
     
     
         19 . A kit for in vitro diagnosis and/or monitoring of a urinary tract infection (UTI) by testing both urine and plasma samples from a subject who has symptoms of and is suspected of having a UTI, or who was previously diagnosed as having a UTI, comprising aliquots of the reagents needed for determining procalcitonin (PCT) concentration in a urine sample and, optionally, in a plasma sample, wherein said reagents include
 (a) one or more aliquots of a primary antibody specific for the procalcitonin; and   (b) one or more aliquots of a negative control and/or one or more aliquots of a positive control for each of the urine and plasma samples, wherein
 (i) said negative controls are, respectively, a urine sample and a plasma sample with a PCT concentration lower than 0.05 ng/ml and 
 (ii) wherein said positive controls are, respectively, a urine sample and a plasma sample with a PCT concentration greater than 0.3 ng/ml.