Methods and devices for detecting obstructive uropathy and associated disorders

Abstract

Methods and devices for diagnosing, monitoring, or determining obstructive uropathy or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining obstructive uropathy or an associated disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.

1 - 23 . (canceled) 
     
     
         24 . A method for diagnosing, monitoring, or determining obstructive uropathy in a mammal, the method comprising:
 a. providing a test sample comprising a sample of bodily fluid taken from the mammal;   b. determining sample concentrations of three or more sample analytes in a panel of biomarkers in the test sample, wherein the sample analytes are selected from the group consisting of alpha-1 microglobulin, beta-2 microglobulin, calbindin, clusterin, CTGF, creatinine, cystatin C, GSTalpha, KIM-1, microalbumin, NGAL, osteopontin, THP, TIMP-1, TFF-3, and VEGF;   c. comparing the concentrations of the sample analytes with concentrations of the sample analytes in a panel of biomarkers from a control sample;   d. identifying the particular disorder based on a statistically significant difference in the concentrations of the sample analytes compared the concentrations of the sample analytes from the control sample; and   e. treating the mammal identified as having the particular disorder.   
     
     
         25 . The method of  claim 24 , wherein the mammal is selected from the group consisting of humans, apes, monkeys, rats, mice, dogs, cats, pigs, and livestock including cattle and oxen. 
     
     
         26 . The method of  claim 24 , wherein the bodily fluid is selected from the group consisting of urine, blood, plasma, serum, saliva, semen, and tissue lysates. 
     
     
         27 . The method of  claim 24 , wherein a combination of sample concentrations for six or more sample analytes in the test sample is determined. 
     
     
         28 . The method of  claim 24 , wherein a combination of sample concentrations for sixteen sample analytes in the test sample is determined. 
     
     
         29 . A method for diagnosing, monitoring, or determining obstructive uropathy in a mammal, the method comprising:
 a. providing a test sample comprising a sample of bodily fluid taken from the mammal;   b. determining sample concentrations of three or more sample analytes in a panel of biomarkers in the test sample, wherein the sample analytes are selected from the group consisting of alpha-1 microglobulin, beta-2 microglobulin, calbindin, clusterin, CTGF, creatinine, cystatin C, GSTalpha, KIM-1, microalbumin, NGAL, osteopontin, THP, TIMP-1, TFF-3, and VEGF;   c. comparing the concentrations of the sample analytes with concentrations of the sample analytes in a panel of biomarkers from a control sample; and   d. identifying the particular disorder based on a statistically significant difference in the concentrations of the sample analytes compared the concentrations of the sample analytes from the control sample.   
     
     
         30 . The method of  claim 29 , wherein the mammal is selected from the group consisting of humans, apes, monkeys, rats, mice, dogs, cats, pigs, and livestock including cattle and oxen. 
     
     
         31 . The method of  claim 29 , wherein the bodily fluid is selected from the group consisting of urine, blood, plasma, serum, saliva, semen, and tissue lysates. 
     
     
         32 . The method of  claim 29 , wherein a combination of sample concentrations for six or more sample analytes in the test sample is determined. 
     
     
         33 . The method of  claim 29 , wherein a combination of sample concentrations for sixteen sample analytes in the test sample is determined. 
     
     
         34 . A system for diagnosing, monitoring, or determining obstructive uropathy in a mammal, the method comprising:
 a. providing a test sample comprising a sample of bodily fluid taken from the mammal;   b. determining sample concentrations for three or more sample analytes in the test sample, wherein the sample analytes are alpha-1 microglobulin, beta-2 microglobulin, calbindin, clusterin, CTGF, creatinine, cystatin C, GSTalpha, KIM-1, microalbumin, NGAL, osteopontin, THP, TIMP-1, TFF-3, and VEGF;   c. inputting the sample concentrations into an analyte input module;   d. comparing the sample concentrations to a data set comprising at least one entry stored in a comparison module, wherein each entry of the data set comprises a list comprising three or more minimum diagnostic concentrations indicative of obstructive uropathy or an associated disorder, wherein each minimum diagnostic concentration comprises a maximum of a range of analyte concentrations for a healthy mammal;   e. determining a matching entry of the dataset in which all minimum diagnostic concentrations are less than the corresponding sample concentrations; and,   f. identifying an indicated disorder comprising the particular disorder of the matching entry.   
     
     
         35 . The method of  claim 34 , wherein the mammal is selected from the group consisting of humans, apes, monkeys, rats, mice, dogs, cats, pigs, and livestock including cattle and oxen. 
     
     
         36 . The method of  claim 34 , wherein the minimum diagnostic concentration in human plasma of alpha-1 microglobulin is about 16 μg/ml, beta-2 microglobulin is about 2.2 μg/ml, calbindin is greater than about 5 ng/ml, clusterin is about 134 μg/ml, CTGF is about 16 ng/ml, cystatin C is about 1170 ng/ml, GST-alpha is about 62 ng/ml, KIM-1 is about 0.57 ng/ml, NGAL is about 375 ng/ml, osteopontin is about 25 ng/ml, THP is about 0.052 μg/ml, TIMP-1 is about 131 ng/ml, TFF-3 is about 0.49 μg/ml, and VEGF is about 855 pg/ml. 
     
     
         37 . The method of  claim 34 , wherein the minimum diagnostic concentration in human sera of alpha-1 microglobulin is about 17 μg/ml, beta-2 microglobulin is about 2.6 μg/ml, calbindin is greater than about 2.6 ng/ml, clusterin is about 152 μg/ml, CTGF is greater than about 8.2 ng/ml, cystatin C is about 1250 ng/ml, GST-alpha is about 52 ng/ml, KIM-1 is greater than about 0.35 ng/ml, NGAL is about 822 ng/ml, osteopontin is about 12 ng/ml, THP is about 0.053 μg/ml, TIMP-1 is about 246 ng/ml, TFF-3 is about 0.17 μg/ml, and VEGF is about 1630 pg/ml. 
     
     
         38 . The method of  claim 34 , wherein the minimum diagnostic concentration in human urine of alpha-1 microglobulin is about 233 μg/ml, beta-2 microglobulin is greater than about 0.17 μg/ml, calbindin is about 233 ng/ml, clusterin is greater than about 0.089 μg/ml, CTGF is greater than about 0.90 ng/ml, cystatin C is about 1170 ng/ml, GST-alpha is greater than about 26 ng/ml, KIM-1 is about 0.67 ng/ml, NGAL is about 81 ng/ml, osteopontin is about 6130 ng/ml, THP is about 2.6 μg/ml, TIMP-1 is greater than about 3.9 ng/ml, TFF-3 is greater than about 21 μg/ml, and VEGF is about 517 pg/ml. 
     
     
         39 . The method of  claim 34 , wherein the bodily fluid is selected from the group consisting of urine, blood, plasma, serum, saliva, semen, and tissue lysates. 
     
     
         40 . The method of  claim 34 , wherein a combination of sample concentrations for six or more sample analytes in the test sample is determined. 
     
     
         41 . The method of  claim 34 , wherein a combination of sample concentrations for sixteen sample analytes in the test sample is determined.