Methods and Devices for Detecting Diabetic Nephropathy and Associated Disorders

Abstract

Methods and devices for diagnosing, monitoring, or determining diabetic nephropathy or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining diabetic nephropathy 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.

What is claimed is: 
     
         1 . A method for generating a dataset, the method comprising:
 a. performing at least one immunoassay to generate sample concentrations for a combination of sample analytes in a test sample comprising a sample of bodily fluid taken from a mammal, wherein the mammal is suspected of having diabetic nephropathy or an associated disorder, and wherein the combination of sample analytes comprises three or more sample analytes selected from the group consisting of alpha-1 microglobulin, beta-2 microglobulin, calbindin, clusterin, CTGF, creatinine, cystatin C, GST-alpha, KIM-1, microalbumin, NGAL, osteopontin, THP, TIMP-1, TFF-3, and VEGF;   b. comparing the combination of sample concentrations to a data set comprising at least one entry, wherein each entry of the data set comprises a list comprising three or more minimum diagnostic concentrations indicative of diabetic nephropathy or an associated disorder, wherein each minimum diagnostic concentration comprises a maximum of a range of analyte concentrations for a healthy mammal; and   c. generating a dataset by determining a matching entry of the dataset in which all minimum diagnostic concentrations are less than the corresponding sample concentrations.   
     
     
         2 . The method of claim  23 , wherein the mammal is selected from the group consisting of humans, apes, monkeys, rats, mice, dogs, cats, pigs, and livestock including cattle and oxen. 
     
     
         3 . The method of claim  23 , wherein the bodily fluid is selected from the group consisting of urine, blood, plasma, serum, saliva, semen, and tissue lysates. 
     
     
         4 . The method of claim  23 , 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 μg/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 μg/ml. 
     
     
         5 . The method of claim  23 , wherein a combination of sample concentrations for six or more sample analytes in the test sample are determined. 
     
     
         6 . The method of claim  27 , wherein sample concentrations are determined for the analytes selected from the group consisting of alpha-1 microglobulin, beta-2 microglobulin, cystatin C, KIM-1, THP, and TIMP-1. 
     
     
         7 . The method of claim  23 , wherein a combination of sample concentrations for sixteen sample analytes in the test sample are determined. 
     
     
         8 . A method for generating a dataset, the method comprising:
 a. performing at least one immunoassay to generate sample concentrations for a combination of at least sixteen different sample analytes in a test sample comprising a sample of bodily fluid taken from a mammal, wherein the mammal is suspected of having diabetic nephropathy or an associated disorder, and wherein the combination of the at least sixteen different sample analytes comprises each of alpha-1 microglobulin, beta-2 microglobulin, calbindin, clusterin, CTGF, creatinine, cystatin C, GST-alpha, KIM-1, microalbumin, NGAL, osteopontin, THP, TIMP-1, TFF-3, and VEGF;   b. comparing the combination of sample concentrations to a data set comprising at least one entry, wherein each entry of the data set comprises a list comprising three or more minimum diagnostic concentrations indicative of diabetic nephropathy or an associated disorder, wherein each minimum diagnostic concentration comprises a maximum of a range of analyte concentrations for a healthy mammal; and   c. generating a dataset by determining a matching entry of the dataset in which all minimum diagnostic concentrations are less than the corresponding sample concentrations.