Methods for Early Diagnosis of Kidney Disease

Abstract

The invention provides reagents and methods for diagnosing kidney disease in a human or animal.

What is claimed is: 
     
         1 . A method for diagnosing kidney disease comprising:
 (a) contacting a urine sample from a diabetic animal and a urine sample from an animal without kidney disease with a mixture of polyclonal antisera or monoclonal antibodies immunologically specific for each of a plurality of proteins;   wherein the plurality of proteins comprises zinc alpha-2-glycoprotein, alpha-1 microglobulin, alpha-1-acid glycoprotein 1, alpha-1-acid glycoprotein 2, IgG kappa chain (IGKV1-5), IgG lambda chain, prostaglandin-H2 D-isomerase precursor, hepatocyte growth factor-like (HGFL) protein, urine protein 1, complement regulatory protein CD59, thrombin, hemopexin, alpha-2-HS-glycoprotein precursor, G(M2)activator protein, pancreatic stone protein, saposin precursor, pepsin, kininogen, alpha-1B-glycoprotein, beta-trace 23 kD glycoprotein, haptoglobin, gelsolin, and whey acid protein;   wherein said mixture of polyclonal antisera or of monoclonal antibodies does not immunologically cross-react with serum albumin;   (b) determining the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the diabetic animal and the urine sample from the animal without kidney disease;   (c) comparing the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the diabetic animal with the amount of the plurality of proteins, or peptides thereof, from the animal without kidney disease; and   (d) diagnosing kidney disease if the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the diabetic animal is greater than the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the animal without kidney disease.   
     
     
         2 . The method of  claim 1 , wherein the animal is a human. 
     
     
         3 . The method according to  claim 1 , wherein the amount of the plurality of proteins, or peptides thereof, is determined using an enzyme-linked immunoassay, an immunoaffinity column, immunomagnetic beads, polystyrene beads, agarose beads, or a radioimmune assay. 
     
     
         4 . The method according to  claim 3 , wherein the enzyme-linked immunoassay produces a detectable reaction product. 
     
     
         5 . The method of  claim 1 , further comprising determining the amount of serum albumin in the urine sample from the diabetic animal and in the urine sample from the animal without kidney disease. 
     
     
         6 . A method for identifying a risk for developing kidney disease comprising:
 (a) contacting a urine sample from a diabetic animal and a urine sample from an animal without a risk of developing kidney disease with a mixture of polyclonal antisera or monoclonal antibodies immunologically specific for each of a plurality of proteins;   wherein the plurality of proteins comprises zinc alpha-2-glycoprotein, alpha-1 microglobulin, alpha-1-acid glycoprotein 1, alpha-1-acid glycoprotein 2, IgG kappa chain (IGKV1-5), IgG lambda chain, prostaglandin-H2 D-isomerase precursor, hepatocyte growth factor-like (HGFL) protein, urine protein 1, complement regulatory protein CD59, thrombin, hemopexin, alpha-2-HS-glycoprotein precursor, G(M2)activator protein, pancreatic stone protein, saposin precursor, pepsin, kininogen, alpha-1B-glycoprotein, beta-trace 23 kD glycoprotein, haptoglobin, gelsolin, and whey acid protein;   wherein said mixture of polyclonal antisera or of monoclonal antibodies does not immunologically cross-react with serum albumin;   (b) determining the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the diabetic animal and the urine sample from the animal without the risk of developing kidney disease;   (c) comparing the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the diabetic animal with the amount of the plurality of proteins, or peptides thereof, from the animal without the risk of kidney disease; and   (d) identifying the risk for developing kidney disease if the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the diabetic animal is greater than the amount of the plurality of the proteins, or peptides thereof, in the urine sample from the animal without the risk of developing kidney disease.   
     
     
         7 . The method of  claim 6 , wherein the animal is a human. 
     
     
         8 . The method according to  claim 6 , wherein the amount of the plurality of proteins, or peptides thereof, is determined using an enzyme-linked immunoassay, an immunoaffinity column, immunomagnetic beads, polystyrene beads, agarose beads, or a radioimmune assay. 
     
     
         9 . The method according to  claim 8 , wherein the enzyme-linked immunoassay produces a detectable reaction product. 
     
     
         10 . The method of  claim 6 , further comprising determining the amount of serum albumin in the urine sample from the diabetic animal and in the urine sample from the animal without the risk of developing kidney disease. 
     
     
         11 . An antigenic mixture comprising a plurality of urinary proteins, or peptides thereof, wherein the plurality of urinary proteins is zinc alpha-2-glycoprotein, alpha-1 microglobulin, alpha-1-acid glycoprotein 1, alpha-1-acid glycoprotein 2, IgG kappa chain (IGKV1-5), IgG lambda chain, prostaglandin-H2 D-isomerase precursor, hepatocyte growth factor-like (HGFL) protein, urine protein 1, complement regulatory protein CD59, thrombin, hemopexin, alpha-2-HS-glycoprotein precursor, G(M2)activator protein, pancreatic stone protein, saposin precursor, pepsin, kininogen, alpha-1B-glycoprotein, beta-trace 23 kD glycoprotein, haptoglobin, gelsolin, and whey acid protein, and wherein the antigenic mixture is depleted of serum albumin.