Methods of detecting early renal disease in animals

• US 20030022262A1
• Filed: 03/28/2002
• Published: 01/30/2003
• Est. Priority Date: 03/28/2001
• Status: Active Grant

• Current Assignee: Heska Corporation (Mars Incorporated)
• Original Assignee: Heska Corporation (Mars Incorporated)
• Inventors: Andrews, Janet S., McDonald, Thomas, Weber, Annika, Jensen, Wayne Arthur
• Granted Patent: US 7,172,873 B2
• Time in Patent Office: Days
• US Class Current: 435/7.92
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: G01N 2800/347 Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

The present invention provides a method for the detection of early renal disease in animals. The method includes the steps of (a) obtaining a sample from an animal to be tested and (b) determining the amount of albumin in the sample. An amount of albumin in the range of from 10 μg/ml to about 300 μg/ml indicates the presence of early renal disease. The present invention also provides antibodies to canine, feline and equine albumin which can be used to detect the presence of early renal disease.

Claims

1. A method to detect early renal disease comprising:

(a) obtaining a sample from an animal; and

(b) determining the amount of albumin in said sample,

wherein an amount of albumin in a range of from about 10 μ

g/ml to about 300 μ

g/ml ill the sample, when the specific gravity of the sample is normalized to 1.010 g/ml, is indicative of early renal disease.

2. The method of claim 1, wherein the amount of albumin in the sample is determined by:

(a) contacting the sample with an albumin-binding compound to form an albumin-compound complex;

(b) detecting the albumin-compound complex; and

(c) assessing the amount of albumin present in the sample from the amount of albumin-compound complex detected.

3. The method of claim 2, wherein the albumin-binding compound is an anti-albumin antibody.

4. The method of claim 2, wherein the albumin-binding compound is an anti-albumin antibody which recognizes albumin from an animal selected from the group consisting of canids, felids and equids.

5. The method of claim 1, wherein the amount of albumin in the sample is determined using an assay selected from the group consisting of an enzyme-linked immunoassay, a radioimmunoassay, a fluorescence immunoassay, a chemiluminescent assay, a lateral-flow assay, a dipstick assay, an agglutination assay, a particulate-based assay, an immunoprecipitation assay, an immunodot assay, an immunoblot assay, an immunodiffusion assay, a phosphorescence assay, a flow-through assay, a chromatography assay, a PAGe-based assay, an electronic-sensory assay, a surface plasmon resonance assay and a fluorescence correlation spectroscopy assay.

6. The method of claim 1, wherein the amount of albumin in the sample is determined using an enzyme-linked immunosorbent assay (ELISA).

7. The method of claim 1, wherein the amount of albumin in the sample is determined using a single-step assay.

8. The method of claim 1, wherein the amount of albumin in the sample is determined using a dipstick-based assay.

9. The method of claim 1, wherein the amount of albumin is determined using an assay that detects albumin in the sample when the amount of albumin is in the range from about 10 μ

g/ml to about 25 μ

g/ml.

10. The method of claim 1, wherein the amount of albumin is determined using an assay that detects albumin in the sample when the amount of albumin is about 50 μ

g/ml.

11. The method of claim 1, wherein the amount of albumin is determined using an assay that detects albumin in the sample when the amount of albumin is about 25 μ

g/ml.

12. The method of claim 1, wherein the amount of albumin is determined using an assay that detects albumin in the sample when the amount of albumin is about 10 μ

g/ml.

13. The method of claim 1, wherein the animal is selected from the group consisting of canids, felids and equids.

14. The method of claim 1, wherein the animal is a canid.

15. The method of claim 1, wherein the animal is a felid.

16. The method of claim 1, wherein the animal is an equid.

17. The method of claim 1, wherein the sample is a bodily fluid useful for measuring leakage of albumin from the glomerulus.

18. The method of claim 1, wherein the sample is urine.

19. The method of claim 1, wherein the sample is pre-treated prior to determining the amount of albumin.

20. The method of claim 1, wherein the sample is pre-treated by adjusting the specific gravity.

21. The method of claim 1, wherein the sample is pre-treated by adjusting the specific gravity to 1.010 g/ml.

22. A kit comprising a means for detecting early renal disease according to the method of claim 1.

23. The kit of claim 22 comprising:

(a) an albumin-binding compound which selectively binds to animal albumin; and

(b) a means for assessing the amount of albumin in the sample when the amount of albumin is in the range of 10 μ

g/ml to 300 μ

g/ml when the specific gravity of the sample is normalized to 1.010 g/ml.

24. The kit of claim 23, wherein the means for assessing the amount of albumin is a single-step assay.

25. The kit of claim 23, wherein the means for assessing the amount of albumin is a dipstick assay or an ELISA assay.

26. A method to identify an animal at risk for developing late-stage renal disease comprising:

(a) obtaining a sample from the animal; and

(b) determining the amount of albumin in said sample,

wherein an amount of albumin in a range of about 10 μ

g/ml to about 300 μ

g/ml in the sample, when the specific gravity of the sample is normalized to 1.010, indicates the animal is at risk for late-stage renal disease.

27. An isolated monoclonal antibody which selectively binds albumin of a specie of animal selected from the group consisting of canids, felids and equids.

28. The isolated antibody of claim 27, wherein said isolated antibody inhibits the selective binding of an antibody selected from the group consisting of H352, H386, H387, H388, H389, H390, H391, H393, H394, H395, H396, H397, H398, H399, H400, H401 and H402 to albumin.

29. The isolated antibody of claim 27, wherein the isolated antibody binds the same epitope recognized by an antibody selected from the group consisting of H352, H386, H387, H388, H389, H390, H391, H393, H394, H395, H396, H397, H398, H399, H400, H401 and H402.

30. The isolated antibody of claim 27, wherein the isolated antibody is selected from the group consisting of H352, H386, H387, H388, H389, H390, H391, H393, H394, H395, H396, H397, H398, H399, H400, H401 and H402.

31. A cultured cell which produces an antibody that selectively binds albumin of an animal selected from the group consisting of canids, felids and equids.

32. The cultured cell of claim 31, wherein said antibody inhibits the selective binding of a second antibody selected from the group consisting of H352, H386, H387, H388, H389, H390, H391, H393, H394, H395, H396, H397, H398, H399, H400, H401 and H402 to albumin.

33. The cultured cell of claim 31, wherein said antibody binds the same epitope recognized by a second antibody selected from the group consisting of H352, H386, H387, H388, H389, H390, H391, H393, H394, H395, H396, H397, H398, H399, H400, H401 and H402.

34. The cultured cell of claim 31, wherein said antibody is selected from the group consisting of H352, H386, H387, H388, H389, H390, H391, H393, H394, H395, H396, H397, H398, H399, H400, H401 and H402.

35. A kit comprising:

(a) an albumin-binding compound which selectively binds to animal albumin; and

(b) a means for detecting the amount of albumin in a sample when the amount of albumin present in the sample collected from an animal, wherein said means said means detects albumin when the amount of albumin is in the range of from about 10 μ

g/ml to about 50 μ

g/ml.

36. The kit of claim 35, wherein the detection means used detects compound-bound albumin when the albumin in the sample is about 50 μ

g/ml.

37. The kit of claim 35, wherein the detection means used detects compound-bound albumin when the albumin in the sample is about 25 μ

g/ml.

38. The kit of claim 35, wherein the detection means used detects compound-bound albumin when the albumin in the sample is about 10 μ

g/ml.

39. The kit of claim 35, wherein the detection means is a single-step assay.

40. The kit of claim 35, wherein the detection means is a dipstick assay or an ELISA assay.