Diagnostic Test for Renal Injury

• US 20100035364A1
• Filed: 03/18/2008
• Published: 02/11/2010
• Est. Priority Date: 03/21/2007
• Status: Active Grant

• Current Assignee: BioPorto Diagnostics A/S (Bioporto A/S)
• Original Assignee: BioPorto Diagnostics A/S (Bioporto A/S)
• Inventors: Uttenthal, Lars Otto, Bangert, Kristian
• Granted Patent: US 8,313,919 B2
• Time in Patent Office: Days
• US Class Current: 436/501
• CPC Class Codes: G01N 2333/82 Translation products from oncogenes
• 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 33/6893 related to diseases not provided for elsewhere

Abstract

A method is provided of diagnosing and monitoring acute renal injury leading to acute renal failure in a human or mammalian subject by determining the ratio of the concentration of neutrophil gelatinase-associated lipocalin (NGAL) in urine to that in plasma or serum.

Claims

1-14. -14. (canceled)

15. A method of diagnosing or monitoring the presence of renal injury which has led to acute renal failure or which signifies an immediate risk of developing acute renal failure in a mammal, said method comprising the steps of

i) determining the concentration of NGAL in a sample of urine taken from the mammal;

ii) determining the concentration of NGAL in plasma or serum from a sample of blood taken from the same mammal immediately before, during or immediately after the period of time over which the urine sample was collected;

iii) Calculating the ratio of the NGAL concentration in the urine to that in the plasma or serum and comparing the value of the ratio obtained with a cutoff value determined from the range of such ratios observed in mammals with and without evidence of renal injury, so that a value greater than the cutoff value indicates that renal injury has occurred.

16. The method of claim 15, wherein said cutoff value of the ratio of the urinary concentration of NGAL to the plasma concentration of NGAL is a value of 0.30 or higher.

17. The monitoring method of claim 15, comprising the further step of repeating steps i), ii) and ii) one or more times.

18. The monitoring method of claim 15, comprising the further step of repeating steps i), ii) and ii) within 24 hours.

19. The monitoring method of claim 15, comprising the further step of repeating steps i), ii) and ii) after a treatment of acute renal failure has been initiated or completed.

20. The method of claim 15, wherein the risk of developing acute renal failure is due to ischemic renal injury.

21. The method of claim 15 wherein the risk of developing acute renal failure is due to a complication of an inflammatory, infective or neoplastic disease.

22. The method of claim 15, wherein the risk of developing acute renal failure is due to critical illness of any cause requiring intensive care.

23. The method of claim 15, wherein the risk of developing acute renal failure is due to a surgical intervention.

24. The method of claim 15, wherein the risk of developing acute renal failure is due to the administration of a nephrotoxic agent.

25. The method of claim 15, wherein the mammal is a human individual.

26. The method of claim 15, wherein NGAL is measured by means of a molecule that binds specifically to NGAL of the mammalian species to which the method is applied.

27. The method of claim 15, wherein the ratio of the NGAL concentration in the plasma or serum to that in the urine is calculated and compared to a cutoff value determined from the range of such ratios observed in mammals with and without evidence of renal injury, so that a value that is less than the cutoff value indicates that renal injury has occurred.

28. The method of claim 27, wherein said cutoff value of the ratio of the plasma or serum concentration of NGAL to the urinary concentration of NGAL is a value of 3.33 or lower, these values being the approximate reciprocals of the corresponding values in claim 16.

29. The monitoring method of claim 27, comprising the further step of repeating steps i), ii) and ii) one or more times.

30. The monitoring method of claim 27, comprising the further step of repeating steps i), ii) and ii) within 24 hours.

31. The monitoring method of claim 27, comprising the further step of repeating steps i), ii) and ii) after a treatment of acute renal failure has been initiated or completed.

32. The method of claim 27, wherein the risk of developing acute renal failure is due to ischemic renal injury, a complication of an inflammatory, infective or neoplastic disease, a critical illness of any cause requiring intensive care, a surgical intervention, or the administration of a nephrotoxic agent.

33. The method of claim 27, wherein the mammal is a human individual.

34. The method of claim 27, wherein NGAL is measured by means of a molecule that binds specifically to NGAL of the mammalian species to which the method is applied.