Ngal for diagnosis of renal conditions

Abstract

Use of serum neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker, alone or in conjunction with creatinine to aid in the diagnosis of renal conditions such as acute tubular necrosis and acute renal failure, and a method and a kit for assigning a diagnosis of acute tubular necrosis or acute renal failure to a subject based on the correlation between the levels of NGAL and optionally creatinine in a sample obtained from a subject when compared to a sample obtained from a normal subject not experiencing acute tubular necrosis or acute renal failure.

1 . A method of assigning a diagnosis of acute tubular necrosis to a subject, comprising;
 a) measuring a level of NGAL in a sample obtained from said subject,   b) comparing the level of NGAL in the sample from said subject with the level of NGAL in a sample from a normal subject, and; assigning a diagnosis of acute tubular necrosis when the level of NGAL in a sample obtained from said subject is greater than said normal subject.   
     
     
         2 . The method of  claim 1  wherein the level of NGAL in said subject is at least about 7 fold greater than said normal subject. 
     
     
         3 . The method of  claim 1  wherein the level of NGAL in a sample from a normal subject is about ng/mL. 
     
     
         4 . A method of diagnosing whether a subject is experiencing acute renal failure or chronic renal failure, comprising;
 a) measuring the level of NGAL in a sample obtained from the subject;   b) measuring the level of creatinine in a sample obtained from the subject;   c) correlating the level of NGAL with the level of creatinine, and assigning a diagnosis of acute renal failure or chronic renal failure based on said correlation.   
     
     
         5 . The method of  claim 4  wherein when there is a high correlation between the measured level of NGAL and creatinine, assigning a diagnosis of acute renal failure to said subject. 
     
     
         6 . The method of  claim 4  wherein when there is no correlation between the measured level of NGAL and creatinine, assigning a diagnosis of chronic renal failure to said subject. 
     
     
         7 . The method of  claim 4  wherein the level of NGAL is measured in a sample of serum obtained from said subject. 
     
     
         8 . The method of  claim 4  wherein the level of creatinine is measured in a sample of serum obtained from said subject. 
     
     
         9 . The method of  claim 4  wherein the level of NGAL is measured in a sample of plasma obtained from said subject. 
     
     
         10 . The method of  claim 4  wherein the level of NGAL is measured in a sample of blood obtained from said subject. 
     
     
         11 . A kit for the diagnosis of acute renal failure or chronic renal failure in a subject, comprising:
 a) a monoclonal antibody that recognises human NGAL;   b) a tube for collecting a blood sample containing either citrate, EDTA or heparin;   c) instructions for obtaining an assay result and performing a correlation of assay data to determine whether a subject has acute renal failure or chronic renal failure; wherein said instructions further indicate that a high degree of correlation between a NGAL level and creatinine level is indicative of acute renal failure; and wherein when there is no correlation between a NGAL level and creatinine level, said instructions indicate chronic renal failure is present.