US2017082639A1PendingUtilityA1

Prediction and recognition of acute kidney injury after surgery

Assignee: ROCHE DIAGNOSTICS OPERATIONS INCPriority: Jun 15, 2010Filed: Nov 22, 2016Published: Mar 23, 2017
Est. expiryJun 15, 2030(~3.9 yrs left)· nominal 20-yr term from priority
G01N 2800/56G01N 33/6893G01N 2333/475G01N 2800/347G01N 33/6872G01N 33/74G01N 2333/47
57
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Claims

Abstract

Systems, kits, and methods for predicting the risk of an adverse event related to acute kidney injury AKI as a consequence of a surgical intervention in a subject. Embodiments of the system and methods include means and steps for determining an amount of liver-type fatty acid binding protein (L-FABP) in a sample, such as a urine-sample of a subject; comparing the amounts of the L-FABP with a reference amount, and predicting the risk of an adverse event related to acute kidney injury as a consequence of surgical intervention in the subject.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for diagnosing acute kidney injury in a subject, comprising:
 determining an amount of liver-type fatty acid binding protein, or a variant thereof, in a portion of a sample of a subject;   comparing the amount of liver-type fatty acid binding protein, or variant thereof, determined in said step of determining to a liver-type fatty acid binding protein reference amount; and   providing a diagnosis of acute kidney injury in the subject if the amount of liver-type fatty acid binding protein, or the variant thereof, determined in said step of determining is greater than the liver-type fatty acid binding protein reference amount.   
     
     
         2 . The method of  claim 1 , wherein the sample is a urine sample. 
     
     
         3 . The method of  claim 1 , wherein the sample is procured from the subject prior to a surgical intervention. 
     
     
         4 . The method of  claim 1 , wherein said step of determining comprises contacting, in vitro, the portion of the sample with an antibody having specific binding affinity for liver-type fatty acid binding protein, or a variant thereof. 
     
     
         5 . The method of  claim 1 , wherein the liver-type fatty acid binding protein reference amount is 10.7 μg/g creatinine. 
     
     
         6 . A method of diagnosing a subject as at increased risk of for an adverse event related to acute kidney injury after a surgical intervention, comprising the steps of:
 a) determining an amount of liver-type fatty acid binding protein, or a variant thereof, in a portion of a sample of a subject, the sample obtained from the subject prior to a surgical intervention;   b) comparing the amount of liver-type fatty acid binding protein, or the variant thereof, determined in said step of determining to a liver-type fatty acid binding protein reference amount; and   c) providing a diagnosis of at increased risk for an adverse event related to acute kidney injury after the surgical intervention if the amount of liver-type fatty acid binding protein, or the variant thereof, determined in said step of determining is greater than the liver-type fatty acid binding protein reference amount.   
     
     
         7 . The method of  claim 6 , wherein sample is a urine sample. 
     
     
         8 . The method of  claim 6 , wherein said step of determining comprises contacting, in vitro, the portion of the sample with an antibody having specific binding affinity for liver-type fatty acid binding protein, or a variant thereof. 
     
     
         9 . The method of  claim 6 , wherein the liver-type fatty acid binding protein reference amount is 10.7 μg/g creatinine. 
     
     
         10 . The method of  claim 6  further comprising the steps of:
 determining the amount of adiponectin, or a variant thereof, in a portion of the sample of the subject; and 
 comparing the amount of adiponectin, or the variant thereof, to an adiponectin reference amount, 
 
       wherein said step of providing a diagnosis further comprises providing a diagnosis of at increased risk for an adverse event related to acute kidney injury after the surgical intervention if the amount of adiponectin, or variant thereof, is greater than the adiponectin reference amount. 
     
     
         11 . The method of  claim 6 , wherein the adiponectin reference amount is 15.5 μg/g creatinine. 
     
     
         12 . A device adapted for diagnosing a subject as at increased risk of for an adverse event related to acute kidney injury after a surgical intervention, comprising:
 means for determining an amount of liver-type fatty acid binding protein, or a variant thereof, in a sample from the subject;   means for comparing the determined amount of liver-type fatty acid binding protein, or the variant thereof, to a liver-type fatty acid binding protein reference amount; and   means for providing a diagnosis of at increased risk for an adverse event related to acute kidney injury after a surgical intervention if the amount of liver-type fatty acid binding protein, or the variant thereof, determined in the sample of the subject is greater than the liver-type fatty acid binding protein reference amount.   
     
     
         13 . The device of  claim 12 , wherein the means for comparing comprises executable implemented rules. 
     
     
         14 . The device of  claim 13 , wherein the executable implemented rules are executed by a processor of a computing device. 
     
     
         15 . The device of  claim 14 , wherein the liver-type fatty acid binding protein reference amount is a stored value. 
     
     
         16 . The device of  claim 12 , further comprising:
 means for determining an amount of adiponectin, or a variant thereof, in a sample from the subject; and   means for comparing the determined amount of adiponectin, or the variant thereof, to an adiponectin reference amount,   
       wherein the means for providing a diagnosis further comprises means for providing a diagnosis of at increased risk for an adverse event related to acute kidney injury after the surgical intervention if the amount of adiponectin, or variant thereof, determined in the sample of the subject is greater than the adiponectin reference amount. 
     
     
         17 . The device of  claim 12  further comprising means for determining an amount of at least one of NGAL, or a variant thereof, and albumin, or a variant thereof, in a sample from the subject. 
     
     
         18 . The device of  claim 12 , wherein the means for determining are adapted for determining an amount of liver-type fatty acid binding protein, or a variant thereof, in a urine-sample of the subject. 
     
     
         19 . The device of  claim 12 , wherein said means for determining the amount of liver-type fatty acid binding protein, or a variant thereof, comprise a micro-plate optical analyzer.

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