US2016011210A1PendingUtilityA1

Troponin and bnp based diagnosis of risk patients and cause of stroke

Assignee: ROCHE DIAGNOSTICS OPERATIONSPriority: Oct 17, 2011Filed: Sep 21, 2015Published: Jan 14, 2016
Est. expiryOct 17, 2031(~5.2 yrs left)· nominal 20-yr term from priority
G01N 2800/326G01N 33/6893G01N 2800/2871G01N 2333/47G01N 33/6887G01N 2333/4712G01N 33/6896G01N 2333/58G01N 33/54306G01N 2800/32C12Q 1/6886
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Claims

Abstract

Method for determination of whether a subject suffers from intermittent atrial fibrillation based on the determination of the amount of a Troponin T in a sample in a patient suffering from atrial fibrillation using a binding assay. Kits and devices adapted to carry out the methods are also provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of diagnosing intermittent atrial fibrillation in a patient suffering from atrial fibrillation, the method comprising the steps of:
 contacting, in vitro, a portion of a plasma or serum sample obtained from the patient with a binding agent that specifically binds Troponin T, whereby a complex of the binding agent and the Troponin T is formed;   separating the complex from binding agent and sample not comprising the complex;   measuring the amount of complex separated in said step of separating, whereby a concentration of the Troponin T in the sample is calculated;   comparing the concentration of the Troponin T in the sample to a first Troponin reference concentration and a second Troponin reference concentration, the second Troponin reference concentration being greater than the first Troponin reference concentration; and   providing a diagnosis of intermittent atrial fibrillation in the patient if the concentration of the Troponin T is greater than the first Troponin reference concentration and less than the Troponin reference concentration.   
     
     
         2 . The method of  claim 1 , wherein the binding agent is an antibody. 
     
     
         3 . The method of  claim 1 , wherein the binding agent comprises a detectable marker. 
     
     
         4 . The method of  claim 3 , wherein said step of measuring comprises quantifying a signal from the detectable label of binding agent comprising the complex. 
     
     
         5 . The method of  claim 1 , wherein the sample is obtained from the patient within 6 hours of onset of symptoms of atrial fibrillation. 
     
     
         6 . The method of  claim 1 , wherein the second Troponin reference concentration is determined from a Troponin reference concentration of a sample obtained from at least one individual previously identified as suffering from atrial fibrillation. 
     
     
         7 . The method of  claim 6 , wherein the first Troponin reference concentration is determined from a Troponin reference concentration of a sample obtained from at least one individual previously identified as not suffering from atrial fibrillation and not suffering from intermittent atrial fibrillation. 
     
     
         8 . A method of diagnosing intermittent atrial fibrillation in a patient suffering from atrial fibrillation, the method comprising the steps of:
 contacting a portion of a serum or plasma sample obtained from the patient with a capture antibody having specific binding affinity for a first epitope of Troponin T and with a detection antibody having specific binding affinity for a second epitope of Troponin T, thereby forming a complex of the capture antibody, Troponin T and the detection antibody, the first epitope being different than the second epitope, the detection antibody having a detectable label;   binding the complex of the capture antibody, Troponin T and detection antibody with a solid support;   separating the complex of the capture antibody, Troponin T and detection antibody bound to the solid support from capture antibody, detection antibody and Troponin T not bound to the solid support;   detecting a signal from the detectable label of the detection antibody comprising the complex separated from capture antibody, detection antibody and Troponin T not bound to the solid support;   quantifying the signal detected in said step of detecting, the signal being proportional to an amount of Troponin T in the sample from the patient, whereby a concentration of the Troponin T in the sample is calculated;   comparing the concentration of Troponin T calculated in said step of quantifying to a first Troponin reference concentration and a second Troponin reference concentration, the second Troponin reference concentration being greater than the first Troponin reference concentration; and   providing a diagnosis of intermittent atrial fibrillation in the patient if the concentration of the Troponin T in the sample calculated in said step of quantifying is greater than the first Troponin reference concentration and less than the second Troponin reference concentration.   
     
     
         9 . The method of  claim 8 , wherein the sample is obtained from the patient within 6 hours of onset of symptoms of atrial fibrillation. 
     
     
         10 . The method of  claim 8 , wherein the second Troponin reference concentration is determined from a Troponin reference concentration of a sample obtained from at least one individual previously identified as suffering from atrial fibrillation. 
     
     
         11 . The method of  claim 8 , wherein the first Troponin reference concentration is determined from a Troponin reference concentration of a sample obtained from at least one individual previously identified as not suffering from atrial fibrillation and not suffering from intermittent atrial fibrillation.

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