Diagnostic method for disorders using copeptin

Abstract

The use of copeptin as diagnostic marker for the determination of the release of vasopressin, especially in connection with disorders associated with non-physiological alterations of vasopressin release from the neurohypophysis, especially for detection and early detection, diagnosing and monitoring of the course of cardiovascular diseases, renal and pulmonary diseases as well as shock, including septic shock, sepsis and diseases/disorders of the central nervous system and neurodegenerative diseases.

1 . A diagnostic in vitro method for the diagnosis and monitoring of disorders associated with or caused by non-physiological alterations of vasopressin release from the neurohypophysis by determining in a sample of a body fluid of the patient the amount of copeptin and/or a pathophysiologically occurring precursor, splice variant, fragment or posttranslationally modified form of copeptin displaying copeptin immunoreactivity, and associating the determined amount of copeptin or copeptin immunoreactivity with the presence and/or course and/or severity and/or prognosis of such disorder. 
     
     
         2 . The method of  claim 1 , wherein said disorder associated with or caused by non-physiological alterations of vasopressin release from the neurohypophysis is selected from the group consisting of chronic or congestive heart failure, cardiac arrest, cardiac shock, cardiac infarction, acute myocardial infarction, arterial hypertension, cardiac surgery; cirrhosis; pulmonary disorders; kidney (renal) diseases as polycystic kidney disease; Diabetes insipidus; forms of hyponatremia, forms of syndrome of inappropriate antidiuretic hormone secretion; hemorrhage, edema-forming states, inflammatory diseases, trauma, burns, infectious complications thereof and sepsis, severe sepsis and septic shock; and diseases/disorders of the central nervous system (CNS). 
     
     
         3 . The method of  claim 1 , wherein the copeptin immunoreactivity is an immunoreactivity which can be determined by using a sandwich immunoassay using a first specific binder recognizing an amino acid sequence present in SEQ ID NO:1, and a second specific binder recognizing an amino acid sequence present in SEQ ID NO:2. 
     
     
         4 . The method of  claim 3 , wherein said specific binders are polyclonal and/or monoclonal antibodies. 
     
     
         5 . The method of  claim 3 , wherein said immuno-assay is a heterogenous immunoassay using a first immobilized specific binder and a second solubilized specific binder which carries a detectable label or which can be selectively labeled by reaction with a labeled marker molecule. 
     
     
         6 . The method of  claim 3 , wherein said immuno-assay is a homogeneous immunoassay. 
     
     
         7 . The method of  claim 1 , wherein the biological fluid is selected from serum, plasma, blood or (cerebrospinal fluid (CSF). 
     
     
         8 . The method of  claim 2 , wherein said disorder is selected from the group consisting of sepsis, cardiac infarction, chronic heart failure and increased arterial blood pressure. 
     
     
         9 - 12 . (canceled) 
     
     
         13 . A method for the diagnosis of a disorder associated with or caused by abnormal alterations of vasopressin release from the neurohypophysis, said method comprising:
 (a) obtaining a sample of a bodily fluid from a patient;   (b) contacting said sample with (i) a first antibody that specifically binds a first epitope on a first peptide consisting of amino acids 132-147 of SEQ ID NO.: 4, and (ii) a second antibody that specifically binds a second epitope on a second peptide consisting of amino acids 149-164 of SEQ ID NO.: 4; wherein at least one of said first and second antibodies comprises a detectable label;   (c) determining the level of detectable label in said sample, wherein the amount of detectable label correlates to the level of copeptin, wherein an increase in the level of copeptin in said sample as compared to the level in healthy individuals indicates the disorder.   
     
     
         14 . A method for the diagnosis of a disorder associated with or caused by abnormal alterations of vasopressin release from the neurohypophysis, said method comprising:
 (a) obtaining a sample of a bodily fluid from a patient;   (b) contacting said sample with (i) a first antibody that specifically binds a first epitope within amino acids 132-147 of SEQ ID NO.: 4, and (ii) a second antibody that specifically binds a second epitope within amino acids 149-164 of SEQ ID NO.: 4; wherein at least one of said first and second antibodies comprises a detectable label;   (c) determining the level of detectable label in said sample, wherein the amount of detectable label correlates to the level of copeptin, wherein an increase in the level of copeptin in said sample as compared to the level in healthy individuals indicates the disorder.   
     
     
         15 . The method of  claim 13 , wherein said disorder associated with or caused by abnormal alterations of vasopressin release from the neurohypophysis is selected from the group consisting of chronic or congestive heart failure, cardiac arrest, cardiac shock, cardiac infarction, acute myocardial infarction, arterial hypertension, cardiac surgery; cirrhosis; pulmonary disorders; kidney disease, polycystic kidney disease; Diabetes insipidus; forms of hyponatremia, forms of syndrome of inappropriate antidiuretic hormone secretion; hemorrhage, edema-forming states, inflammatory diseases, trauma, burns, infectious complications thereof and sepsis, severe sepsis and septic shock; and diseases/disorders of the central nervous system (CNS). 
     
     
         16 . The method of  claim 13 , wherein said disorder associated with or caused by abnormal alterations of vasopressin release from the neurohypophysis is selected from the group consisting of cardiac infarction, sepsis, chronic heart failure and increased arterial blood pressure. 
     
     
         17 . The method of  claim 13 , wherein said first and second antibodies are both polyclonal antibodies, both monoclonal antibodies or a polyclonal antibody and a monoclonal antibody. 
     
     
         18 . The method of  claim 13 , wherein said method comprises a homogeneous immunoassay. 
     
     
         19 . The method of  claim 13 , wherein said method comprises a heterogeneous immunoassay. 
     
     
         20 . The method of  claim 13 , wherein the biological fluid is selected from serum, plasma, blood or cerebrospinal fluid (CSF).