Use of procalcitonin (pct) in risk stratification and prognosis of patients with a primary, non-infectious disease

Abstract

Subject of the present invention are assays and in vitro methods for the in vitro diagnosis, prognosis and risk stratification of a patient having a primary, non-infectious disease, whereby the level of Procalcitonin (PCT) in a sample of a body fluid of the patient is indicative for the risk of the patient to contract a further disease or medical condition.

1 . An in vitro method for prognosis for a patient having a primary disease not being an infection, the method comprising: determining the level of procalcitonin or fragments thereof of at least 12 amino acids in length, in a sample selected from the group consisting of a blood sample, a serum sample and a plasma sample or an extract of any of the aforementioned samples obtained from said patient; and correlating said level of procalcitonin or fragments thereof to a risk of the patient to contract a further disease or medical condition which has not yet been manifested and/or is not yet symptomatic, wherein said correlating step comprises comparing said level of procalcitonin or fragments thereof to a threshold level, whereby, when said level of procalcitonin or fragments thereof exceeds said threshold level, said patient is predisposed to said risk and wherein said threshold level is between 0.02 and 0.25 ng/mL. 
     
     
         2 . In vitro method according to  claim 1 , wherein said level of procalcitonin or fragments thereof is indicative for a bacterial infection in the patient. 
     
     
         3 . In vitro method according to  claim 2 , wherein said infection is a local infection. 
     
     
         4 . In vitro method according to  claim 2 , wherein said bacterial infection is treatable with an antibiotic. 
     
     
         5 . In vitro method according to  claim 4 , wherein the risk of contracting a further disease or medical condition decreases when said patient is treated with an antibiotic. 
     
     
         6 .- 7 . (canceled) 
     
     
         8 . In vitro method according to  claim 1 , wherein said primary disease is selected from the group consisting of cancer, diabetes, chronic gastrointestinal diseases, chronic renal diseases, hypertension, orthopaedic diseases including osteoporosis and neurodegenerative diseases including Alzheimer's disease. 
     
     
         9 . In vitro method according to  claim 1 , wherein said further disease or medical condition is selected from the group consisting of cardiological diseases selected from the group consisting of atherosclerosis, acute coronary syndromes and heart failure. 
     
     
         10 . (canceled) 
     
     
         11 . A method according to  claim 1 , further comprising correlating said level of procalcitonin or fragments thereof with the level of one or more additional prognostic biomarkers, whereby the combination of said level of procalcitonin or fragments thereof with said level of additional prognostic biomarker(s) increases the predictive value of said level of procalcitonin or fragments thereof or the level of said related marker for said risk. 
     
     
         12 . A method according to  claim 11 , wherein one of said prognostic biomarker(s) is proBNP or fragments thereof in a sample obtained from said patient. 
     
     
         13 . A method according to  claim 12 , wherein said fragment of proBNP is NT proBNP or BNP. 
     
     
         14 . A method according to  claim 11 , further comprising determining the level of one or more additional prognostic biomarkers in a sample obtained from said patient, and correlating both said level of procalcitonin or fragments thereof and said level of one or more additional prognostic biomarkers to said predisposition to a risk, whereby the combination of said level of procalcitonin or fragments thereof with said level of one or more additional prognostic biomarkers increases the predictive value of said level of procalcitonin or fragments thereof for said risk. 
     
     
         15 . A method according to  claim 11 , wherein the additional prognostic biomarker is selected from a group consisting of troponin, myeloperoxidase, CRP, neopterin, GDF-15, ST2, cystatin-C, as well as the following peptides in form of their mature peptides, precursors, pro-hormones and associated prohormone fragments: natriuretic peptides, adrenomedullin, endotlielins, vasopressin. 
     
     
         16 . A method according to  claim 11 , wherein the correlation between said level of procalciton or fragments thereof and said level of one or more additional prognostic biomarkers is conducted with a mathematical algorithm. 
     
     
         17 .- 27 . (canceled) 
     
     
         28 . In vitro method according to  claim 3 , wherein said bacterial infection is treatable with an antibiotic. 
     
     
         29 . In vitro method according to  claim 28 , wherein the risk of contracting a further disease or medical condition decreases when said patient is treated with an antibiotic. 
     
     
         30 . In vitro method according to  claim 2 , wherein said primary disease is selected from the group consisting of cancer, diabetes, chronic gastrointestinal diseases, chronic renal diseases, hypertension, orthopaedic diseases including osteoporosis and neurodegenerative diseases including Alzheimer's disease. 
     
     
         31 . In vitro method according to  claim 2 , wherein said further disease or medical condition is selected from the group consisting of cardiological diseases selected from the group consisting of atherosclerosis, acute coronary syndromes and heart failure. 
     
     
         32 . A method according to  claim 2 , further comprising correlating said level of procalcitonin or fragments thereof with the level of one or more additional prognostic biomarkers, whereby the combination of said level of procalcitonin or fragments thereof with said level of additional prognostic biomarker(s) increases the predictive value of said level of procalcitonin or fragments thereof or the level of said related marker for said risk. 
     
     
         33 . A method according to  claim 12 , further comprising determining the level of one or more additional prognostic biomarkers in a sample obtained from said patient, and correlating both said level of procalcitonin or fragments thereof and said level of one or more additional prognostic biomarkers to said predisposition to a risk, whereby the combination of said level of procalcitonin or fragments thereof with said level of one or more additional prognostic biomarkers increases the predictive value of said level of procalcitonin or fragments thereof for said risk. 
     
     
         34 . A method according to  claim 13 , further comprising determining the level of one or more additional prognostic biomarkers in a sample obtained from said patient, and correlating both said level of procalcitonin or fragments thereof and said level of one or more additional prognostic biomarkers to said predisposition to a risk, whereby the combination of said level of procalcitonin or fragments thereof with said level of one or more additional prognostic biomarkers increases the predictive value of said level of procalcitonin or fragments thereof for said risk. 
     
     
         35 . A method according to  claim 12 , wherein the additional prognostic biomarker is selected from a group consisting of troponin, myeloperoxidase, CRP, neopterin, GDF-15, ST2, cystatin-C, as well as the following peptides in form of their mature peptides, precursors, pro-hormones and associated prohormone fragments: natriuretic peptides, adrenomedullin, endotlielins, vasopressin. 
     
     
         36 . A method according to  claim 13 , wherein the additional prognostic biomarker is selected from a group consisting of troponin, myeloperoxidase, CRP, neopterin, GDF-15, ST2, cystatin-C, as well as the following peptides in form of their mature peptides, precursors, pro-hormones and associated prohormone fragments: natriuretic peptides, adrenomedullin, endotlielins, vasopressin. 
     
     
         37 . A method according to  claim 14 , wherein the additional prognostic biomarker is selected from a group consisting of troponin, myeloperoxidase, CRP, neopterin, GDF-15, ST2, cystatin-C, as well as the following peptides in form of their mature peptides, precursors, pro-hormones and associated prohormone fragments: natriuretic peptides, adrenomedullin, endotlielins, vasopressin.