# US 8,465,941 B2 · Procalcitonin-based diagnosis of infections or inflammatory diseases of the respiratory tract in a patient with heart failure > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,465,941 B2 - Document ID: US8465941B2 - Status: Granted - Kind: B2 - Application number: 12/443,897 - Filed: 2007-10-01 - Published: 2010-02-25 - Granted: 2013-06-18 - Earliest claimed: 2006-10-01 - Assignees: B.R.A.H.M.S GmbH - Applicants: Andreas Bergmann; Nils Morgenthaler; Jana Papassotiriou; Joachim Struck - Inventors: Andreas Bergmann; Nils Morgenthaler; Jana Papassotiriou; Joachim Struck - Web page: https://patentgrep.com/patent/US8465941B2 ## CPC - G01N 33/74: involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors} - G01N 2333/585: Calcitonins - G01N 2800/12: Pulmonary diseases - G01N 2800/325: Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract The invention relates to a method for diagnosis of infections or inflammatory diseases of the airways and lungs with associated heart failure, wherein the marker procalcitonin or a partial sequence thereof is determined in a patient to be examined, in particular for classifying patients according to risk. The invention further relates to a diagnostic device and kit for carrying out the method. ## Claims ### Claim 1 An in vitro method for diagnosis of an infection or inflammatory disease of the respiratory tract, in a patient having cardiac insufficiency, comprising: determining the level of the biomarker procalcitonin or fragments thereof, in a sample obtained from said patient, and employing a threshold value which is used to indicate when said patient has an infection or inflammatory disease of the respiratory tract with associated cardiac insufficiency, said threshold value being a level of procalcitonin or fragments thereof that is between 0.03 ng/mL and 0.25 ng/mL. ### Claim 2 (depends on 1) The in vitro method according to claim 1, wherein the threshold value is between 0.03 ng/mL and 0.1 ng/mL. ### Claim 3 (depends on 1) The in vitro method according to claim 1, wherein the threshold value is between 0.03 ng/mL and 0.06 ng/mL. ### Claim 4 (depends on 1) The in vitro method according to claim 1, wherein the biomarker procalcitonin consists of amino acids 1-116 and/or amino acids 3-116 of procalcitonin. ### Claim 5 (depends on 1) The in vitro method according to claim 1, wherein the inflammatory disease of the respiratory tract or lung is selected from the group consisting of interstitial pulmonary diseases, lung fibrosis, chronic obstructive pulmonary disease (COPD), asthma bronchiale, and bronchial carcinoma. ### Claim 6 (depends on 1) The in vitro method according to claim 1, further comprising determining the level of one or more biomarkers selected from the group consisting of inflammatory markers, cardiovascular markers, neurohormonal markers and ischemic markers in a sample of said patient. ### Claim 7 (depends on 6) The in vitro method according to claim 6, wherein the inflammatory biomarker is one or more biomarkers selected from the group consisting of c-reactive proteins (CRP), cytokines, interleukins, and adhesion molecules. ### Claim 8 (depends on 6) The in vitro method according to claim 6, wherein the cardiovascular biomarker is one or more biomarkers selected from the group consisting of creatine kinase, myoglobins, natriuretic proteins, cardiac troponins, CRP, circulatory regulating prohormones, and fragments thereof, respectively. ### Claim 9 (depends on 6) The in vitro method according to claim 6, wherein the ischemic biomarker is one or more biomarkers selected form the group consisting of troponin-I, troponin-T and CK-MB. ### Claim 10 (depends on 6) The in vitro method according to claim 6, wherein the neurohormonal biomarker is one or more biomarkers selected from the group consisting of natriuretic proteins and fragments thereof. ### Claim 11 (depends on 6) The in vitro method according to claim 6, wherein the level of said biomarkers is determined in parallel or simultaneously. ### Claim 12 (depends on 6) The in vitro method according to claim 6, wherein the determination of said biomarkers is conducted in one or more samples obtained from said patient. ### Claim 13 (depends on 1) The in vitro method according to claim 1, wherein said determination is conducted by means of an automated analysis device. ### Claim 14 (depends on 1) The in vitro method according to claim 1, wherein said determination is conducted via a rapid test. ### Claim 15 (depends on 1) The in vitro method according to claim 1, wherein the determination is conducted for risk stratification in said patient. ### Claim 16 (depends on 1) The in vitro method according to claim 1, wherein the diagnosis is conducted for risk stratification in said patient for making clinically relevant decisions concerning further treatment options, by means of pharmaceuticals for the use in the treatment or therapy or cardiac insufficiency, and treatment of infections and/or inflammatory diseases of the respiratory tract and lung, as well as for the control of administering antibiotics, or intensive care or emergency medicine treatment. ### Claim 17 (depends on 1) The in vitro method according to claim 1, wherein the diagnosis is conducted for prophylaxis, for early differential diagnosis or diagnosis, for assessment of the degree of severity, or for therapy-accompanied-evaluation of follow-up on infections or inflammatory diseases of the respiratory tract and lung with associated cardiac insufficiency in said patient. ### Claim 18 (depends on 1) The in vitro method according to claim 1, wherein the infection is caused by bronchitis, pneumonia, sarcoidosis, bronchiectasis or non-cardiological pulmonary edema.