Abstract: The invention relates to a method for therapy guidance, stratification and/or control in a patient with symptoms of an infectious disease, comprising a prognosis of disease progression, the method comprising: providing a sample from said patient, and determining a level of proADM or fragment(s) thereof in said sample, wherein a low risk level of proADM level or fragment(s) thereof in said sample indicates that the patient is not at risk of a disease progression to a condition that requires hospitalization, wherein said low risk level is preferably equal or below 1.2 nmol/l±20%, and/or wherein a high risk level of proADM level or fragment(s) thereof in said sample indicates that the patient is at risk of a disease progression to a condition that requires hospitalization, wherein said high risk level is preferably above 1.2 nmol/l±20%. The invention further relates to a test kit for carrying out the method.

Abstract: The present invention relates to diagnosis, prognosis, risk assessment, and/or risk stratification of an adverse event, particularly mortality, of a subject. The invention relates to a method that comprises determining a level of proadrenomedullin (proADM) in a sample of said subject, and wherein said level of proADM is indicative of said adverse event of said subject, wherein said level of proADM is compared to a reference level of proADM; and wherein said adverse event of said subject is identified based on the comparison. The invention further relates to kits for carrying out the methods of the invention.

Abstract: The present invention is in the field of clinical diagnostics. Particularly, the present invention relates to the assessment of severity of a subject being suspected of an infection or having an infection, who may have physiological signs or increased risk factors for infection, in particular from an infectious disease by determination of the levels of Procalcitonin (hereinafter: PCT) (SEQ ID No: 1 and/or proadrenomedullin (hereinafter: proADM)) (SEQ ID No: 3) or a partial peptide or fragment thereof, in particular midregional proadrenomedullin (MR-proADM) (SEQ ID No: 2), in a sample of a patient and the invention is related to a workflow hereto. Moreover, the invention refers to the assessment related to an infection like ruling out/in a patient and stratification, risk assessment, in particular to avoid rehospitalisation and hospital and post-discharge mortality.

Abstract: The invention relates to a method for antibiotic therapy guidance, stratification and/or control in a patient suspected of having an infection. In particular, the method comprises providing a sample form said patient, determining a level of proADM or fragment(s) thereof in said sample, and wherein the level of proADM or fragment(s) thereof in said sample is indicative of whether an initiation or a change of an antibiotic treatment is required. In a preferred embodiment of the invention, the method comprises additionally determining in a sample from said patient a level of PCT or fragment(s) thereof. Furthermore, the invention also relates to a kit for carrying out the method of the present invention.

Abstract: Method of obtaining and/or verifying a binder to prepro-Vasopressin (SEQ ID NO. 1) or fragments thereof of at least 6 amino acids in length, including Copeptin (SEQ ID NO. 2), comprising at least one of the steps of: a) generating the binder using a developer comprising an amino acid sequence of at least 6 amino acids in length contained in an amino acid sequence corresponding to the C-terminal part but lacking amino acid 164 of prepro-Vasopressin (SEQ ID NO. 1); b) determining whether the binder is capable of binding to an amino acid sequence of at least 4 amino acids in length contained in an amino acid sequence corresponding to the C-terminal part but lacking amino acid 164 of prepro-Vasopressin (SEQ ID NO. 1); c) selecting and optionally isolating the binder from a plurality of binders which is capable of binding to an amino acid sequence contained in an amino acid sequence corresponding to the C-terminal part but lacking amino acid 164 of prepro-Vasopressin (SEQ ID NO.

Abstract: CSF diagnostic in vitro method for the diagnosis of dementias and neuroinflammatory diseases, in which a determination of the procalcitonin immunoreactivity (PCT immunoreactivity) is carried out in a sample of cerebrospinal fluid (CSF) of a patient who is suffering from a dementia or neuroinflammatory disease or is suspected of suffering from such a disease. Conclusions about the presence, the course, the severity or the success of a treatment of the dementia or neuroinflammatory disease are drawn from a measured PCT immunoreactivity which is above a threshold value typical for healthy individuals.

Abstract: The present invention relates to a vasopressin receptor 1B (V1B) antagonist for use in the treatment of depressive symptoms and/or anxiety symptoms in patients showing an elevated arginine vasopressin (AVP) level and/or an elevated copeptin level. The present invention further relates to a method for predicting the treatment response to a V1B antagonist in patients with depressive symptoms and/or anxiety symptoms.

Abstract: The invention relates to a method for the diagnosis and/or risk stratification of invasive fungal infections (IFI)/invasive fungal diseases (IFD) and in particular associated with sepsis or septic shock, wherein a determination of the marker proadrenomedullin (proADM) or a partial peptide or fragment thereof, in particular midregional proadrenomedullin (MR-proADM), or contained in a marker combination (panel, cluster), is carried out from a patient to be examined. Furthermore, the invention relates to a diagnostic assay and a kit for carrying out the method.

Abstract: A method for antibiotic therapy guidance, stratification and/or control in a patient with one or more comorbidities comprising an impaired innate immune response and suspected of having an infection. Also, a method for antibiotic therapy guidance, stratification and/or control in a patient with one or more comorbidities comprising an impaired innate immune response, wherein the comorbidity is preferably selected from the group comprising metabolic disorder (obesity), diabetes, hypertension, renal disease, thrombosis, malignancy or cancer, and suspected of having an infection. In particular, the method comprises providing a sample from said patient and determining a level of PCT or fragment(s) thereof in said sample, wherein the level of PCT or fragment(s) thereof in said sample is indicative of whether an initiation or a change of an antibiotic treatment is required. Furthermore, a kit for carrying out the method of the present invention.

Abstract: A method for therapy monitoring, comprising: the prognosis, risk assessment and/or risk stratification of a subsequent adverse event in the health of a patient; providing a sample of said patient, wherein the patient was diagnosed as critically ill and medical treatment initiated, wherein the sample is isolated from the patient after diagnosis and treatment initiation; determining a level of proADM or fragment(s) thereof in said sample, wherein said level of proADM or fragment(s) thereof correlates with the likelihood of a subsequent adverse event in the health of said patient. In a preferred embodiment the invention relates to a method comprising additionally determining a level of procalcitonin (PCT) or fragment(s) thereof in a sample isolated from the patient. Optionally, further determining a level of PCT or fragment(s) thereof in samples isolated from the patient and using the PCT levels also in the prognosis, risk assessment and/or risk stratification.

Abstract: The invention relates to a method for determining, diagnosis, prognosis, treatment guidance, treatment monitoring, risk assessment and/or risk stratification of patients with abnormal platelet levels comprising providing a sample of said patient, determining a level of proadrenomedullin (proADM) or fragment(s) thereof in said sample, wherein said level of proADM or fragment(s) thereof correlates with the abnormal platelet levels in said patient. In embodiments of the invention, a level of proADM or fragment(s) thereof of high severity indicates low platelet levels in the subject and subsequent initiating or modifying a treatment of the patient to improve said condition. In some embodiments of the invention the method comprises determining a level of one or more additional markers in a sample isolated from the patient, such as the level of platelets, the level of PCT or fragment(s) thereof, one or more markers of thrombocytopenia and/or one or more markers of an inflammatory response.

Abstract: The invention relates to a method of therapy guidance, stratification and/or monitoring of fluid therapy based on proadrenomedullin (proADM) levels. The invention therefore relates to a method for therapy guidance, stratification and/or monitoring of a fluid therapy, comprising providing a sample of said patient, determining a level of pro adrenomedullin (proADM) or fragment(s) thereof in said sample, wherein said level of proADM or fragment(s) thereof indicates the prescription of fluid therapy to be administered to the patient. The invention further relates to methods for guiding fluid therapy volume and to methods of treating disease using fluid therapy based on the proADM stratification of patients based on the methods described herein.

Abstract: A method for antibiotic therapy guidance, stratification and/or control in a patient suffering from an infectious disease and receiving treatment with one or more antibiotic agents. The method comprises isolating a first and subsequently second sample from said patient and initiating antibiotic treatment, determining levels of procalcitonin (PCT) or fragment(s) thereof in both samples, and determining a level of proadrenomedullin (proADM) or fragment(s) thereof in at least the second sample, wherein the levels of PCT or fragment(s) thereof in said samples, and the level of proADM or fragment(s) thereof in the second sample, indicate whether a change in the treatment with one or more antibiotic agents is required. The method may comprise additionally determining a level of proADM or fragment(s) thereof in the first sample. Changes in the proADM and PCT levels between the first and second samples may indicate a need for changing the antibiotic treatment.

Abstract: The invention relates to a method for the diagnosis, prognosis, risk assessment, risk stratification, monitoring, therapy guidance and/or therapy control of an infectious disease in a subject, wherein said method comprises providing a sample of said subject; determining a level of matrix metalloprotease-8 (MMP-8) or fragment(s) thereof in a sample of said subject, wherein said level of MMP-8 or fragment(s) thereof distinguishes between the presence and absence of an infectious disease in a patient with symptoms of a systemic inflammatory condition. In a preferred embodiment the invention relates to the determination of procalcitonin (PCT) and MMP-8 and their combined use to distinguish between the presence and absence of infectious disease in patients with symptoms of systemic inflammatory condition. The invention also relates to a computer-implemented method and a kit for conducting the method of the invention.

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.

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.

Abstract: The present invention relates to an in vitro method for the prognosis of an adverse event in asymptomatic subjects comprising the determination of the level of Procalcitonin (PCT) or a fragment thereof or a precursor or fragment thereof having at least 12 amino acid residues in a sample of a bodily fluid from said subject and the correlation of the determined level to a potential risk of sustaining an adverse event.

Abstract: The invention relates to a method for risk stratification for acute coronary syndrome (ACS), in particular acute myocardial infarction (AMI) and angina pectoris (AP), wherein provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II, is determined by an in vitro diagnosis.

Abstract: The present invention relates to an in vitro method for the detection of Procalcitonin or a fragment thereof of at least 20 amino acid residues in length in a biological sample derived from a bodily fluid obtained from a subject, comprising the steps of: (i) contacting said sample with at least two antibodies or functional fragments thereof directed against different epitopes within Procalcitonin, and (ii) qualitatively or quantitatively detecting binding of said at least two antibodies to Procalcitonin or said fragment thereof, wherein binding indicates the presence or concentration of Procalcitonin or said fragment in said sample, wherein at least one antibody or functional fragment thereof is directed against an epitope comprised in the sequence spanning amino acid residues 2 to 52 of Procalcitonin. The invention also pertains to antibodies directed against an N-terminal epitope of Procalcitonin and kits comprising antibodies directed against PCT.

Abstract: The invention refers to a method for determining a marker in a small volume of a sample of a bodily fluid, the method comprising the steps of: providing a flow test element having a plurality of functional zones (3, 4, 5, 6, 7), the plurality of functional zones (3, 4, 5, 6, 7) being at least partially fluidly connected and comprising an application zone (3) and a testing zone (5) fluidly connected to the application zone (3) and configured for determination of a marker in a bodily fluid and/or a constituent of the bodily fluid, applying a small volume of a liquid sample to the sample application zone (3) of the flow test element, determining a correct test performance, wherein the step of determining correct test performance comprises the steps of measuring at least one optical parameter for one or more functional zones (3; 4; 5; 6; 7), comparing the at least one optical parameter measured to at least one predefined optical parameter assigned to the one or more functional zones (3; 4; 5; 6; 7), and, if the c