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: A method for treating a subject to reduce the risk of early onset preeclampsia in a pregnant subject determining a level of soluble fms-like tyrosine kinase-1 (sFlt-1) or fragment(s) thereof in a sample that has been isolated from said pregnant subject. The the sample is isolated from a subject before the end of the 12th week of gestation, where the level of sFlt-1 or fragment(s) thereof is indicative of early onset preeclampsia occurring before the end of the 33rd week of gestation. The subject is then treated to decrease the risk of developing, delay the time point of the onset and/or reduce the severity of preeclampsia.

Abstract: The present invention relates to a method for the diagnosis, prognosis, risk assessment, risk stratification, monitoring, therapy guidance and/or therapy control of a fungal infection, in particular invasive fungal infections (IFI) and/or the ruling in or ruling out of an fungal infection and/or the differential diagnosis of a fungal colonization vs. an invasive fungal infection in a subject, wherein in particular the subject has an increased risk of getting or having a fungal infection and/or the subject is in a critical disease state, particularly has an existing infection and/or a state of sepsis, particularly a septic shock. The method of the invention comprises determining the level of at least one marker selected from the group of ICAM1, AHSG, CPN1, FABP1, HRG, PIGR, RAP1A, THBS1, VCL, ET-1. Furthermore, the invention relates to a diagnostic assay and a kit for carrying out the method.

Abstract: A method for sample preparation 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 sample preparation for antibiotic therapy guidance, stratification and/or control in a patient with one or more comorbidities comprising an impaired innate immune response. 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.

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: 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: 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 the subject and the correlation of the determined level to a potential risk of sustaining an adverse event.

Abstract: The present invention relates to a method for diagnosing a respiratory tract infection in a subject, comprising determining in a sample from said subject the level of High-Mobility-Group-Protein B1 (HMGB1), and/or determining in a sample from said subject the level of a histone protein, and/or determining in a sample from said subject the level of Insulin-like growth factor binding protein, acid labile subunit (IGFALS), wherein the subject is diagnosed with a bacterial respiratory tract infection when the level of IGFALS is below a predetermined threshold level and/or the level of the histone protein is above a predetermined threshold value, and/or wherein the subject is diagnosed with a respiratory tract infection when the level of HMGB1 is above a predetermined threshold level.

Abstract: The invention relates to a method for prognosing disease progression in a patient that has or is at risk of developing a severe acute respiratory syndrome (SARS), wherein the method comprises determining a level of pro-adrenomedullin (proADM) or fragment(s) thereof in a sample from the patient, wherein said level indicates the severity of SARS progression. The method is in some embodiments configured for use when a patient exhibits symptoms of a severe acute respiratory syndrome (SARS), a patient exhibits symptoms of infection with a SARS-virus, the patient is infected with a SARS-virus, such as a SARS-coronavirus, such as SARS-CoV2.

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: The invention relates to a method for determining whether a subject diagnosed with a cardiovascular disease should be prescribed a remote patient management, the method comprising measuring particular biomarkers in a sample from said patient. The invention therefore relates to a method for therapy guidance, stratification and/or monitoring of a remote patient management for a patient diagnosed with a cardiovascular disease, comprising providing at least one sample of a patient, determining a level of at least one biomarker selected from the group consisting of proADM, proBNP and proANP or fragment(s) and comparing said level of the at least one biomarker to one or more reference values, wherein said level is indicative of prescribing or not prescribing a remote patient management for said patient.

Abstract: The present invention relates to the determination of the level of marker peptides in a sample derived from a bodily fluid of a subject presenting with non-specific complaints.

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 present invention relates to method for detecting a free histone protein in a biological sample of a subject, e.g. using an immunoassay or a mass spectrometric assay. It also pertains to a method for the diagnosis, prognosis, risk assessment, risk stratification and/or therapy control of a disease or medical condition, comprising detecting a free histone protein or peptide fragment thereof in a biological sample of a subject, wherein the presence of said free histone protein or fragment thereof is indicative for said disease or medical condition.

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 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: In vitro methods such as in vitro diagnosis, prognosis and risk stratification of a patient having a primary disease, whereby the level of Procalcitonin (PCT) or fragment thereof in a sample of a bodily fluid of the patient is indicative for the risk of the patient to contract a further disease or medical condition. Assays for performing such methods and samples containing complex resulting from such methods.

Abstract: The invention relates to a method for the diagnosis, prognosis, prediction, risk assessment and/or risk stratification of a subsequent trauma-related complication in a polytrauma patient, comprising providing a sample of said patient, wherein the sample is isolated from the patient after the polytrauma, determining a level of pro ADM or fragment(s) thereof in said sample, wherein said level of pro ADM or fragment(s) thereof correlates with the likelihood of a subsequent trauma-related complication

Abstract: The present invention relates to a method for the diagnosis, prognosis, risk assessment, risk stratification, monitoring, therapy guidance and/or therapy control of a fungal infection, in particular invasive fungal infections (IFI) and/or the ruling in or ruling out of an fungal infection and/or the differential diagnosis of a fungal colonization vs. an invasive fungal infection in a subject, wherein in particular the subject has an increased risk of getting or having a fungal infection and/or the subject is in a critical disease state, particularly has an existing infection and/or a state of sepsis, particularly a septic shock. The method of the invention comprises determining the level of at least one marker selected from the group of ICAM1, AHSG, CPN1, FABP1, HRG, PIGR, RAP1A, THBS1, VCL, ET-1. Furthermore, the invention relates to a diagnostic assay and a kit for carrying out the method.

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.