Abstract: The present invention provides a method of using increased levels of one or more biomarkers to identify subjects having non-celiac gluten sensitivity or non-celiac wheat sensitivity. The identification would aid the physician or health professional to determine a specific treatment for the patient, for example, a diet that eliminates wheat, rye, and/or barley. In one embodiment, the biomarkers are one or more of soluble CD 14 (sCD14), lipopolysaccharide-binding protein (LBP), anti-lipopolysaccharide antibodies, anti-flagellin antibodies, anti-gliadin antibodies, and intestinal fatty acid-binding protein (FABP2). The present invention also provides a method of using the same markers to monitor the response to treatment for non-celiac wheat sensitivity in a subject.

Abstract: A method and apparatus for the rapid and reliable preparation of a sample for use in testing for target analytes such as bacteria, viruses, toxins and pathogenic agents in various products. A sample for testing the target analyte is collected from various sources. The method for sample preparation provides for an express process for preparing collected samples for testing. The collected sample may be concentrated by centrifugation, filtration, or other means suitable for sample concentration, homogenized with the addition of a broth and enriched for specified period of time. Immunomagnetic separation of the sample occurs with receptor-coated magnetic microspheres in different test-specific formulations (singleplex or multiplex). An automatic testing system is disclosed which includes a biological testing cassette, in which testing of the sample occurs using liquid crystal diagnostic methodologies.

Abstract: The invention is a method for treating a heart failure patient with the steps of measuring the concentration of IGFBP2 in a blood, plasma or urine sample obtained from the heart failure patient and comparing the patient's IGFBP2 level to a threshold value derived from IGFBP2 measured in samples taken from a group of patients with heart failure selected from the group consisting of stage I, stage stage III and stage IV heart failure, according to New York Heart Association (NYHA) classification system. A patient with an IGFBP2 level that exceeds the threshold value is admitted or readmitted to a hospital and treated with at least one treatment selected from the group consisting of administration of a beta-blocker, an angiotensin-converting enzyme inhibitor, an angiotensin receptor blocker, an aldosterone antagonist, an implantable cardiac defibrillator, a cardiac resynchronization therapy, an implantable left ventricular assist device and a heart transplant.

Abstract: Provided herein are methods and markers for diagnosing cardiovascular disease and/or neurodegenearative diseases in a subject. The methods include obtaining a biological sample from a subject in need of diagnosis and detecting the amount of a citrullinated protein or a citrullinated peptide in the biological sample obtained from said subject.

Abstract: Methods for determining the presence of pathologic amylin in a subject with diabetes or pre-diabetes are provided herein. The method includes obtaining a skin sample from a subject and determining if there is pathologic amylin present in the skin sample.

Abstract: A determination method for determining, in an immunodepressed subject, a humoral response due to the presence of a target infectious agent, by detection, in a biological sample of the subject, of at least one target antibody that is susceptible of being produced by the subject when the latter is infected with or has been infected with the target infectious agent. Also, a determination method for determining a humoral response due to the presence of a target infectious agent from a biological sample from an immunodepressed or non-immunodepressed subject, in which the dilution ratio of the sample is selected as a function of the immunodepressed condition or otherwise of the subject concerned.

Abstract: A biomarker and a technology for utilizing the same, of the present invention, can be useful in the early diagnosis, in urine, of a renal function abnormality due to diabetes and drugs and in the prediction and evaluation of disease severity, and, further, can accurately determine, with high sensitivity and specificity, a renal function abnormality due to diabetes and exposure to drugs, and enable the early and effective diagnosis of kidney abnormality symptoms through a relatively simple method, thereby being widely usable in various fields, such as in clinical experiments essential for new drug development and in diagnosing drug-causing acute/chronic renal failure, which can frequently occur in the clinical treatment process.

Abstract: This application describes novel therapeutic strategies for treating patients with hypertriglyceridemia and/or chylomicronemia based on the presence of GPIHBP1 autoantibodies. It was unexpectedly found that autoantibodies to GPIHBP1, a GPI anchored protein of capillary endothelial cells that shuttles lipoprotein lipase to its site of action in the capillary lumen, were found to be present in patients with hypertriglyceridemia, and that the autoantibodies blocked the binding of lipoprotein lipase (LPL) to GPIHBP1. Patients having hypertriglyceridemia and/or chylomicronemia and also having GPIHBP1 autoantibodies may be treated with a therapeutically effective amount of an immunosuppressive treatment and/or GPIHBP1 activator.

Abstract: A method for detecting and quantifying anti-neutrophil-cytoplasmic antibodies (ANCA) in a sample of bodily fluid from a patient suspected of suffering from an autoimmune disease, including the steps of contacting human polymorphonuclear neutrophils able to release extracellular traps (NETs) with microspheres to produce NET-coated microspheres, contacting the NET-coated microspheres with the sample of bodily fluid, and labeling and subsequent analyzing of anti-neutrophil-cytoplasmic antibodies by flow cytometric methods.

Abstract: Provided herein are methods for predicting or determining whether a subject with coronary artery disease is likely to experience or develop a major adverse cardiovascular event (MACE) based on determining cardiac troponin (cTnI) levels in a human at rest and during or after exercise.

Abstract: Aspects of the present disclosure include methods that include co-culturing a cell and a microparticle that includes a capture ligand, in a culture medium under conditions in which a biomarker produced by the cell is bound by the capture ligand. Such methods may further include detecting (e.g., by flow or mass cytometry) complexes that include the microparticle, the capture ligand, the biomarker, and a detection reagent. The methods may further include determining the proportion or number of cells among a heterogeneous cell population that produced the biomarker and/or the level of biomarker secreted by such cells. Compositions, systems and kits are also provided.

Abstract: A novel serological target marker GP73 used for diagnosing and identifying a simple fatty liver and steatohepatitis in populations with fatty liver and a detection application method thereof. The serological target marker GP73 and the application thereof can replace golden standard liver puncture to identify and diagnose the simple fatty liver and steatohepatitis in populations with fatty liver, reduce the detection pain of a patient, and have an extremely high clinical application value in clinically identifying and diagnosing the simple fatty liver and steatohepatitis in the populations with fatty liver and assisting the treatment of the simple fatty liver and steatohepatitis.

Abstract: Subject of the present invention is an in vitro method for therapy follow-up in septic patients wherein the concentration of mature ADM 1-52 and/or mature ADM 1-52-Gly in a sample of bodily fluid of said septic patient is determined using an assay comprising two binders that bind to two different regions within the region of mature adrenomedullin and/or adrenomedullin-Gly that is aminoacid 21-52-amid SEQ ID No. 1 or aminoacid 21-52-Gly SEQ ID No. 2 wherein each of said regions comprises at least 4 or 5 amino acids. The invention further relates to assays and calibration methods.

Abstract: The present invention provides methods, kits, and compositions for purifying HDL molecules from a sample (e.g., blood sample) using HDL tagging molecules comprising an HDL lipophilic core binding peptide (e.g., portion of ApoA1) and an affinity tag. The present invention also provides methods, kits, and compositions for detecting non-fragmented ApoA1 with mass spectrometry. The present invention further provides methods, kits, and compositions for tagging HDL molecules in a sample with detectably labeled ApoA1 molecules such that the ratio of detectably labeled ApoA1 molecules to native ApoA1 proteins may be determined.

Abstract: Disclosed herein is a method for classifying a patient at risk for heart failure, wherein the method comprises the steps of (i) measuring the concentration of IGFBP2 in a sample obtained from the patient and (ii) comparing the concentration of IGFBP2 measured in step (i) to a control value derived from the concentration of IGFBP2 in samples from patients who are at particular stages of heart failure and/or to a control value derived from the concentration of IGFBP2 in blood samples from healthy patients.

Abstract: Compositions and methods for determining post-transfusion survival or toxicity of red blood cells and the suitability of red blood cell units for transfusion by measuring the levels of one or more markers in a red blood cell sample are provided.

Abstract: Presented is a method for diagnosing and/or grading diastolic dysfunction or at least one structural or functional abnormality associated with diastolic dysfunction. The method involves measuring the level of IGFBP7 (Insulin like growth factor binding protein 7) and, optionally, the level of at least one further marker in a patient suffering from heart failure, and comparing the level to a reference level. Further envisaged is a method of monitoring diastolic function in a patient suffering from heart failure. Also described are kits and devices adapted to carry out the method.

Abstract: Method for determination of whether a subject suffers from intermittent atrial fibrillation based on the determination of the amount of a Troponin T in a sample in a patient suffering from atrial fibrillation using a binding assay. Kits and devices adapted to carry out the methods are also provided.

Abstract: Disclosed is a prediction method for the prognosis of sepsis comprising measuring an sCD14-ST level in a sample. sCD14-ST, to be measured in the present invention, is a marker superior to procalcitonin, known as a marker to predict the prognosis in sepsis patients.

Abstract: The present invention relates to the field of myocardial injury. More specifically, the present invention provides methods and compositions useful in the diagnosis, prognosis and/or assessment of myocardial injury. In a specific embodiment, a method comprises the steps of (a) diagnosing a subject as having myocardial injury based on the statistically significant over expression of one or more markers described herein compared to a baseline value, wherein the markers are measured in a biological sample obtained from the subject; and (b) treating the subject with one or more of an anti-thrombolysis agent, coronary bypass surgery or angioplasty.