Abstract: The invention relates to methods and kits for determining platelet susceptibility to activation in a patient. More particularly, the present invention relates to a method for determining platelet susceptibility to activation in a patient, comprising a step consisting of measuring the level of GPVI dimers at the platelet surface in a blood sample obtained from said patient.

Abstract: The invention generally relates to the field of immunochemistry including antibody therapy, diagnostics, and basic research and specifically relates to the area of selecting affinity molecules such as natural antibodies, including artificial antibodies, antibody mimics, and aptamers. The invention relates particularly to a method of selecting affinity molecules using a homogeneous noncompetitive assay in a high throughput process.

Abstract: Provided is a method for determining immunoglobulins in a neonatal ungulate. The method entails obtaining a sample of oral secretions from the neonatal ungulate and measuring an amount of immunoglobulins in the sample of oral secretions. The method is faster and more convenient than previously available methods for determining immunglobulins in neonatal ungulates, such as neonatal horses and cattle.

Abstract: Provided are methods and compositions for determining whether an individual has Sjögren's disease (SD). The method entails determining in a biological sample from the individual the presence of antibodies directed to salivary gland protein 1 (SP-1), parotid secretory protein (PSP), carbonic anhydrase 6 (CA6), or determining a combination of the antibodies. Determining that the individual has SD is based on the presence of the antibodies. The method provides for detection of early SD. Kits for antibody detection containing the antigens to which the antibodies of SD patients are directed are also provided.

Abstract: The invention is directed to ?1-6 glucans, compositions, diagnostic kits, and devices comprising the same, and methods of use thereof in modulating immune response and treating, delaying progression of, reducing the incidence or severity of cancer, infection, inflammation, and autoimmune diseases. The ?1-6 glucans of certain embodiments of the invention are enriched for O-acetylated groups and/or conjugated to a solid support or linked to a targeting moiety. The ?1-6 glucans of certain embodiments of the invention recruit immunoglobulin G antibodies to mediate complement and neutrophil killing. The conjugated ?1-6 glucans of certain embodiments of the invention are targeted to cells to stimulate the immune response at the target location by activating complement-mediated lysis and recruitment of neutrophils.

Abstract: Provided herein are kits and methods for assays with internal calibration.

Abstract: Provided herein methods for determining whether a subject, particularly a human subject, is at risk of developing, having, or experiencing a complication of cardiovascular disease, and methods of treating subjects who are identified by the current methods of being at risk for cardiovascular disease. In one embodiment, the method comprises determining levels of one or more oxidized apolipoprotein A-I related biomolecules in a bodily sample from the subject. Also, provided are kits and reagents for use in the present methods. Also provided are methods for monitoring the status of cardiovascular disease in a subject or the effects of therapeutic agents on subjects with cardiovascular disease. Such method comprising determining levels of one or more oxidized apolipoprotein A-I related molecules in bodily samples taken from the subject over time or before and after therapy.

Abstract: An assay for identifying an individual having or at risk of developing vascular calcification, said assay comprising obtaining a blood sample from an individual and measuring the level of a vesicular compound in a matrix vesicle present in the blood sample from said individual; wherein an increased level of said compound indicates an individual at risk of developing vascular calcification.

Abstract: Methods for assessing the condition of keratinized structures, including hair, in particular methods to determine the condition of keratinized structures in relation to suitability for analysis of analytes of interest in a test sample, are presented. The methods comprise contacting the keratinized structure with a non-proteolytic reducing agent and an optional proteolytic agent. The methods further include inspection of the hair sample, or measurement of free protein eluted from the keratinized structure, after reduction and optional proteolysis to determine condition prior to analyte identification and quantitation by known techniques such as immunoassays.

Abstract: Methods of determining levels of activity of bacteria in the lungs of patients are described, in which levels of a marker of a bacterial iron scavenging processes (for example, siderophores) and levels of a secreted bacterial protein are measured over time. Changes in the measured levels over time allow levels of bacterial activity to be determined, and exacerbations of bacterial infection to be predicted and/or monitored. Additional markers may also be used. The methods of the invention may also be used for monitoring effectiveness of antibiotic treatment of lung infection. The invention is particularly useful for monitoring P. aeruginosa levels in lungs of cystic fibrosis patients. Kits for use in the methods are also described.

Abstract: Embodiments herein relate to the field of screening tools for fetal/maternal wellness, and, more specifically, to biomarkers for gestational diabetes. In various embodiments, the methods may provide non-invasive and minimally-invasive screening tools for gestational diabetes that involve detection of changes in a proteomic profile of a test sample relative to a reference sample. In particular embodiments, the method may include determining whether a proteomic profile of a test sample from the subject includes at least one expression signature characteristic of gestational diabetes, wherein the proteomic profile comprises information on the expression of glycosylated fibronectin and glycosylated PSG, for example information on levels of fibronectin-SNA or a fibronectin-antibody complex, and PSG-AAL or a PSG-antibody complex.

Abstract: In one or more embodiments, the present invention provides a novel biomarker which provides a link between a distinct clinical phenotype and a biochemical effect of an autoantibody on an enzyme implicated in disease pathogenesis. In particular, the present invention provides an isolated or purified human autoantibody to PAD3 protein. Methods of diagnosis of subjects for rheumatoid arthritis (RA) using these antibodies as well as diagnosis of the severity of RA in the subject, and methods for monitoring treatment of a subject with RA are also provided. The biomarkers provided herein are also useful in the diagnosis of connective tissue-interstitial lung disease (CT-ILD) in patients having or suspected of having RA.

Abstract: A method for predicting a need for Renal Replacement Therapy (RRT) in a patient comprises: determining a concentration of pi glutathione S transferase-(?GST) in a first urine sample from the patient; and wherein a need for RRT is predicted when the ?GST concentration is determined to be elevated in comparison to a patient without kidney injury. The method according to the invention can further comprise detecting for the presence of risk factors for RRT in a patient, the risk factors including elevated serum creatinine concentration, type I diabetes, type II diabetes, hypertension, dyslipidemia, hyperglycaemia, proteinuria and hypoalbuminemia.

Abstract: The invention features methods and kits for determining the presence of, or a predisposition to develop, Sjögren's syndrome in humans. The invention features methods to detect changes in the levels of one or more LMP-2 protein isoforms, in particular phosphorylated isoforms of LMP-2, and to detect changes in cellular protein phosphorylation and ubiquitination in samples from Sjögren's patients.

Abstract: The invention is directed to a method of determining whether a non-purified sample contains a target protein bound to a ligand of interest comprising the steps of: a) exposing said non-purified sample to a temperature which is capable of causing or enhancing precipitation of the unbound target protein to a greater extent than it is capable of causing or enhancing precipitation of the target protein bound to said ligand; b) processing the product of step a) in order to separate soluble from insoluble protein; and c) analyzing either or both the soluble and insoluble protein fractions of step b) for the presence of target protein, wherein said target protein is not detected on the basis of enzymatic activity of a tag, peptide, polypeptide or protein fused thereto. Particularly, the invention may be used to determine whether drugs can bind to their protein targets in samples derived from patients to ascertain whether a certain drug can be used in a therapy for that patient.

Abstract: Aspects of the present invention include methods for diagnosing and monitoring IgAN in a subject. In practicing one aspect of the subject methods, a sample from a subject is analyzed for the presence of one or more specific autoantibodies to determine the IgAN phenotype of the subject. Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Provided is a method for using low molecular weight compounds found in the body as a biomarker for diagnosing depression. Specifically, more than one compound selected from a group comprising the following are used: ADP-ribose, ATP, ADP, AMP, serotonin, tryptophan, kynurenine, SDMA (symmetrical dimethylarginine), threonine, glyceric acid, serine, N-acetylaspartic acid, glutamic acid, trigonelline, creatine, 2-methylserine, sphingosine, homovanillic acid, piperidine, sulfoxidized methionine, pipecolic acid, sphinganine, gamma-butyrobetaine, guanidinoacetic acid, isobutyric acid, creatinine, sarcosine, 3-methylbutyric acid, nicotinamide, betaine, ornithine, carnitine, ethanolamine, phosphoethanolamine, taurine, hypotaurine, aspartic acid, methionine, and tyrosine.

Abstract: The present invention provides methods and compositions for identifying fatigue, disease states associated with fatigue, recovery from fatigue and/or physical performance capability in a subject.

Abstract: A method for diagnosing the development of a tissue injury in a subject comprising administering a sample of neoantibodies to the subject's tissue for the purpose of detecting the presence of neoepitopes bearing complement proteins.

Abstract: We disclose cleavage-sensitive antibodies with epitopes spanning the scissile bond of the toxins molecular target protein, enabling toxin-associated proteolysis to be measured in a variety of assay formats.