Abstract: This disclosure provides, in one aspect, a method for analyzing a sample from a subject for a biomarker that is indicative of the subject's immune response to ?-glucan. Generally, the method includes obtaining a biological sample from a subject, analyzing the sample for a biomarker anti-?-glucan antibody compared to a reference standard, computing a Relative Antibody Unit (RAU) value for anti-?-glucan antibody in the sample, and identifying the subject as biomarker positive if the RAU value is greater than a predetermined RAU value for the biomarker anti-?-glucan antibody.

Abstract: The invention provides binding agents and assays tor insulin signal peptide. The agents and assays are useful in methods tor predicting, diagnosing, assessing or monitoring acute cardiac disorders, glucose handling disorders and diabetes in a subject. Also provided are nucleotides, polypeptides, and kits useful in the methods of the invention.

Abstract: The present invention provides a technique that suppresses a background value of a detection signal to construct an immunoassay system that detects a modified nucleobase. Specifically, the present invention provides a method for measuring a modified nucleobase including incubating a nucleic acid sample, a capture probe, and a solid phase probe in a solution and measuring a modified nucleobase using an antibody against the modified nucleobase in the obtained solution. The present invention also provides a kit for measuring a modified nucleobase including a capture probe, a solid phase probe, and an antibody against a modified nucleobase.

Abstract: The present disclosure relates to assays and methods for the detection of renal inflammation by measuring the level of P2Y14 and/or UDP-glucose in a sample from a subject, such as a urine sample. The present disclosure also relates to methods for the treatment of renal inflammation by administering a P2Y14 inhibitor.

Abstract: The invention relates to a method of determining the inflammatory disorder status of a subject comprising detecting the presence or absence, or the level, of (i) citrullinated tenascin-C and/or one or more fragments of citrullinated tenascin-C; and/or (ii) autoantibodies with specificity for citrullinated tenascin-C and/or one or more fragments of citrullinated tenascin-C, in a sample from said subject.

Abstract: Compositions, methods, articles of manufacture, and kits are provided for storage and delivery of proteins.

Abstract: Aspects of the invention relate to methods for measuring the binding constant of a lipophilic or amphiphilic molecule acceptor for a lipophilic or amphiphilic molecule. Methods involve rapid, cell-free competition assays including a labeled lipophilic or amphiphilic molecule and nanoparticle.

Abstract: Disclosed are genetically-modified phages, comprising a first nucleic acid sequence encoding at least a first peptide able to bind to a magnetic nanoparticle, and a second nucleic acid sequence encoding at least a second peptide able to bind with high specificity to a predetermined biomarker, and a method for using the genetically-modified phage displaying the first peptide and second peptide in a method for analyzing a fluid sample for the predetermined biomarker.

Abstract: Provided herein are assays and kits useful for avoiding “prozone phenomenon” or “hook effect” and which expand the range of accurately measurable analyte concentrations.

Abstract: Measurement of circulating ST2 and/or IL-33 concentrations is useful for the prognostic evaluation of subjects, in particular for the prediction of adverse clinical outcomes, e.g., mortality, and the detection of severe disease.

Abstract: The present invention relates to a novel method for diagnosing high-affinity binders, in particular antibodies or autoantibodies, and the identification, characterization and selection of marker sequences and diagnostic use thereof, in particular in the form of a panel. The invention also relates to a singleplex assay in which the discovered selection of marker sequences is used in the form of a panel and high-affinity binders are detected using a single signal.

Abstract: The invention relates to compositions and methods for detecting renal injury in a subject, such as proximal tubular injury associated with acute kidney injury.

Abstract: Methods for proteomic screening on random protein-bead arrays by mass spec is described. Photocleavable mass tags are utilized to code a protein library (bait molecules) displayed on beads randomly arrayed in an array substrate. A library of probes (prey) can be mixed with the protein-bead array to query the array. Because mass spec can detect multiple mass tags, it is possible to rapidly identify all of the interactions resulting from this mixing.

Abstract: We identified >40 proteins that elicited at least a 2-fold increase in antibody response post-pancreatic-cancer vaccination, from each of three patients' sera. The antibody responses detected against these proteins in patients with >3 years disease-free survival indicates the anti-tumor potential of targeting these proteins. We found that tissue expression of proteins PSMC5, TFRC and PPP1R12A increases during tumor development from normal to pre-malignant to pancreatic tumor. In addition, these proteins were shown to be pancreatic cancer-associated antigens that are recognized by post-vaccination antibodies in the sera of patients that received the vaccine and have demonstrated a favorable disease free survival.

Abstract: Specific peptides, and derived ionization characteristics of the peptides, from the Insulin Receptor protein (IR), and its isoforms IR-A and IR-B, that are particularly advantageous for quantifying the IR protein, IR-A isoform and/or IR-B isoform, directly in biological samples that have been fixed in formalin by the method of Selected Reaction Monitoring (SRM) mass spectrometry, or what can also be termed as Multiple Reaction Monitoring (MRM) mass spectrometry. Such biological samples are chemically preserved and fixed and are selected from tissues and cells treated with formaldehyde containing agents/fixatives including formalin-fixed tissue/cells, formalin-fixed/paraffin embedded (FFPE) tissue/cells, FFPE tissue blocks and cells from those blocks, and tissue culture cells that have been formalin fixed and or paraffin embedded.

Abstract: The present invention provides methods for aiding in the diagnosis of irritable bowel syndrome (IBS) in an individual. In particular, the present invention is useful for determining whether the individual does not have either celiac disease or inflammatory bowel disease (IBD), and has IBS and/or a subtype thereof. Thus, the present invention provides an accurate diagnostic prediction of IBS and is useful for guiding treatment decisions.

Abstract: This disclosure describes assay methods and kits for detecting a target. The methods and kits can be used to detect a target that is present in a sample at low concentration because the methods and kits amplify the signal indicating the presence of target in the sample. Generally, the methods and kits involve nanoparticle aggregation as a detectable signal that is enhanced by a trigger released from a vesicular compartment when the target is bound to a capture agent.

Abstract: Provided is a method of bioassay for the quantification of peptide fragments elevated in lung diseases such as COPD, SCC, or IPF. The peptide fragments comprise a neo-epitope formed at a cleavage site by cleavage in vivo of elastin by a proteinase. In the method a sample is contacted with an antibody having specific binding affinity for the neo-epitope amino acid sequence and determining the level of binding is determined where the antibody binds one of the following terminal sequences: . . . FGPGVV, . . . VPGLGV or IKAPKL . . . . Also provided are antibodies and immunoassay kits for use in such methods.

Abstract: The invention provides a method for determining the efficacy of compositions used to treat articular joint conditions in mammals. The method includes measuring the change in levels of one or more cartilage degradation biomarkers in a mammal from before exercise and after exercise, then administering a composition used to treat articular joint conditions to the mammal, and measuring the change in levels of one or more cartilage degradation biomarkers in the mammal from before exercise and after exercise.

Abstract: Methods and compositions are provided for diagnosing ectopic pregnancy in a mammalian subject by detecting changes in expression of the selected genes, gene fragments or transcripts or expression products, or changes in the expression levels of one or more of proteins or peptide fragments, identified in Table 2 and FIGS. 8 and 9 herein. A selected gene, gene transcript or protein/peptide expression product, or profiles or signatures formed by combinations of same, detected in a biological fluid, preferably sera, of a subject, enables comparison of the corresponding genes, proteins or profiles from that of a reference or control having a normal intrauterine pregnancy. Detection of characteristic changes in the gene profile or protein expression signature of the subject is correlated with a diagnosis of ectopic pregnancy.