Abstract: A method for identifying a ligand or compound which binds to albumin comprises the steps of contacting a reaction mixture comprising a site-specific probe and albumin in the presence and the absence of the ligand or compound and measuring either dissociation constant KD, inhibitor concentration IC50 or fluorescence displacement; whereby a change in KD, IC50 and/or fluorescence in the presence of the ligand or compound is indicative of the ligand or compound binds to albumin.

Abstract: A magnetic binding substance, which is a first binding substance that specifically binds with a target substance, having magnet enveloping dielectric particles, which have magnetic particles enveloped therein and surfaces modified with functional groups that exhibit polarity within a liquid sample, attached thereto, and a labeling binding substance, which is a second binding substance that specifically binds with the target substance having photoresponsive labels attached thereto, are mixed with the liquid sample such that binding reactions occur. A magnetic field is generated within a sample cell, to draw the magnetic binding substance to a local region. Excitation light is irradiated only onto a predetermined region including the local region while the magnetic binding substance is drawn to the local region, causing the photoresponsive labels present therein to generate optical signals. The optical signals are detected.

Abstract: The present invention provides an assay for detecting serum IgE antibody levels to cetuximab and to other proteins. The present invention further provides a method for predicting whether a subject will respond adversely to cetuximab treatment. The present further provides a method for detecting sensitivity to compounds comprising galactose-alpha-1,3-galactose.

Abstract: The present invention is related to compositions useful for the measurement of free or unbound analyte concentrations in a fluid. The present invention includes the use of capture ligands and stabilizing agents to improve the accuracy of analyte concentration assays. Methods and tools for using the present invention are also disclosed.

Abstract: Provided are methods and compositions for predicting the development of kidney disease, including acute kidney injury. In certain aspects and embodiments the provided methods and compositions are particularly useful for predicting kidney injury following an event likely to cause kidney injury and/or kidney failure in a patient, such as a cardiac surgery, e.g., a surgery involving a cardiopulmonary bypass (CPB), such as a coronary artery bypass graft surgery. In some embodiments, the higher the urinary hepcidin-to-urinary creatinine ratio (uHep/uCr) at 6-24 hours following initiation of CPB, the lower is the risk for development of AKI determined by RIFLE criteria in the ensuing four to five days. Conversely, the higher the urinary NGAL to urinary creatinine ratio (uNGAL/uCr) at 6-24 hours following initiation of CPB, the higher is the risk of developing CPB-mediated AKI over the same time period.

Abstract: Disclosed are procedures and methods for diagnosing latent and active cancers in a subject. The described methods include the use of sandwich ELISA assays containing antibodies specific for certain epitopes on the A-protein. This enables the assay to discriminate between the monomelic and homopolymeric forms of A-protein.

Abstract: A method for diagnosing or predicting the risk of developing preeclampsia by measuring the level of A1 M and one or more of the compounds HbA, HbF in a sample and comparing the obtained values with reference values. By using a combination of information relating to A1 M and HbF improved diagnose or prediction is observed.

Abstract: The present invention concerns a procedure and a device to determine the concentration of protamine-1 and protamine-2 and the ratio between protamine-1 and protamine-2 as protamine/protein ratio in a questionable sample from an individual to be examined in order to assess the fertility of the sperm in vitro. This assessment is of great importance for the prognosis of the success of an artificial insemination of an egg in vitro. The test strip comprises a sperm pretest to determine the sperm concentration and a protamine rapid test to determine the concentrations of protamine-1 and protamine-2 and the ratio between protamine-1 and protamine-2 as protamine/protein ratio.

Abstract: The present invention comprises novel analogs of gemcitabine and novel gemcitabine immunogens leased out of, i.e., derived from, the 5?-hydroxy position of gemcitabine. The invention also comprises unique monoclonal antibodies generated using gemcitabine linked immunogens as well as unique conjugates and tracers which antibodies, conjugates, and tracers are useful in immunoassays for the quantification and monitoring of gemcitabine in biological fluids.

Abstract: The present invention is related to a method for detection of a biological target in an affinity assay, the method comprising the steps of providing a biological sample volume containing the biological target, adding a first capturing moiety to the biological sample volume comprising the biological target, wherein the first capturing moiety is adhered to a particle, concentration of the captured biological target into an elution volume that is smaller than the biological sample volume in step a), cleavage of the first capturing moiety or the biological target from the particle and direct or indirect detection and/or quantification of the biological target in a sandwich or competitive affinity assay format, wherein the biological target is associated with at least one capturing moiety, preferably at least two capturing moieties.

Abstract: A method for determining whether early stage cancer is present in a subject comprises detecting the expression level of GASP-1 in the subject by detecting the amount of GASP-1 peptide fragments present in a biological sample of the subject. Because cancer can be detected at an early stage, therapeutic targeting may be initiated before cancer reaches late stage (e.g., before the development of overt symptoms). A method for treating early stage cancer in a subject comprises administering to the subject an effective amount of a GASP-1 inhibitor to inhibit the progression of early stage cancer to late stage cancer. A Competitive ELISA capable of detecting GASP-1 peptide fragments at a concentration of less than 1 ng/ml was developed.

Abstract: Antibodies, polypeptides, and polynucleotides are provided for the detection, prevention, amelioration and treatment of diseases caused by Actinobacillus actinomycetemcomitans.

Abstract: Methods for the detection, identification and quantification of gram negative bacteria and gram negative bacterial antigens are rapid, efficient and highly specific. Compositions for the detection and identification of highly variable serogroups are provided.

Abstract: An embodiment of the invention relates to a device for detecting an analyte in a sample. The device comprises a fluidic network and an integrated circuitry component. The fluidic network comprises a sample zone, a cleaning zone and a detection zone. The fluidic network contains a magnetic particle and/or a signal particle. A sample containing an analyte is introduced, and the analyte interacts with the magnetic particle and/or the signal particle through affinity agents. A microcoil array or a mechanically movable permanent magnet is functionally coupled to the fluidic network, which are activatable to generate a magnetic field within a portion of the fluidic network, and move the magnetic particle from the sample zone to the detection zone. A detection element is present which detects optical or electrical signals from the signal particle, thus indicating the presence of the analyte.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: The invention relates to methods for the quantitative or qualitative detection of an analyte in an assay and adequate reagents therefor, particularly a homogeneous binding test. According to the invention, an analyte-specific binding partner R1 comprises more than one specific binding point for a specific binding partner X that is associated with a component of a signal-forming system while a second analyte-specific binding partner R2 comprises more than one specific binding point for a specific binding partner Y which is also associated with a component of a signal-forming system.

Abstract: A lateral flow test system together with methods for its use in the detection of one or more analytes, or components, of interest within a sample, such as a biological sample, is provided. The system comprises a liquid formulation of a gold conjugate and a lateral flow assay device that does not include a conjugate pad having conjugate dried thereon.

Abstract: Novel immuno-interactive fragments of the ?C portion of a mammalian inhibin ? subunit, together with their variants and derivatives, produce antigen-binding molecules that are interactive with the ?C portion, and which are chemically well defined and which can be produced in commercially significant quantities. The antigen-binding molecules of the invention can be used for the detection of a mammalian inhibin and for the treatment and/or prevention of conditions associated with aberrant levels of a mammalian inhibin.

Abstract: The present invention relates to ???8 antagonists, anti-???8 antibodies or immunoconjugates for reducing TGF? activation in an individual. Further provided are compositions comprising one of the ???8 antagonists, anti-???8 antibodies or immunoconjugates, methods for using the compositions, and related subject matter.

Abstract: An object of the present invention is to provide a monoclonal antibody which is effective for diagnosing IgA nephropathy and specifically recognizes and binds to a hinge region of a polypeptide encoded by a heavy chain gene of immunoglobulin A1 that comprises a serine/threonine-linked sugar chain to which galactose is not bound. According to the present invention, it is possible to provide a monoclonal antibody or an antibody fragment thereof that specifically recognizes and binds to a hinge region of a polypeptide encoded by a heavy chain gene of immunoglobulin A1 that comprises a serine/threonine-linked sugar chain to which galactose is not bound, to provide a diagnostic agent using the antibody or the antibody fragment thereof, and to provide a therapeutic agent comprising the antibody or the antibody fragment thereof as an active ingredient.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in competitive analyte immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads opsonized for leukocytes; and (b) performing a competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: The present invention provides diagnostic methods for determining the risk of developing an autism spectrum disorder (ASD) in a fetus or child by detecting in a biological sample from the mother antibodies that bind to one or more biomarkers selected from the group consisting of lactate dehydrogenase (LDH), guanine deaminase (GDA), collapsin response mediator protein 1 (CRMP1), stress-induced phosphoprotein 1 (STIP1), alpha subunit of the barbed-end actin binding protein Cap Z (CAPZA2), Y Box Binding Protein 1 (YBX1), eukaryotic translation and elongation factor 1A1 (EEF1A1), microtubule-associated protein Tau (MAPT), dihydropyrimidinase-like protein 2 (DPYSL2), dynamin 1-like protein (DNM1L), radixin (RDX), moesin (MSN), and ezrin (EZR).

Abstract: The invention relates to selective diagnosis of gluten-induced autoimmune diseases by binding assays utilizing the main celiac epitope present on proteins of the transglutaminase family. The invention also relates to treatment of gluten-induced autoimmune diseases by inhibiting binding of celiac autoantibodies by therapeutic compounds.

Abstract: The application discloses new biomarkers for hypertensive disorders of pregnancy and particularly preeclampsia; methods for the diagnosis, prediction, prognosis and/or monitoring said disorders based on measuring said biomarkers; and kits and devices for measuring said biomarker and/or performing said methods.

Abstract: A test kit detects the presence of a target analyte in a fluid sample. In particular, the test kit includes reagents capable of detecting the target analyte of interest in breast milk. More particularly, the test kit is capable of detecting the presence of alcohol, caffeine, nicotine, drugs of abuse, therapeutic drugs, triglycerides, lactose, capsaicin, and gluten, for example, in breast milk.

Abstract: The present invention relates to an anti-idiotypic polypeptide scaffold that includes two or more peptide sequences that mimic a discontinuous epitope of a pathogen that is recognized by or induces formation of a broadly neutralizing antibody. Using a fibronectin FNfn10 scaffold bearing two or more modified discontinuous loops, scaffolds that recognize broadly neutralizing antibodies in vitro and from patient serum have been identified. These scaffolds should induce an immune response or mobilize germline specificities to initiate their affinity maturation.

Abstract: The present invention relates to methods for determining the prognosis of a condition which requires critical care, said methods comprising determining the level of SgII, or fragments thereof in a subject. The methods of the invention can also be used to determine whether an individual is suffering from a condition which requires critical care and determining the severity of a condition which requires critical care.

Abstract: Non-invasive methods are provided herein for the diagnosis of melioidosis with specific antibodies capable of detecting molecules associated with melioidosis in a biological fluid, such as urine or serum. These molecules can be identified using proteomic methods, including but not limited to antibody based methods, such as an enzyme-linked immunosorbant assay (ELISA), a radioimmunoassay (RIA), or a lateral flow immunoassay. Methods of inducing an immune response to melioidosis are also disclosed. The methods include the use of the immunogenic melioidosis polypeptides, nucleic acids encoding these polypeptides, and/or viral vectors encoding an immunogenic melioidosis polypeptide, alone or in conjunction with other agents, such as traditional melioidosis therapies. Also disclosed are methods for treating a subject having melioidosis.

Abstract: The invention relates to selective diagnosis of gluten-induced autoimmune diseases by binding assays utilizing the main celiac epitope present on proteins of the transglutaminase family.

Abstract: The invention concerns a method for increasing the dynamic measuring range of especially immunological test elements in particular immunological chromatography test strips that can be evaluated optically that are based on specific binding reactions. The invention enables the dynamic measuring range of test elements based on specific binding reagents, especially of immunological test elements to be shifted towards higher analyte concentrations without impairing the lower detection limit.

Abstract: A method of assaying a sample with the use of the aggregation reaction of immunological microparticles and an assay kit. The assay is conducted by using microparticles wherein the same or an analog of the analyte and a substance that specifically binds to a substance that can specifically bind to the analyte are both bound to an insoluble carrier. Thus, it becomes possible to conveniently carry out the assay even in the case where the analyte has only a small number of specific binding sites, without especially adding a competitive substance carrying hapten bonded thereto to the reaction system so as to induce simultaneous competition of the target substance and the competitive substance.

Abstract: A homogeneous immunoassay method and system for quantitative determination of total immunoglobulin E and specific antibody levels to a plurality of allergens, in which a relatively small sampling of blood is required. The method utilizes relatively small microparticles in aqueous suspension. The immunoassay procedure is an immunometric sandwich procedure preferably utilizing biotin-streptavidin signal amplification techniques and R-phycoerytherin fluorescent labels.

Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: The present invention is in the field of autoimmunity. More specifically, the present invention relates to the detection of autoantibodies to domain 4 of beta 2-glycoprotein I (?2-GPI) as an indicator for atherosclerosis.

Abstract: The invention relates to the detection and quantification of carbamazepine drugs and their metabolites. The invention is underpinned by novel polyclonal antibodies with unique binding properties which enable immunoassay methods and kits for various applications.

Abstract: An embodiment of the invention relates to a device for detecting an analyte in a sample. The device comprises a fluidic network and an integrated circuitry component. The fluidic network comprises a sample zone, a cleaning zone and a detection zone. The fluidic network contains a magnetic particle and/or a signal particle. A sample containing an analyte is introduced, and the analyte interacts with the magnetic particle and/or the signal particle through affinity agents. A microcoil array or a mechanically movable permanent magnet is functionally coupled to the fluidic network, which are activatable to generate a magnetic field within a portion of the fluidic network, and move the magnetic particle from the sample zone to the detection zone. A detection element is present which detects optical or electrical signals from the signal particle, thus indicating the presence of the analyte.

Abstract: The invention relates to lipid bilayer coated beads and methods of using those beads in immunoassays, in analytical assay and the like.

Abstract: A methodology for developing highly sensitive and selective sensors that can achieve portable, low-cost and quantitative detection of a broad range of targets using only a personal glucose meter (PGM) is disclosed. The method uses recognition molecules specific for a target agent, enzymes that can convert an enzyme substrate into glucose, and a PGM. Also provided are sensors, which can include a solid support having attached thereto a recognition molecule that permits detection of a target agent, as well as an enzyme that can catalyze the conversion of a substance into glucose, wherein the enzyme is attached directly or indirectly to the recognition molecule, and wherein in the presence of the target agent the enzyme can convert the substance into glucose. The disclosed sensors can be part of a lateral flow device. Methods of using such sensors for detecting target agents are provided.

Abstract: Use of busulfan amide as stabilized standards in immunoassays for quantifying the amount of busulfan in samples of human biological fluids, methods for carrying out said immunoassay and kits for use in said immunoassay.

Abstract: The present invention provides a method for screening and evaluating ameliorants of dry skin caused by atopic dermatitis, comprising: evaluating a candidate drug as being an ameliorant of dry skin caused by atopic dermatitis in the case the candidate drug significantly increases expression and/or activity of bleomycin hydrolase in comparison with a control drug.

Abstract: Methods and kits for performing a two-phase optical assay for one or more than one analyte without intrinsic optical contrast in a sample are disclosed. The method requires use of a functionalized microparticle immobilized with two or more than functional components and an additional set of one or more than one functional component. The assay can be performed in one single container and does not need a wash step.

Abstract: This document provides methods and materials related to detecting neurotransmitters and other biologically active small molecules. For example, methods for detecting and measuring hapten levels in a biological sample using antibodies specific for conjugated haptens are provided.

Abstract: Based on the observation of the cooperation of osteopontin (OPN) and matrixmetalloproteinase-9 (MMP-9) in the promotion of the metastatic phenotype, therapies and diagnostic assays are disclosed for the treatment of a tumor that overexpresses OPN, such as hepatocellular carcinoma (HCC), for example metastatic HCC. In one example, methods of treating a tumor include administration of an agent that reduces cellular invasion resulting from the interaction between a fragment of OPN (OPN-5kD) generated by MMP-9 cleavage and CD44 receptor. Examples of such agents include fragments of OPN-5kD and antibodies specific for OPN-5kD. Therapeutic compositions are also provided that include such agents. Also provided are methods of diagnosing or prognosing a tumor, for example by detecting expression of OPN-5kD peptide or OPN-c mRNA in a biological sample obtained from the subject. Also provided are antibodies that specifically bind OPN-5kD.

Abstract: This invention provides devices and methods for detecting an analyte suspected to be present in a sample. The subject devices and methods are particularly useful for performing immunoassays on a variety of analyte, especially those present in a bodily fluid.

Abstract: Disclosed are procedures and methods for diagnosing latent and active cancers in a subject. The described methods include the use of sandwich ELISA assays containing antibodies specific for certain epitopes on the A-protein. This enables the assay to discriminate between the monomelic and homopolymeric forms of A-protein.

Abstract: Computer-implemented methods and systems are provided for the analysis of multiplex fluorescent-dyed microsphere assays. The methods of the invention provide for determination of differences in analyte quantities between samples obtained from multiplex fluorescent-dyed microsphere assays by analysis of individual bead fluorescence and adjusting for variance; variance-stabilization of the data, and determining significance with hypothesis testing with tolerance determined by power estimation. The methods of the invention provide a benefit in allowing access to low signal or poor quality data, increased statistical power and decreased variability compared to standard curve methodology.

Abstract: An in vitro process for the detection and early detection of neurodegenerative diseases, for determination of the severity, and to evaluate the progression of and render a prognoses of neurogenerative diseases, in a patient suffering from a subjectively or objectively detectable cognitive impairment, by determining the concentration of an analyte selected from natriuretic peptides, in particular ANP, and, if necessary, BNP and/or CNP in a biological fluid of the patient, whereby the determination of the analyte is performed directly and/or indirectly as the determination of a relevant co-peptide generated from a mutual propeptide, and is based upon the measured concentration of the determined analyte thus making it possible to form conclusions about a neurodegenerative disease or an early form typical of such a disease or the course of the disease and/or the success of the efforts to relieve or prevent the disease.

Abstract: The present disclosure provides methods and/or kits for detecting an analyte in a sample. Some embodiments provide a method for detecting a non-nucleic acid analyte in a sample using a solid substrate comprising a bound immobilisation agent and an antibody capture agent and a detectable agent, which can bind to the analyte. The antibody capture agent comprises, at a plurality of sites, a ligand for the immobilisation agent. A complex between the analyte, the antibody capture agent and a detectable agent is formed and immobilised on the solid substrate by binding between the immobilisation agent and the ligand. In some embodiments, the ligand and the immobilisation agent are a binding pair comprising a peptide tag and an anti-peptide tag antibody.

Abstract: Novel conjugates and immunogens derived from lenalidomide and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of thalidomide and lenalidomide in biological fluids.

Abstract: A method for analyzing a biological sample by antibody profiling for identifying forensic samples or for detecting the presence of an analyte. In an embodiment of the invention, the analyte is a drug, such as marijuana, Cocaine (crystalline tropane alkaloid), methamphetamine, methyltestosterone, or mesterolone. The method comprises attaching antigens to a surface of a solid support in a preselected pattern to form an array wherein locations of the antigens are known; contacting the array with the biological sample such that a portion of antibodies in the sample reacts with and binds to the antigens in the array to form immune complexes; washing away antibodies that do form immune complexes; and detecting the immune complexes, to form an antibody profile. Forensic samples are identified by comparing a sample from an unknown source with a sample from a known source.