Abstract: The present invention provides assays for detecting and measuring the presence or level of anti-TNF? drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF? drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.

Abstract: A kit includes a reference probe to react with a first sample; and an analyte probe to combine with a second sample, a marker and a spectral probe to react to form the analyte probe to combine with the second sample, the marker to react with the reference probe to form the analyte probe to combine with the second sample, or a combination thereof. A process for staining includes forming a reference composition by reacting a reference probe and a first sample to form a reference; and forming an analyte composition by combining an analyte probe and a second sample to form an analyte.

Abstract: The present invention relates to functional, modified glucose-galactose binding proteins (GGBPs), that have a greater melting temperature (Tm) than a reference GGBP. The present invention also relates to biological sensors, e.g., glucose sensors, comprising these thermostable GGBPs. The present invention also relates to nucleic acids encoding these thermostable GGBPs.

Abstract: Embodiments of the invention relate to integrated chemiluminescence devices and methods for monitoring molecular binding utilizing these devices and methods. These devices and methods can be used, for example, to identify antigen binding to antibodies. The devices include both a chemiluminescence material and a detector integrated together.

Abstract: A microchip capable of sending liquid in a micro flow channel to a predetermined place irrespective of the pressure difference and sending a mixture of two or more liquid masses to a predetermined place even if the channel structure is simple. The microchip comprises an intermediate reservoir portion provided in a micro flow channel and adapted for temporarily holding liquid sent through the micro flow channel. The microchip is characterized in that the intermediate reservoir portion has a side channel, the volume of the intermediate reservoir portion is smaller than the total volume of the liquid sent into the intermediate reservoir portion, the side channel is provided for communication of a micro flow channel on the upstream side of the intermediate reservoir portion with a micro flow channel on the downstream side thereof, and the cross-section area of the side channel is smaller than that of the micro flow channel.

Abstract: A sample support structure comprising a sample support manufactured from a semiconductor material and having one or more openings therein. Methods of making and using the sample support structure.

Abstract: The present invention relates to specific markers capable of detecting the development of colorectal cancer and the colorectal cancer inhibitory effect of SeMet (selenomethionine) having a chemopreventive effect against colorectal cancer. When the expressions of the biomarkers according to the present invention are measured and the expression levels thereof are analyzed in combination, whether SeMet (selenomethionine) is to be administered to prevent colorectal cancer can be determined and the development of colorectal cancer and the inhibitory effect of SeMet (selenomethionine) against the development of colorectal cancer can be monitored. Thus, these markers can be effectively used to observe the colorectal cancer inhibitory effect of SeMet (selenomethionine) and the prognosis of colorectal cancer resulting from the intake of SeMet (selenomethionine).

Abstract: The genome sequences and the nucleotide sequences coding for the PWD circovirus polypeptides, such as the circovirus structural and non-structural polypeptides, vectors including the sequences, and cells and animals transformed by the vectors are provided. Methods for detecting the nucleic acids or polypeptides, and kits for diagnosing infection by a PWD circovirus, also are provided. Method for selecting compounds capable of modulating the viral infection are further provided. Pharmaceutical, including vaccine, compositions for preventing and/or treating viral infections caused by PWD circovirus and the use of vectors for preventing and/or treating diseases also are provided.

Abstract: Methods and compositions are provided for detecting molecular translocations, particularly protein translocations within and between sub-cellular compartments, using at least two components that exhibit a localization-dependent difference in complementation activity. In particular, alpha-complementing ?-galactosidase fragments are provided. These ?-galactosidase reporter fragments display significantly enhanced enzymatic activity when one fragment is localized in a membrane. Methods for carrying out no-wash ELISA assays based on the reporter component system are also provided.

Abstract: The present invention provides monoclonal antibodies which specifically recognize the shorter A? peptides obtained after cleavage of the APP protein mediated by ?-secretase, i.e. the A?-peptide fragments A?1-37, A?3-37, A?3p-37, A?1-37 and A?11p-37, and other like fragments ending at the 37th amino acid of APP, hereinafter also referred to as the A?x-37 peptides. It further provides hybridoma cells producing the monoclonal antibodies as well as methods for producing the antibodies and the hybridoma cells; and an immunoassay for an A?x-37 peptide by a competitive method or a sandwich method using the antibody of the present invention; and methods for measuring the level of A?x-37 peptides in a sample, such as a biological sample.

Abstract: This invention relates to a method for detecting or examining a cancer selected from colorectal cancer and esophageal cancer with high detection sensitivity and accuracy and with less invasiveness to a subject. Specifically, it relates to a method for examining a cancer comprising measuring in vitro a COTL1 protein in a body fluid sample from a subject and evaluating whether or not the subject suffers from the cancer based on the measured amount of the COTL1 protein. It further relates to a kit for diagnosis of a cancer selected from colorectal cancer and esophageal cancer comprising an antibody or a fragment thereof capable of specifically binding to the protein.

Abstract: The present invention provides a method of determining the susceptibility of a subject to treatment with a leukotriene modifier by determining the subject's cysteinyl leukotriene (CysLT) level and the subject's level of eosinophilic airway inflammation and identifying a subject with a high ratio of CysLT levels to eosinophilic airway inflammation as susceptible to treatment with the leukotriene modifier. Also discussed is a method of treatment of subjects who are susceptible to treatment that includes administering a leukotriene modifier to such a subject.

Abstract: Described are methods for diagnosing and predicting the risk of pregnancy loss in a subject based on the presence of an aberrant humoral response to three proteins, Apolipoprotein B-100, alpha2macrogloblin (alpha2M), and fibronectin. The presence or a detectable level of maternal IgG antibodies to trophoblast-derived fibronectin and/or ApoB-100, and/or the absence or a non-detectable level of antibodies specifically binding to alpha2M is associated with a history of RPL and an increased risk of pregnancy loss. Also described are methods for identifying subjects at risk of pregnancy loss, selecting subjects for participation in a clinical study, and methods of decreasing the risk of pregnancy loss in a subject which include detecting the presence or absence of antibodies to one or more of trophoblast-derived ApoB-100, alpha2M, and fibronectin. Also provided are kits that contain ApoB-100, alpha2M, and fibronectin.

Abstract: Progastrin levels are determined to diagnose one or more liver pathologies.

Abstract: The invention provides reagents and methods for lateral flow assays and quantitative capture or determination of components, including cells, in a sample. In one aspect, reagents and methods for diagnostic assay are provided. In one embodiment an assay for determining T cell numbers, particularly a CD2+ CD4+ T cell assay is provided. A manufacturing method for producing rapid diagnostic assays in a decentralized manner is also described. The method generates net economic advantages over conventional diagnostic manufacturing practices.

Abstract: The invention provides novel immunogenic proteins LigA and LigB from Leptospira for use in the development of effective vaccines and antibodies, as well as improved diagnostic methods and kits.

Abstract: The present invention provides methods of detecting an antigen in a sample comprising contacting the sample with affinity agents to form an antigen-affinity agent-label complex, separating the antigen-affinity agent-label complex from uncomplexed components, partitioning label from the separated sample into multiple partitions, and detecting the presence of the label in one or more partitions. Compositions and kits for detecting an antigen in a sample are also provided.

Abstract: The present application provides a method of diagnosing bacterial infections using engineered glycoproteins in an immunoassay. The engineered bacterial glycoproteins used in the immunoassay comprise a bacterial antigen covalently attached to a protein via polysaccharyltransferase (PTase)-mediated glycosylation, wherein the bacterial antigen is selected based on the bacterial infection of interest. Antibodies in a bodily fluid of subjects infected with a bacteria will bind to the engineered glycoprotein, and the resulting binding complexes are detected or quantitated.

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 present invention relates to a biosensor using dual amplification of signal amplification by means of enzymes coupled with signal amplification by means of redox cycling, and to the use of a technology that maintains a slow reaction state between redox cycling materials without the use of redox enzymes, and induces quick chemical-chemical redox cycling. In addition, the present invention relates to a biosensor which obtains triple amplification by inducing electrochemical-chemical-chemical redox cycling, in addition to signal amplification by means of enzymes and signal amplification by means of chemical-chemical redox cycling.

Abstract: Embodiments of the present disclosure set forth a biosensor for detecting a target. One example sensor includes a first electrode. The first electrode includes a first electron conducting molecule and a first probe. The first probe includes a second electron conducting molecule. The first probe is configured to bind to the target of interest in solution. The first and second electron conducting molecules are different.

Abstract: The present invention relates to kits designed for the collection of stool samples and methods of analyzing those samples for biological markers of maldigestion, inflammation, and imbalanced gut flora.

Abstract: A method for performing a multiplexed diagnostic assay, such as for two or more different targets in a sample, is described. One embodiment comprised contacting the sample with two or more specific binding moieties that bind specifically to two or more different targets. The two or more specific binding moieties are conjugated to different haptens, and at least one of the haptens is an oxazole, a pyrazole, a thiazole, a nitroaryl compound other than dinitrophenyl, a benzofurazan, a triterpene, a urea, a thiourea, a rotenoid, a coumarin, a cyclolignan, a heterobiaryl, an azo aryl, or a benzodiazepine. The sample is contacted with two or more different anti-hapten antibodies that can be detected separately. The two or more different anti-hapten antibodies may be conjugated to different detectable labels.

Abstract: 3-dimensional surface-enhanced Raman scattering (SERS), as well as absorption/fluorescence/luminescence detection is carried out using a platform based on nanoparticle-functionalized flow-through multi-hole capillaries for rapid analyte detection. The configuration provides an increased active area and fluidic channels for efficient sample delivery, and also confines and transmits light for a large signal accumulation. Using a capillary consisting of thousands of micron-sized holes adsorbed with gold nanoparticles, a detection limit better than 100 fM is achieved.

Abstract: The present invention provides compositions comprising chimeric polypeptides that bind to free ubiquitin proteins or free ubiquitin-like proteins with high affinity, as well as chimeric polypeptides that bind to both free and conjugated ubiquitin proteins or free and conjugated ubiquitin-like proteins, and methods of using the chimeric polypeptides to determine the amount of free or total ubiquitin or free or total ubiquitin-like proteins in various types of samples.

Abstract: The invention provides compositions and methods of use thereof for labeling peptide and proteins in vitro or in vivo. The methods described herein employ lipoic acid ligase or mutants thereof, and lipoic acid analogs recognized by lipoic acid ligase and lipoic acid ligase mutants.

Abstract: This invention is directed to methods and compositions for sorting and/or determining microscopic organisms or cells. The methods and compositions are directed to the use of molecular probes to selectively stain the organisms or cells in combination with the use of binding partners to selectively immobilize the stained organisms or cells to a solid carrier. By combining the selectivity of both molecular probes and binding partners in an orthogonal method for staining and immobilization, these methods and compositions increase both the discriminating power of the assays and/or the certainty of the result obtained therefrom.

Abstract: This disclosure describes methods and compositions for immunohistochemically detecting the presence of a SRP autoantibody in a biological sample.

Abstract: Methods of predicting whether a cancer will respond to an EGFR inhibitor are provided.

Abstract: The present invention lies in the field of visualization and quantification of immobilized targets in samples using immunochemical means. In particular, the invention relates to a method and reagents for detection, visualization and quantification of a molecular target in immunostained histological samples using particular compositions of the target specific binding agent. Methods and compositions of the invention are suitable for any assay that uses a target visualization system in histological samples based on detection of the target by the target specific binding agent. The methods and compositions are useful for evaluation of targets that are biomarkers of diseases in medical diagnostic.

Abstract: Screening assays and methods of performing such assays are provided. In certain examples, the assays and methods may be designed to determine whether or not two or more species can associate with each other. In some examples, the assays and methods may be used to determine if a known antigen binds to an unknown monoclonal antibody.

Abstract: Methods and genetic constructs are provided for detecting the binding of nuclear hormone receptors to a coactivator/corepressor. The methods employ enzyme fragment complementation using fragments of ?-galactosidase as the detection system. Cells are transformed to express the large fragment of ?-galactosidase fused to a member of the complex with NHR for initiation of transcription and have it localized in the nucleus and to express the small fragment of ?-galactosidase fused to the nuclear hormone receptor for binding to the member upon stimulation with a ligand.

Abstract: Conserved polypeptides from protozoan parasitic species which are secreted through the endoplasmic reticulum/Golgi dependent secretory pathway, their identification and their use.

Abstract: The anti-canine N-terminal pro-atrial natriuretic peptide antibodies (anti-canine NT-proANP antibodies) according to the present invention comprise anti-canine NT-proANP recognizing a partial portion or a whole portion of the amino acid sequence 31 to 67 of canine NT-proANP and anti-canine NT-proANP recognizing a partial portion or a whole portion of the amino acid sequence 68 to 98 thereof. The anti-canine NT-proANP antibodies are useful for immunologically measuring canine NT-proANP involved in heart diseases and infections of companion animals such as dogs, such as heart failure, mitral valve insufficiency and filariasis. The immunochromatographic assay using the immunochromatographic means such as immunochromatographic strip is extremely convenient and simple for measuring canine NT-proANP and is used as hand-carried and simple devices.

Abstract: Methods and compositions are provided for diagnosing and treating a diabetic kidney disease (DKD) in an individual. In aspects of the methods, the levels of soluble circulating urokinase receptor (suPAR) in the blood are measured to predict a DKD, diagnose a DKD, or provide a prognosis pertaining to a DKD. In addition, reagents, devices and kits thereof that find use in practicing the subject methods are provided.

Abstract: The invention relates to novel immunogens, antibodies, methods and kits for use in immunoassays to detect and quantify zaleplon, metabolites of zaleplon and indiplon. These are the first described immunoassays for these compounds and have greater sensitivity than alternative analytical techniques.

Abstract: The present invention relates to a method of in vitro determining functional deficiencies in the lectin pathway of the complement system, the method comprises the steps of (a) diluting a mammalian sample of body fluid with a diluent comprising one or more inhibitors of the activation of the classical and the alternative pathways of the complement system; (b) activating the lectin pathway of the complement system in the sample obtained from (a); and (c) determining in the sample obtained from (b) the activation of one or more of the complement factors C3, C4, or one or more of the components of the C5-C9 complex. The invention furthermore relates to kits for use in connection with the above-mentioned method, the first kit comprises i) a first component comprising a carrier, one or more inhibitors of the classical and the alternative complement pathways and a diluent; and ii) a second component comprising one or more substances for activation of the lectin complement pathway and optionally an inert carrier.

Abstract: In sporadic Alzheimer's disease, neurofibrillary lesion formation is preceded by extensive post-translational modification of the microtubule associated protein tau. Immunoassays have been developed recently that detect tau in biological specimens, thus providing a means for pre-mortem diagnosis of Alzheimer's disease, which has remained elusive. These assays have been improved by the analysis of relevant post-translational modifications, such as phosphorylation, however opportunity for improvement remains. The present invention addresses this issue by disclosing synthetic methylated peptides derived from the tau protein of paired helical filaments and non-diseased control brain. Alzheimer's disease specificity is provided by the presence or absence of methyl moieties on lysine residues and differences between mono-, di-, and tri-methylation.

Abstract: This invention relates to a method and apparatus for detecting a biological molecule associated with enzyme activity in a sample. The invention is applicable to detecting a microorganism associated with an enzyme in a sample such as water, food, soil, or a biological sample. According to a preferred embodiment of the method of the invention, a sample containing an enzyme of interest or a microorganism associated with the enzyme is combined with a suitable substrate, and a fluorescent product of the enzyme-substrate reaction is selectively detected. The fluorescent product is detected with a partitioning element or optical probe/partitioning element of the invention. In one embodiment the partitioning element provides for partitioning of only the fluorescent product molecule into the probe. The invention also provides an automated system for monitoring for biological contamination of water or other samples.

Abstract: Methods of inhibiting fibroblast growth factor mediated activation of fibroblast growth factor receptors for the treatment of chronic kidney disease, diabetes, and cardiac diseases are enclosed. Pharmaceutical compositions for the treatment of such diseases using the methods are also disclosed as are methods of determining whether a subject would benefit from the methods of treatment and pharmaceutical compositions.

Abstract: The present invention relates to compositions and methods for cancer diagnosis, research and therapy, including but not limited to, cancer markers. In particular, the present invention relates to polypeptides found in extracellular microvesicles as diagnostic and screening markers, and clinical targets for cancer (e.g., prostate cancer).

Abstract: A bioassay for the quantification of peptide fragments comprising a neo-epitope formed by cleavage of a titin protein by a proteinase comprises contacting a sample with an antibody specifically binding said neo-epitope and determining the level of binding.

Abstract: A device for volumetric metering a liquid biologic sample is provided. The device includes an initial chamber, a second chamber, a third chamber, a first valve, a second valve and a third valve. The chambers are each configured so that liquid sample disposed in the respective chamber is subject to capillary forces. Each chamber has a volume, and the volume of the initial chamber is greater than the volume of either the second or the third chambers. The valves each have a burst pressure. The burst pressure of the first valve is greater than the third burst pressure. The first valve is in fluid communication with the second chamber. The second valve is disposed between, and is in fluid communication with, the initial chamber and the third chamber. The third valve is in fluid communication with the third chamber.

Abstract: Levetiracetam (LEV) derivatives, methods for synthesizing LEV derivatives, and immunodiagnostic assays for LEV. The synthesis methods described herein include chirally-selective, liquid-phase synthesis steps to produce selected LEV derivatives in high-yield. LEV derivatives can include operative groups, such as: immunogenic moieties that can be used to prepare anti-LEV antibodies; antigenic moieties that can be used in immunodiagnostic assays for LEV; or tracer moieties that can be used in immunodiagnostic assays. Additionally, the LEV derivatives can be used in immunodiagnostic assays to compete with LEV for anti-LEV antibodies.

Abstract: Methods, compositions and kits are disclosed directed at levetiracetam derivatives, immunogens, signal generating moieties, antibodies that bind levetiracetam and immunoassays for detection of levetiracetam.

Abstract: In some aspects, provided are methods relating to the use of bacterial N-methyl-2 superfamily proteins as a biomarker for the presence of bacteria in a sample. The invention also relates to novel methods of diagnosis of the presence of bacteria in a liquid or solid sample, detection of bacterial infections in humans or animals, and use of antibodies or other specific binding molecules capable of binding to N-methyl-2 superfamily proteins.

Abstract: The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step.

Abstract: Immunoassays and methods for detecting and quantifying biological levels of intact fibroblast growth factor (FGF)-23, as well as the N-terminal and C-terminal fragments thereof in a biological sample. The relative amounts or ratios of FGF-23 relative the N-terminal and C-terminal fragments can also be determined. The systems and methods deploy antibodies that are specific to antigenic regions formed upon either the N-terminal or C-terminal regions of FGF-23 and are systematically applied such that intact FGF-23 and the fragments thereof can be detected and quantified. In certain embodiments, dissimilar labels conjugated to tracer antibodies or labeled antibodies specific to N-terminal and/or C-terminal tracer antibodies are utilized to facilitate detection and quantification of both whole length FGF-23 and any fragments thereof.

Abstract: The present disclosure relates to diagnostic test devices that provide increased comfort and ease of use. The diagnostic test device can include a test member, such as a lateral flow assay test strip. The test device can further comprise a housing that comprises a substantially arch shaped handle. The housing of the test device can comprise a base member that is attached to a curved lower surface of the housing and that can improve stability of the device in an upward facing position as well as enable angled positioning of the device relative to a flat, horizontal surface. The curvature of the test device in particular can provide secure handling of the device while also improving ease and comfort of use thereof. The disclosure further relates to methods of determining the presence of an analyte in a fluid sample and methods for evaluating a test result of a personal use diagnostic test device.

Abstract: A sample collection device for a fluid sample includes: a body including a capillary channel having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; an air vent located in the vicinity of the second end and in fluid communication with the capillary channel; a barrier positioned within the capillary channel to prevent flow of the fluid by capillary action thereacross; and features on opposing sides of the body to form an axis of rotation, which is substantially perpendicular to the overall direction of the capillary channel from the first end to the second end. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a sample manipulation device to bring the first end into position with the sample manipulation device.