Abstract: An implantable medical device is provided for use with an external detector to detect an analyte in vivo. In one embodiment, the device consisting essentially of a substrate; a plurality of discrete reservoirs located in the substrate, each reservoir having at least one opening; a reacting component contained in each reservoir; and at least one non-degradable barrier layer covering each reservoir opening, the barrier layer being permeable to an analyte to be detected, wherein the reacting component remains inside the reservoirs and can react with the analyte to be detected, and wherein the device is adapted for implantation into the body of a patient.

Abstract: A method for detecting lysosomal storage diseases including the steps of performing an assay for a single species of glycosaminoglycan contained in a specimen and correlating results of the assay with lysosomal storage diseases. A body fluid such as urine or blood can be employed as a specimen. The assay can be performed by use of a polypeptide that is capable of specifically binding to a glycosaminoglycan-containing molecule. The polypeptide may be an antibody, or a polypeptide having an antigen-binding site of an antibody.

Abstract: Methods for detecting invasive trophoblast antigen (ITA) in biological samples comprise screening the samples for ITA using antibodies that bind to the ITA. The methods are useful to detect pregnancy, trophoblastic diseases, and Down's syndrome in fetuses of pregnant women. Some methods include screening the samples with a plurality of capture antibodies that specifically bind ITA. Chemiluminescent immunoassays are disclosed. The methods may be practiced with the diagnostic kits of the invention.

Abstract: The invention relates to a process for the production of a biomolecule-linker conjugate of uniform stochiometry. It especially relates to a conjugate consisting of a biomolecule of a molecular weight between 5 kD and 500 kD and a hydrophilic linker molecule said linker having a molecular weight between 1 and 15 kD and between 4 and 60 charged residues, characterized in that said conjugate comprises at least one biomolecule-linker product of uniform stoichiometry in a pre-selected amount.

Abstract: A multi-stage method for diagnosing an immunologic food sensitivity or intolerance in a companion animal. Firstly a saliva or other non-serum bodily fluid sample is collected. The screening the saliva or other non-serum bodily fluid sample detects the presence of at least one of IgA or IgM antibody to a particular food ingredient or composition. An immunologic food sensitivity or intolerance based on the presence of the antibody is diagnosed. Secondly a blood sample is collected and serum from the sample is screened to detect the quantitative presence of at least one of an IgA, IgM or IgG antibody or immune complex to a particular food ingredient or composition. An immunologic food sensitivity or intolerance based on the presence of the antibody or immune complex is diagnosed. Thirdly a biologically active nutrient in relation to the animal from a molecular dietary signature is determined.

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: The present invention relates to a method for identifying a subject at risk of developing hypertensive end organ damage, such as and in particular heart failure, comprising: a) obtaining a biological sample of said subject; b) determining the level of at least one non-myocytal marker in said sample; c) comparing the level of said marker to a standard level; and d) determining whether the level of the marker is indicative of a risk for developing hypertensive end organ damage. The non-myocytical marker preferably is galectin-3 or thrombospondin-2.

Abstract: A method of detecting liver damage in a subject comprises measuring the level of caspase-3 generated cytokeratin-18 fragments in the bodily sample. The level of measuring the level of caspase-3 generated cytokeratin-18 fragments is then correlated with liver disease progression.

Abstract: A method for the determination of cardiovascular risk factors in biological samples that comprising the steps of a) sampling, b) altering the sample into a dry blood sample c) conducting a sample preparation where appropriate and d) analyzing the sample to offer a simple yet effective method for the determination of cardiovascular risk factors in biological samples. It also relates to dry blood filter for performing this method, that filter comprises at least one substance of the group consisting of antioxidants, coagulants, disinfectants, detergents and inhibitors.

Abstract: Analysis of complex media (e.g.—blood and seawater) is difficult because the media are composed of particles of different sizes and chemical profiles. Disclosed is a method for the detection of a constituent in a medium that enhances the molecular selectivity of a detector by separating the detector from the medium by a membrane of specified permeability. Proxy reporters are employed to enhance particle specificity. The novel combination of the invention has application to chemical detection in a broad range of fields.

Abstract: The invention relates to a method for quantitatively or qualitatively detecting an analyte in a sample, with the sample being incubated, for the purpose of avoiding, diminishing and/or detecting the high-dose hook effect, with an analyte-specific binding partner R1, which is associated with a solid phase, an analyte-specific binding partner R2, which is associated with a label L1, and an analyte-specific binding partner R3, which is associated with a label L2, and the L1-dependent measurement signal being determined either at a different time from the L2-dependent or L1 plus L2-dependent measurement signal or using a different measurement method.

Abstract: Diagnosing an immunologic food sensitivity or intolerance in companion animals comprises collecting a sample; screening the sample to detect the presence of an antibody to a particular food ingredient or composition. The sample can be serum, saliva or other bodily fluid to detect the presence of an IgA, IgM or IgG antibody or immune complex to a particular food ingredient or composition. The food ingredient for which sensitivity or intolerance is tested is contained in at least one of a preprocessed food composition, balanced diet or recipe. Offending ingredient(s) in a preprocessed food composition, balanced diet or recipe is determined. An assessment is made as to whether it is possible to use a different preprocessed food composition, balanced diet or recipe, or whether a special diet needs to be formulated without the offending ingredient(s).

Abstract: Improved single-container, two-phase optical assays for analytes are provided which are faster and require less steps than conventional two phase optical assays. The assays of the invention involve first mixing and incubating an assay mixture including a buffer, solid particles (e.g., agarose beads), an analyte-containing sample, and an affinity agent operable to bind analyte(s) to the solid particles, followed by separation of the mixture into a particle-rich phase and a substantially particle-free phase. In one aspect, the settling step is gravity-induced and is instrumentally monitored to determine when substantially full separation has occurred. Thereafter, the respective phases may be photometrically measured to obtain qualitative and/or quantitative information about the analyte(s). It has been found that measurements taken with only one sensor set before and after settling of the particle-rich fraction give scientifically valid results as a two phase optical assay.

Abstract: We have discovered a new method to analyze and characterize complex cell signaling networks. The method is based on specific binding of protein-protein interaction modules to a single type of protein or a mixture of proteins. The method utilizes a number of different protein-protein interaction domains as probes or sensors for the signaling state of the system under investigation.

Abstract: A homogeneous assay for determining the aflatoxin content in agricultural products uses the technique of fluorescence polarization. A solvent is used to extract aflatoxins from a sample of the agricultural product. A mixture is prepared by combining the extract with a tracer and with a monoclonal antibody specific for aflatoxin. The tracer is able to bind to the monoclonal antibody to produce a detectable change in fluorescence polarization. The tracer is prepared by conjugating an aflatoxin oxime to a suitable fluorophore. The fluorescence polarization of the mixture is measured. The aflatoxin concentration of the mixture may be calculated using a standard curve obtained by measuring the fluorescence polarization of a series of aflatoxin solutions of known concentration.

Abstract: The present invention relates to methods of diagnosing myasthenia gravis in a subject, by determining an amount of at least one autoantibody that specifically binds one or more autoantigens selected from heat-shock protein 60 (hsp60), heat-shock protein 90, alpha isoform (hsp90?), and heat-shock protein 90, beta isoform (hsp90?). The invention also provides diagnostic kits for identifying a subject having myasthenia gravis.

Abstract: A non-radioisotopic method detects T3AA and T4AA thyroid autoantibodies in a sample from a non-human species such as the canine species. Antibodies and autoantibodies are bound, and a precipitated or bound antigen-antibody or antigen-autoantibody complex is formed. The supernatant or surrounding fluid of the bound or precipitated antigen-antibody or antigen-autoantibody complex is then removed. The thyroid activity of the bound complex, precipitate, supernatant or surrounding fluid is measured. The thyroid analyte is at least one of T3, Free T3, T4 or Free T4.

Abstract: A non-radioisotopic method of detecting thyroid analytes comprising detecting T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in a sample of a non-human species. Each one of these analytes in an assay profile includes non-radio isotopic measurement of T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in the sample from the non-human species. A non-radioisotopic method detects T3AA and T4AA thyroid autoantibodies in a sample from a non-human species such as the canine species. A non-radioisotopic method detects Free T4 in a sample of a non-human species.

Abstract: Method for diagnosis of autoimmune diseases of the GSE-type or associated with gluten sensitive enteropathy comprising taking a sample and testing the sample for antibodies against human tissue transglutaminase, tissue-specific transglutaminases, or other transglutaminases.

Abstract: A method for detecting a parasitic worm infection of the digestive tract of a mammal. The method includes detecting the binding of a worm antibody to a worm antigen present in the soluble portion of a fecal sample of infected mammals.