Abstract: The present invention contemplates use of encapsulated aqueous and non-aqueous reagents, solutions and solvents and their use in laboratory procedures. These encapsulated aqueous or non-aqueous reagents, solutions and solvents can be completely contained or encapsulated in microcapsules or nanocapsules that can be added to an aqueous or non-aqueous carrier solution or liquid required for medical and research laboratory testing of biological or non-biological specimens.

Abstract: The present invention refers to an aqueous solution for use as medium for the specific binding reaction of a binding pair, wherein a first binding member recognizes its complementary second binding member. The solution contains a) a buffer to control pH; b) a compound A selected from a compound defined by the general formula I R1—[[CR2R3]P—O]q—R4, wherein R1 is hydrogen or hydroxy group, R2 for each unit independently is hydrogen or hydroxy group, R3 is hydrogen, methyl group, or ethyl group, R4 is hydrogen or alkyl group, p is an integer of from 2 to 10 and q is an integer of from 1 to 100, with the proviso that the compound at least carries two hydroxy groups; a polyol; or saccharide; and c) a non-ionic detergent.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises measuring assay signal resulting from background only and measuring assay signal resulting from the presence of analyte in the sample plus background and subtracting the first measurement from the second measurement to determine the concentration of analyte in the sample. For example, a measurement result 1 is determined by means of an assay conducted on a portion of the sample where analyte in the sample is substantially sequestered and a measurement result 2 is determined by means of the assay conducted on an equal portion of the same sample where analyte in the sample is substantially non-sequestered. Measurement result 1 is subtracted from measurement result 2 to determine the concentration of analyte in the sample.

Abstract: The subject invention relates in part to the surprising and unexpected discovery that insects that are resistant to Bacillus thuringiensis Cry toxins have measurably altered alkaline phosphatase (ALP) activity as compared to insects that are susceptible to Cry toxins. This and other surprising discoveries reported herein have broad implications in areas such as managing and monitoring the development of insect resistance to B.t. toxins. For example, the subject invention provides a simple and fast assay (enzymatic or otherwise) for detecting ALP activity levels and thereby monitoring the development of resistance by insects to crystal protein insect toxins. There was no prior motivation or suggestion to go about resistance monitoring using this simple and easy approach.

Abstract: The present invention contemplates use of encapsulated aqueous and non-aqueous reagents, solutions and solvents and their use in laboratory procedures. These encapsulated aqueous or non-aqueous reagents, solutions and solvents can be completely contained or encapsulated in microcapsules or nanocapsules that can be added to an aqueous or non-aqueous carrier solution or liquid required for medical and research laboratory testing of biological or non-biological specimens.

Abstract: Disclosed are antibodies that selectively bind to blood coagulation factor FVIII, and highly sensitive immunological assays comprising these antibodies. Preferred assays can detect FVIII at about 3500-fold below the normal physiological levels, and have a wide array of applications including accurate monitoring of FVIII concentration in pharmaceutical products for treatment of blood coagulation disorders, and determination of FVIII levels in plasma of human patients, including those with blood coagulation disorders such as hemophilia.

Abstract: A method of treating samples containing hepatitis C virus (HCV) which method comprises treating HCV-containing samples with a treating agent containing (1) an acidifying agent, and (2) a protein-denaturing agent, or an amphoteric surfactant or a cationic surfactant having both a straight chain alkyl group of 10 or more carbon atoms and a tertiary amine or a quaternary ammonium salt in the same molecule, to effect the release of the HCV antigen and the inactivation of antibodies that bind to the HCV antigen, and the like.

Abstract: The invention relates to antibodies, including monoclonal and polyclonal, or fragments thereof, which discriminate between the histidine and tyrosine isoforms of Complement Factor H and to their use in diagnostic methods and therapeutic treatments relating to Complement Factor H mediated diseases.

Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium that includes the sample, a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent includes a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further include a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties. The pretreated sample may be subjected to an assay for determining the hydrophobic drug.

Abstract: The binding specificity of at least one plasma protein suspended or dissolved in a liquid medium is altered by exposing the protein to an oxidizing agent or an electric current sufficient to alter its binding specificity. A masked protein such as an autoantibody can be recovered from blood or blood products or extracts by oxidizing the protein to change its binding specificity.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises measuring assay signal resulting from background only and measuring assay signal resulting from the presence of analyte in the sample plus background and subtracting the first measurement from the second measurement to determine the concentration of analyte in the sample. For example, a measurement result 1 is determined by means of an assay conducted on a portion of the sample where analyte in the sample is substantially sequestered and a measurement result 2 is determined by means of the assay conducted on an equal portion of the same sample where analyte in the sample is substantially non-sequestered. Measurement result 1 is subtracted from measurement result 2 to determine the concentration of analyte in the sample.

Abstract: The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CELLSPOTTER® fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Abstract: Disclosed are antibodies that selectively bind to blood coagulation factor FVIII, and highly sensitive immunological assays comprising these antibodies. Preferred assays can detect FVIII at about 3500-fold below the normal physiological levels, and have a wide array of applications including accurate monitoring of FVIII concentration in pharmaceutical products for treatment of blood coagulation disorders, and determination of FVIII levels in plasma of human patients, including those with blood coagulation disorders such as hemophilia.

Abstract: A method for identifying a platelet population, preferably a population of immature, reticulated platelets, in a biological sample involves incubating the biological sample for less than 5 minutes with at least one labeled, ligand (e.g., monoclonal antibody) that binds to an epitope or antigen on platelets and with a nucleic acid dye. In one embodiment, the dye is Acridine Orange and the label on the ligand is PE-Cy7. The sample is then analyzed and one or more platelet populations is rapidly identified or quantified by passing the incubated sample through a sensing region of a flow cytometer. In one embodiment, this method occurs without a washing or physical cell separation step. The incubated sample is irradiated with a laser light source, and fluorescence of the labeled ligand and the nucleic acid dye are measured along with at least one additional parameter, e.g., light scatter, direct current, axial light loss, opacity, radio frequency, and fluorescence.

Abstract: This invention describes a method of using controlled fluidic forces to improve the performance of a biochemical binding assay where a target molecule is captured by specific molecular recognition onto a substrate surface with an affinity coating, and then labeled with a detectable micrometer-scale particle using a second specific molecular recognition reaction with the target. By using specific ranges of label sizes and laminar flow conditions, controlled fluidic forces can be applied to the label particles in order to selectively remove molecules bound to a surface according to their binding strength, and thereby increase the ratio of specifically bound labels to more weakly attached non-specifically bound labels. This method can be used with a wide variety of label types and associated detection methods, improving the sensitivity and selectivity of a broad range of binding assays.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction are disclosed. Troponin I and T exist in various conformations and the ratios of monomeric troponin I and T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed are systems to determine the presence of a troponin form or a group of troponin forms in whole blood, serum or plasma samples. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays. Also disclosed are antibodies which recognize unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Abstract: A method of in situ immunohistochemical analysis of a biological sample is provided. The method allows for the multiplex and simultaneous detection of multiple antigens, including multiple nuclear antigens, in a tissue sample.

Abstract: The invention provides a method of depleting anti-MHC antibodies in a sample comprising contacting said sample with one or more recombinant MHC molecules or functionally equivalent variants, derivatives or fragments thereof and removing at least the recombinant MHC molecules to which antibodies to said recombinant MHC molecules contained within the sample have bound. This method allows the depletion of one or more specific MHC particularly HLA allele antibodies from a sample.

Abstract: Methods that permit the rapid release of one or more analytes from head or body hair or other keratinized structures of an individual (who may previously have ingested one or more of the analytes) are provided. The methods can include contacting the keratinized structure with a reducing agent but not with a proteolytic agent. The methods can further include identification and quantification of the one or more analytes by known analytical techniques such as immunoassays. The described methods do not damage the analyte and do not cause harmful effects on a subsequently-used analyte detection probe (e.g., an antibody).

Abstract: A method of detecting ?-defensin in a bodily sample from a subject includes reducing the electrostatic interaction between ?-defensin and negatively charged moieties in the bodily sample prior to detecting the ?-defensin with an antibody or epitope binding fragment thereof.

Abstract: Methods for measuring an endocrine substance, such as feline insulin, in a biological sample taken from an animal with high accuracy, rapidity and brevity. The methods involve pre-treating a biological sample by removing an autoantibody bound to an endocrine substance present in a sample and measuring the endocrine substance after the pre-treatment. The methods can be used to measure autoantibody bound to an endocrine substance in the sample. Methods for diagnosis and treatment of diseases associated with endocrine substances are disclosed involving measuring an autoantibody value for an endocrine substance in a biological sample.

Abstract: The subject invention relates in part to the surprising and unexpected discovery that insects that are resistant to Bacillus thuringiensis Cry toxins have measurably altered alkaline phosphatase (ALP) activity as compared to insects that are susceptible to Cry toxins. This and other surprising discoveries reported herein have broad implications in areas such as managing and monitoring the development of insect resistance to B.t. toxins. For example, the subject invention provides a simple and fast assay (enzymatic or otherwise) for detecting ALP activity levels and thereby monitoring the development of resistance by insects to crystal protein insect toxins. There was no prior motivation or suggestion to go about resistance monitoring using this simple and easy approach.

Abstract: An object of the present invention is to overcome the problem of nonspecific adsorption of a labeled antibody on the detection site and to provide an immunochromatography method by which the false positive signal can be suppressed, and wherein the detection sensitivity is high and the highly reliable measurement can be performed.

Abstract: Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium. The combination comprises (i) the sample, (ii) a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and (iii) a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent comprises a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further comprise a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties.

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: In order to accurately and reliably quantitate HLE on the plasma membranes of the lymphocytes and mononuclear phagocytes, a test sample containing the lymphocytes and mononuclear phagocytes is initially treated with a first antiserum specific for CD4 receptors on the plasma membrane or with a second antiserum specific for chemokine receptors on the plasma membrane. Once the CD4 or chemokine receptors have been rendered non-reactive (competitive) relative to the HLE receptors (also “binding sites”) on the plasma membrane, the test sample is contacted with an immunoreagent specific for interaction with one or more of the HLE receptors on the plasma membranes of the lymphocytes and mononuclear phagocytes. The immunoreagent forms a complex with the HLE binding sites and produces a characteristic physical change in the lymphocytes and mononuclear phagocytes that can be monitored by anyone of a number of standard techniques, (e.g., confocal laser scanning microscopy and flow cytometry).

Abstract: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.

Abstract: An assay device and method for measuring the concentration of LDL-associated cholesterol in a blood-fluid sample are described. The method employs selective precipitation of VLDL and chylomicrons and immunoseparation of HDL from a blood fluid sample. The assay device allows the assay to be performed entirely in a flow strip format.

Abstract: This invention describes a method of using controlled fluidic forces to improve the performance of a biochemical binding assay where a target molecule is captured by specific molecular recognition onto a substrate surface with an affinity coating, and then labeled with a detectable micrometer-scale particle using a second specific molecular recognition reaction with the target. By using specific ranges of label sizes and laminar flow conditions, controlled fluidic forces can be applied to the label particles in order to selectively remove molecules bound to a surface according to their binding strength, and thereby increase the ratio of specifically bound labels to more weakly attached non-specifically bound labels. This method can be used with a wide variety of label types and associated detection methods, improving the sensitivity and selectivity of a broad range of binding assays.

Abstract: The present invention provides materials, methods, and kits for reducing nonspecific binding of molecules to a surface, particularly in a solid phase material, and more specifically a solid phase material that includes a hydrophobic portion, by contacting the solid phase material with a fluorinated nonionic surfactant comprising two or more fluorinated hydrophobic segments and one or more hydrophilic segments.

Abstract: The invention relates to analytical methods in which the partition of a labeled substance between a liquid and a solid phase is determined. The assays include solid-phase reagents which can be particulate or monolithic such as, for example, a coated tube. Assays of this type are known per se to the person skilled in the art and include immunoassays and immunometric assays.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: A method for detection and/or quantification of cardiac troponin I (cTnI) in a sample derived from an individual's blood, the method being based on a sandwich immunoassay employing at least two capture antibodies and at least one tracer antibody, in which a first capture antibody is directed to the N-terminal part of cTnI, to the C-terminal part of cTnI or to the part of the cTnI midfragment, which is slightly affected by the interfering factor, and a second capture antibody is directed to another of these parts, and a tracer antibody is directed to the N-terminal part of cTnI, to the C-terminal part of cTnI or to TnC, which is complexed with cTnI.

Abstract: Surfaces coated with a target-induced fluorescent compound are used to detect target elements, especially trace elements. The target-induced fluorescent compound does not fluoresce when excited at a specific wavelength until it has bound a target element. The use of these coated surfaces provides several benefits including reduced background for greater sensitivity and eliminating the need to separate target-induced fluorescent compound that has not bound target element from target-induced fluorescent compound that has bound target element. Coated nanoparticles are especially useful for detection of target elements.

Abstract: Using two types of antibodies, i.e., a first antibody having a higher affinity for a target substance than for a competitive substance and a second antibody having a higher affinity for the competitive substance than for the target substance, a specimen is treated with these two antibodies. Then, the competitive substance in the specimen first binds to the second antibody and thus the ratio of the target substance to the competitive substance in the specimen is enlarged. As a result, the target substance becomes liable to bind to the first antibody and, in its turn, the reactivity of the target substance is elevated compared with the case of using the first antibody alone. Thus, the target substance in the specimen can be accurately assayed while avoiding the effects of the competitive substance contained in the specimen.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex.

Abstract: The present application describes a method for pretreating a biological sample from an autoimmune disease subject in order to avoid interference, especially where the sample is to be subjected to a cell-based biological activity assay, such as a neutralizing antibody assay.

Abstract: Methods for enhancement in accuracy of immunochemical analysis of heterogeneous biological fluids containing exogenous substances that can interfere in immunochemical analysis for endogenous analytes of interest. According to this method a heterogeneous biological fluid sample is pretreated with an interferant suppression effective amount of a molybdenum coordination complex, so as to reduce manifestation of the presence of said exogenous material under immunoassay conditions. This invention is suitable for the suppression of manifestation of exogenous substances, specifically metabolites of drugs of abuse, during the immunoassay of biological fluids of infants for detection of endogenous substances indicative of a wellness or disease state. This invention also has application for similar suppression exogenous substances in the biological fluid of adults that have been inadvertently exposed to such substances (e.g. secondhand smoke).

Abstract: In a method for analysis biomolecules (3) attached to a solid surface of a substrate (1) are used for detecting the presence of analytes (4) in a sample by binding of the analytes to the biomolecules. The biomolecules (3) are attached directly to the surface of the substrate together with biomolecule-repellent molecules (5), which cover the surface between the biomolecules (3) to prevent nonspecific binding of analytes (4) and other biomolecules. The invention relates also to a biosensor where biomolecules (3) are attached directly to the substrate (1) together with biomolecule-repellent molecules (5), which cover the surface between the biomolecules (3) to prevent non-specific binding of analytes (4) and other biomolecules. The biomolecules (5) can be self-assembled hydrophilic polymers. One example of using the invention is immunological analysis using surface plasmon resonance (SPR).

Abstract: The present invention is directed to improving productivity of an enzymatic method for making esterified, transesterified or interesterified products. Specifically, a method that can greatly improve the productivity of enzymatic transesterification or esterification by deodorization alone, or by deodorization and purification of the initial substrate to extend the useful life of the enzyme is disclosed.

Abstract: The present invention provides an antibody which specifically recognizes a CNS tau protein but not a peripheral tau protein. More specifically, the present invention provides an antibody obtainable by using a polypeptide comprising an amino acid sequence of a connective portion between the amino acid sequence encoded by Exon 4 of a gene encoding a tau protein and the amino acid sequence encoded by Exon 5 thereof as an epitope specific to the isoform of tau protein predominantly existing in central nervous tissues. The present invention further provides a method of detecting Alzheimer's disease and a reagent kit using the antibody.

Abstract: Proteins expressed from within the prion protein genes of all animals and humans, “prionins”, against which reagents can be prepared for accurate pre-symptomatic diagnosis, for detecting latent TSE, for detecting TSE contamination of food, blood and blood products and for therapeutic treatment of Bovine spongiform encephalopathy (BSE) in cows, Scrapie disease in sheep and Creutzfeldt-Jacob syndrome in humans, are revealed.

Abstract: A method for preventing or inhibiting non-specific binding reactions between a detection reagent and an antigen in an immunological assay is described. The method involves using tetrameric antibody complexes that can bind to the antigen and are comprised of two monoclonal antibodies of a first animal species linked to two monoclonal antibodies of a second animal species that can bind the antibodies of the first animal species. Preferably, the antigen is an Fc Receptor and the method reduces the binding of a detection antibody with Fc receptors present on the surface of many cells.

Abstract: The invention relates to a technology by which antibodies directed to sources of infection in body fluids can be assayed with high accuracy, expediency and specificity. More particularly, the invention provides an antibody immunoassay method in which the antigen-antibody reaction between a target antibody in a sample and an assay antigen is conducted in the presence of an E. coli component and an antibody assay method which comprises using a reagent having a specific affinity for the Fc region of an antibody IgG as the antibody assay reagent.

Abstract: The invention provides a flow cytometric method for measuring dendritic cell function in whole blood, comprising: (a) contacting a whole blood sample with a dendritic cell activator; (b) adding to the sample a plurality of dendritic cell-distinguishing antibodies and at least one cytokine-specific antibody; and then (c) flow cytometrically assaying the sample for the binding of the cytokine-specific antibody by at least one distinguishable DC subset. Other assays are presented in which DC activation markers are assessed.

Abstract: A method for detection and/or quantification of cardiac troponin I (cTnI) in a sample derived from an individual's blood, the method being based on a sandwich immunoassay employing at least two capture antibodies and at least one tracer antibody, in which a first capture antibody is directed to the N-terminal part of cTnI, to the C-terminal part of cTnI or to the part of the cTnI midfragment, which is slightly affected by the interfering factor, and a second capture antibody is directed to another of these parts, and a tracer antibody is directed to the N-terminal part of cTnI, to the C-terminal part of cTnI or to TnC, which is complexed with cTnI.

Abstract: The instant invention describes an analytical assay to accurately measure an analyte in the presence of an interfering substance.

Abstract: The invention concerns a method for the detection of an analyte in a sample using analyte-specific conjugates which have at least one heterologous group for an analyte-independent binding to a control zone. The present invention additionally provides new conjugates and reagent kits.

Abstract: There is provided a method and kit for measuring the amount of an objective constituent contained in a specific lipoprotein in a biological sample such as serum and plasma, specifically for measuring the amount of cholesterol contained in high density lipoprotein, which can be applicable to clinical tests.