Abstract: A test device (20) for detecting human blood includes a strip (22) having an introduction station (24), a test station (26), and a control station (28) disposed in spaced apart relationship. The test sample introduction station (24) has labeled antihuman Hb antibodies, the test station (26) has immobilized antihuman Hb antibodies, and the control station has immobilized polyclonal antibodies. A test sample (500) is deposited at the introduction station (24). If human hemoglobin is present in the test sample (500), a colored line will appear at the test station (26) and at the control station (28). If no human hemoglobin is present in the test sample (500), a colored line will only appear at the control station (28).

Abstract: This invention provides a novel Cryptosporidium parvum protein disulfide isomerase polypeptide, and nucleic acids that encode this polypeptide. The invention also provides methods, reagents, and kits that are useful for diagnosing infection by Cryptosporidium parvum. The methods are based on the discovery of binding agents, including recombinant polyclonal antibodies, that bind to the protein disulfide isomerase polypeptide of C. parvum.

Abstract: The invention provides methods for identifying antibody preparations that can form a pair of antibodies that optimally detect a target antigen, for example, in a sandwich immunoassay. These methods provide high affinity and epitope-specific antibodies.

Abstract: The present invention discloses a method for detection and prediction of mastitis. The method comprises the steps of determining the values of mastitis indicators and comparing the values with predetermined standards, wherein deviation from the standards provides a measure of mastitis.

Abstract: The present invention is concerned with methods for determining predisposition to infection in a subject exposed to stressors. In particular the present invention is concerned with methods of assessing the risk of susceptibility to infection in a subject by monitoring the levels of IgA and IgA1.

Abstract: Pooled human plasma is processed by cold ethanol fractionation to produce purified immunoglobulin G antibodies for intravenous administration. Immunoglobulin A is an unwanted by-product since intravenous administration of immunoglobulin A-containing immunoglobulin G can cause life-threatening anaphylaxis in some people. The present invention is the topical application of immunoglobulin A coupled with J chain, and optionally coupled with secretory component in order to render the immunoglobulin A more physiologically active, for the prevention or treatment of ocular diseases including ocular immune deficiency and infections. Antigen-specific monoclonal immunoglobulin A may be used.

Abstract: Methods of detecting antibodies to one or more glycosphingolipid(s) of interest in a sample are disclosed which comprise using a solid-phase reactant having carbonyl groups attached theron, and the glycosphingolipid(s) of interest linked to the solid-phase reactant by an amide bond between an amino group of the glycosphingolipid of interest and a carbonyl group attached to the solid-phase reactant. The methods of detecting antibodies to glycosphingolipid(s) of interest can be used in methods of diagnosing autoimmune diseases in an individual.

Abstract: Immunoassay methods and apparatus are provided which utilize flow cytometry, coated latex microspheres, and fluorochrome labeled antibodies, to simultaneously detect the presence and amount of one or more analytes in a sample. Beads of several different sizes, colors or shapes, each bead are coated with a different analyte, for the simultaneous detection of one or more analytes and of cell components. The invention is also directed to platelet Ig positive control reagents and assays which provide for the setting of the fluorescence positive region for each patient. The platelet control is sized to fit between the platelets and red cells and thus making it ideal as a true biological control.

Abstract: The invention relates to a method of evaluating the immunological status of a subject comprising the steps of 1) determining the content of an antibody in a liquid sample from the subject using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the presence of other constituents of the sample to obtain a measurement 1, 2) determining the content of an antibody in the liquid sample using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the absence of other constituents of the sample to obtain a measurement 2, and 3) interrelating measurements 1 and 2 to express the interference and using the interference as a parameter for evaluating the immunological status of the subje

Abstract: Immunoassay methods and apparatus are provided which utilize flow cytometry, coated latex microspheres, and fluorochrome labeled antibodies, to simultaneously detect the presence and amount of one or more analytes in a sample. By combining FALS and fluorescence, it is practical to use beads of several different sizes, colors or shapes, each bead coated with a different analyte, for the simultaneous detection of one or more analytes and of cell components such as platelets in a sample.

Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Abstract: The present invention provides monoclonal antibodies which are highly specific for Bacillus spores. Also provided are peptides derived from those monoclonal antibodies. Both the antibodies and peptides are highly specific and can discriminate between spores of potentially lethal organisms such as Bacillus anthracis and other harmless but closely related bacilli and provide a very powerful tool in the construction of detection instruments as counter measures.

Abstract: Methods of using a complex (scuPA/suPAR) which has thrombolytic activity under physiological conditions and in the presence of IgG, or of at least one IgG-derived peptide, which complex comprises a single chain urokinase type plasminogen activator (scuPA) and a soluble urokinase plasminogen activator receptor (suPAR), for the treatment and/or prevention of thromboembolic disorders associated with the formation of fibrin clots are disclosed.

Abstract: A non-instrumental assay for the diagnosis of celiac disease based on the general immunochromatographic assay principles. The assay is rapid and simple and allows the reliable detection of anti transglutaminase antibodies, of both IgA and IgG isotype, in samples of human serum, plasma or blood, using as tracer the antigen transglutaminase conjugated to a colored substance, like colloidal gold or colored latex particles. The conjugated antigen is deposited onto an inert fibrous support, from where it can be released by a liquid sample. The antibodies in the sample react with the conjugated antigen developing an immunocomplex that migrates through a carrier membrane, like nitrocellulose or nylon with a pore size that allows a laminar flow of the reagents, until it reacts with the same antigen transglutaminase immobilized onto a reactive zone of the membrane. As a consequence of this reaction the immunocomplex will be trapped in the reaction site and a colored signal will be seen.

Abstract: The invention relates to a method for detecting specific target-cells in a simple and time saving way, using paramagnetic particles, antibodies recognizing the Fc portions of target-cell associating antibodies and target-cell associating antibodies directed to specific antigen determinants in the target-cell membranes. Incubation of the cell suspension with a mild detergent and/or second set of antibodies or antibody fragments, prelabeled or not with fluorescent agents, metallocolloids, radioisotopes, biotincomplexes or certain enzymes allowing visualization, with dramatically increase the specificity of the method. The method can further be used for isolation of the target-cells by magnetic field application and kit for performing the method according to the invention is described.

Abstract: The present invention relates to equine Fc epsilon receptor alpha chain nucleic acid molecules, proteins encoded by such nucleic acid molecules, antibodies raised against such proteins, and inhibitors of such proteins. The present invention also includes methods to detect IgE using such proteins and antibodies. Also included in the present invention are therapeutic compositions comprising such proteins, nucleic acid molecules, antibodies and/or inhibitory compounds as well as the use of such therapeutic compositions to mediate Fc epsilon receptor-mediated biological responses.

Abstract: A method for conveniently detecting binding between the von Willebrand factor and glycoprotein Ib and a means to be used therein. The von Willebrand factor fixed in a reactor immobilized in a reaction vessel in the presence of bottrocetin is bound to a chimeric protein constructed by fusing the carboxyl terminal of a partial protein containing the von Willebrand factor-binding site of glycoprotein Ib with the amino terminal of the Fc region of an immunoglobulin molecule. Then the Fc region of the above immunoglobulin molecule is detected to thereby detect the binding between the von Willebrand factor and the glycoprotein Ib or inhibition of this binding.

Abstract: The present invention concerns a method for determining the degranulation activity of basophilic granulocytes in a sample as well as a reagent kit that is suitable for this. Furthermore the invention also concerns a method for diagnosing allergic hypersensitivity and for monitoring the response to a hyposensitization therapy.

Abstract: The present invention involves techniques for evaluating in vivo cytokine production through the in vivo capture of secreting cytokines by labeled cytokine-binding reagents, followed by in vitro measurement of serum levels of captured cytokine. The methods of the present invention make use of the ability of a neutralizing antibody to a cytokine, when injected into a person or expierimental animal, to bind that cytokine and prevent its catabolism, excretion, or binding to a cytokine receptor. This causes the cytokine, which may normally have a very short in vivo half life, to accumulate in vivo as a cytokine/anti-cytokine antibody complex. If the anti-cytokine antibody is either labeled with a molecule that can be bound by another molecule (e.g.; biotin, which is bound by avidin or streptavidin), or is itself capable of being bound by another molecule (e.g.

Abstract: A solid phase with at least one test area is described which contains reagents for the detection of at least one analyte in a sample, wherein the solid phase additionally comprises at least one control area for the detection of interfering reactions.

Abstract: The invention provides isolated nucleic acid and amino acid sequences of TL-&ggr;, antibodies to TL-&ggr;, methods of screening for TL-&ggr; modulators using biologically active TL-&ggr;, and kits for screening for TL-&ggr; modulators.

Abstract: The present invention provides neuronal progenitor cells which have been identified in histological sections of the adult human brain. The present invention also provides methods to localize, characterize, harvest, and propagate neuronal progenitor cells derived from human brain tissue. Additional methods are provided for introducing and expressing genes in the brain.

Abstract: A competitive assay to determine the presence and concentration of an intracellular analyte (e.g., cAMP) in a sample is provided. All of the steps of the assay can be performed on the same assay plate, thereby eliminating the need to transfer the cells from a tissue culture plate on which the cells are grown, induced and lysed to a separate assay plate. The assay procedure includes combining, in a reaction chamber provided with a capture antibody, an antibody for the analyte, the sample to be assayed, and a conjugate of the analyte and an enzyme such as alkaline phosphatase. The mixture is incubated and washed and an enzyme labile substrate (e.g., a chemiluminescent, fluorescent or calorimetric substrate) is added. The assay can also be performed with a tagged analyte (e.g., an analyte having a radioactive or fluorescent tag) instead of an enzyme conjugate.

Abstract: According to the present invention, the biological or pharmacological activity of a test material like a plant or herbal material, an extract of a plant or herbal material, a natural or synthetic compound or some combination thereof, can be quantified by observing the pattern of structural changes induced in a eukaryotic cell's proteins. These structural changes may be evidenced by protein phosphorylation, by protein-protein interactions and the like. The amount and nature of protein phosphorylation is qualitatively and quantitatively related to the in vitro concentration of biologically/pharmacologically active components to which the mammalian cells are exposed. Additionally, formation or loss of protein-protein complexes may be determined in whole cell homogenates through the use of non-denaturing electrophoresis and staining for proteins or protein phosphorylation.

Abstract: Methods for detecting anti-lipidic particles antibodies and lipidic particles in cellular membranes for the diagnosis of diseases associated to the antiphospholipid syndrome are disclosed. Kits or sets to put these methods of diagnosis into practice are also disclosed. Methods for the therapeutically treatment of diseases associated to the antiphospholipid syndrome are disclosed as well. In addition, methods for the detection of the diverse physiologic states of cells, and those kits useful for this are also disclosed.

Abstract: Diagnostic test devices, including diagnostic strip tests, are provided in which identifying information and the test result are machine-readable. Also provided are methods for obtaining identifying information and test results from the diagnostic test devices.

Abstract: A diagnostic assay, preferably immunoassay, is provided for the detection and determination of MGP in a human serum sample, which comprises the use of one or more antibodies, in particular monoclonal antibodies, specifically recognising epitopes on and/or conformations of human Matrix Gla-Protein. Also, a method is provided for using MGP-related antigens as biomarkers for certain diseases, for example, atherosclerosis and other vascular diseases, and angiogenesis/neogenesis in tumor development. Further, monoclonal antibodies of class IgG are provided for use in the assay, which are defined herein as mAb3-15 and mAb35-49.

Abstract: Methods for determining the strongly hydrophobic pulmonary surfactant protein SP-C, SP-C specific antibody and a reagent kit for carrying out the methods are described.

Abstract: The present invention relates to an antibody or functional fragment thereof which binds to a mammalian (e.g., human) CC-chemokine receptor 1 (CCR1) or a portion of the receptor and blocks binding of a ligand to the receptor. The invention further relates to a method of inhibiting the interaction of a cell bearing mammalian CCR1 with a ligand thereof, and to use of the antibodies and fragments in research, therapeutic, prophylactic and diagnostic methods.

Abstract: Novel magnetic assay methods and systems. According to a preferred embodiment, a chromatographic medium, which preferably comprises a test strip, is provided that is designed to be contacted with a test solution having activated magnetic particles such that the solution flows bilaterally thereacross. A magnetic field, generated by a magnet or electromagnet, is selectively applied to the medium which causes the charged particles to become substantially bound at a site on the medium specified by the position off the magnet, to thus form a captured line or zone. In one preferred embodiment, the magnetic field is applied at the site on the medium at which the test solution is contacted. The degree of magnetic force applied to the membrane may be selectively adjusted to vary the width or surface area of the capture line or zone.

Abstract: A strain of hepatitis E virus from Pakistan (SAR-55) implicated in an epidemic of enterically transmitted non-A, non-B hepatitis, now called hepatitis E, is disclosed. The invention relates to the expression of the whole structural region of SAR-55, designated open reading frame 2 (ORF-2), in a eukaryotic expression system. The expressed protein is capable of forming HEV virus-like particles which can serve as an antigen in diagnostic immunoassays and as an immunogen or vaccine to protect against infection by hepatitis E.

Abstract: The invention provides a cDNA which encodes tapasin-like protein. It also provides for the use of the cDNA, protein, and antibody in the diagnosis, prognosis, treatment and evaluation of therapies for cancer. The invention further provides vectors and host cells for the production of the protein and transgenic model systems.

Abstract: A test device (20) for detecting semen includes a strip (22) having an introduction station (24), a test station (26), and a control station (28) disposed in spaced apart relationship. The introduction station (24) has labeled p30 antibodies, the test station (26) has immobilized p30 antibodies, and the control station has immobilized polyclonal antibodies. A test sample (500) is deposited in the introduction station (24). If semen is present in the test sample (500), a colored line will appear at the test station (26) and at the control station (28). If no semen is present in the test sample (500), a colored line will only appear at the control station (28).

Abstract: The present invention relates to a method of selecting a protein variant having reduced immunogenicity as compared with the parent protein.

Abstract: A competitive assay for the concentration of a cyclic nucleotide such as cyclic adenosine monophosphate combines, in a reaction chamber provided with a capture antibody, an antibody for the cAMP or other cyclic nucleotide, the sample to be assayed and a conjugate of cAMP and alkaline phosphatase. The mixture is incubated and washed, and after washing, a 1,2-dioxetane which is caused to decompose when contacted by the alkaline phosphatase of said conjugate is added. The light emission caused by decomposition is measured, with the strength of the signal being inversely related to the concentration of the cyclic nucleotide. Optionally, an enhancement agent in the form of a polymeric onium salt may be added, to further enhance the light emission.

Abstract: Two novel mutant amyloid protein precursors (ABriPP and ADanPP) and their amyloid peptides (ABri and ADan) associated with Familial British Dementia and Familial Danish Dementia, respectively, are disclosed. Genetic constructs comprising DNA encoding these proteins is used to produced transgenic mammals that are useful models for neurological diseases associated with amyloid deposits, neurofibrillary tangles, non-neuritic plaques, neuronal degeneration and behavioral deficits characteristic of dementia and other symptoms of the human diseases. These models are used for testing potential therapeutic agents and methods. Also provided is a DNA-based test for detecting the mutations, the mutant proteins and peptides, antibodies specific for the proteins and peptides. Immunoassays permit detection of the mutant proteins, particularly in affected brain tissue, or detection of an antibody specific for a mutant peptide.

Abstract: The invention includes novel methodology for diagnosing immunologic food or drug sensitivities. A method for diagnosing food sensitivities includes using diagnoses of other related disorders as indicators in the diagnosis of the food sensitivity. Additionally, failure to respond to or a relapse after treatment for microscopic colitis with bismuth subsalicylate is disclosed as being a further indicator in the diagnosis of immunologic food sensitivity. Finally, the presence of certain HLA-DQ alleles, particularly HLA-DQ1,1; -DQ1,3; -DQ1,7; -DQ1,8; and -DQ1,9 as indicators in diagnosing immunologic food sensitivity is also disclosed by the invention. A method for food sensitivity panel testing (for sensitivities other than gluten sensitivity) by detecting IgA antibodies in serum is also disclosed. A method for testing stool samples for the presence of particular antibodies is also disclosed for diagnosing immunologic food sensitivities.

Abstract: A method for diagnosing whether a patient has a disease comprising interpreting the results of an immunoassay, wherein the immunoassay is viewed as a series of separate tests performed in parallel. The immunoassay can be a Western blot and the disease can be Lyme Disease.

Abstract: A method of determining the concentration of IgG antibodies in the biological fluids of mammals. The assay may be performed in a lateral flow cassette or dipstick format where dehydrated immobilized reagents are spaced along a membrane. A sample of a mammalian biological fluid is exposed first to an IgG complexing agent to yield a conjugate. The conjugate then moves along the membrane and is exposed to a standard mammalian IgG applied to the membrane at a test position. Binding of the IgG is indicated by a color change at the test position on the membrane. A control reagent of dehydrated anti-IgG complexing agent may be applied to the membrane at the control position spaced downstream from the test position. Interaction of the IgG complexing agent with the anti-IgG complexing agent forms a visible line at the control position on the membrane.

Abstract: The invention relates to antibodies against VASP (vasodilator-stimulated phosphoprotein) which only bind VASP as an antigen when VASP is present in phosphorylated form, to hybridoma cells for their preparation, and to the use of the antibodies or antibody fragments as diagnostic agents and/or therapeutic agents.

Abstract: The present invention involves a method for assaying a substance. The method of the present invention comprises contacting the substance with an assay agent comprising a catalytic agent to associate the substance with the catalytic agent, contacting the resulting associated substance with a label precursor capable of reacting catalytically with the catalytic agent to release the label, and detecting a mass label. The present invention also involves a kit for assaying a substance. The kit of the present invention comprises an assay agent comprising a catalytic agent, and a label precursor capable of reacting catalytically with the catalytic agent to release a mass label.

Abstract: The invention concerns a method for the determination of antigen-specific antibodies of the immunoglobulin G class in the presence of immunoglobulins of the M class in body fluids by incubation with at least two different receptors R1 and R2 and optionally additional receptors, an essential component of R2 being a binding partner in monomeric form, a reagent for determining an antigen-specific antibody of the immunoglobulin G class as well as the use of binding partners in monomeric form for the determination of an antigen-specific antibody of the immunoglobulin G class.

Abstract: Modified proteins are disclosed that maintain enzymatic and insecticidal activity while displaying reduced or eliminated allergenicity. Epitopes which bind to anti-patatin antibodies were identified, and removed via site directed mutagenesis. Tyrosines were observed to generally contribute to the allergenic properties of patatin proteins. Removal of glycosylation sites was observed to reduce or eliminate antibody binding. Permuteins are also disclosed which have a rearranged amino acid sequence while retaining enzymatic activity. Deallergenized proteins and permuteins can be used as insecticidal materials, as nutritional supplements, and as immunotherapeutic agents.

Abstract: The invention concerns a method for the purification of a target substance from a biological sample by immobilizing the target substance on a solid phase by means of a high affinity binding pair and subsequently eluting it by adding a partner of the binding pair in a free form. In addition reagent kits for carrying out the method are disclosed.

Abstract: Immunoassay methods and apparatus are provided which utilize flow cytometry, coated latex microspheres, and fluorochrome labeled antibodies, to simultaneously detect the presence and amount of one or more analytes in a sample. By combining FALS and fluorescence, it is practical to use beads of several different sizes, colors or shapes, each bead coated with a different analyte, for the simultaneous detection of one or more analytes and of cell components such as platelets in a sample.

Abstract: An assay method for detecting the response or activation of cells, including lymphocytes, and a method for detecting immunological sensitization in a subject, which involves the introduction of cell-activating substance which causes an enzyme of the cells to become available for reaction, and the measurement of the enzymatic reaction using a substrate which generates a detectable product, and a kit for performing such assays.

Abstract: An immunochemical method for the determination of antibodies which are specific for an antigen and are of one of the immunoglobulin classes: A, M, D or E in a fluid, with this fluid being contacted with a solid phase to which the antibodies against this immunoglobulin class, or a fragment of an antibody of this type, are bound, which results in the immunoglobulin of this class being bound to this solid phase, and this solid phase being contacted with the antigen, which carries a labeling means where appropriate, and with a labeled antibody or a labeled fragment of an antibody against the antigen if the antigen is unlabeled and determination, from the amount of labeling means which is bound to the solid phase, of the amount of these antibodies which are specific for an antigen and are one of the immunoglobulin classes, which comprises the solid phase being simultaneously in contact with the fluid containing the antibody which is to be determined and with the antigen, which is labeled where appropriate, there b

Abstract: Methods of detecting antibodies to one or more glycosphingolipid(s) of interest in a sample are disclosed which comprise using a solid-phase reactant having carbonyl groups attached thereon, and the glycosphingolipid(s) of interest linked to the solid-phase reactant by an amide bond between an amino group of the glycosphingolipid of interest and a carbonyl group attached to the solid-phase reactant. The methods of detecting antibodies to glycosphingolipid(s) of interest can be used in methods of diagnosing autoimmune diseases in an individual.

Abstract: A method of assaying for an analyte including the steps of: (i) passing a sample suspected of containing an analyte and reagents comprising a target ligand-analyte receptor conjugate and a detectable tracer containing a label for the analyte through filter apparatus containing a plurality of discrete flow zones wherein at least one zone functions as a capture zone having bonded thereto a receptor ligand for said target ligand; (ii) allowing the sample and accompanying reagents to incubate prior to passage through said at least one zone to facilitate formation of complex(es) of said conjugate and said at least one analyte in a liquid or fluid phase; and (iii) detecting the presence of analyte in the sample by activation of the label in said at least one zone after binding of the complex(es) conjugate to the associated receptor ligand(s).

Abstract: The invention provides improved immunoassay techniques for detecting the presence of analytes in a liquid sample. The present immunoassay methods utilize anti-allotypic monoclonal antibodies as capture reagents for primary binding proteins specific for the analytes of interest. The monoclonal antibodies are highly specific for the allotypic determinants present on the primary binding protein. The use of anti-allotypic monoclonal antibodies as capture reagents provides improved levels of specificity and accuracy of the immunoassay, in part because interference from endogenous immunoglobulins in the sample is significantly reduced. The invention further provides anti-allotypic monoclonal antibodies.