Abstract: The invention relates to a method for detecting an infection of a mammal with an acid-resistant microorganism, wherein (a) a stool sample of a mammal is incubated with at least two different monoclonal antibodies, fragments or derivatives thereof or aptamers under conditions allowing a complex formation of antigens of the acid-resistant microorganism with antibodies, fragments or derivatives thereof or the aptamers, and wherein (aa) the first monoclonal antibody or the fragment or the derivative thereof or the first aptamer specifically binds an epitope of the first antigen, which shows at least with some mammals a structure after the intestinal passage that corresponds to the native structure or the structure which a mammal produces antibodies against after being infected or immunised with the acid-resistant microorganism or an extract or lysate thereof or a protein therefrom or a fragment thereof or a synthetic peptide; (ab) the second monoclonal antibody or the fragment or the derivative thereof or the sec

Abstract: A method and device for carrying out immunoassays in which non analyte specific binding of heterophilic antibodies to a labeled antibody in a capture region produces an incorrect measure of the amount of an analyte attached to the antibody. Immunoglobulin from the same animal source as the labeled antibody is added to the sample fluid to prevent non-specific binding of the heterophilic antibodies in the capture region. One part of specific binding pair is added to said antibody or its label capable of binding to a second part of the binding pair immobilized in a control region downstream of said capture region for trapping the portion of the labeled anti-body which is not bound to the analyte. Preferably said binding pair is biotin/avidin or fluoroscein/anti-fluoroscein.

Abstract: A method or screen for assessing the potential of a compound to treat a pathological condition, such as arrhythmia, which is manifested by an increased late sodium current in a heart is disclosed. The method employs a mutant sodium channel protein having an amino acid sequence in which one or more amino acids among the ten amino acids occurring at the carboxy end of the S6 segments of D1, D2, D3 or D4 domains of mammalian Nav1 differs from the amino acid in wild-type Nav1 by substitution with tryptophan, phenylalanine, tyrosine or cysteine. Cells transfected with a nucleic acid that encodes a mutant mammalian Nav1 protein, as well as isolated nucleic acids comprising a nucleotide sequence that codes for a mutant mammalian Nav1 protein are disclosed.

Abstract: The present invention provides an improved system for detecting the presence or level of an analyte in a sample. In “competition-like” assays of the present invention, a sample including an analyte is mixed with a second ligand to which the analyte binds, and the mixture is exposed to a solid phase containing a first ligand that can compete with the analyte for binding to the second ligand. According to the present invention, the time of exposure of the mixture to the solid phase is limited so that substantially no dissociation of analyte/second ligand complex occurs. The competition-like assays of the present invention are preferably performed with a solid phase containing a substantial excess of first ligand. In “sandwich-type” assays of the present invention, a sample including an analyte is contacted with a solid phase including a first ligand that binds the analyte and, simultaneously or subsequently, is contacted with a second ligand that binds the analyte (or the analyte/first ligand complex).

Abstract: A method or screen for assessing the potential of a compound to treat a pathological condition, such as arrhythmia, which is manifested by an increased late sodium current in a heart is disclosed. The method employs a mutant sodium channel protein having an amino acid sequence in which one or more amino acids among the ten amino acids occurring at the carboxy end of the S6 segments of D1, D2, D3 or D4 domains of mammalian Nav1 differs from the amino acid in wild-type Nav1 by substitution with tryptophan, phenylalanine, tyrosine or cysteine. Cells transfected with a nucleic acid that encodes a mutant mammalian Nav1 protein, as well as isolated nucleic acid comprising a nucleotide sequence that codes for a mutant mammalian Nav1 protein are disclosed.

Abstract: The instant invention involves the use of a combination of preparatory steps in conjunction with mass spectroscopy and time-of-flight detection procedures to maximize the diversity of biopolymers which are verifiable within a particular sample. The cohort of biopolymers verified within such a sample is then viewed with reference to their ability to evidence at least one particular disease state; thereby enabling a diagnostician to gain the ability to characterize either the presence or absence of at least one disease state relative to recognition of the presence and/or the absence of the biopolymer, predict disease risk assessment, and develop therapeutic avenues against the disease.

Abstract: Monocolonal antibodies having a higher reactivity with tartrate-resistant acid phosphatase 5b (TRACP 5b) than tartrate-resistant acid phosphatase 5a (TRACP 5a) and having a higher specificity to TRACP 5b can be obtained by cell fusion using as antigens TRACP 5b purified from human osteoclasts. By using the monoclonal antibody, TRACP 5b in a sample can be detected specifically with a high sensitivity.

Abstract: The anti-19P2 ligand monoclonal antibodies of the invention (in particular P2L-1Ca) have very high binding ability and can neutralize the arachidonic acid metabolite releasing activity of the 19P2 ligand. Therefore, they can be used, among others, as diagnostic, prophylactic and/or therapeutic agents for various diseases caused by some or other abnormality in the pituitary function modulating activity (e.g. prolactin secretion promoting activity), central nervous system modulating activity and pancreatic function modulating activity, among others, supposedly possessed by the 19P2 ligand. The immunoassay method using the monoclonal antibodies of the invention by the sandwich technique (in particular the sandwich technique using the monoclonal antibody and an antibody recognizing an intermediate portion of the 19P2 ligand) can assay the 19P2 ligand or a derivative thereof specifically and with high sensitivity.

Abstract: An object of the present invention is to provide a method for detecting a protein using a nonradioactive label which is prevented to a smaller extent than in the case of the interaction of biotin/(strepto)avidin, and which achieves higher detection sensitivity than that of the detection system using DIG. The present invention provides a method for detecting a target substance, which comprises steps of: (A) allowing a target substance to come into contact with a protein labeled with a compound having a 6-membered ring, so as to carry out a binding reaction; and (B) detecting the protein labeled with the compound having a 6-membered ring, which was bound to the target substance, by using an antibody against the above compound having a 6-membered ring.

Abstract: A method is provided for determining the level of an analyte in the blood of an individual based on determination of the level of the same analyte in non-blood sample (e.g. urine, saliva and hair) obtained from the individual. The non-blood sample contains red blood cells and the volume of the blood in the sample together with the amount of the analyte in the sample are the basis for calculating the level of the analyte in the individual's blood. Kits for carrying out the above method are also provided.

Abstract: A method and apparatus for the manipulation of colloidal particulates and biomolecules at the interface between an insulating electrode such as silicon oxide and an electrolyte solution. Light-controlled electrokinetic assembly of particles near surfaces relies on the combination of three functional elements: the AC electric field-induced assembly of planar aggregates; the patterning of the electrolyte/silicon oxide/silicon interface to exert spatial control over the assembly process; and the real-time control of the assembly process via external illumination. The present invention provides a set of fundamental operations enabling interactive control over the creation and placement of planar arrays of several types of particles and biomolecules and the manipulation of array shape and size. The present invention enables sample preparation and handling for diagnostic assays and biochemical analysis in an array format, and the functional integration of these operations.

Abstract: A novel monoclonal antibody which specifically binds to apo-B-48 is disclosed. The monoclonal antibody specifically binds to apo-B-48 but does not bind to apo-B-100.

Abstract: Methods for detecting and treating a female reproductive tract disorder relate to the discovery that IL-13 and IL-15 are differentially expressed in biological samples from subjects suffering from a reproductive tract disorder compared to samples from healthy subjects. A female reproductive tract disorder is detected by providing a biological sample derived from the subject; analyzing the expression of IL-13 and/or IL-15 in the sample; and correlating the expression of the cytokine with the presence or absence of the female reproductive tract disorder in the subject. Cytokine expression is modulated in female reproductive tract tissue by contacting the tissue with an agent that modulates expression of IL-13 and/or IL-15 in the tissue.

Abstract: The present invention describes a process for detecting threonine or serine kinase activity in an immunoassay using a pre-phosphorylated substrate.

Abstract: Division arrested cells are used in screening assays to determine the effect of a substance of interest on the cells. The division arrested cells can be used in drug screening assays, signal transduction assays, and are especially useful in large scale, high throughput assays.

Abstract: The invention provides an improved test cell for detecting the presence of an analyte in a liquid sample. The device has an elongate casing defining a liquid sample inlet, a reservoir volume, a test volume, and a window through the casing at the test volume. Disposed within the cell is a sample absorbent, a novel biphasic substrate and a reservoir, together capable of transporting an aqueous solution within the casing along a flow path extending from the sample inlet through the test volume and into the reservoir volume. The invention further comprises a method for detecting the presence of an analyte in a liquid sample using the device and a biphasic chromatographic material for carrying out the method.

Abstract: Methods, compositions and kits are disclosed for determining one or more target polypeptides in a sample where the target polypeptides have undergone phosphorylation. A mixture comprising the sample and a first reagent comprising a cleavage-inducing moiety and an IMAC resin for a binding site on a target polypeptide is subjected to conditions under which binding of respective binding moieties occurs. The binding site is the result of phosphorylation activity involving the target polypeptide. The method may be employed to determine the target polypeptide itself. In another embodiment the presence and/or amount of the target polypeptide is related to the presence and/or amount and/or activity of an agent such as an enzyme involved in phosphorylation of the target polypeptide.

Abstract: The object of present invention is to provide an immunoassay for dioxins which can rapidly and simply afford measured values having a good correlation with analytical values of dioxins by the official method (GC/MS method). The above object is achieved by using the monoclonal antibody of the present invention having not only a reactivity with the indicator isomer among 17 kinds of PCDDs and PCDFs each having a predetermined WHO-TEF value, but also a high cross-reactivity with several kinds of dioxin isomers having five or six chlorine atoms which contribute largely to a TEQ value, and also having a stable reactivity with the antigens in a measuring solvent.

Abstract: By allowing serum or plasma samples collected from humans to react with laminin-1 or a fragment thereof, and then determining whether or not anti-laminin-1 antibody, an auto-antibody against laminin-1, in the sample bound to laminin-1 to detect anti-laminin-1 antibody in the sample, gynecology-related diseases such as habitual abortion, sterility, infertility, and endometriosis can be diagnosed.

Abstract: The invention relates to assays for measuring ubiquitin ligase activity and for identifying modulators of ubiquitin ligase enzymes.

Abstract: Peptide sequence tags are identified and used to produce a class of global antibodies, which recognize all members of a particular protein family with uniform specificity, regardless of the species of origin. The tags are used to create antibodies to the major proteins of photosynthesis, and carbon and nitrogen metabolism. The antibodies have a range of applications as diagnostic detection reagents for major environmental processes.

Abstract: Improved receptor assays for the detection of thyroid stimulating hormone receptor (TSHR) autoantibodies are described which use immobilized, affinity-purified rTSHR preparations as specific binders. This format, as well as novel measures for neutralizing pathologically increased human TSH (hTSH) levels in the sera, e.g., by the addition of anti-hHSH antibody, and/or eliminating the influence of anti-bovine TSH antibody, result in increased assay reliability and open up the possibility of preparing the assay constituents in a ready to use and/or well-standardized form for automatic processing and/or convenient marketing.

Abstract: The invention relates to methods for diagnosing and treating macular degeneration-related disorders. The invention also related to methods for identifying genes that cause macular degeneration-related disorders.

Abstract: A method and kit for screening a sample of body fluid for at least one autoantibody to at least one antigen. A source of at least one antigen to the autoantibody is provided. A substrate having immobilized thereto at least one antibody to the antigen is also provided. The antigen source is contacted with the sample of body fluid, so as to obtain a mixture wherein the antigen is allowed to substantially bind with the autoantibody, when the latter is present in the sample of body fluid. The mixture is allowed to flow relative to the substrate so as to allow the mixture to contact the antibody immobilized to the substrate. Labeling means are provided to permit monitoring of binding of the autoanitbody and the antigen present in the mixture, so as to provide an indication of the presence of the autoanitbody in the sample of body fluid.

Abstract: The instant invention involves the use of a combination of preparatory steps in conjunction with mass spectroscopy and time-of-flight detection procedures to maximize the diversity of biopolymers which are verifiable within a particular sample. The cohort of biopolymers verified within such a sample is then viewed with reference to their ability to evidence at least one particular disease state; thereby enabling a diagnostician to gain the ability to characterize either the presence or absence of at least one disease state relative to recognition of the presence and/or the absence of the biopolymer.

Abstract: A novel protein, enkurin, that is preferentially expressed in sperm has been discovered. Enkurin binds to TRPCs including TRPC2-S, a protein encoded by TRPC2 that is not predicted to be a calcium channel subunit. The invention includes methods of identifying compounds that affect enkurin expression or activity, and are useful, e.g., for contraception and treatment of infertility.

Abstract: Antibodies and methods are described for the detection and quantitation of cardiac specific troponin I in samples. Cardiac-specific troponin isoforms exist in various forms in the blood, including free and complexed forms. By selecting antibodies that are insensitive and/or sensitive to these various forms, the present invention can provide immunoassays that more accurately reflect the clinical state of an individual. These described antibodies and methods can be used for providing indicators of myocardial infarction and other cardiac pathologies.

Abstract: This invention relates to a method for immunoassays based on infrared reflection absorption spectroscopy that utilizes proteins such as antigen and antibody that have specific absorptions in infrared absorption spectrum under 1550 cm?1. A chip is made from infrared reflective substrates such as a gold or silver plate, whereon the antibodies or antigens are immobilized by the specific bonding action between metal surfaces of the chip and proteins, and the protein signals are then detected by infrared reflection-absorption and infrared microscopy. Since infrared radiation is capable of interacting with any organic molecules, there is no need to label the samples with fluorescent reagents or nucleic irradiation reagent. This invention thus provides a label-free process that can avoid the inconvenience of labeling common biochemical material for detection in the prior art, thus achieving the purpose of higher speed of detection.

Abstract: A method for the evaluation of a material to determine whether the material is susceptible to bacterial contamination or colonization comprising providing bacteria which are modified to produce a first detectable signal, exposing the material being evaluated to the bacteria and determining whether the first signal is present determining whether the first signal is present on the material or within the material.

Abstract: Provided are methods and compositions for assaying for ubiquitin agents that are enzymatic components of ubiquitin-mediated proteolysis and, more particularly, methods and compositions for assaying for agents that modulate the activity of such ubiquitin agents.

Abstract: The present invention relates to a protienaceous compound or functionally active derivative or part thereof having a binding site for a group represented by formula (I) which is part of a group of toxins derived from various cyanobacteria, to a method for its production, to diagnostic kits and to an affinty matrix (e.g. for use in immunoaffinity columns, online detection and purifications devices) containing the proteinaceous compound as well as to methods for substantially decreasing the amount of a compound containing the group represented by formula (I) in fluids or for concentrating compounds, e.g. toxins, containing the group represented by formula (I) from fluids such as crude water samples, extracts of algae or other tissue samples, e.g. to determine toxin concentrations.

Abstract: When insoluble magnetic carrier particles are used in immunoassay, a method is provided which is suitable for saving labor and for treating a large number of samples within a short time while avoiding problems including difficulties in the stability of sensitized insoluble magnetic particles and in their preparation. In assaying an antigenic substance in test samples, no use is made of insoluble magnetic particles carrying an antibody specific to the said antigenic substance but insoluble magnetic carrier particles are provided in a state free from adsorbing said antibody, etc. Then the antigenic substance per se to be assayed is adsorbed on the insoluble magnetic carrier particles followed by reaction with a labeled antibody specific to the said adsorbed antigenic substance. Thus, the antigenic substance in the test sample can be efficiently assayed in a mode suitable for automation.

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: 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. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays.

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: Lethal Toxin Neutralizing Factor has been isolated in purity from opossum serum by high pressure liquid chromatography (HPLC) fractionation. The amino acid sequence from the N-terminal for the first fifteen amino acids of LTNF-n is: Leu Lys Ala Met Asp Pro Thr Pro Pro Leu Trp Ile Lys Thr Glu. Antibodies to LTNF-n and synthetic peptides consisting of fifteen, ten and five amino acids from the N-terminal of the above sequence, designated as LTNF-15, LTNF-10 and LTNF-5 were produced by immunizing Balb/C mice to produce Anti-LTNF-n, Anti-LTNF-15, Anti-LTNF-10 and Anti-LTNF-5. The anti LTNF-n, anti-LTNF-15, anti-LTNF-10 and anti-LTNF-5 react immunologically with all types of toxins derived from animal, plant and bacteria and can be assayed by immunological in vitro test such as ELISA tests. Anti-LTNFs react roughly proportional to lethal dose of biological toxins under in vitro immunological ELISA test similar to the mouse bioassay test.

Abstract: The invention concerns a method for preparing Ig fractions from human polyvalent intravenous Immunoglobulins (IV Ig) which are in particular likely to be responsible for the immunomodulatory effect observed during the treatment of certain autoimmune diseases. The invention concerns Ig fractions having reactivity to IgM, IgG F(ab?)2 or DNP hapten and no or little reactivity to non-self antigens, that is Ig fractions which have idiotypic interactions among themselves (connected fraction) or which include natural antibodies reacting with the DNP hapten. Said fractions exhibit a polyreactivity to specific autoantigens.

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: Provided are methods and compositions for assaying for ubiquitin agents that are enzymatic components of ubiquitin-mediated proteolysis and, more particularly, methods and compositions for assaying for agents that modulate the activity of such ubiquitin agents.

Abstract: A method for the assay of N samples each containing a compound to be tested, comprises providing N reaction vessels each containing a population of carrier beads and other reagents for performing the assay, where N is at least 2 e.g. 80-4000. Each population of carrier beads is distinguishable from every other population. After adding the samples to the reaction vessels and performing the assays, the contents of all the reaction vessels are mixed and subjected to analysis by flow cytometry. By means of flow cytometry, each carrier bead is rapidly analysed to identify its population and also to determine the presence or concentration or biological activity of the compound to be tested.

Abstract: A novel compound comprising an immunologically invisible polyethylene glycol copolymer is used to carry one or more immunologically reactive substances. The novel compounds may be used as part of kits for immunological assays.

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: Method of diagnosing and/or prognosticating HIV infection in a subject comprising the steps of: (a) performing in vitro a measurement of the level of a marker in the form of (i) urokinase plasminogen activator receptor (uPAR), (ii) soluble urokinase plasminogen activator receptor (suPAR), (iii) urokinase-type plasminogen activator (uPA), (iv) one or more degradation products of (i), (ii), or (iii), and/or (v) an mRNA for (i), (ii) or (iii), in a biological fluid sample from a subject, and (b) using the measurement value obtained to evaluate the state of the subject.

Abstract: The invention is a method for detecting squalene in sera.

Abstract: The disclosed invention relates to assays for detecting and quantifying A? peptide, using solid supports that are coated with heavy metal cations, such as zinc (II) or copper (II) form of a nitriloacetic acid. Further, diagnostic kits are described which are used to carry out the assays of the present invention. An improvement in an assay for detection of A? peptide is suggested which comprises forming a heavy metal cation/solid support complex. The preferred heavy metal cations for this improvement are zinc (II) or copper (II) form of a nitriloacetic acid. Finally, methods and kits for bulk purification of A? peptides from biological fluids are taught.

Abstract: The invention relates to methods and compositions for the isolation of neural progenitor cells.

Abstract: Arterial and venous endothelial cells are molecularly distinct from the earliest stages of angiogenesis. This distinction is revealed by expression on arterial cells of a transmembrane ligand, called EphrinB2 whose receptor EphB4 is expressed on venous cells. Targeted disruption of the EphrinB2 gene prevents the remodeling of veins from a capillary plexus into properly branched structures. Moreover, it also disrupts the remodeling of arteries, suggesting that reciprocal interactions between pre-specified arterial and venous endothelial cells are necessary for angiogenesis. This distinction can be used to advantage in methods to alter angiogenesis, methods to assess the effect of drugs on artery cells and vein cells, and methods to identify and isolate artery cells and vein cells, for example.

Abstract: Pregnancy-associated glycoproteins (PAGs) are structurally related to the pepsins, thought to be restricted to the hoofed (ungulate) mammals and characterized by being expressed specifically in the outer epithelial cell layer (chorion/trophectoderm) of the placenta. By cloning expressed genes from ovine and bovine placental cDNA libraries, the inventors estimate that cattle, sheep, and most probably all ruminant Artiodactyla, possess possibly 100 or more PAG genes, many of which are placentally expressed. The PAGs are highly diverse in sequence, with regions of hypervariability confined largely to surface-exposed loops. Selected PAG that are products of the iOnvasive binucleate cells, expressed highly in early pregnancy at the time of trophoblast invasion and expressed weakly, if at all, in late gestation are useful in the early diagnosis of pregnancy. In a preferred embodiment, the invention relates to immunoassays for detecting these PAGs.

Abstract: The present invention relates to oxidized fungal antigens and methods of making and using thereof. More particularly, the present invention provides a method for producing an oxidized fungal antigen in culture filtrate. The present invention also provides for the produced oxidized fungal antigens. Devices comprising such oxidized fungal antigens, methods for testing for fungal antibodies using the oxidized fungal antigens and methods for producing anti-fungal antibodies using oxidized fungal antigens are further provided. Antigen detection devices comprising anti-fungal antibodies raised against oxidized fungal antigens produced by the present methods are further provided.

Abstract: The invention relates, among other things, a preparation comprising Alzheimer's disease antigen (A68), as well as methods of obtaining this purified antigen, and methods of using this purified antigen, for instance, for diagnosing Alzheimer's disease and for detecting human autoantibodies to the Alzheimer disease antigen. The antigen preparation according to the invention is purified in that it is substantially free of immunoglobulin G. The invention further relates to methods of making Alzheimer disease antigens that can be used instead of or along with the A68 antigen preparation (e.g., for diagnosing AD), such as recombinant human tau, tau isolated from various species including human, and phosphorylated recombinant human tau or isolated tau, as well as A68 anti-idiotypic antibodies.