Abstract: The invention provides methods for separating bound label from unbound label within an assay mixture, for predispensing assay reactants in self-contained assay vessels, as well as for detecting the presence and/or amount of an analyte within a fluid sample. In addition, a reusable detection vessel for use therein and with specific binding assays in general is disclosed. In the methods, generally an analyte within a sample is detected or measured by forming an assay mixture containing sample, analyte binding components and label, placing the assay mixture in contact with an immisable primary layer, subjecting the assay mixture to conditions that separate the analyte bound with binding components and label from unbound binding components and label, and subsequently detecting bound label.

Abstract: The present invention concerns methods for masking inhomogeneity of a member of a specific binding pair (sbp) employed in a capillary electroseparation. The method comprises binding the sbp member to synthetic particles that become localized during capillary electroseparation. Also disclosed is one embodiment of the present invention, which is a method for conducting a capillary electroseparation specific binding assay. The method involves the electroseparation of a labeled first member of a specific binding pair that is bound in a complex from labeled first member that is not bound in the complex. The complex comprises the first member and a second member of a specific binding pair. A combination is provided comprising a sample suspected of containing an analyte, a labeled first member of a specific binding pair, and a second member of a specific binding pair under conditions for forming a complex between labeled first member and the second member.

Abstract: A dual particle immunoassay method and kit for detecting analyte in a sample in which the sample to be analyzed, a binding molecule specific for the analyte, and a particle coated with the analyte to be detected or coated with a second binding molecule are reacted and applied to a porous membrane. The competitive immunoassay utilizes an analyte-coated particle, whereas the sandwich immunoassay employs a second binding molecule-coated particle. All of the reagents except for the coated particle are able to pass through the porous membrane. Detectable particles coated with a binding substance that binds to the binding molecule, such as protein A protein G, second antibody reactive to the binding molecule, or a small synthetic affinity ligand, are reacted with coated particles retained on the membrane surface. The detectable particles will pass through the membrane if not complexed with the coated particle.

Abstract: The present invention relates to a process for the determination of an analyte, in which a sample optionally containing the analyte to be determined is brought into contact with a first receptor R1, which has a binding affinity for the analyte, immobilized on a solid phase, and a receptor R2, which likewise has a binding affinity for the analyte, is added and in which furthermore the resulting immune complexes are brought into contact with a binding factor which has a binding affinity for the analyte and for a receptor R3 immobilized on the same or a second solid phase and in which the amount of the analyte bound to the first solid phase or, if present, to the second solid phase is detected in a suitable manner.

Abstract: The present invention provides a method of determining the status of a multiple sclerosis patient, i.e., predicting the transition from a status of relapsing-remitting to a progressive phase of multiple sclerosis, comprising the step of measuring the levels of urinary myelin basic protein-like material in the patient. The present invention also provides a method of determining the amount of lesions and total lesion area of a multiple sclerosis patient, comprising the step of measuring the levels of urinary myelin basic protein-like material in the patient. Further provided is a method of monitoring myelination in a developing child, comprising the step of: measuring the levels of myelin basic protein-like material in the urine of said child.

Abstract: The present invention relates to novel methods and devices for detecting non-complexed prostate specific antigen (free PSA), which is used in conjunction with total PSA tests to identify patients having either benign prostatic diseases (BPD), such as benign prostatic hyperplasia, prostatitis, or glandular atrophy or prostatic adenocarcinoma (CAP). In a biological sample, one can find not only free PSA, but also prsotate specific antigen (PSA) which has formed a complex with .alpha.1-antichymotrypsin (ACT). The present invention removes complexed PSA (PSA-ACT) from a fluid sample, thereby removing any possible interference due to binding of complexed PSA to an allegedly free PSA specific antibody in an immunoassay for free PSA.

Abstract: The invention provides a method for separating target cells from a plurality of cells which is based on a reversible high affinity interaction between two molecules. The method comprises: forming a target cell/cell binding reagent/first molecule/second molecule/solid support complex, wherein the cell binding reagent is specific for target cells present within a plurality of cells and wherein the first molecule reversibly binds to the second molecule; removing non-target cells of the plurality of cells not attached to the solid support; and reversing the first molecule binding to the second molecule, thereby releasing the target cells as separate cells from the plurality of cells.

Abstract: A method of performing immunoassay to detect the level of target proteins common to various malignancies including metallopanstimulin or metallopanstimulin-like materials as well as complement components, in a biologic sample is provided wherein the protein molecules in the patient sample compete with radiolabeled peptide for sites on the Anti-peptide-specific antibody. The amount of radioactivity measured is inversely proportional to the concentration of protein molecules present in the patient sample, which is determined from a standard curve. Another method includes determining the presence of a protein elevated in the serum of patients with neoplasms by the detection of the interference of binding or precipitation of a first antibody by a second antibody by the target protein.

Abstract: For the qualitative or/and quantitative detection of a substance to be determined in a test sample with the aid of an immunoassay or nucleic acid hybridization assay the following components are used:a) a capture reagent which enables a specific detection of the substance to be determined by means of two different binding sites 1) if desired together with further test components and 2) is bound or is capable of binding to an active solid phase via a specific binding pair one partner of which is linked to the capture reagent and the second partner of which is coupled to an active solid phaseb) an active solid phase andc) an inactive solid phase which substantially corresponds to the active solid phase but to which the capture reagent cannot bind,wherein the test sample is either firstly brought into contact with the inactive solid phase alone and only later with the active solid phase, or is simultaneously brought into contact with the active and inactive solid phase during which the capture reagent and if des

Abstract: A diagnostic method is provided for inflammatory bowel disorders (IBD), based on the relative levels of eosinophil granule proteins in physiological samples obtained from the GI tract of mammals suspected of having an IBD.

Abstract: An immunoassay is provided which is selective for an analyte over immunologically related substances which may be present in a sample to be tested. The presence of the analyte is detected using a first binding substance, typically an antibody, in the presence of a second binding substance, typically another antibody. The first binding substance recognizes an epitope which is characteristic of the analyte and cross-reacts with a related epitope on the cross-binding substance. The second binding substance preferentially binds the common epitope on the cross-binding substance, thus reducing non-specific binding of the first binding substance.

Abstract: Use of an anti-cardiolipin antibody, anti-lipoprotein antibody or anti-.beta.2-glycoprotein I antibody together with an immobilized antibody thereof enables to accurately assay for a complex of .beta.2-glycoprotein I and an oxidized lipoprotein in a blood sample, according to a sandwich immunoassay. Thus, the oxidized lipoprotein in blood can be detected, whereby diagnosis of arteriosclerotic disease is enabled.

Abstract: A solid phase system for use in ligand-receptor assays, particularly immunoassays using monoclonal antibodies, is disclosed. The solid phase system comprises a porous matrix in which microspheres, bound with a receptor capable of capturing a target ligand, are entrapped. Preferably, the microspheres are entrapped within a discrete zone or zones of the porous matrix.

Abstract: The present invention provides a method of detecting and diagnosing myocardial infarction which detects myocardial infarction by immunoassay using a monoclonal antibody having specific reactivity for human hepatocyte growth factor (HGF) as obtained by using human HGF as immunogen as well as a disganostic agent for myocardial infarction which comprises, as essential component thereof, the monoclonal antibody mentioned above. The method of the present invention makes it possible to detect and diagnose patients with myocardial infarction.

Abstract: Described are cloning and sequencing of genes encoding novel isoforms (paxillins .beta. and .gamma.) of focal adhesion protein paxillin. According to the present invention, there is provided a novel gene for an isoform of focal adhesion protein paxillin. This gene is useful medical applications such as diagnosis of progress of cancer malignancy, development of a drug (cancer treatment) for preventing the metastasis and infiltration of cancer cells, etc.

Abstract: The novel analytical devices and methods of the present invention involve a semiquantitative specific binding assay method for the detection of the presence of at least a predetermined minimum concentration of an analyte in the test sample. A calibration reagent is present at a concentration sufficient to inhibit the formation of a detectable analyte complex unless a predetermined minimum concentration of analyte is present in the test sample.

Abstract: Compositions and methods are provided which are useful in determining the levels of the C-telopeptide of human Type I collagen. The levels of the C-telopeptide are used as a marker of collagen degradation in an individual, and thus serve as a sensitive and specific indicator of bone resorption. Assays for the C-telopeptide find a variety of uses, including use in diagnosing metabolic bone disorders such as osteoporosis or postmenopausal rapid bone losers, monitoring the efficacy of therapeutic regimens designed to treat such disorders, determining the extent of imbalances between bone formation and resorption.

Abstract: Corticotropin Releasing Factor-binding protein (CRF-BP) is produced recombinantly and is useful for modulating the biological activity of CRF. CRF-BP or fragments thereof and/or antibodies to such polypeptides are employed in diagnostic assays to determine the levels of CRF and CRF-BP and the ratio of CRF/CRF-BP in a vascular fluid sample. Following such an assay, pregnancy-related pathological disorders, such as increased risk of premature labor, can be treated, for example, by administering CRF-BP to lower the ratio of CRF/CRF-BP to within a normal range for pregnancy. Anti-CRF-BP antibodies are also useful to purify CRF-BP and to modulate the biological effect of CRF-BPs.

Abstract: Methods for the detection, monitoring and treatment of malignancies in which the HER-2/neu oncogene is associated are disclosed. Detection of specific T cell activation (e.g., by measuring the proliferation of T cells) in response to in vitro exposure to the HER-2/neu protein, or detection of immunocomplexes formed between the HER-2/neu protein and antibodies in body fluid, allows the diagnosis of the presence of a malignancy in which the HER-2/neu oncogene is associated. The present invention also discloses methods and compositions, including peptides, for treating such malignancies.

Abstract: A carboxyterminal propeptide of type I procollagen free from type III procollagen carboxyterminal propeptide can be used to produce an antibody which is specific for carboxyterminal propeptide of type I procollagen and which has no affinity for the type III procollagen carboxyterminal propeptide. This antibody can be used to assay more accurately the propeptide which is a measure of the rate of production of type I procollagen and useful in diagnosing and monitoring e.g. bone diseases.

Abstract: SLO peptide antigens are described. These peptide antigens are suitable for the determination of SLO antibodies, as immunogens for the production of antibodies against SLO and as vaccines for the production of vaccines against SLO.

Abstract: Trace components in samples can be measured rapidly with high precision by applying interaction between an analyte to be measured and an affinity substance and using a membrane having specific separating capability.

Abstract: This invention presents novel assay devices employing capture reagents, involving a specific binding member attached to a charged substance, and porous material containing a capture or reaction zone that is oppositely charged with respect to the charged substance included in the capture reagent. In one embodiment, a test sample suspected of containing the analyte of interest is contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged capture or reaction zone to attract, attach, and immobilize the capture reagent/analyte complex. With an appropriate indicator reagent, both sandwich and competitive assays can be performed.

Abstract: There are disclosed a hybridoma obtained by fusing a myeloma cell with an anti-thymosin .alpha.1 antibody-producing cell and selecting a hybridoma which produces a monoclonal antibody that recognizes the N-terminus of thymosin .alpha.1; an anti-thymosin .alpha.1 monoclonal antibody which is produced by the hybridoma, and a method for measuring thymosin .alpha.1 which comprises forming a three-component complex comprising thymosin .alpha.1, the anti-thymosin .alpha.1 monoclonal antibody (A), and an anti-thymosin .alpha.1 antibody (B) that recognizes a different site of thymosin .alpha.1 than antibody (A) does; forming a four-component complex of said three- component complex with a labeled substance (C) that specifically binds to antibody (A) or antibody (B) of the three-component complex; and detecting the labeled substance in said four-component complex.

Abstract: A method is described for determining a hapten which method comprises (i) contacting the hapten with a binding partner of the hapten, whereby the hapten becomes bound to some of the binding partner, (ii) contacting the unbound binding partner with a secondary binding partner therefor, (iii) contacting the binding partner with an antibody which binds the binding partner which has bound thereto the hapten but which does not bind the binding partner which has bound thereto its secondary binding partner; and (iv) determining the amount of antibody bound to the binding partner. Kits for use in the method are also described.

Abstract: A method of dispensing wash solution to separate free from bound labels in a slide immunorate assay. The method comprises dispensing wash first as separate drops spaced to allow complete absorption prior to the next drop, followed by a time at which the rate of dispensed wash exceeds the rate of fluid uptake of the slide, to form a continuous stream. The first phase of this wash method provides a more complete separation of bound from free under the dispense tip than occurs if only a continuous stream is used throughout.

Abstract: Human red blood cells with antigenic determinants recognized by unexpected alloantibodies are mixed with serum from the potential recipient. Following incubation, multivalent monoclonal IgM antibodies specific to the antigenic determinant present on the test red blood cells are added. If the recipient's serum is negative for an unexpected antibody which would bind to the antigens present on the test red blood cells, then the multivalent antibody will agglutinate the red cells. Conversely, if an unexpected antibody specific to those determinants is present in the recipient's serum, hemagglutination will be inhibited.

Abstract: An assay for determining the presence of a threshold concentration of an analyte in a sample comprises first reacting the sample with an amount of anti-analyte selected to reduce the free analyte to a marginally detectable concentration. The sample is then contacted with anti-analyte immobilized on a test region or indicator zone on a solid phase, whereby the residual free analyte may be bound. The binding of free analyte to immobilized anti-analyte is detected by a variety of techniques to indicate the presence of the threshold concentration. By employing limited amounts of anti-analyte on the solid phase, the change between maximum binding of label and no binding of label will be responsive to very small changes in the analyte concentration originally present in the sample.

Abstract: An antibody raised to type I collagen carboxyterminal cross-linked telopeptide isolated from decalcified human or animal bone, may be used in an assay to determine the concentration of liberated carboxyterminal telopeptide region of the type I collagen molecule in a sample. When the sample is a body fluid such as serum or urine the degradation product measured is resistant to further degradation, since it contains a multivalent intermolecular cross-link, and can thus be found in the body fluid. The assay may be used to assess the degradation of type I collagen, the major organic constituent of bone matrix.

Abstract: Immunoassays for vitamin B.sub.12 using novel monoclonal antibodies to the intrinsic factor:vitamin B.sub.12 complex and to the vitamin B.sub.12 binding site on intrinsic factor.

Abstract: Assay reagents, devices, methods and kits used in the analysis of low molecular weight analytes which by themselves are too small or unable to bind to two specific binding members at the same time. The invention involves the use of an analyte-substitute reagent (ASR) comprising at least two components, the first of which is identical to or an analog of the analyte to be determined, while the second is an unrelated ligand for which an antibody or other specific binding member can be obtained or produced.

Abstract: An animal tissue antigen for osteoporotic patients that reacts with antibody in a serum of human osteoporotic patients, but does not react with that in normal human serum. Preferably, a specific antigen for osteoporotic patients in rat or mouse epithelium of tongue mucous membrane, epithelium of tracheal mucous membrane, upper lip epidermis or follicular epithelium containing upper lip hair shafts, or a specific antigen for osteoporotic patients contained in cultured cells of a human squamous cell tongue carcinoma cell lines such as SCC-9 and fibroblast cell lines such as MRC-5. Osteoporosis can be both specifically and easily diagnosed by bringing the above-mentioned antigen in contact with a serum of a subject and then testing for the presence of an antigen-antibody reaction.

Abstract: The present invention provides novel monoclonal antibodies HE-22A, HE-35A, HE-39E, and HE-69B against human IgE, a mixture thereof, hybridomas producing the antibodies, and immunoassays of human IgE employing the antibodies, which are useful for clinical diagnosis of allergic diseases or parasitic infections.

Abstract: The present invention provides chromatographic assay devices that can perform multiple assays simultaneously in the same test strip, as well as methods for their use. One of the assays can be an immunological assay to detect an antigen, such as human chorionic gonadotropin, while another assay can be a serological assay to detect an antibody, such as anti-rubella antibody. An assay device according to the present invention can comprise: (1) a first opposable component including at least one chromatographic medium having a specific binding partner to the first analyte and a specific binding partner to the second analyte immobilized thereto in separate, discrete, non-overlapping zones; and (2) a second opposable component including an absorber.

Abstract: A method is described for determining a hapten which method comprises (i) contacting the hapten with a binding partner of the hapten, whereby the hapten becomes bound to some of the binding partner, (ii) contacting the unbound binding partner with a secondary binding partner therefor, (iii) contacting the binding partner with an antibody which binds the binding partner which has bound thereto the hapten but which does not bind the binding partner which has bound thereto its secondary binding partner; and (iv) determining the amount of antibody bound to the binding partner. Kits for use in the method are also described.

Abstract: The present invention relates to the determination of thrombocytopenia induced by an inductor drug such as heparin. According to the invention, a sample is mixed with a complex of an antigenic substance such as platelet factor 4 (pF4) and heparin to determine if the sample contains antibodies which react with the complex. The presence of these antibodies is indicative of heparin-induced thrombocytopenia.

Abstract: The present invention includes novel digoxin assays employing a capture reagent, involving a first binding member conjugated to a polymeric anion substance, and a solid phase material containing a reaction site comprising a polymeric cation substance having a nitrogen content of at least about two percent. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: A method for carrying out a binding assay is described wherein a member of a specific binding pair (sbp) and a sample are combined with a matrix of non-porous beads in a liquid medium under conditions such that the beads bind to the sbp member. The liquid medium is removed from the beads by aspiration using an aspiration tube having one or more orifices each of a diameter smaller than the minimum diameter of the smallest bead thereby allowing removal of the liquid medium while prohibiting aspiration of the beads.

Abstract: The subject invention provides an antigen characterized as having a molecular weight of approximately 68 kD, being reactive with autoantibodies associated with mental illness especially schizophrenia, being located in neuronal cells, and co-migrating with a protein band in SDS-PAGE which is recognized by rabbit antibodies which react with the peptide whose sequence is Ala-Lys-Xaa-Val-Lys-Phe-Gly-Ala-Asp-Ala-Xaa-Ala-Leu-Met-Leu (SEQ ID NO: 2). The invention also provides methods for detecting in a sample from a subject the presence of an antibody to the neuronal antigen, determining the propensity of a subject toward a psychiatric disease, diagnosing and treating a subject having mental illness.

Abstract: Hybridomally produced monoclonal IgM antibodies having high affinity are useful for the immunoassay and purification of vital antigens.

Abstract: The present invention relates to an apparatus for determining the presence or absence of a target analyte in a liquid sample, comprising:(i) a container capable of accommodating the liquid sample and having a transparent portion; and(ii) an insertion member which is capable of being inserted into the container comprising;a porous member which has a main surface and a reverse surface and which has on the main surface a substance capable of specifically binding to the target analyte; andan absorbent bonded to the reverse surface of the porous member;the porous member being supported in the insertion member whereby, when the insertion member is inserted into the container, the main surface can be observed from the outside of the container through the transparent portion of the vessel and the liquid sample is absorbed into the absorbent through the porous member.According to the analyzer of the present invention, the presence or absence of a target analyte in a sample can be easily determined.

Abstract: The present invention provides a method for type determination in body fluids of antibodies of a definite immunoglobulin class which are directed against an antigen A according to the immunoassay principle by incubation of the sample solution with at least two receptors R.sup.1 and R.sup.2, of which R.sup.1 is immobilizable and binds with the antibody to be determined and R.sup.2 is labelled and binds either with the antibody to be determined or with the antigen A, separation of the solid phase from the liquid phase and measurement of the label in one of the two phases, wherein the immunological reaction is carried out in homogeneous phase and the sample solution is incubated simultaneously with receptor R.sup.1 and an excess of human antibodies or fragments thereof which belong to the same immunoglobulin class as the antibody to be determined and are not bindable with the antigen A and subsequently receptor R.sup.2 and possibly further receptors are added thereto.

Abstract: The present invention first provides monoclonal antibodies recognizing membrane phospholipase A.sub.2, namely, monoclonal antibodies PL-49, PL-71, PL-76, and PL-78, hybridomas producing them, methods for producing them, and immunoassays of membrane phospholipase A.sub.2 using them.The immunoassay of PLA.sub.2 M is useful for the diagnosis of articular rheumatism, cancers, and a wide variety of inflammatory states.

Abstract: The degradation of type III collagen in the body is quantitatively determined by measuring the concentration of the liberated aminoterminal telopeptide region of the type III collagen molecule in the body fluid by a specific immunological method. This degredation product is resistant to further degradation and can thus be found in body fluids e.g. in serum or urine. For the determination the telopeptide region must be isolated from a human source e.g. from uterine leiomyoma.

Abstract: Assay reagents, devices, methods and kits used in the analysis of low molecular weight analytes which by themselves are too small or unable to bind to two specific binding members at the same time. The invention involves the use of an analyte-substitute reagent (ASR) comprising at least two components, the first of which is identical to or an analog of the analyte to be determined, while the second is an unrelated ligand for which an antibody or other specific binding member can be obtained or produced.

Abstract: Two hybridomas that produce receptors containing antibody combining sites that immunoreact with apolipoprotein B-100 are disclosed as are uses for the receptors, compositions and diagnostic systems that include the receptors.

Abstract: This invention relates to methods that have been found useful in reducing non-specific binding in immunochemical assays, via methods that can be implemented much faster than those used by Ishikawa. The techniques include the use of a lipophilic bridge, such as a liposome, or the elution of the antigen-antibody complex from the solid phase by the use of an anti-idiotypic antibody or an antibody, or the use of a heterologous reversible bridge.

Abstract: The invention includes an agglutinant complex which is useful for the investigation of the antigens present on erythrocytes, and which results from affinity couplings between nonagglutinant IgG type antibodies specific for the antigen to be identified, a protein capable of binding to at least two sites on the Fc part of antibodies and an anti-immunoglobulin antibody or its fragments.

Abstract: Disclosed is a novel immunoassay methodology, bridge immunoassay, which employs a primary free solution analyte/receptor binding reaction, for example, in a sandwich-type format (two or more analyte receptors), in a competitive format (single analyte receptor) or in a related immunoassay format, and a universal solid phase and capture system. The universal capture system comprises a first receptor bound to a solid phase and a bridge receptor (a second receptor) which functions both as a ligand for said bound first receptor and as a receptor for a ligand conjugated to a sample analyte receptor (a third receptor). The bridge receptor is used to immobilize the immunocomplexes formed free in solution by linking them to the bound first receptor. The universal capture system can be used for assays for any analyte as the bridge receptor binds to a ligand, for example, a hapten or binding protein, conjugated to the sample analyte receptor. Methods, compositions and test kits for such bridge immunoassays are provided.

Abstract: This invention provides a quantitative assay for determining the amount of a biologically active ligand selected from the group consisting of human chorionic gonadotropin and luetinizing hormone present in a sample comprising contacting the sample with both the receptor to which the ligand naturally binds in order to effect its biologicaly activity and a monoclonal antibody directed to the ligand or to a complex of the ligand and the receptor so as to form a complex of the ligand bound to both the receptor, at the site to which the ligand naturally binds to the receptor, and the monoclonal antibody. In the complex so formed, either the receptor or the monoclonal antibody is labeled with a detectable marker and a determination is made of the amount of labeled receptor or of labeled monoclonal antibody bound to the ligand or the amount of labeled receptor or of labeled monoclonal antibody not bound to the ligand, or both such amounts.