Abstract: Hybridoma for production of monoclonal antibody to an antigen found on the peptide fragment of the B.beta. chain of human fibrinogen or fibrin I containing amino acid residues 1-42. The hybridoma is formed by fusing an animal myeloma cell, e.g., a mouse myeloma cell, with a splenocyte from an animal, e.g., a mouse, immunized with an NH.sub.2 -terminal of human fibrinogen or fibrin I. Hybridoma for production of monoclonal antibody to an antigen found on the peptide fragment of the B.beta. chain of human fibrin II containing amino acid residues 15-42. The hybridoma is formed by fusing an animal, e.g., mouse myeloma cell with a splenocyte from an animal, e.g., mouse, immunized with a NH.sub.2 -terminal of human fibrin II. Diagnostic and therapeutic uses of the monoclonal antibodies are also disclosed.

Abstract: A method and reagent kit means are provided for assay of a selected antigen such as hCG or CEA in an aliquot of body fluid. The method comprises the steps of constituting the aliquot in a mixture comprising tracer (which may be an enzyme tracer or a radioactive tracer) conjugated with monoclonal antibody, and separate immobilized monoclonal antibody, incubating the mixture to enable separation of a solid phase antigen antibody conjugate in sandwich relation, and measuring the tracer content and corresponding antigen content of the aqueous phase or the solid phase. The antibody (conjugated and/or immobilized) comprises multiple monoclonal antibodies from different cell lines so that the specificity of the assay is enhanced, and the possibility of unrecognized antigen fragments is reduced.

Abstract: To determine whether a patient will react adversely when injected intravenously with an iodine-containing contrast media, a sample of the patient's whole blood, whole blood depleted of red blood cells or plasma is treated to activate complement, and the level of at least one product resulting from complement activation is quantified and compared to the level of that product obtained in patients of known reactivity to radiographic contrast media.

Abstract: A murine monoclonal antibody specific for an antigenic determinant on the surface or in the cytoplasm of human carcinoma cells and tissue. A cell line is provided for producing such specific monoclonal antibodies for the detection, diagnosis, and therapeutic treatment of a plurality of human carcinomas by means of selective labelling of said monoclonal antibodies.

Abstract: Retroviruses associated with Acquired Immune Deficiency Syndrome (AIDS), including Lymphadenopathy Associated Virus (LAV), are isolated from the sera of patients afflicted with Lymphadenopathy Syndrome (LAS) or AIDS. LAV is a Human Immunodeficiency Virus (HIV). Viral extract, structural proteins and other fractions of the retrovirus immunologically recognize the sera of such patients. Immunological reaction is used to detect antibodies that specifically bind to antigenic sites of the retrovirus in samples of body fluids from patients with AIDS or risk of AIDS. A kit for in vitro assay of LAS or AIDS is provided.

Abstract: Early pregnancy can be determined by detection of a protein in milk, which protein is associated with the placental membrane. The protein is characterized by having an approximate molecular weight of 47,000 to 53,000 and an isoelectric point of from about 4.0-4.4.

Abstract: An agent for quantitative determination of microorganisms, which comprises(a) an antibody prepared from a strain of the same species as the species of microorganisms to be determined,(b) an insolubilized cell component of a strain which can sufficiently bind to the antibody (a) but does not release and replace to other strains which have been bound with the antibody (a), and(c) a labelled second antibody, and a method for the quantitative determination of microorganisms. The agent and method of the present invention are useful for determinating simultaneously not only a strain from which the antibody is prepared but also other strains of the same species which are contained in the test sample.

Abstract: The invention relates to monoclonal anti-idiotypic antibodies to human anti-DNA antibodies. Monoclonal, anti-idiotypic antibodies are produced using hybridoma technology. The antibodies are used as diagnostic reagents in methods to determine the presence of anti-native DNA antibodies in serum from patients suspected of having systemic lupus erythematosus.

Abstract: The invention relates to monoclonal anti-idiotypic antibodies to human anti-DNA antibodies. Monoclonal, anti-idiotypic antibodies are produced using hybridoma technology. The antibodies are used as diagnostic reagents in methods to determine the presence of anti-native DNA antibodies in serum from patients suspected of having systemic lupus erythematosus, and as therapeutic reagents in methods to remove the anti-native DNA antibodies from the serum of patients with systemic lupus erythematosus.

Abstract: The invention relates to a method of testing for the presence of cancer. An antibody is produced which contains antibodies specific to a modified nucleoside component. The antibody is admixed with a body fluid drawn from a subject mammal. An immunoassay is performed on the admixture to quantify an amount of cancer associated nucleoside present in the fluid and reactive with the antibody.

Abstract: Monoclonal receptors that immunologically bind to human apolipoprotein A molecules, particularly apo-A-I and apo-A-II, are described as are their methods of use and articles of manufacture containing them.

Abstract: A murine monoclonal antibody combining site produced by a hybridoma formed by fusion of cells from a myeloma cell line and lymphocytes that produce antibodies that react (1) with isolated human C3b receptor and (2) with C3b receptor-bearing cells from a mammal immunized with human C3b receptor is disclosed.

Abstract: This invention describes a process for immuno-chemical quantitative determination of immunologically active substances. The method involves a first incubation of a sample containing the active substance with a labelled binder, which contains an antibody or antibody fragment. After complexing has taken place, solid phase bound active substance identical to the substance being quantitatively determined is added. The solid phase bound substance binds with free binder, and the solid and liquid phases are separated. A second antibody which is specific either to antibody or the solid phase antibody-substance complex is then added to the liquid phase. This second antibody is non cross-reactive with individual complex components. The amount of labelled first antibody bound to second antibody is then determined.

Abstract: Homogeneous immunoassays employing double ligand binding conjugates comprising an anti-idiotype binding partner. The anti-idiotype binding partner competes with ligand for an insolubilized ligand specific binding partner. Inhibition of binding of the conjugate to the insolubilized binding partner due to ligand binding permits the second binding partner in the conjugate to bind with insolubilized label means. Thus, detection of label is inversely related to the presence of ligand in the sample.

Abstract: A method and system for detecting and preferably measuring the presence of an activated complement complex in a sample is discussed. The presence of such an activated complex is indicative of complement pathway activation and includes a first complement component and a second complement component. The method uses a first binding agent specific to the first complement component and a second binding agent specific to the second complement component which when bound with the complex forms an aggregate. The second specific binding agent includes a label whose presence is used to detect and measure the amount of aggregate and therefore activated complex in a sample. An assay system and aggregate for use in an assay system are also discussed.

Abstract: Process for the determination of carcinoembryonic antigen (CEA) in a sample of serum or plasma. The process comprises contacting a slightly acidic buffered sample of the serum or plasma with hydrophilic silica at room temperature, separating the silica from the sample and carrying out a radioimmunoassay for carcinoembryonic antigen on said sample.

Abstract: Collagen profiles of human body tissues and fluids, i.e., the types of distinct connective tissue proteins present, their distribution in human body tissues and fluids, and the concentration ratios among distinct types, are subject to change during certain pathological conditions and during therapeutic regimens for the treatment of such conditions. These changes in collagen profiles can be detected by immunohistological, immunocytological and immunoserological techniques. In vitro diagnostic methods employing monoclonal antibodies specific for connective tissue proteins are provided which can be used for monitoring the results of therapeutic measures taken against inflammatory diseases, fibrotic diseases and cancer and for detecting or following the pathogenesis of such diseases.

Abstract: An antigen/antibody precipitate is obtained, using monoclonal antibodies, the monoclonal antibodies (samples I or II or III or IV) being selected so as to be specific to two distinct antigenic binding sites (L or C 2 or C 3) on a protein (IgG) in a sample under test. The proportions of sub-populations of immunoglobulins (IgG kappa, IgG lambda) in a sample is determined by reacting the sample with a combination of antibodies (II and IV) both of which are specific to the heavy chains (H) of both sub-populations (IgG kappa, IgG lambda) and reacting the sample with an antibody combination (I and II) specific to said heavy chain (H) and to an antigenic determinant expressed by only one (IgG kappa) of the sub-populations.

Abstract: Immunoassays which utilize an enzyme linked ligand or receptor wherein the enzyme is bacterial luciferase; mercantile kit useful in performing said immunoassay; and compounds utilized in performing said assay.

Abstract: An assay for determining the Lewis blood group of a patient consists of testing a body sample for the presence of Lewis.sup.a and Lewis.sup.b antigens. Monoclonal antibodies specific for either of these antigens are employed which do not cross-react with other related antigens, such as the H blood antigen. Body samples which may be tested include: saliva, serum, urine, and paraffin-embedded tissue samples. Hybridoma cell lines and the antibody compositions they produce specific for these antigens are provided for use in the assay.

Abstract: A continuous hybridoma cell line which secretes recoverable quantities of monoclonal antibodies having specificity against Vitamin B.sub.6, which antibodies are useful in a method for detecting the presence of vitamin B.sub.6 in an animal sample.

Abstract: A method for rapid diagnosis of gonorrhea is set forth comprising assay of the enzyme immunoglobulin A protease (IgAP). Immunoassays including radioimmunoassay and enzyme-linked immunoassay with monoclonal antibodies to IgAP are disclosed. A kit for early detection of gonorrhea is given. The assay and kit of the present invention may also be used in the detection of meningitis.

Abstract: Competitive immunofluorescence assays for antigens in which immune complexes are precipitated with a nonfluorescent, nonlight-scattering precipitant such as polyethylene glycol and the resulting immunoprecipitate is dissolved with a nonfluorescent solvent of low ionic strength that maintains the pH of the solution substantially constant for immunofluorescence intensity reading. The assays are carried out by incubating the sample with fluorescent-labeled antigen, anti-antigen antibody, and a secondary antibody to the anti-antigen antibody followed by addition of the precipitant to form an immunoprecipitate. The precipitate is separated by centrifuging, dissolved in the solvent, and the immunofluorescence intensity of the solution is read with a fluorometer and compared to a standard curve.

Abstract: A method of diagnosis using an attached material for binding to an immune complex, by treating the bound complex with a series of different reagents or mixtures thereof and detecting the presence or absence of reaction in each case, this method being based on immune complexes produced in the body during infection and allowing much earlier detection and diagnosis of infection thereby providing the facility for treatment to reduce the damage caused to the body by the formation of complex.

Abstract: The present invention provides a process for the immunological determination of creatinine, wherein creatinine is converted into 1-methylhydantoin, the 1-methylhydantoin formed is incubated in an aqueous medium with antibodies which are directed against a conjugate of a first hydantoin derivative of the general formula: ##STR1## in which R.sup.1, R.sup.2, R.sup.3 and R.sup.4, which can be the same or different, are hydrogen atoms, alkyl radicals containing up to 3 carbon atoms or phenyl radicals, with a first hapten carrier substance suitable for antibody formation, reacted with a conjugate of a second hydantoin derivative of general formula (I) with a second hapten carrier substance, one of the components antibody and conjugate being present in the solid phase or in dissolved form and the other component being present in dissolved form, and the inhibition of the binding reaction between the antibodies and the hydantoin conjugate with the second hapten carrier substance is measured.

Abstract: A hybridoma cell line is disclosed that secretes monoclonal antibodies which serve as a high titer, reproducible, biological reagent useful in biological/medical research for isolating and identifying phosphotyrosine-containing proteins. In addition, the antibodies have potential uses in diagnosis of a variety of diseases, including certain cancers. The antibodies, which have demonstrated affinity for a variety of molecules containing o-phosphotyrosine residues, were prepared using a synthetic analog, p-azobenzyl phosphonate (ABP) covalently linked to a carrier protein, as the antigen.

Abstract: The invention pertains to an improved heterogeneous enzymeimmunoassay involving the use of a reversibly soluble polymeric substance acting as the support for the antibody. In the direct method the antigen to be detected and an enzyme labeled antigen are bound by antibody which is chemically linked to the soluble polymeric substance. The polymer is rendered insoluble and removed from the test solution. After resolubilization into a solution containing substrate for the enzyme label, the assay for antigen is completed by determination of enzymatic activity. In the indirect method, the antigen to be detected and an enzyme labeled antigen are incubated with a primary antibody unattached to the polymeric substance. After addition of a second antibody which is chemically linked to the polymeric substance, the polymer is rendered insoluble and the assay is performed as in the direct method described above.

Abstract: The present invention describes an apparatus and method for conducting immunochemical reactions in a self-contained sealed unit that requires only the addition of an unknown sample and water. The apparatus comprises a test tube with at least three chambers each containing different chemicals, including a solid sphere, and separated from each other by a water-soluble barrier.

Abstract: Ligand having at least two determinant or binding sites is contacted with a labeled first binder, an unlabeled second binder different than the first binder and a precipitating binder specific for the second binder, with such contacting precipitating a complex of the ligand and the first and second binders to thereby separate bound labeled binder from unbound labeled binder. The bound and/or unbound labeled binder is determined as a measure of the ligand.

Abstract: The invention comprises a method for the purification of a human lung tumor-associated antigen (hLTAA) specific to human lung tumors of diverse histological characteristics; serum levels of hLTAA correlate with lung tumor incidence, and appear to usefully discriminate between various stages of the malignancies. The invention further comprises an immunoassay predicated on purified hLTAA for the detection and quantitative determination of hLTAA in biological fluids, particularly blood serum, and diagnostic systems for clinical immunoassay procedures.

Abstract: A method, kit and a solution for assaying enzyme, such as prostate acid phosphatase (PAP), in a sample. The sample is contacted with a first antibody (Ab.sub.1) against the enzyme and incubated. The resulting Ab.sub.1 -enzyme complex is contacted with a second antibody (Ab.sub.2) specific for Ab.sub.1. The resulting Ab.sub.2 -Ab.sub.1 -enzyme complex precipitates out of the medium. The precipitated complex is separated and solubilized with a pH controlled solution of gamma globulin. The resulting solution is then assayed for enzyme activity.

Abstract: A conjugate useful in determining the amount of antigen or antibody in a liquid sample, said conjugate having a marker, an immunoreactive component (i.e. antigen or antibody) bound to the marker and an insolubilizing binding component which is also bound to the marker. The insolubilizing binding component portion of the conjugate will react with an insolubilizing receptor to form a solid product of conjugate and receptor unless the conjugate reacts with the corresponding antigen or antibody to be analyzed in which event the conjugate will not react with the insolubilizing receptor. The conjugate will be added to a liquid sample containing an unknown amount of, for example, an antibody. A known amount of the corresponding antigen is also added which reacts with both the conjugate and antibody. After the reaction is complete, the liquid sample is contacted with the insolubilizing receptor.

Abstract: The antigens procollagen peptide (type (III) and procollagen peptide col 1 (type III) can be determined together immunologically by either(a) reacting a specified amount in each case of labeled procollagen peptide (type III) or procollagen peptide col 1 (type III) and a highly specific antiserum containing antibodies having affinity for both the antigens mentioned together with a sample having an unknown content of procollagen peptide (type III) and/or procollagen peptide col 1 (type III), separating off the antigen-antibody complex formed and measuring the amount of labeling in the complex and/or in the supernatant, or(b) bringing a specified amount of the highly specific antiserum to reaction with a sample having an unknown content of procollagen peptide (type III) and/or procollagen peptide col 1 (type III), fixing the unreacted amount of the antibody to procollagen peptide (type III) or procollagen peptide col 1 (type III) bound to a support, and bringing to reaction with a labeled second antibody, and th

Abstract: The present invention relates to a novel method for the quantitative determination of PEP (progestagen-associated endometrial protein) in a body fluid by radioimmunoassay. The technique is useful in monitoring the function of the human endometrium.

Abstract: An immunoassay process for the detection of an antigen in a sample, which comprises: (a) forming a mixture of the sample with (1) a preformed complex of a primary antibody and a secondary binding macromolecule therefor, wherein the primary antibody is present at low concentrations and has substantial specificity for the antigen, the secondary binding macromolecule has substantial affinity for the Fc portion of the primary antibody, and the second binding macromolecule is affinity purified; and with (2) a detectably labeled form of the antigen; (b) incubating the mixture formed in step (a) for a time sufficient to allow the antigen and the detectably labeled antigen to competitively bind to the primary antibody of the preformed complex; (c) detecting the separated complex or the separated suspension medium.

Abstract: This invention relates to a highly-sensitive mini-iodinated radioactive hormone tracer which has both initial low iodine-to-hormone molar ratios and low specific activity. This invention also relates to methods for preparing and using such tracers in a radio-immunoassay which takes much less time than used heretofore and to a method of preparing said tracers.

Abstract: A method for immunochemical assay of an antigen or antibody by labelling the antigen or antibody with a specific cyanine or merocyanine dye containing a carboxy group followed by effecting an immune reaction and photochemical processing thereof is provided. The amount of the antigen or antibody is measured in term of optical density of developed silver halide which is brought into contact with either the antigen-antibody reaction product or the unreacted material.This immunochemical assay method gives high detection sensitivity in a simple operation manner.

Abstract: An improvement in assaying methods involving biospecific affinity reactions, in which there are used from 2 to 4 reactants, one of which, reactant (I), is labelled with at least one analytically indicatable atom or group and is soluble in the aqueous liquid in which the biospecific affinity reaction is carried out, the reactants forming, by means of biospecific reactions, a conjugate in which labelled reactant (I) is incorporated; and in which assaying methods the analytically indicatable atom or group is assayed in the conjugate and/or in labelled reactant (I), which is not bound to the conjugate. The conjugate that has been formed or labelled reactant (I) not bound to the conjugate is bound covalently to an insoluble carrier or to an insolubilizable carrier, which latter carrier is made insoluble after the covalent binding has been carried out, whereafter the assay of the analytically indicatable atom or group is carried out.

Abstract: A method and reagent kit means are provided for assay of a selected hapten in an aliquot of body fluid containing lipid. The method comprises the steps of constituting the aliquot in a mixture with surfactant and incubating the mixture to solubilize the same. The content of hapten in the incubated mixture is taken up selectively by hapten-specific antibody and read by hapten non-lipid conjugate tracer assay.

Abstract: Reagents and methods are described for an immunoassay test of increased sensitivity and decreased complexity employing an immunoglobulin specific for an antigen naturally or artificially placed upon the surface of an indicator particle coupled through the use of a hetero-bifunctional coupling reagent to a second antibody of differing specificity and specific for the antigen to be detected. In a preferred embodiment, a hetero-bifunctional coupling agent couples via a sulfhydryl group, a univalent immunoglobulin specific for the surface antigens on erythrocytes to a second multivalent immunoglobulin through an amide linkage with the latter immunoglobulin wherein said second immunoglobulin is specific for hepatitis-B surface antigen.

Abstract: "Two-site" or "sandwich" immunometric assay techniques for determination of the presence and/or concentration of antigenic substances in fluids using monoclonal antibodies. One monoclonal antibody is presented in a soluble labeled form and a second monoclonal antibody is presented bound to a solid carrier; the soluble and bound monoclonal antibodies may be the products of either the same or different cell lines. Each monoclonal antibody has an affinity for the antigenic substances of at least about 10.sup.8 liters/mole.

Abstract: Pterin derivatives are described having the formula (I) ##STR1## wherein R represents a hydroxyphenyl group, a radioiodinated hydroxyphenyl group, a tyraminocarbonyl group, a radioiodinated tyraminocarbonyl group, a proteinocarbonyl group or a carboxy group; Q represents a straight or branched chain alkylene group having 1 to 6 carbon atoms; and R.sub.6 and R.sub.7 each represents a hydrogen, an alkyl group having from 1 to 6 carbon atoms, a hydroxyalkyl group having from 1 to 6 carbon atoms; and a radioimmunoassay method is described using a radioiodinated 4-hydroxy-2-tyraminopteridine derivative or a radioiodinated 4-hydroxy-2-tyraminocarbonylalkylaminopteridine derivative as the tracer.

Abstract: A process is presented for conducting fluorescence immunoassays without the use of added labels by utilizing ultraviolet radiation and internal reflection optics to activate fluorescent groups present in the molecules of interest.

Abstract: This invention relates to a highly accurate, rapid and simple estimation of thyroxine (T.sub.4) directly from blood serum and also relates to the accurate measurement of triiodo-L-thyronine (T.sub.3) directly from blood serum. More specifically, the invention relates to a rapid, specific and reliable radioimmunoassay (RIA) technique for measurement of both T.sub.4 and T.sub.3 in unextracted serum. The method requires very small amounts of serum, e.g., 25 microliters (.mu.l) to measure T.sub.4 concentration in nearly all specimens representing clinical states of eu-, hypo- and hyperthyroidism, and 250 .mu.l to measure T.sub.3 concentrations in specimens representing most clinical states.