Abstract: The invention provides a process and products for the detection of the C peptide of relaxin in the body fluids of animals, as a positive indication of pregnancy. The invention may employ monoclonal antibodies generated to various epitopes on the C peptide.

Abstract: A simultaneous dual analyte assay for determining the fertile period of the human menstrual cycle. The assay utilizes a capture reaction component consisting of P-3-G immobilized on a microporous membrane, a blocking reaction component consisting of anti E.sub.1 -3-G antibody, a labelled reaction component consisting of gold particle labelled anti E.sub.1 -3-G antibody, and an ambifunctional reaction component consisting of a hybrid immunoreactive substance having an anti P-3-G antibody binding site and a plurality of E.sub.1 -3-G determinant binding sites. An aqueous sample containing P-3-G and E.sub.1 -3-G is contacted with the components and the assay is calibrated to provide a positive assay result only when the concentration of P-3-G in the sample is less than a predetermined concentration and the concentration of E.sub.

Abstract: A method of high sensitivity immunoassay characterized by inclusion of processes (A), (B), (C) and (D) described below.Process (A): A process of binding of a solid carrier and a complex comprising the specific antibody or antigenic substance to be assayed in the test solution and one or more active components.Process (B): A process of dissociating said complex from the solid carrier.Process (C): A process of binding this complex to another solid carrier.Process (D): A process of assay for the complex on the solid carrier mentioned in the description of process (C) above.Permitting rapid, high sensitive immunoassay irrespective of whether the subject of assay is an antibody or an antigen, the method of the present invention is very useful for quick diagnosis of various diseases.

Abstract: The invention relates to an assay for determining an analyte in a fluid sample. Three receptors are used, with formation of a quaternary or four member complex. One of the receptors is bound to a solid phase, and binds to complexes of another receptor and the analyte. A third receptor is labelled, and it, too, binds analyte. The invention also involves the use of a displacement solution to wash fluid sample from solid phase after the first portion of the quaternary complex forms, i.e., prior to binding with the labelled receptor.

Abstract: Hapten-biotin conjugates in which the hapten is linked with biotin via a spacer, which has 26 to 40 atoms in its chain and contains at least 5 heteroatoms, are novel and are suitable, in particular for use in a competitive homogeneous immunoassay in which the agglutination which occurs in the reaction is evaluated by turbidimetric or nephelometric measurements.

Abstract: Means for the detection of free ligand analogue conjugate in fluids from competitive ligand-receptor assay processes. Ligand analogue antibodies that bind the ligand analogue conjugate with substantially greater affinity than their affinity for target ligand are selected and used in competitive ligand-receptor assay processes to bind the free fraction of the ligand analogue conjugate. This means permits the detection of the free fraction of ligand analogue conjugate even in the presence of substantially higher concentrations of free target ligand. For the purposes of the present invention, ligand analogue antibodies are antibodies that exhibit at least 100.times.greater affinity for the ligand analogue conjugate compared to their affinity for the target ligand.

Abstract: An immunoassay method comprising applying an aqueous solution containing the analyte antigen to one end of a multi-zoned test strip device such that the solution moves along the strip by capillary action. The zones are arranged so that the solution (a) first contacts and reconstitutes dry, diffusible labelled component comprising colloidal gold conjugated to an antibody specific for said analyte antigen and then (b) contacts and reconstitutes dry, diffusible biotinylated second antibody specific for said analyte antigen such that a diffusible, dispersed sandwich reaction product forms. The reaction product diffuses along the strip with the solution and into a zone containing capture component consisting of a latex and avidin complex which avidin collects the reaction product by means of reaction with its biotin moiety. Thus, gold particles are collected and concentrated in the detection zone for visual determination.

Abstract: Antigens, immunogens, inocula, antibodies, and particularly diagnostic methods and systems relating to Epstein-Barr virus nuclear antigen (EBNA) are disclosed. The diagnostic methods and systems utilize a synthetic, random copolymer polypeptide containing about 8 to about 40 amino acid residues that includes the overlapping five and six amino acid residue sequences--Gly--R.sup.1 --Gly--R.sup.2 --Gly-- (i)wherein R.sup.1 and R.sup.2 are amino acid residues selected from Ala, Asn, Arg, Gly, Leu, Pro, Ser, and Thr with the provision that R.sup.1 and R.sup.2 are not both Gly; and--Gly--Ala--Gly--Gly--Ala--Gly--. (ii)The polypeptide contains at least 50 mole percent Gly residues. The diagnostic method and system are particularly useful for assaying for the stage of mononucleois disease, and the presence of nasopharynegeal carcinoma.

Abstract: Antigens, immunogens, inocula, antibodies, and particularly diagnostic methods and systems relating to Epstein-Barr virus nuclear antigen (EBNA) are disclosed. The diagnostic methods and systems utilize a synthetic, random copolymer polypeptide containing about 8 to about 40 amino acid residues that includes the overlapping five and six amino acid residue sequences(i) --Gly--R.sup.1 --Gly--R.sup.2 --Gly--wherein R.sup.1 and R.sup.2 are amino acid residues selected from Ala, Asn, Arg, Gly, Leu, Pro, Ser, and Thr with the provision that R.sup.1 and R.sup.2 are not both Gly; and(ii) --Gly--Ala--Gly--Gly--Ala--Gly--.The polypeptide contains at least 50 mole percent Gly residues. The diagnostic method and system are particularly useful for assaying for the stage of mononucleois disease, and the presence of nasopharynegeal carcinoma.

Abstract: The invention provides a process and products for the detection of the C peptide of relaxin in the urine of animals, as a positive indication of pregnancy. The invention may employ monoclonal antibodies generated to various epitopes on the C peptide.

Abstract: In a novel, erythrocyte agglutination assay, the agglutination reagent comprises at least one erythrocyte binding molecule coupled to at least one specific analyte binding molecule wherein the erythrocyte binding molecule does not cause agglutination when incubated with erythrocytes in the absence of analyte (in the case of a direct assay) or analyte binding reagent (in the case of an indirect assay). Preferably, the erythrocytes are endogenous to the blood sample to be tested, that is, a whole blood sample is assayed. Mixtures of conjugates and conjugates of analyte analogues with erythrocyte binding molecules may also be used as agglutination reagents. The reagents and their use in direct or indirect assays is disclosed.

Abstract: The invention involves an apparatus useful in analysis of liquid samples. At least 3 zones are provided which contain reactants which interact with the analyte and each other, leading to the detection reaction. The apparatus also has a fluid application means for reception of a liquid, and a waste zone, which absorbs excess liquid after the detection reaction has taken place. The fluid application means and waste zone are positioned at opposite ends of the apparatus.

Abstract: Antigens extracted from chlamydial or gonococcal organism are rapidly and ionically bound directly to a polymeric solid support which has cationic groups on its surface. The support is substantially free of any antibody or other biological compound reactive with the antigen. Ionically bound antigen is then contacted with suitable chlamydial or gonococcal antibodies to form a bound immunological complex which is detected in suitable fashion, for example by using a labeled anti-body. The entire assay, carried out at room temperature, requires less than 30 minutes and is highly sensitive.

Abstract: A method of confirming the diagnosis of Kawasaki disease in a patient which comprises assaying the patient's body fluid for the presence of elevated levels of a substance specifically bound by an anti-tumor necrosis factor monoclonal antibody.

Abstract: Methods and devices for separating bound label from unbound label within an assay mixture and for predispensing assay reactants in self-contained assay vessels, as well as a method for detecting the presence and/or amount of an analyte within a fluid sample, and a reusable detection vessel for use therein and with specific binding assays in general are disclosed. Significant to the separation of bound label from unbound label is the use of a cushion comprising generally one primary layer and in some cases one or more secondary layers.

Abstract: A novel immunoassay techniques is provided which is useful in the detection and determination of antibodies to antigens. Antibodies of all classes to a given antigen or the specific subclass of immunoglobulin to a specified antigen can be detected. A conjugate of labelled antibody and specific antigen is used as the third reagent in a sandwich assay.

Abstract: An anti-human gastric cancer monoclonal antibody, AMC-462, which belongs to the class IgG.sub.1, reacts with human digestive system cancer, and recognizes sialylated glycoproteins or glycolipids as the antigen is disclosed. It is effective for diagnosis of digestive system cancer, especially pancreatic cancer.

Abstract: The present invention provides a process for the determination of an analyte in a body fluid, in which there are used two binding components capable of specifically binding with one another, one of the binding components being enzyme-labelled and not carrier-fixed and the other binding component being carrier-fixed. The process contains a step in which the binding components are incubated with one another so that binding reaction takes place. The amount of enzyme-labelled binding component not bound to the carrier-fixed binding component is a measure of the concentration of the analyte which is determined by allowing the labelling enzyme to act upon a substrate producing a detection signal.

Abstract: Binding assay reagents for use in optical assay systems are disclosed. Assays, such as immunoassays, employing the reagent are also disclosed. The reagent is comprised of paired, associated polypeptides one of which has multiple optically active dye labels. The binding assay reagents exhibit enhanced binding activity over that of the dye labelled polypeptides alone and also enhance the sensitivity of the binding assay by providing increased amounts of optical label.

Abstract: A two site cross-reaction immunometric sandwich assay method for the detection and measurement of an analyte, such as creatine phospho-kinase-MB, in serum comprising the selection of two different antibodies each of which is specific to a different analyte but each of which will cross-react with the analyte of interest. The first antibody is reacted with the unknown sample utilizing a solid-phase to bind the first antibody. Separation of the solid and liquid portions of the first reaction is accomplished and the solid portion thereof is reacted with the second antibody which is tagged. The solid portion and liquid portion of the second reaction are separated and the solid portion is tested for the tag as an indication of the presence of said analyte. With particular reference to testing for creatine phospho-kinase-MB in human serum, the cross-reacting antibodies utilized are antibody to creatine phospho-kinase-BB and creatine phospho-kinase-MM.

Abstract: A two site cross-reaction immunometric sandwich assay method for the detection and measurement of an analyte, such as creatine phospho-kinase-MB, in serum comprising the selection of two different antibodies each of which is specific to a different analyte but each of which will cross-react with the analyte of interest. The first antibody is reacted with the unknown sample utilizing a solid-phase to bind the first antibody. Separation of the solid and liquid portions of the first reaction is accomplished and the solid portion thereof is reacted with the second antibody which is tagged. The solid portion and liquid portion of the second reaction are separated and the solid portion is tested for the tag as an indication of the presence of said analyte. With particular reference to testiong for creatine phospho-kinase-MB in human serum, the cross-reacting antibodies utilized are antibody to creatine phospho-kinase-BB and creatine phospho-kinase-MM.

Abstract: Methods for detecting a unique strain of chlamydia associated with acute respiratory disease are disclosed. These methods utilize monoclonal antibody directed against an antigenic determinant of the TWAR strain of chlamydia. Also disclosed is a method for determining the presence of antibodies to the TWAR strain, utilizing elementary bodies of the TWAR strain as antigen.

Abstract: Compositions and methods are disclosed for multiple simultaneous assays of different analytes using radioactive labeled antibodies to the analytes, at least one portion of the assay being an immunoradiometric assay in which there is employed a metal isotope label, e.g., .sup.57 Co, attached to an antibody to the analyte through a chelator, e.g., ethylenediaminetetraacetic acid. Multiple simultaneous immunoradiometric assays can be performed by this method, as can multiple simultaneous assays in which one portion of the assay is an immunoradiometric assay and another portion or portions involve one or more other radioassay techniques.

Abstract: The monoclonal antibodies are specific for a determinant found on hepatitis B surface antigen, and show high affinity for this determinant. Hybridomally produced monoclonal IgM antibodies having high affinity are useful for the immunoassay and purification of viral antigens.

Abstract: The present invention provides a process for the determination of a bindable analyte according to the principle of heterogeneous immunoassay by incubation of a sample solution which contains the analyte with a labelled first receptor specifically bindable with the analyte and present in dissolved phase and a second receptor present in a solid phase which does not cross-react with the first receptor and can fix a complex which contains the analyte and first receptor, separation of the phases after incubation and quantitative measurement of the labelling bound to the solid phase, wherein there is determined the back dissociation velocity of the labelling bound to the solid phase into the dissolved phase and the quotients of the back dissociation velocity and measurement value are used as a measure for the correctness of the test result of the first measurement.

Abstract: An immunoassay method for one-step detection of specific antibodies which includes incubation of a solid phase support or matrix having a spot of the antigen bound thereto with a sample of the clinical fluid to be tested in the presence of a signal developing reagent, including a detector substance, which is preferably a colloidal metal sol, and a ligand, such as protein A or other antibody binding ligand. A diagnostic field kit containing the test antigens and signal developing reagent is also described.

Abstract: A substantially pure antigen found on normal and benign breast epithelial cell membranes and in breast cancer cells, fused cell hybrids which produce antibodies specific for such antigen, the monoclonal antibodies produced by such fused cell hybrids, a method for detecting the presence of breast cancer in a patient which is based on measuring the concentrations of one or more determinants of such antigen in a patient sample, and a method for either identifying those breast cancer patients whose tumors would respond to estrogen manipulation or determining prognosis based on the degree of differentiation, which method is based on measuring the concentration of an estrogen-modulated determinant of such antigen.

Abstract: Methods are disclosed for detecting an antigen in a biological sample. The methods involve providing in combination a solid support, which is substantially free of specific binding proteins, and a medium comprising an antigen from the sample and an antibody for the antigen. The combination is incubated under conditions sufficient for the antibody when bound to the antigen to bind to the support. The presence or amount of antibody on the support or in the medium is determined and is related to the presence of antigen in the sample. The methods have particular application to the detection of gram-negative bacteria.

Abstract: A method for the determination of a free protein subunit of a quaternary protein in a sample, which comprises:(a) contacting a sample with a first immunological binding partner which is or will be bound to a carrier, wherein the first immunological binding partner binds epitopic determinants bindable only on the free protein subunit;(b) incubating the components of step (a) for a period of time and under conditions sufficient to form an immune complex between the free protein subunit, the first immunological binding partner, and the carrier;(c) separating the carrier of step (b) from the sample;(d) adding to the carrier of step (c), a detectably-labeled second immunological binding partner, wherein the second immunological binding partner binds epitopic determinants bindable on both the free protein subunit and the quaternary protein; and(e) determining the detectably-labeled second immunological binding partner in the carrier or in liquid phase.

Abstract: Methods for delivering substances into, removing substances from, or reacting substances with a selected environment utilizing polymer gels or coatings characterized by a critical solution temperature (CST) are disclosed. The CST as well as the pore structure, pore size, pore distribution, and absorbing capacity of the gel may be selectively controlled. The substances may be physically or chemically immobilized within the polymer gels. In addition, a method for altering the surface wettability of CST polymers is also disclosed.

Abstract: A method for enzyme immunoassay includes contacting under binding conditions a liquid suspected of containing an analyte, an antianalyte affixed to a solid support and a tracer having an enzyme conjugated thereto. A bound fraction is separated from the liquid and incubated in a second liquid with a masked ligand. The masked ligand is converted by the enzyme on the bound fraction to give free lignad which binds to an antiligand. A signal system, such as a signal enzyme and substrate therefor, or a label-loaded vesicle and vesicle lysing agent, is added to generate a signal used to detect or measure the analyte in the liquid. The invention includes a kit of materials useful in performing the assay of the invention.

Abstract: In an erythrocyte agglutination assay, the agglutination reagent comprises at least one erythrocyte binding molecule coupled to at least one specific analyte binding molecule wherein the erythrocyte binding molecule does not cause agglutination when incubated with erythrocytes in the absence of analyte. Preferably, the erythrocytes are endogenous to the blood sample to be tested, that is, a whole blood sample is assayed. Mixtures of conjugates and conjugates of analyte analogues with erythrocyte binding molecules may also be used as agglutination reagents. The reagents and their use in direct or indirect assays is disclosed.

Abstract: This invention relates to apparatus useful in determining a component or components of a test sample, as well as methods using these apparatus. Of particular interest are apparatus and methods which involve formation and determination of quarternary complexes.

Abstract: Antigens, immunogens, inocula, antibodies, receptors, diagnostic methods and systems relating to tuberculosis mycobacteria are disclosed. Each of the compounds, compositions, methods or systems contains about 40 residues, or an antibody containing site that immunoreacts with such a polypeptide. The polypeptide includes the thirteen or fourteen amino acid reside sequence (AlaLysValAsnIleLysProLeuGluAspLysIleCys) or (CysAlaLysValAsnIleLysproLeuGluAspLysIleCys). When linked to a carrier and introduced in an effective amount into a mammalian host, the polypeptide is capable of inducing production of antibodies that immunoreact with an antigen to a tuberculous mycobacterium.

Abstract: The present invention provides a process for the quantitative determination of a polyvalent antigen by incubation with three different receptors of which the first (R1) and the third (R3) are present in liquid phase and are bindable with the antigen, the second receptor (R2) is present in solid phase and is bindable with receptor (R1), and receptor (R3) carries a label and does not cross-react with (R1) and (R2), separation of the solid phase from the liquid phase and measurement of the label in one of the phases, wherein a first receptor (R1) is used which consists of at least two antibody molecules or antibody molecule fragments bound with one another, at least one of which binds specifically with the antigen to be determined.

Abstract: For the determination of a reaction partner of an immunological reaction according to the principle of immunoassay, the reaction partner to be determined is brought into contact with a marked specific receptor R.sub.1 and at least 1 unmarked receptor R.sub.2, one of the unmarked receptors R.sub.2 being bonded on a solid phase by a binding-capable substance R.sub.3. In order to determine the sample blank value, the unmarked receptor R.sub.2, which is bonded by the receptor fixed on the solid phase, is then replaced by another unmarked receptor R'.sub.2 which does not react with the reaction partner of R.sub.2 to be determined.

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

Abstract: A method of detecting the presence of first antibodies against a chorionic gonadotropin-like substance in a first biological sample obtained from an organism other than domestic poultry. The first biological sample is contacted with a chorionic gonadotropin-like substance, preferably isolated from Progenitor cryptocides microorganism, which has been immobilized on a solid phase, under conditions permitting first antibody/chorionic gonadotropin-like substance binding. Unbound sample components are removed from the solid phase, and a plurality of second antibodies, each comprising an immunological conjugate of the first antibody, are contacted with the solid phase, under conditions permitting second antibody/first antibody binding. Unbound second antibodies are removed from the solid phase and the presence of chorionic gonadotropin-like substance/first antibody/second antibody complex, if any, is observed, as a measure of the presence of first antibodies in the first biological sample.

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., 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: Human-nonhuman heterohybridomas capable of expressing IgM type antibodies can be screened to select hybridomas expressing IgM antibodies comprising human J chain components. Method comprises contacting separate samples of IgM antibodies (or IgM J chain components) from a given cell line with anti-human J chain antibodies and anti-non-human J chain antibodies to determine which antibody complexes with the J chain component of the samples, thereby identifying and permitting the early selection of a heterohybridoma expressing IgM having a human J chain component.

Abstract: A simultaneous sandwich immunoassay employing high-affinity monoclonal antibodies is disclosed. This simultaneous sandwich assembly has surprising sensitivity compared to forward and reverse sandwich assays for the detection of multi-determinant antigens such as hepatitis B surface antigen.

Abstract: Competitive immunoassays, which employ idiotypic and antiidiotypic monoclonal antibody reagents, are described. These competitive immunoassays are particularly useful for the detection of low concentrations of analyte for which labeled reference analyte is difficult to obtain in quantity. Antiidiotypic monoclonal antibody reagents serves as a substitute for the labeled reference analyte. The antiidiotypic monoclonal antibody reagent exhibits a congruency of structure with one or more epitopes of the analyte or antigen. The antiidiotypic monoclonal antibody is prepared against an idiotypic monoclonal antibody, which, in turn, was prepared against the antigen or analyte. During the immunoassay, the antiidiotypic monoclonal antibody is allowed to compete with the antigen, whose concentration is being determined, for a limited number of antibody binding sites present on an idiotypic antibody, which was also prepared against the antigen or analyte.

Abstract: A kit for assaying the activation of terminal complement cascade is disclosed. The kit includes a plurality of containers which contain a first antibody having a specificity for poly C9 neoantigen. The containers further have a second antibody which is different from the first antibody and has a specificity for a constituent of terminal complement cascade. A third antibody is optionally present which recognizes the second antibody. The kit also includes a substrate splitting enzyme, a substrate for the enzyme which produces a color reaction when split, and a SCb-9 standard microtiter plate. Pipettes and instructions for performing the assay are also included.

Abstract: An immunoassay in which a thermally induced phase separation is used to effect the separation of specifically bound reactants from free reactants is disclosed. A first reactant is conjugated to a temperature-sensitive polymer to form a polymer/reactant conjugate, and a second reactant is conjugated to a reporter to form a reporter/reactant conjugate. The polymer/reactant, reporter/reactant, and biological fluid samples suspected of containing the analyte are admixed in solution at a temperature other than that at which the polymer will precipitate. Specific binding is allowed to occur, thereby forming a ternary complex. The salt concentration of the adjusted solution is then adjusted to a concentration sufficient to cause the complex to precipitate from the solution, the amount of reporter activity in the precipitated complex or in the solution measured and the presence and/or concentration of the analyte therefrom determined.

Abstract: Disclosed are murine-derived hybridoma tumor cell lines and monoclonal anti-thaumatin antibody substances produced by these cell lines. The monoclonal antibody substances may be used alone or in combination in immunological procedures for isolation of thaumatin and for quantitative detection of thaumatin in fluid samples.

Abstract: A method of visualizing individual submicroscopic metal particles by subjecting said particles to bright field or epi-polarization microscopy and enhancing the contrast of the image so obtained by electronic means.

Abstract: The invention concerns assays, such a immunoassays or two-site immunometric assays, performed using a labelled reagent and another reagent bound to magnetically attractable particles which are suspendable but insoluble in a liquid assay medium. After the labelled reagent has become partitioned between the liquid phase and the particles, in proportions which depend on the concentration of an analyte in a sample, the liquid phase is removed. Then the particles are re-suspended in another liquid medium, and the concentration of label observed. The method is particularly suitable for fluorescent and chemiluminescent' label systems, and can conveniently be performed in microtiter plates in which the wells are optically screened from one another, the observations being made from above or below the wells.

Abstract: A method is disclosed for the determination of human serum factors which are specific for human carcinomata antigens, in which method the serum of a patient with a carcinoma is incubated with CEA that has been radioactively labeled and anti-goat immunoglobulin serum in toto or depleted of the cross-reaction capacity for human IgA, IgG and IgM is added, then the whole mass is incubated and centrifugated, the supernatant is decanted and the precipitate is counted with a gamma counter. These specific serum factors are employed as a marker of primitive tumoral forms.

Abstract: A method for assaying complement fragment C.sub.3 a, C.sub.4 a or C.sub.5 a or the des-Arg derivative thereof in a biological sample which comprises combining equal volumes of the biological sample and a solution of 0.8 to 1.6% of an acridine derivative selected from the group consisting of acrinol, acriflavine, acriflavine hydrochloride, and aminacrine, incubating the mixture for about one minute to 2 hour at about 25.degree. C., recovering the supernatant from the resultant precipitate, incubating the supernatant with a known amount of a labeled complement fragment selected from C.sub.3 a, C.sub.4 a or C.sub.

Abstract: An immunoassay is disclosed which measures the concentration of cyclosporin analytes in sample fluids. Also disclosed is radioiodinated cyclosporin having a specific activity greater than 50 ulCi/ug and fluorescent labeled cyclosporin, both of which is cross-reactive with cyclosporin analytes.