Abstract: A method of assaying for the presence or quantity of a suspect nucleic acid in a suspect sample using a modified genetic probe in combination with an imaging procedure. The probe is modified by addition and provides an easy and very effective technique of modifying a genetic probe preparatory to its use in a kit. The genetic probe is then introduced into contact with DNA or RNA of the suspect sample and permitted to hybridize therewith. A kit for performing an assay using the modified probe is also disclosed.

Abstract: The invention relates to DNA molecules coding for human CENP-B polypeptides. The invention provides DNA molecules comprising an epitopically functional part of the cDNA sequence of human CENP-B polypeptide. The inventBACKGROUND OF THE INVENTIONThis work was supported a Grant from the National Institutes of Health. The U.S. Government may retain certain rights in this invention.

Abstract: A method of detecting or determining the sequence of monomers which is a topological equivalent of the epitope which is complementary to a particular paratope of an antibody of interest, comprises the steps of: 1) synthesizing a plurality of catamer preparations; each of the catamer preparations consisting of a plurality of catamers in which the composition at one or more designated positions in each catamer is known, and the composition at the remaining positions is randomly made up from members of a defined set of monomers; and the plurality of catamer preparations comprises preparations in which the composition at the designated positions is systematically varied to contain members from a defined set of monomers; 2) contacting each of the plurality of catamer preparations with the antibody of interest; and 3) detecting or determining the presence or absence of binding between each of the plurality of catamer preparations and the given antibody to indicate a partial sequence of the mimotopes for the paratop

Abstract: A method of purifying LFA-3 using affinity chromatography. Purified LFA-3 is useful for quantitating or separating out CD-2-containing cells.

Abstract: Modified proteins for carrying hapten are provided. These carriers are prepared by blocking the amino groups of the original protein and then introducing amino groups into the carboxyl groups of the original protein. The blocking groups may be eliminated at the later stage to regenerate the amino groups of the original protein. The modified protein or polypeptide carrier have the three-dimensional structures different from the original proteins so that they are used in immunoassay while carrying low molecular weight haptens without the fear of forming antibodies for the original proteins. The modified protein carrier may also be used in the passive agglutination immunoassay without the need of absorbing the anti-hapten antibodies by the hapten-carrying carriers.

Abstract: For the detection of compounds containing carbohydrate the compound to be detected is reacted with a conjugate which contains a group which enables a specific binding to the substance to be detected and contains a hapten with a molecular weight from 300 to 1200, afterwards the complex formed is brought into contact with labelled antibodies directed against the hapten and the label is determined in a known way.

Abstract: Disclosed is a synthetic peptide, useful as an immunocontraceptive agent and for the diagnosis of autoimmune infertility, which corresponds to an autoantigenic epitope of Rabbit Sperm Membrane Autoantigen (RSA). The synthetic peptide is selected from the group consisting of the decapeptide NH.sub.2 -pro-gly-gly-gly-thr-leu-pro-pro-ser-gly-COOH and the antigenic equivalents thereof.Also disclosed is a method of diagnosing autoimmune infertility in a human subject. The method comprises the step of, first, contacting an immune sera sample from the subject with an antigen, the antigen selected from the group consisting of RSA, other proteins which bind selection antibodies which bind to RSA, and derivatives thereof which bind selection antibodies which bind to RSA. The next step is to detect the presence of antibodies from the immune sera sample bound to the antigen, the presence of antibodies bound to the antigen suggesting the subject is afflicted with autoimmune infertility.

Abstract: The invention is a method for measuring a hapten poorly soluble in aqueous solution in a sample which includes the steps of reacting the hapten with an antibody specific for the hapten; and comparing the result of the reaction of the hapten and the antibody with the result of the reaction of the antibody and a water-soluble conjugate of the hapten and a water-soluble macromolecule having a molecular weight greater than about 1,000.

Abstract: The invention is a cloned T cell prepared by infecting a human T cell, H9, with HTLV-III B, which cloned human T cell is antigenic for HTLV-III B, does not have a syncytium-forming activity, and does not produce infectious HTLV-III B virions.

Abstract: A quantitative immunoassay for a beta-lactam antibiotic in a sample, which may contain open and closed ring forms of the antibiotic, is disclosed. Closed-ring forms of the antibiotic in the sample are converted to open-ring protein conjugates and detected through immunospecific reaction with antibodies raised against the open-ring protein conjugate form of the beta-lactam antibiotic.

Abstract: New and useful chromophores have been isolated from the reaction mixture of proteins exposed to reducing sugars in the presence of sulfite over time. The chromophores are believed to be intermediates in nonenzymatic polypeptide glycosylation. The measurement of this chromophore makes possible both qualitative and quantitative assessment of the presence of nonenzymatic browning. Diagnostic and test kits are also disclosed.

Abstract: A biochemical reagent comprises an oligosaccharide, preferably one which has been liberated from an immunogenic glycoprotein or proteoglycan, which is immobilized on a carrier via an intermediate spacer molecule such as a lipid. The lipid molecule should preferably have at least two long lipid tails so that the oligosaccharide is held in spaced relationship to the carrier where is exhibits antibody-binding ability which is almost indistinguishable from that of the original glycoprotein or proteoglycan. The reagent has its application in biochemical testing of oligosaccharides and systems which bind to them.

Abstract: Compounds having detergent properties are disclosed. When a modifying reagent is brought into contact with these compounds, the detergent properties are decreased. These compounds are useful, for example, as solubilizing agents for microbial antigens and/or antibodies and for reversibly wetting hydrophobic surfaces. Accordingly, methods are disclosed for increasing the hydrophilic properties of a material, such as a microbial antigen and/or antibody, the methods generally comprising the steps of contacting the material with the compound having detergent properties and a modifiable group, and modifying the compound with a modifying reagent. Kits are also disclosed for use in accordance with this methodology.

Abstract: Histamine derivatives, immunogen conjugates comprising histamine or said histamine derivatives coupled to immunogenic carrier materials and antibodies prepared against such immunogen conjugates are disclosed. Such antibodies are useful in immunoassays for determining histamine release in biological fluids.

Abstract: Surfactants bound to a ligand and dissolved in a single phase aqueous solution form a precipitate when a multivalent antiligand is added to the solution. This invention can be used in an affinity precipitation test procedure (and kit) for detecting the presence or absence of a multivalent antiligand in a sample suspected of containing the multivalent antiligand, in an affinity precipitation inhibition test procedure (and kit) for detecting the presence or absence of a target ligand in a sample suspected of containing the target ligand, and in a process for separating a multivalent antiligand from a crude material containing the multivalent antiligand.

Abstract: The present invention involves a method for producing a substrate useful in a system for the detection of antibodies directed against platelet antigens. This method comprises several steps. A platelet sample of interest is initially treated with an aqueous solution comprising a dialyzable nonionic detergent. This initial treatment is under conditions to solubilize platelet components and produce a platelet lysate. Such conditions may involve treatment of a platelet sample with an aqueous solution comprising nonionic detergent at a concentration between about 0.2% and about 0.5%. Platelet antigens are most preferably solubilized for about 30 min and at about 0.degree. C. in an aqueous solution comprising about 1 mg dialyzable nonionic detergent per mg platelet protein.The partially purified platelet antigens resulting from these manipulations are then preferably affixed to a solid matrix.

Abstract: Ligand-label conjugates which are an oligopeptide of 5 to 100 amino acid residues, bonded to a ligand or receptor, which contain a plurality of chemiluminescent or fluorescent labels and a plurality of polyoxoanions of sulfur or phosphorus are useful for immunoassays. Such conjugates are hydrophilic and exhibit very low nonspecific binding, thereby significantly increasing the signal to background ratio in immunoassays.

Abstract: A protein which satisfies all the biological criteria which are characteristic of inhibin has been isolated from a gonadal source. The purification and characterization of inhibin and the use of the purified material to raise antibodies, the use of inhibin and said antisera in a quantative radioimmunoassay, and applications in vitro and in vivo of inhibin and antibody to inhibin, are described.There is provided a purified protein, inhibin, characterised in thata. the apparent molecular weight as determined by SDS-PAGE is 56,000.+-.1,000b. the isoelectric point is in the range 6.9-7.3c. the protein can bind specifically to Concanavalin A-Sepharosed the protein consists of two sub-units, characterized in thati. their apparent molecular weights as determined by SDS-PAGE are 44,000.+-.3,000 and 14,000.+-.2,000 respectively.ii. the isoelectric point of the 44,000 molecular weight sub-unit is in the range 6.0-7.0iii. the N-terminal amino acid sequences of the two sub-units are as described hereine.

Abstract: The present invention is directed to a fluorescence polarization immunoassay for determining the phenylacetylglutamine (PAG) content in body fluids, to the various components needed for preparing and carrying out such an assay, and to the methods of making these components. Specifically, tracers, immunogens and antibodies are disclosed, as well as methods for preparing them. The assay is conducted by measuring the degree of polarization of plane polarized light that has been passed through a solution continuing sample, antiserum and tracer.

Abstract: Anti-hepatitis B virus surface protein (anti-HBS) antibody is adsorbed onto the surface of a substratum. Hepatitis B virus PreS2+S (PreS2+S) protein is then adsorbed onto the same surface through the interaction of the anti-HBS antibody with the "S" portion of the PreS2+S protein. The coated surface is then incubated concomitantly with the test sample and a radiolabelled antibody specific for the "PreS2" portion of the PreS2+S protein.

Abstract: 2-methyl-4-hexene- and 3-methyl-5-heptene-1,2-diol derivatives are disclosed together with methods for preparing such derivatives. Where the derivative is a 2-methyl-4-hexene- or 3-methyl-5-heptene-1,2-diol conjugated to a label, the conjugates are useful in immunoassays. Where the 2-methyl-4-hexene or 3-methyl-5-heptene-1,2-diol is conjugated to an immunogenic carrier, the conjugates may be employed as an immunogen for use in the preparation of antibodies. The label conjugate and the antibodies can be utilized in an immunoassay for the determination or detection of cyclosporin in a sample suspected of containing cyclosporin.

Abstract: A method of assaying a ligand in a sample which method includes the steps of contacting the sample with components comprising(a) a specific binding partner to the ligand and, if desired,(b) at least one reagent selected from ligand analogues and specific binding, partners,at least one of the said components (a) and (b) being labelled with an electron-donor or electron-acceptor,and determining whether (and, if desired, the extent to which) transfer of electrons between the said electron-donor or electron-acceptor label and a suitable charge-transfer partner resulting in charge-transfer complex formation is perturbed by ligand complex formation and/or by controlled external influences.

Abstract: The invention relates to cDNA molecules coding for eukaryotic topoisomerase I polypeptide. The invention provides cDNA mlecules comprising a part of the cDNA sequence of topoisomerase I which encode at least one epitope for autoantibodies to eukaryotic topoisomerase I. The invention also provides cloning vehicles capable of replication and expression comprising cDNA molecules coding for eukaryotic topoisomerase I. The invention further provides for hosts transformed with a vehicle having a cDNA molecule coding for eukaryotic topoisomerase I. In another embodiment, the invention provides for the detection of autoantibodies to eukaryotic topoisomerase I using the eukaryotic topoisomerase I polypeptides coded for by the cDNA molecules of the invention.

Abstract: Chemically synthesized polypeptides containing about 6 to 40 amino acid residues and having amino acid residue sequences that substantially correspond to the primary amino acid residue sequences of particular variable or hypervariable regions of immunoglobulins, when administered alone or as polymers or as conjugates bound to carriers, induce the production of anti-idiotype antibodies of predetermined specificities.

Abstract: This invention relates to a method for the immunoassay of AZT (3'-azido-3'-deoxythymidine), also known as zidovudine, in biological fluids such as serum, semen, plasma and urine, as well as other body fluids. The invention also includes (1) various novel analogs of AZT useful in preparing immunogens for antibodies to AZT and in preparing labeled AZT, (2) immunogens for antibodies to AZT, (3) monoclonal and polylonal antibodies to AZT, (4) labeled AZT analogs and (5) diagnostic test kits for the immunoassay.

Abstract: Substantially pure modified .beta..sub.2 -microglobulin (m.beta..sub.2 m) of the formula I ##STR1## wherein R.sub.1 is 24-amino acid residue, with the sequence Ile-Gln-Arg-Thr-Pro-Lys-Ile-Gln-Val-Tyr-Ser-Arg-His-Pro-Ala-Glu-Asn-Gly-Ly s-Ser-Asn-Phe-Leu-Asn, R.sub.2 is a 30-amino acid residue with the sequence Tyr-Val-Ser-Gly-Phe-His-Pro-Ser-Asp-Ile-Glu-Val-Asp-Leu-Leu-Lys-Asn-Gly-Gl u-Arg-Ile-Gly-Lys-Val-Glu-His-Ser-Asp-Leu-Ser, R.sub.3 is a 20-amino acid residue with the sequence Trp-Ser-Phe-Tyr-Leu-Leu-Tyr-Tyr-Glu-Phe-Thr-Pro-Thr-Glu-Lys-Asp-Glu-Tyr-Al a, R.sub.4 is a 19-amino acid residue with the sequence Arg-Val-Asn-His-Val-Thr-Leu-Ser-Gln-Pro-Lys-Ile-Val-Lys-Trp-Asp-Arg-Asp-Me t, X is Phe, Phe-Ser, or Phe-Ser-Lys, and Y is Asp, Lys-Asp, or Ser-Lys-Asp is disclosed. The presence of the protein in body fluids is a diagnostic and/or prognostic marker for the development of a variety of disorders such as different types of cancer and diseases involving the immune system. Also disclosed are specific anti-m.

Abstract: A dye-providing composition is useful in various diagnostic assays wherein a peroxidase-labeled specific binding species is used. This composition is substantially free of peroxidase and such labeled species, and comprises an imidazole leuco dye and 4'-hydroxyacetanilide present in an amount up to about 2.5 mmolar. This composition can be included as part of a diagnostic test kit.

Abstract: The invention relates to a process for preparing antigen fractions designed for the detection of antibodies, the presence of which, in a certain quantity, in the human blood serum correlates with a cardiovascular risk condition. An arterial tissue is ground, freed of lipids and is subjected to the action of at least one agent selected from the group formed by an aqueous solution of an alkali metal salt or of an alkaline-earth metal salt at ambient temperature, of a hot acid of urea, of guanidine and proteolytic enzymes. The invention also relates to antigen fractions thus obtained and their utilization in the diagnosis of a cardio-vascular risk condition by counter-current electrophoresis or by an ELIFA test or an ELISA test.

Abstract: Disclosed are monoclonal antibodies which react with human tumor cells, particularly metastatic human tumor cells, but not with normal human tissues tested. The monoclonal antibodies are prepared against a 580 kilodalton glycoprotein antigen, designated gp580, which is isolated from either rat or human tumor cells. Methods for isolating the glycoprotein antigen are disclosed as well. Moreover, techniques are disclosed for utilizing these antibodies both in the detection and in the prevention of human tumor lesions.

Abstract: A dye-providing composition comprises a water-soluble or -dispersible polymer, such as a vinylpyrrolidone polymer, and an imidazole leuco dye capable of providing a dye in the presence of hydrogen peroxide and a peroxidative substance. The weight ratio of polymer to leuco dye is from about 10,000:1 to about 100:1. The dye-providing composition can be included with a peroxidase substrate in a diagnostic test kit. A method for the determination of a ligand can be carried out using a peroxidase labeled-receptor for the ligand and the dye-providing composition described above. The method is particularly useful for the determination of human chorionic gonadotropin (hCG).

Abstract: New and useful chromophores have been isolated from the reaction mixture of proteins exposed to reducing sugars in the presence of sulfite over time. The chromophores are believed to be intermediates in nonenzymatic polypeptide glycosylation. The measurement of this chromophore makes possible both qualitative and quantitative assessment of the presence of nonenzymatic browning. Diagnostic and test kits are also disclosed.

Abstract: This invention relates to a flotation immunoassay employing a novel buoyant matrix to which an antigen or antibody is coupled and which separates the bound and free products of the assay by floating to the surface of the reaction liquid. The novel flotation device which makes it possible to detect and to quantitate either antigen or antibody can also be used to fractionate cells and molecules.

Abstract: An aqueous wash solution is buffered to a pH of from about 5 to about 9 and contains at least about 0.01 weight percent of a compound comprising a dodecyl sulfate anion and an alkali metal or ammonium cation, such as sodium dodecyl sulfate. This wash solution is particularly useful in a method for the determination of an immunological ligand. Particularly, it is useful for washing the immunological complex formed between the ligand and a receptor molecule therefor. Unreacted materials can be readily separated from the complex by the washing, particularly if the separation is carried out using a filtration membrane in a test device. a test kit for ligand determination comprises the wash solution as well as one or more receptors for the ligand, at least one of which is labeled for detection. This kit is particularly useful for measuring human chorionic gonadotropin (hCG) as an early indicator of pregnancy.

Abstract: A completely water-soluble, solid, labile biochemical-containing diagnostic reagent is prepared without the need of a lyophilization step, by spraying, preferably by a fluidized bed process, an aqueous solution of labile biochemical, e.g., an enzyme, onto small particles, e.g., lower than 20 mesh, of an inert, completely water-soluble solid bulking agent, e.g., mannitol; drying the resultant labile biochemical-coated bulking agent to the desired dryness; and then forming resultant dried labile biochemical-coated bulking agent into a tablet suitable for a diagnostic test reagent, said tablet having a predetermined rate of dissolution.

Abstract: A method of measuring chain breakage in the DNA of a eucaryotic cell is disclosed. This method includes (a) contacting the cell with a stripping solution that lyses and solubilizes the cell without denaturing its DNA, thereby forming a nucleoid having a halo, (b) measuring the width of the halo, and (c) determining the number of chain breaks from the measured width. The halo includes at least one loop of undenatured DNA, and has a width related to the number of DNA chain breaks in the loop. The cell to be examined may be adhered to a support prior to its contact with the stripping solution. The number of DNA chain breaks can be determined by compairing the measured width of the nucleoid halo with a reference value.

Abstract: A method is disclosed for discriminating between cattle vaccinated against and those infected with Brucella spp. The method involves immunoassay using a purified polysaccharide containing 4,6-dideoxy-4-acylamido-D-mannopyranosyl units obtained from B. abortus or from cross-reacting organisms, and results in improved differentiation between vaccinated and infected animals. Test kits are also disclosed for performing the assay and a process is disclosed for obtaining the O-chain polysaccharides in high purity and yield.

Abstract: The present invention is an improved means for detecting neuroanatomical pathways in animals comprising introducing an atoxic fragment C of tetanus toxin into the motor target of a neural circuit, and permitting the atoxic fragment to transport through the neural circuitry. The fragment C of tetanus toxin is then localized along the neuroanatomical pathway by reacting the fragment C with monospecifically reactive antibody produced by a hybridoma cell line selected from the group consisting of .alpha.TTC-17, .alpha.TTC-44, .alpha.TTC-49 and .alpha.TTC-114. The present invention also includes the individual hybridoma cell lines which produce the reactive antibody along with the antibody themselves.

Abstract: The present invention provides hapten derivatives of the general formula: ##STR1## wherein Hap is a residue formed from a hapten carrying a keto or aldehyde group by splitting off an oxo group and R.sup.1 and R.sup.2, which can be the same or different, are alkyl radicals containing up to 7 carbon atoms and one of the symbols R.sup.1 and R.sup.2 can also represent a hydrogen atom.The present invention also provides hapten-protein conjugates of the general formula: ##STR2## wherein Hap, R.sup.1 and R.sup.2 have the above-given meanings and E--NH is the residue of a protein bound via an .epsilon.-amino group of a lysine residue.

Abstract: Synthetic polypeptides having influenza virus antigenic properties are disclosed. These polypeptides correspond substantially to particular regions in the matrix protein of influenza virus. Salts, derivatives, and conjugates of these polypeptides are disclosed as well as methods for using these materials for diagnostic and medical/veterinary purposes.

Abstract: Species-linked diamine triacetic acids of the formula ##STR1## wherein T is an organic species containing at least one amine, hydroxyl, or thiol functional group, L is the residue of at least one of those functional groups and R is a two or more atom long covalent bridge, are disclosed. Methods for their preparation, for the preparation of metal chelates from them and for the use of the chelates are also disclosed. In a preferred embodiment, the metal ions employed in the formation of the chelates are rare earth metal ions capable of forming fluorescent chelates which can in turn be employed in fluoroassay techniques.

Abstract: A purified common antigen for colorectal and mucinous ovarian cancer (COTA) is provided which is antigenically distinct from CSAp, CEA and Ca 19-9. The COTA antigen is useful for producing a COTA antibody which is nonreactive with CSAp, CEA or Ca 19-9.

Abstract: Methods and materials for preparing specific binding reagents with a multiplicity of relatively noninterfering label moieties are described. By spacing the labels at the surface of a specific reagent with bulking agent, increased sensitivity can be achieved without interference between individual labeling entities.

Abstract: The present invention involves a method for producing a substrate useful in a system for the detection of antibodies directed against platelet antigens. This method comprises several steps. A platelet sample of interest is initially treated with an aqueous solution comprising a dialyzable nonionic detergent. This initial treatment is under conditions to solubilize platelet components and produce a platelet lysate. Such conditions may involve treatment of a platelet sample with an aqueous solution comprising nonionic detergent at a concentration between about 0.2% and about 0.5%. Platelet antigens are most preferably solubilized for about 30 min and at about 0.degree. C. in an aqueous solution comprising about 1 mg dialyzable nonionic detergent per mg platelet protein.The partially purified platelet antigens resulting from these manipulations are then preferably affixed to a solid matrix.

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: The present invention provides resorufin derivatives of the general formulae: ##STR1## wherein R.sup.1, R.sup.2, R.sup.3, R.sup.4 and R.sup.5, which can be the same or different, are hydrogen, halogen, carboxyl, carboxamido, lower alkoxycarbonyl, cyano or nitro groups or lower alkyl or lower alkoxy radicals, which can be substituted by carboxyl, carboxamido, lower alkoxycarbonyl, cyano or nitro groups, and wherein R.sup.4 and R.sup.5 can together also represent an anellated aromatic residue, Z is a bridge member, A is the residue of a ligand and n is a whole number of from 1 to 200.The present invention also provides processes for the preparation of these resorufin derivatives, as well as intermediates for the preparation thereof.

Abstract: Novel methods and compositions are provided for the enhancement of the biodistribution of immunoconjugates useful in the diagnosis and treatment of a variety of conditions including cancer in many of its forms. The compositions of the present invention provide for enhanced bioavailability of immunoconjugates for the most part by blocking mammalian cell surface receptors present on cells of the reticuloendothelial system, especially in tissues responsible for the elimination of waste products and blood filtration. Such tissues include the liver, spleen, and kidneys. The compositions are administered in conjunction with an immunoconjugate in a pharmaceutically acceptable vehicle and may be provided in kits for convenient administration.

Abstract: A procedure for the immunoassay of a proteolytic procoagulant enzyme in biological samples is described. The presence of the enzyme is indicative of malignant disease, and the immunoassay is used as a diagnostic test for cancer.

Abstract: A method and kit are described for detecting the presence of cancers and pre-neoplastic cells that produce an oncofetal phosphoprotein having a molecular weight of approximately 60,000 and having the capacity to increase the release of ribonucleic acid from cell nuclei. The method involves detecting the presence of auto-antibodies to this oncofetal phosphoprotein in a subject suspected of suffering from a cancer or pre-neoplastic cells which produce this cancer marker protein. The kit includes purified oncofetal phosphoprotein.

Abstract: A method for enhancing the chemiluminescent signal of an acridinium ester in a chemiluminescent reaction which comprises oxidizing the acridinium ester in the presence of an enhancer selected from the group consisting of: (a) a cationic surfactant; (b) a nonionic surfactant; and (c) a sulfated primary alcohol.

Abstract: The present disclosure relates to an improved method based on hormone-receptor binding for the determination of follicle stimulating hormone and to improved reagents useful for the determination of follicle stimulating hormone in a hormone-receptor binding assay.