Abstract: A sensitive direct immunoassay system is provided for the detection of an antigen associated with hepatitis in body fluids. A single antibody which reacts with a hepatitis antigen or antigens and which is bonded to an insoluble member, is incubated with a test sample. During this first period of incubation a portion of an antigen present in the test sample will combine with the antibody immobilized on the insoluble member. The antibody bonded member, to which antigen is attached, is then washed and incubated with an enzyme tagged antibody reagent. During the second incubation, the tagged antibody reacts with antigen fixed to the antibody member in the first incubation. Thus, an immobilized "sandwich" is formed of an insoluble member- antibody-antigen-enzyme tagged antibody. After the second incubation, the member is washed again to remove unreacted enzyme antibody reagent. The member is then exposed to a substrated which is converted by the enzyme to produce an end product.

Abstract: This invention relates a simplified and reliable process for the detection and measurement of viral specific immunoglobulins such as IgG, IgM and IgE wherein relatively large-diameter plastic beads, e.g., 1/4", diameter polystyrene balls with a specular finish, are used as the solid matrix upon which a high concentration of standard cells are first grown or cultured. The cells are then infected with a particular virus to express a high concentration of unpurified viral antigen(s), and are then fixed to preserve the viral antigen(s) concentration. The resulting fixed plastic beads (PB) are washed (to remove fixing agent) and then employed as the basis of the detection of specific immunoglobulins in the patient's serum. The detection process involves simply incubating a measured dilution of patient serum with each PB whereby the various specific immunoglobulins in the patient serum will attach to the viral antigen(s) on the PB. The specific immunoglobulins (e.g.

Abstract: Colorectal carcinoma is detected by testing body fluids for the colorectal carcinoma monosialoganglioside identified by monoclonal antibodies produced by fused cell hybrid ATCC HB 8059.

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 newly discovered particle in the urine and serum of non-A, non-B hepatitis patients has been associated with non-A, non-B hepatitis. The particle resembles a togavirus and is 50-60 nm in diameter with a discrete core of about 40 nm in diameter. The virus loses its infectivity for tissue culture upon heating at 25.degree. C. in aqueous suspension or by exposure to ether. The particle may be cultured in vitro or recovered from body fluids or tissues to make immunoassays and vaccines. The immunoassays may be employed to detect the particle antigens or antibodies thereto in test samples.

Abstract: A novel purification scheme is described for obtaining two novel and useful forms of bovine glycoprotein (BGP) from bovine erythrocytes, each of which acts as an antigen in testing for the presence of the heterophile antibodies of human infectious mononucleosis.The first, or partially purified, BGP is obtained from crude BGP and contains about 10% by weight of a complex glycoplipid. It forms a single band upon gel electrophoresis at pH 7.0 under specified conditions.The second, or homogeneous, BGP is obtained by removing essentially all of the complex glycolipid. It forms substantially a single band upon gel electrophoresis at pH 7.0 under specified conditions.Both forms may be used to detect or quantify hemagglutination inhibition of a test sample (and hence to determine the presence or extent to mononucleosis infection) in a glass slide test wherein the partially purified or homogeneous BGP is carried on latex or synthetic resin beads.

Abstract: A process for determining the presence of an antigen or antibody in a sample wherein said antigen or antibody exists in the form of an immune complex which comprises:A. contacting the immune complex originating from the sample suspected of containing immune complex with a dissociating buffer whereby said immune complex, if present, is dissociated into antigen and antibody;B. contacting a solid support which binds proteins with said dissociating buffer suspected of containing antigen or antibody and removing said buffer;C. washing said solid support;D. adding protein to fill unoccupied sites on said solid support;E. adding radioactively labeled or enzyme labeled antibody or antigen to said solid support, said labeled antibody or antigen corresponding to antigen or antibody on said solid support, incubating the resultant mass and washing the same;F. measuring the radioactivity or enzymatic activity associated with the solid support.

Abstract: A rapid, specific, serological method for identification of microorganisms is carried out by immunizing a warm-blooded mammal with a killed microorganism to obtain an antisera, conjugating the antisera with an enzyme marker, bonding a microorganism to a solid support, adding the enzyme-conjugated antisera to the bonded microorganism in the presence of a color reactant and identifying the microorganism from the color reaction. Preferably, immunizing is carried out with two injections of about 10.sup.9 killed microorganisms each with the second injection being about 14 to 21 days after the first, and recovering the antisera about 14 to 21 days after the second injection.

Abstract: An enzyme immunoassay for detecting an antigen in a biologic fluid or tissue which comprises contacting the fluid or tissue with an antibody specific for the antigen under binding conditions, at least one of the fluid or tissue and antibody having a solid component, contacting the resulting solid with a conjugate bindable with the antibody under binding conditions and determining the enzyme activity of the resulting solid phase is described. The conjugate is of peroxidase and an allergen, non-immunoglobulin protein or primary amino group containing drug having an average of 2-3 molecules of peroxidase per molecule of substance with an average molecular weight of about 30,000 daltons, prepared by reacting peroxidase previously treated with phenyl isothiocyanate and oxidized to form aldehyde groups with the substance to form a Schiff's base which is titrated with a reducing agent to form a stable conjugate.

Abstract: An immunoassay of a specimen of a serum or the like to determine immune complexes, includes producing on a plastic base a layer of a non-proteinaceous, non-ionic polymer which will adhere to the plastic base and has the capability of absorbing immune complexes of the specimen, placing a specimen on the layer and treating the layer to produce an indication of the amount of immune complexes. The polymer may be polyethylene glycol, dextran, polyvinyl chloride, a polymeric polyol or an adduct of polyethylene glycol. Washing with conventional solutions, addition of an antihuman IgG coupled with an enzyme and addition of a substrate reactive therewith, are similar to the ELISA test, with color measurement as by spectrophotometer. Or, the addition of anti IgG-I.sup.125 and measurement by a scintillation counter may be used. The ethylene glycol may range in molecular weight from 2,000 to 20,000, although 6,000 to 8,000 is preferred.

Abstract: A device for determining the presence of antigens which comprises a first zone containing antigens and enzyme-linked antibodies which are capable of immunologically reacting with said antigens, said antibodies being positioned in said first zone such that they will be removed from said first zone when reacted with antigens passing through said first zone but not removed from said first zone in the absence of such antigens, and a second zone containing material capable of reacting with said enzyme-linked antibodies to produce a color forming reaction which indicates the presence of said antibodies.

Abstract: A method, sensor and semiconductor device for determining the concentration of an analyte in a medium. The device features an element constructed of semiconductive organic polymer associated with a binding substance having specific affinity for the analyte.

Abstract: A method for the rapid determination of analyte in a sample is provided. The sample is contacted with a solid phase having immobilized thereon an analyte-analogue to which there is displaceably bound a labeled anti-analyte antibody. Because the antibody has greater affinity for the analyte than the analyte-analogue, the labeled antibody is displaced from the solid phase. The complex is separated from the solid phase, and the amount of complex is measured. The measured amount is related to the amount of analyte initially present in the sample.

Abstract: An analytical element for analysis of a liquid having an interconnected void structure zone positioned on one side of a liquid-impermeable, light-transmissive support, being characterized in that said interconnected void structure zone comprises a bound particulate structure which is a three-dimensional lattice, being non-swellable in the liquid and having interconnected voids with a void volume of 25 to 85% among the particles to provide transport of said liquid, the material for said bound particulate structure being non-swellable in and impermeable to said liquid and said bound particulate structure being constituted of heat-stable, organic polymer particle units having reactive groups with particle sizes of 1 to 350 microns which are chemically bonded directly to each other through said reactive groups in the areas of contact. A method of analysis utilizing the analytical element in immunoassay is also disclosed.

Abstract: A reaction vessel, test device, and method of detection or measurement are disclosed, featuring the use of at least two operatively connected zones formed by transport surfaces spaced apart throughout most of the zones a capillary distance. The zones are fluidly connected by meniscus control means effective to stop capillary flow of the liquid from one zone to the other, until an externally generated actuation pressure is applied.

Abstract: A method and device for assaying a test substance utilizing a primary absorbent substance for selectively allowing only a quantity of an analytical reagent proportional to the quantity of test substance to pass therethrough when test substance and analytical reagent are contacted with the primary absorbent. An analytical absorbent is disposed in a series of zones for sequentially absorbing the analytical reagent which passes through the primary absorbent so that detection of the last zone of absorbed analytical reagent indicates the quantity of test substance. The method comprises passing test substance and analytical reagent through the primary absorbent and then the analytical absorbent followed by detection of the last zone in which analytical reagent is absorbed. The device comprises a funnel with the primary absorbent therein for directing the test substance and analytical reagent to a narrow tube holding the analytical absorbent.

Abstract: Process for chemically binding organic compounds containing carbohydrate residues, onto a support bearing at least one reactive --NH.sub.2, in which at least one --CH.sub.2 OH group of the carbohydrate residue is transformed in a --CHO group, by oxidation and then the --CHO groups thus obtained are reacted with at least a reactive --NH.sub.2 carried by the side chains covalently bound on a solid, insoluble support, the side chains are chosen from among amines, polyamines, diacids, amino-acids, hydrazines, and are eventually coupled, by the intermediary of their reactive --NH.sub.2, with a nitrogen-containing compound chosen from aliphatic or aromatic amines, aliphatic or aromatic hydrazines, or amino acids, comprising eventually jointly a --SH group and a --NH.sub.2 group.Products resulting from this process and biological reagents containing said products as their active constituents.

Abstract: A diagnostic reagent for immunological tests for detecting or measuring a component in human or animal body fluids or for labeling cells, including immunochemicals immobilized on a particulate carrier characterized in that fine particles having an average diameter in the range of about 0.03 to about 10 .mu.m and comprising a cross-linked polymer having a repeating unit represented by the general formula ##STR1## wherein R stands for hydrogen or a methyl group, are used as the particulate carrier.

Abstract: An immunoassay for the measurement of free thyroid hormone, i.e., thyroxine or 3,5,3'-triiodothyronine, in a liquid sample in which the thyroid hormone is present in both free and combined states, which immunoassay comprises the steps of:A. combining the sample with a labeled thyroid hormone-horseradish peroxidase conjugate which does not significantly interact with the thyroxine-binding globulin and thyroxine-binding prealbumin originally present in the sample and immobilized antibody which is specific for the thyroid hormone;B. incubating the resulting mixture;C. separating a solid phase from the liquid phase; andD. measuring the amount of labeled thyroid hormone-horseradish peroxidase conjugate present in either phase by means of the activity of the label.

Abstract: A method for diagnosing mammalian breast cancer by detecting in the physiological fluid of said mammal an antigen (ACRT) having immune cross-reactivity with human reverse transcriptase, or detecting antibodies against said ACRT or detecting antibody-ACRT complexes, wherein the reverse transcriptase is substantially purified, has a molecular of about 70,000 and a sedimentation coefficient on a glycerol gradient of between 5 and 5.5 S. A process for the purification of reverse transcriptase from human milk.

Abstract: In the immunoassay of antigens in liquids, a reaction mixture is formed containing the liquid under assay, labelled antigen, and a mixed binding reagent which contains an antigen-binding site and a label-binding site, the two sites being spaced apart in the reagent so that a single molecule of labelled antigen cannot bind to both sites. The label is one whose activity is changed upon binding to a label-binding site, and the amount of antigen in the original liquid sample is determined by measuring the activity of the label in the reaction mixture. A preferred label is a fluorophore. The mixed binding reagent preferably consists of two antibodies linked together.

Abstract: Process for the preparation of test reagents comprising antigens or antibodies adsorbed on a surface, for example, the surface of synthetic or natural polymer particles in which the test material to be adsorbed is dissolved in a solvent in contact with the adsorbing surface and precipitated by the addition of a liquid which is miscible with the solvent, but does not dissolve the test material.

Abstract: A method and an implementation are disclosed for measuring the contents of a certain component (e.g. a hormone) in a biological fluid. The basic principle of the method is that a complex is formed starting from the antagonist of the component sought for with the product of conjugation of the latter with a tracer (e.g. a radioisotope), said complex is introduced in the biological fluid to be tested and the quantity of the tracer which has been set free is measured with a measuring or dosing technique which is appropriate for the tracer which has been selected.

Abstract: A diagnostic reagent for hepatitis A antibody is prepared by adhering hepatitis A antibody to a surface by non-specific adsorption followed by specific coupling of hepatitis A antigen to the antibody. This reagent is useful in an in vitro assay for hepatitis A antibody.

Abstract: An element for the analysis or transport of liquid, especially aqueous liquids, contains a structure comprising a plurality of heat-stable, organo-polymeric particles non-swellable in and impermeable to the liquid, and an adhesive concentrated at particle surface areas contiguous to adjacent particles bonding the particles into a coherent, three-dimensional lattice that is non-swellable in the liquid. A substantial portion of the particle surface area in this lattice structure is therefore effectively free from adhesive. The lattice structure has interconnected void spaces among the particles representing a total void volume of about 25 to 80 percent to provide for transport of the liquid. The adhesive comprises an organic polymer different from that of the particles and insoluble in the liquid under analysis. The amount of adhesive in the structure is less than 10 weight percent of the particles.

Abstract: A method for performing multiple, simultaneous in vitro diagnostic tests is provided. The method utilizes a solid phase device comprising a receptacle and an insert. The receptacle has one or more fixed components immobilized on its inner surface. The insert has one or more fixed components--different from those immobilized on the receptacle--immobilized on its surface which is in contact with a fluid sample when inserted therein. The test is performed by placing a fluid sample, having two or more mobile components reactive with the fixed components, into the receptacle and in contact with the insert for a period of time and measuring the changes which are a function of the concentration of the mobile components.

Abstract: A conjugate for use in the detection and quantification of antibodies and antigens in body fluids by immunoassay procedures and chemiluminescent immunoassay procedures utilizing the conjugate. The conjugate is capable of reacting with an antigen or an antibody or both and includes a tag capable of catalyzing a chemiluminescent reaction. The conjugate may be an antibody or an antigen to which a metallo porphyrin tag is attached and preferably comprises immunoglobulin to which hemoglobin is attached.

Abstract: Processes, reagents and test kits for the qualitative and/or quantitative determination of an immunochemically reactive component, in which one or more labelled components are used, that are obtained by direct or indirect coupling of such a component or components to particles of an aqueous dispersion of a hydrophobic dye or pigment, or of polymer nuclei coated with such a dye or pigment.During the reaction or after an adequate reaction time the nature and/or the quantity of the dye is determined in the test medium, or optionally after a separation of the bound and free labelled components in one of the fractions.

Abstract: Polyglutaraldehyde (PGL) is polymerized in aqueous base or in aqueous highly polar solvent basic media to prepare powders, castable films or coatings for substrates such as amine substituted microbeads. PGL microspheres can be prepared by suspension polymerization in presence of a surfactant or by precipitating PGL from solution containing surfactant. Magnetic PGL microspheres are formed by suspension polymerization in the presence of magnetic particles such as iron oxide. Polyglutaraldehyde can be converted to a fluorescent polymer by reaction with m-aminophenol or other reagent. Proteins can be readily covalently bound to the polyglutaraldehyde.

Abstract: A new and useful process is disclosed for manufacturing a device for use in a bioprocess, comprising: (a) providing solid support means insoluble in water or organic solvent solutions; (b) coating said solid support means with water-based polymeric film means capable of applying one or more biomaterials; and (c) adsorbing or covalently bonding at least one functional biomaterial to said polymeric film means. The polymeric film means, for example, can be used to coat antigens, antibodies, haptens, enzymes, living bacteria, yeasts, etc. (i.e., biomaterials) to a glass (or other) support material, e.g., a glass tube, with surprising retention of the biomaterial's essential characteristic properties. The solid support means include but are not limited to those comprising glass, ceramics, metals, polymers and woods. The device of the invention is particularly useful in various immunoassays using a solid support for separation of phases.