Abstract: A monoclonal antibody which specifically binds to HIV-2 gp36 antigen and does not specifically bind to HIV-1 antigens. The monoclonal antibody is useful in immunoassays as a capture reagent, as part of an indicator reagent, and/or as a positive control.

Abstract: This invention relates to improved "sandwich" immunoassays for antibodies in body fluids of the type where antigen specific for the antibody to be detected is disposed on a solid support and binds antibody from the body fluid, from which the antibody bound to the solid support is detected by a labeled antigen to the antibody to be detected. The improvement comprises using antigens from heterologous cell sources.

Abstract: A valveless metering pump includes a simultaneously reciprocating and rotating piston. The pump head includes radially spaced coplanar ports for drawing and dispensing fluids as the piston rotates sequentially past the ports. The reciprocating stroke of the piston is controlled by adjusting the axis of the piston relative to the drive axis. The pump is designed so that the angular relationship of the ports also can be adjusted relative to the piston to balance the output at the sequential ports. The plurality of adjustments provide a valveless, positive displacement metering pump which is reliable and dependable for dispensing precise volumes of fluid through a plurality of outlet ports.

Abstract: A disposable device suitable for performing automated solid-phase diagnostic assays which employs microparticles to complex an analyte and where the microparticle complex becomes retained and immobilized on a fibrous matrix such that the presence of analyte on the microparticles can be detached by optical means.

Abstract: A method for performing a microparticle diagnostic assay in a device having a shallow sample well for receiving a sample and reagents for forming a reaction mixture, a read well positioned adjacent to said sample well and separated from said sample well by a wall which is constructed and arranged such that when wash fluid is injected into said sample well, sample and reaction mixtures are washed from said shallow sample well, over the wall and into said read well. The steps of the method comprise forming microparticle analyte complexes in said shallow sample well; washing said microparticle analyte complexes from said shallow sample well over the wall and into said read well where a fibrous matrix retains and immobilizes said microparticle analyte complexes; adding to said read well an indicator substance capable of forming an assay signal when said microparticle analyte complexes are present; and detecting said assay signal produced by said indicator substance.

Abstract: A buffer composition which can be used to dilute assay components and which also can be used when performing immunohematological procedures. The buffer composition includes effective concentrations of phosphate buffer, polyvinylpyrrolidone, cholic acid, bovine serum albumin, a biological detergent and sodium hydroxide, at a pH of from about 5.6 to 7.2. The method of using the buffer composition and a kit containing the buffer composition also is provided.

Abstract: The present invention provides monoclonal antibodies demonstrating specific reactivity with HIV-1 p24. One monoclonal antibody designated 31-42-19 recognizes an unique epitope on HIV-1 p24 that is not immunogenic in humans. 31-42-19 also reacts with an antigenically cross reactive epitope on HIV-2 p24. Another monoclonal antibody designated 31-90-25 recognizes an epitope within a highly immunogenic region of HIV-1 p24. The present invention also provides cell lines capable of producing these monoclonal antibodies. The invention also includes a highly sensitive enzyme immunoassay for the detection of HIV-1 p24 in biological fluids, using a monoclonal antibody mixture. The present invention further provides methods for the use of these monoclonal antibodies for the detection of anti-HIV-1 p24 antibodies and HIV-2 p24 antigen in biological samples.

Abstract: A diagnostic testing device is disclosed. The testing device includes a base member and a cover member which defines an opening for the reception of a liquid specimen. A distribution wheel delivers portions of the specimen to antibiotic units which are circumferentially spaced. Indicator units are in communication with the cover member. A delivery cylinder extends upwardly from each of the antibiotic units toward a respective one of the indicator units. Relative vertical movement between the delivery cylinder and the indicator unit places the cylinder and the indicator unit into an engaging relationship. A change in coloration at an indicator unit indicates a positive reaction.

Abstract: Reagents and an immunoassay for detecting the presence or amount of polychlorinated biphenyls in a test sample. The assay is performed by adding a known concentration of a tracer labeled with a detectable moiety and a known concentration of an analyte-specific antibody to a test sample to form a mixture, incubating the mixture to form labeled tracer-antibody and analyte-antibody complexes, and determining the presence or amount of tracer-antibody complexes formed as a measure of the presence or amount of analyte in the test sample. Reagents provided include tracers, immunogens and an additive compound useful in preventing non-specific binding of the polychlorinated biphenyls to proteins which may be present in the test sample. A kit for performing the assay also is provided.

Abstract: An immunoassay which is capable of simultaneously detecting any desired number of antigens of one infectious agent, or combinations of antigens of several infectious agents, or any desired number of immunoglobulins of one infectious agent, or combinations of immunoglobulins of several infectious agents on a single solid support. A test sample is contacted with a solid support on which one or more antigens are immobilized as discrete test sites. Antigen-antibody complexes are formed and detected on the solid support.

Abstract: A fluorescence polarization immunoassay (FPIA) for detecting the presence of one or more amphetamine-class analytes in a test sample is provided. The immunoassay uses competition between the analyte and a fluorescently labeled tracer for the binding site on an antibody specific for phenethylamine derivatives. The concentration of amphetamine-class analyte in the sample determines the amount of tracer that binds to the antibody. The amount of tracer/antibody complex formed can be quantitatively measured and is inversely proportional to the quantity of analyte in the test sample. The invention relates to tracers, to immunogens used to elicit antibodies for use as assay reagents, and to assay kits incorporating these tracers and assay reagents.

Abstract: Apparatus and method for performing a chemiluminescence assay involving the immobilization of a chemiluminescent reaction complex to a solid, porous element. The solid, porous element is preferably treated to provide an immobilizing interaction with the chemiluminescent reaction complex wherein the chemiluminescent reaction complex is thereby immobilized to the solid, porous element. The activating and reading of the chemiluminescent reaction are separately performed by evenly distributing a concentrated chemiluminescent activating solution to form a puddle on the surface of the porous element to which the chemiluminescent reaction complex is immobilized.

Abstract: A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immuno assays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge.

Abstract: A method for cutting fibrous materials using ultrasonic energy involves chemically modifying a fibrous material prior to the application of ultrasonic energy. Preferred fibrous materials include cellulose materials and its derivatives, such as, paper. Chemical modification includes oxidation or hydrolysis. Also disclosed is a test device made according to the method. The invention allows for the fusing of plastic and the simultaneous cutting of a chemically modified fibrous material along the line of fusion.

Abstract: The invention is a novel immunoassay method for detection of the immunoglobulin IgA.sub.1 with O-linked oligosaccharides lacking sialic acid in fluid samples, such as blood, serum and plasma. Particuarly, the invention is an immunoassay method which extracts total IgA from fluid samples by reaction with an immobilized anti-IgA antibody, and then detects only the IgA.sub.1 fraction with labeled peanut agglutinin.

Abstract: A disposable device suitable for performing automated solid-state diagnostic assays which employs microparticles to complex an analyte and where the microparticle complex becomes retained and immobilized on a fibrous matrix such that the presence of analyte on the microparticles can be detected by an optical device.