Abstract: A dry detection reagent for detecting an immunologically active substance is prepared containing solid fine polymer particles immobilizing a substance immunologically active for the substance detected. The polymer particles are prepared by one of the following methods: a) ternary copolymerization of a monomer having carboxyl groups, a monomer having amino groups and styrene or its derivatives; b) binary copolymerization of a monomer having carboxyl groups and styrene or its derivatives, and reacting part of the carboxyl groups with a bifunctional amine such as ethylene diamine to provide amino groups; or c) copolymerizing styrene or its derivatives with a monomer having amide groups, and converting part of the amide groups to amino groups and carboxyl groups with the Hofmann reaction, or hydrolyzing part of the amide groups to form carboxyl groups.

Abstract: An assay for photometrically detecting and/or quantitating the presence of an analyte in a sample in which the signal generated by a label associated with the analyte is photometrically detected in the presence of a suspended solid support.

Abstract: An assay device for detecting the presence of analytes in an unknown sample includes a reaction system wherein resilient storage reservoirs containing reagents are fluidly connected to a track containing the sample. An actuation mechanism forces the reagent from each of the reservoirs into the track where the reagents mix together and with the sample. The mechanism produces a first flow rate and the mechanism is operable to reverse the pressure applied to the reservoirs to reverse the direction of flow of the fluids in the track for a predetermined period of time after which the flow is again reversed. The mechanism then reduces the force applied to allow a second flow rate less than the first flow rate so that reaction can occur whereby a determination may be made as to whether the target analyte is present in the sample.

Abstract: Red blood cells are removed from whole blood or a fraction thereof by contacting whole blood with a combination of an agglutinating agent and nucleating particles to form clusters of red blood cells. High molecular weight polyethylene glycol may be added further to enhance agglutination. The clusters of red blood cells are much larger than the size of individual red blood cells, so that the clusters can easily be filtered through a porous medium. The plasma which is substantially free of red blood cells is further passed through a filter that optionally contains an additional agglutinating agent.

Abstract: The invention relates to the use of collagen as solid binding substrate for a sensor called ligand or refining agent, capable of reacting specifically with an element to be detected in a biological medium, to form a specific complex.Preferably, the solid substrate comprises atelocollagen or a mixture of atelocollagen and of polyholoside.The invention thus makes it possible to provide a biological reactant of high specificity and of which the constituents are of natural origin. It can be used easily and quickly.

Abstract: Sets and libraries of sets of polypeptides that are related in sequence to melittin are disclosed that have antimicrobial, hemolytic and hydrolyrically catalytic activities, as are processes for making and using the same. A contemplated set is a mixture of equimolar amounts of a polypeptide of SEQ ID NO:2, and more preferably SEQ ID NO:3.

Abstract: Immunoassays of psychoactive drugs including psychotomimetic drugs, narcotic drugs, and tetrahydrocannabinols and treatment methods based on the antigenic properties of protein conjugates of these drugs. These methods are based upon treating the psychoactive substances as haptens and utilizing their protein conjugates to produce antibodies to the psychoactive materials themselves. The immunoassay methods include both agglutination and agglutination-inhibition reactions. The treatment methods include treatment or both exogenous, administered drugs (such as cannabinols, LSD, heroin and morphine) and endogenous substances (such as N,N-Dimethyltryptamine and 5-Methoxy-N,N-Dimethyltryptamine by active immunization and also passive immunization.

Abstract: Disclosed are materials and methods for detecting biomolecules in samples employing transponders having memory elements associated with particle(s) used as a solid phase in art assay, and information pertinent to the assay is encoded on the transponder memory elements. A dedicated read/write device is used remotely to encode or remotely to read the information encoded on the transponder memory elements. The invention can be used in direct or competitive ELISA-type assays, or in multiplex assays for the simultaneous assay of several analytes.

Abstract: Gelatin and aminodextran coated polymer core particles useful in immunoassays and methods of making the same are disclosed. The preparation of aminodextrans having varying amounts of amine groups is also described, as is a method of crosslinking gelatin and aminodextran without the use of a stabilizer.

Abstract: Disclosed are devices for detecting the presence of a preselected analyte in a fluid sample. The devices comprise a substrate microfabricated to define a sample inlet port, and a mesoscale flow system that includes a sample flow channel extending from the inlet port. The mesoscale flow system further includes an analyte detection region in fluid communication with the flow channel comprised of a binding moiety for specifically binding the analyte. The detection region is constructed with a mesoscale dimension sufficiently small to enhance binding of the binding moiety and the analyte. The binding moiety may be immobilized in the detection region. The mesoscale detection systems of the invention may be used in a wide range of applications, including the detection of cells or macromolecules, or for monitoring reactions or cell culture growth.

Abstract: A method for verifying that an assay methodology is properly performed, that assay reagents employed possess the necessary potency for accurately performing such assay methodology, and whether or not test samples or assay reagents have been tampered with or are adulterated, is described. The method is performed by employing an assay verification sample, comprising a positive analyte component and the test sample under analysis, wherein the assay verification sample is analyzed employing the same assay reagents and essentially the same assay methodology employed to analyze the test sample. The method is particularly useful for performing heterogeneous immunoassays on an automated continuous and random access analytical system.

Abstract: Methods for modulating the rates and dose responses of immunoassays through the incorporation of one or more detergents into the immunoassay reaction are disclosed. The methods are particularly suitable for automated immunoassay formats, especially with formats that use analyte-biotin bidentate reagents. The methods may be used to facilitate the detection of any desired, preselected pharmacological agent.

Abstract: HIV-1 peptides having at least one point mutation between position 593 and 611 of the HIV-1 gp160 amino acid sequence. The point mutation either is at position 604 or 610, or both positions. Immunoassays which utilize these peptides are provided, as well as, diagnostic test kits which contain these peptides.

Abstract: Stabilized microspherical particles having hydrophobic liquid cores prepared as oil-in-water microemulsions. The particles are stabilized by a surface layer comprising an amphiphilic compound and may be functionalized to allow covalent coupling of a ligand to the surface of the particle. When used as tracers in assays, a water insoluble dye may be incorporated in the core liquid of the microparticles.

Abstract: Fluorescent latices, well suited for a wide variety of analytical techniques, comprise polymer particles having at least one hydrophobic fluorochrome encapsulated therein, notably at least one condensed polyaromatic compound or derivative thereof, or a tetraphenylporphine and/or organometallic complex thereof, and have a detection threshold for fluorescence which is less than or equal to 10.sup.-12 mol of particles per liter of latex.

Abstract: Stabilized microspherical particles having hydrophobic liquid cores prepared as oil-in-water microemulsions. The particles are stabilized by a surface layer comprising an amphiphilic compound and may be functionalized to allow covalent coupling of a ligand to the surface of the particle. When used as tracers in assays, a water insoluble dye may be incorporated in the core liquid of the microparticles.

Abstract: A method for the flow cytometric assay of an analyte using monodisperse particles carrying a specific binding partner, the analyte and binding partner being selected from the group consisting of (a) antigen and specific antibody, (b) hormone and hormone receptor, (c) hapten and antihapten, (d) polynucleotide and polynucleotide binding protein, (e) biotin and avidin or streptavidin, (f) enzyme and enzyme cofactor and (g) lectin and specific carbohydrate, and the method comprising the steps of adding to the aqueous sample a predetermined amount of particles and a predeterminded amount of a labelled ligand having affinity for the analyte or the binding partner and detecting and quantifying the resulting labelled ligand-carrying particles by a flow cytometer, the method using a pair of different particle types which are distinguishable from each other by the flow cytometer and which respectively carry binding partners having the same specificity but different binding affinity for the analyte and independently but

Abstract: Stabilized microspherical particles having hydrophobic liquid cores prepared as oil-in-water microemulsions. The particles are stabilized by a surface layer comprising an amphiphilic compound and may be functionalized to allow covalent coupling of a ligand to the surface of the particle. When used as tracers in assays, a water insoluble dye may be incorporated in the core liquid of the microparticles.

Abstract: Compositions are disclosed comprising (a) a metal chelate wherein the metal is selected from the group consisting of europium, terbium, dysprosium, samarium osmium and ruthenium in at least a hexacoordinated state and (b) a compound having a double bond substituted with two aryl groups, an oxygen atom and an atom selected from the group consisting of oxygen, sulfur and nitrogen wherein one of the aryl groups is electron donating with respect to the other. Such composition is preferably incorporated in a latex particulate material. Methods and kits are also disclosed for determining an analyte in a medium suspected of containing the analyte. The methods and kits employ as one component a composition as described above.

Abstract: The invention relates to methods for labeling or detecting one or more target materials using surface coated fluorescent microparticles with unique characteristics. The unique microparticles used to practice the invention have at least two components: an external substance or coating that is selective for each target material and an internal mixture of multiple fluorescent dyes. The mixture of dyes is a series of two or more fluorescent dyes having overlapping excitation and emission spectra allowing efficient energy transfer from the excitation wavelength of the first dye in the series, transfer through the dyes in the series and re-emitted as an optical signal at the emission wavelength of last dye in the series, resulting in a desired effective Stokes shift for the microparticle that is controlled through selection of appropriate dyes. The unique microparticles are combined with a sample thought to contain the target material(s), so that the microparticles label the target materials.

Abstract: An assay for detecting an analyte which comprises applying a sample containing analyte to a surface of an absorbent material having at least one binder for the analyte supported on at least a portion of the surface. The absorbent material has a porosity which is capable of retaining non-charged particles having a size of at least 0.1 micron and no greater than 10 microns on the surface thereof. The sample flows past the binder and into the absorbent material. Porous plastics or ceramics are preferred absorbent materials.

Abstract: The invention relates to a method for determining analytes, in which a sample of a biological material which possibly contains this analyte is incubated with at least one binding partner which is specific for the analyte and which is immobilized on a particulate carrier material, and the change in turbidity brought about by the analyte is determined.

Abstract: A method for detecting multiple subpopulations of analytes of interest in a sample employing a complementary binding moiety to each of said analytes bound to a solid support, wherein each analyte and its complementary binding moiety comprise first and second members of a specific binding pair (msbp) respectively is provided. The method includes the steps of forming a mixture of known proportions of multiple subpopulations of said complementary binding moieties, wherein each subpopulation comprises a different complementary binding moieties, contacting the sample with the mixture so that specific binding pairs are formed on the solid supports, and relating the presence of analytes of interest in the sample to the formation of specific binding pairs associated with each unique proportion of said multiple subpopulations. The method can be performed with solid supports of a single average size and a single fluorochrome and without the need for using three detection systems (fluorescence FS & SS).

Abstract: Methods for determining the presence of a ligand in a sample suspected to contain the ligand are provided, along with apparatus suitable for performing the methods. The methods depend upon a color visualization indicating the ligand's presence or absence in the sample. Preferred methods comprise contacting the sample with colored particles which bear on their surface a receptor specific for the ligand, passing the sample/particle mixture through a filter, and then analyzing the color of the filtrate. The presence of ligand in the sample is established where the color of the filtrate is substantially different from the color of the receptor-bearing particles.

Abstract: Encoded combinatorial chemistry is provided, where sequential synthetic schemes are recorded using organic molecules, which define choice of reactant, and stage, as the same or different bit of information. Various products can be produced in the multi-stage synthesis, such as oligomers and synthetic non-repetitive organic molecules. Conveniently, nested families of compounds can be employed as identifiers, where number and/or position of a substituent define the choice. Alternatively, detectable functionalities may be employed, such as radioisotopes, fluorescers, halogens, and the like, where presence and ratios of two different groups can be used to define stage or choice. Particularly, pluralities of identifiers may be used to provide a binary or higher code, so as to define a plurality of choices with only a few detachable tags. The particles may be screened for a characteristic of interest, particularly binding affinity, where the products may be detached from the particle or retained on the particle.

Abstract: A polypeptide sequence from Candida albicans is described which has significant sequence homology with known stress proteins from other organism, particularly the heat shock protein hsp 90 of Sacchromyces cerevisiae. Corresponding DNA sequences are also described, together with antibodies raised against fragments of the sequence. The polypeptide and DNA sequences and antibodies provide separate means for the diagnosis and/or treatment of fungal, particularly Candida, infections.

Abstract: The invention concerns a method for the determination of the content of a particular haemoglobin derivative in a blood sample. In particular, the invention concerns a method for the determination of the content of haemoglobin derivatives such as glycated haemoglobin which require the separate determination of the total haemoglobin content and the determination of the haemoglobin derivative in order to determine the proportion of the derivatized haemoglobin in the blood as well as a suitable haemolysis reagent for this.

Abstract: Immunoassay devices and methods that employ non-antibody control substances are disclosed. A non-antibody substance, such as Protein A, that specifically binds to the Fc portion of IgG is used to determine whether patient sample is properly added to the device during the assay procedure.

Abstract: A method is disclosed for separating a substance from a liquid medium. The method comprises combining the liquid medium containing the substance with magnetic particles under conditions for non-specific chemical binding of the magnetic particles. Thereafter, the medium is subjected to a magnetic field gradient to separate the particles from the medium. The preferred non-specific binding is achieved as the result of charge interactions between the particles usually by means of a polyionic reagent. The method of the invention has particular application to the separation of cells and microorganisms from aqueous suspensions and also to the determination of an analyte in a sample suspected of containing the analyte. The analyte is a member of a specific binding pair (sbp). The sample is combined in an assay medium with magnetic particles and a sbp member complementary to the analyte.

Abstract: A substrate for surface-enhanced analytical procedures, such substrates prepared for use in specific procedures to detect specific binding partner molecules, and a method for making them. The substrate is a body having a substrate surface on which there are randomly spaced apart metal islands. A continuous layer of coupling agent coats the islands and any intervening substrate surface. First binding partner molecules are bonded to the coupling agent. These are specifically attractive to specified second partner molecules for an analytical procedure for detecting the presence of, and perhaps the concentration of second partner molecules, or in some procedures, of a specified third binding partner molecule which becomes bonded to the second binding partner molecule. The thickness of the coupling agent layer is selected to improve the sensitivity of a given analytical procedure for detecting or measuring the specific binding partner molecule.

Abstract: Particle size distributions with greatly improved accuracy are prepared for diagnostic analysis using antigen/antibody reactions to concentrate sensitized insoluble carriers into non-aggregated and aggregated particles of known size. The analyte is analyzed by an electronic analyzer to determine the quantity and size distribution of concentrated non-aggregated and aggregated insoluble carriers resulting from the antigen/antibody reaction, as well as spurious particles that may be present in the analyte. The concentrated non-aggregated and aggregated insoluble carriers occur in known regions of the measured size distribution. The spurious particles exist throughout the size distribution. The distribution of spurious particles is determined in the regions where the desired particles are known to be absent. A complete distribution of spurious particles is constructed by interpolation using a cubic spline function.

Abstract: A method for assaying for the presence of analyte in a sample based on differential binding affinity involves detecting dissociation of a complex of receptor and ligand in the presence of analyte. The receptor binds the analyte with high affinity and with the ligand with low affinity. The receptor-ligand complex may be formed in situ or may be preformed. In the presence of free analyte, the receptor releases from the receptor-ligand complex and binds free analyte. Release of the receptor-ligand complex is detectable. A kit for performing release assays to detect the presence of analyte is also provided.

Abstract: An antibody test suitable for the rapid detection of ciguatoxin and other related low molecular weight polyether marine lipid toxins in fish tissue in the field or laboratory is disclosed. The test utilizes the reaction between antibody coated, mixed latex beads and any lipids in an extract of a sample of fish tissue eluted in a solvent. The presence of toxins is determined within about thirty minutes by ascending chromatography, which separates the mixed beads. The toxin concentration is determined by reference to standard data. A kit suitable for performing the testing procedure in the field is also disclosed. The kit includes a support having a nylon membrane covering, and antibody coated, mixed beads applied on the membrane, a testing container, a supply of solvent and a biopsy tool.

Abstract: The present invention relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of generic anti-hapten antibodies. Also disclosed are multi-analyte immunoassay methods. Reagents, devices, and kits using the anti-hapten antibodies are also disclosed. The present invention also relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of a dual antibody format.The present invention also relates to dyed erythrocytes, preferably fixed, which are coated with antibodies. Also disclosed is the use of these dyed erythrocytes in agglutination assays to detect and measure the presence of an analyte in a sample. The analyte can be a hapten, an antigen, or an antibody. Also included are agglutination assays, compositions and kits using these dyed and coated erythrocytes.

Abstract: Contaminants in particulate materials may be separated and quantitated by contacting the particulate material with an immobilized biomolecule which specifically binds to the contaminant, separating the contaminant-immobilized biomolecule complex from the particulate material, and counting the bound contaminant. The method may be conveniently carried out when the biomolecule is immobilized on a magnetic particle. An apparatus for carrying out the method contains a receptacle for receiving a reaction vessel and magnets positioned such that magnetic particles contained in the reaction vessel will be drawn to and adhere to the sides of the reaction vessel when placed in the receptacle.

Abstract: The present invention provides methods for detecting the presence of antibodies to a microorganism (e.g., Chlamydia trachomatis) associated with a sexually transmitted disease in a biological sample, preferably urine. The methods of the invention comprise contacting the sample with an antigen from the microorganism and detecting the formation of an antigen-antibody complex.

Abstract: A suspension of inert particles is prepared in an aqueous solution, to which an antibody or an antigen and a carrier-bound antigen or antibody, respectively, are added in any desired order. After centrifuging, the positive, weakly positive, or negative reaction can easily be recognized on the basis of a simple pattern.

Abstract: An immunoassay method for the detection or quantitation of an analyte suspected of being in a solution comprising: (a) combining said specimen, a first binding component, insoluble particles, and second binding component labelled with a signal generating material in a solid phase retention and separation apparatus having a sufficient pore size such that said particles are trapped within said filter yet permitting rapid passage of fluid therethrough in such a manner that an immunological reaction occurs if analyte is present in said specimen, resulting in the formation of an immunocomplex of insolublized first binding component:analyte:second labelled binding component on or within said filter means; (b) separating bound from unbound material; and (c) determining the presence and/or amount of signal produced which is correlative with the amount of analyte present in the solution.

Abstract: The present invention provides a novel immunoassay for the detection of multiple analytes such as amphetamine and methamphetamine in a single assay of a biological fluid sample. In this assay, a single labelled binding partner is utilized capable of cross reacting at differing sensitivities to antibodies derived from conjugate derivatives of the different analytes such that the presence of the analytes at selected levels of concentration of the analytes singly or in combination can be detected.

Abstract: A hybridoma capable of producing monoclonal antibody for recognizing hCG-.beta. core region and hCG-.beta. subunit, which is obtained by cell fusion of an antibody producing cell of a mammal immunized with hCG-.beta. subunit and a lymphoid cell line, and the monoclonal antibody are disclosed. The monoclonal antibody can be used in an immunochemical determination method useful for diagnosis of cancers.

Abstract: An assay device for detecting the presence of analytes in an unknown sample including a reaction system wherein storage reservoirs containing reagent are fluidly connected to a track containing the sample. An actuation mechanism forces the reagent from the reservoirs and into the track where it mixes the reagents together and then with the sample at a first flow rate. The mechanism then reduces the force on the reagent to allow a second flow rate less then the first flow rate to force the reagent and sample mixture through the track so that reaction can occur, whereby a determination as to whether the target analyte was present may be made.

Abstract: New method for the detection of specific binding agents and their corresponding bindable substances by employing a label which is a latex particle which can be visually detected.

Abstract: This invention relates to novel quaternary ammonium immunogenic conjugates and reporter reagents useful for eliciting antibodies and in immunoassays. Processes for preparing such quaternary ammonium immunogenic conjugates and their use in immunoassays and in eliciting antibodies are also disclosed.

Abstract: A method and device for detecting the presence of a suspected antigen in a sample whereby the antigen is trapped using affinity chromatography and the remaining eluant is differentially analyzed against a parallel processed control. The sample is first chromatographically segregated into distinct zones and the resulting eluant is split into two streams. One stream is contacted with a solid phase having immobilized capture ligands specific to the antigen of interest. The other stream is passed through a similar solid phase where the capture ligands have been omitted. The two streams are then differentially analyzed, for example, with ultraviolet light absorption.

Abstract: A vessel for conducting blood cell agglutination assays is disclosed. A barrier retains reactants in an upper chamber during incubation, then, in response to a force, permits reagents to enter a lower chamber containing a matrix for separating agglutination.

Abstract: The present invention provides methods and kits for determining the presence or amount of a substance by detection of a colloidal dye associated with agglutinated particles. The disclosure of the present invention shows that the use of a suspension of colloidal dye, which contains dye unattached to the particles to be agglutinated, enhances the amount of colloidal dye associated with the particles following agglutination. The methods and kits are disclosed in direct and indirect (e.g., competitive) formats. In one aspect, the present invention provides methods and kits utilizing a single colloidal dye. In another aspect, methods and kits are provided which include two colloidal dyes, wherein one colloidal dye functions as a background-enhancing dye.

Abstract: A method and a device for performing an assay in order to detect or determine the amount of an analyte in a test liquid, wherein bound and unbound reactants can be separated, comprising a capillary canal for liquid transport that is at least partly bordered by a semi-permeable layer, wherein during performance of an assay a movable solid phase material bearing a ligand capable of binding the analyte or binding a reactant for the analyte is within the capillary channel adjacent to the semi-permeable layer, said semi-permeable layer having pores that are sufficiently small to prevent the passage of the movable solid phase material and sufficiently large to permit passage of unbound reactants there through.

Abstract: Embodiments of the invention provide methods of preparing an activated acridinium microparticle. Generally, the methods involve direct covalent coupling or an affinity format. The direct covalent coupling method involves coating a microparticle with a proteinaceous compound. Then, a 10-methyl-N-tosyl-N-(2-carboxyethyl)-9-acridinium carboximide trifluoromethane sulfonate is coupled to the proteinaceous compound. In the affinity format, a microparticle is coated with a biotinylated proteinaceous compound. The microparticle is reacted with an anti-biotin labelled 10-methyl-N-tosyl-N-(2-carboxyethyl)-9-acridinium carboximide trifluoromethane sulfonate. Methods are also provided for using such a microparticle. Those methods of use can estimate transfer efficiency, calibrate optics, and measure membrane pore size of a chemiluminescence based instrument. Test elements for analytical instruments are also provided.

Abstract: Methods have been developed to produce novel compounds by covalently coupling thiazolidinedione insulin sensitivity enhancers (ISEs) to proteins. These novel compounds are well suited for producing antibodies, which are specific for thiazolidinedione ISEs and which are well suited for fluorescent immunoassays of thiazolidinedione and non-thiazolidinedione ISEs in buffers and biological tissues. Antibodies also are well suited for high-volume screening for immunologically related novel, non-thiazolidinedione and thiazolidinedione ISEs.

Abstract: The invention relates generally to colloidal particle having a core material and a gelatin/aminodextran coating with pendent functional groups attached thereto. Biological substances or molecules, especially monoclonal antibodies, may be attached to said particles. The monoclonal antibody containing particles are useful in a variety of positive and negative biological assays.