Abstract: Apparatuses and methods are disclosed which can be used in the field (i.e., outside the laboratory environment) to determine qualitatively and at least semiquantitatively the presence or absence of minute quantities of ligand. The apparatus can be in the form of a strip comprising a support means provided with a groove intermediate its ends forming a crease line upon which the strip can be folded upon itself with bibulous elements and spaced from the crease line and arranged so that when the strip is folded upon itself the bibulous elements become aligned with each other and come into liquid contact.

Abstract: A carrier coated with antibodies or antigens is proposed, which performs a serological reaction with human, animal or plant material to be investigated and which is received in a multi-well plate. The carrier is made from nitrocellulose or a material having the adsorption characteristics of nitrocellulose and its shape is adapted to the multi-well plate used for performing serological reactions and is introduced into the latter. A plastic reinforcing structure provides support for the coated carrier. The coated carrier is not completely bound to the plastic reinforcing structure, so that both sides of the carrier will be contacted by material in the multi-well plate.

Abstract: Methods and kits are described for performing immunoassays. The kit includes a reaction cell having a microporous membrane and an absorbent capable of drawing liquid sample through the membrane. An applicator is provided for applying a small volume of the liquid sample to the membrane by contacting a port of the applicator to the membrane and allowing the sample to flow therethrough by capillary action. Analyte in the sample is immobilized, typically by immunoadsorption, and the immobilized analyte may then be visualized using conventional signal producing systems, such as color, fluorescence, and luminescent systems.

Abstract: A device for the detecting of an individual's Gell-Coombs Types I, II, III and IV immune response reactions to edible substances includes a mixture of an edible substance and a solution of non-toxic aprotic solvent, such as DMSO and water. The solvent acts as a carrier transporting the food beneath the skin. The device holds the mixture against the skin and prevents evaporation of the solution. The method includes the preparation of a plurality of mixtures of different edible substances and a solution of non-toxic aprotic solution, the application of the mixture to the skin of the individual and the holding of the mixture on the skin for a predetermined period of time. The mixture is subsequently removed, and the site is inspected to determine whether a Type I, II, III or IV Gell-Coombs immune response reaction has occurred. Control sites containing the solvent only and a control site containing a food substance which causes the skin to fluoresce upon exposure to an ultraviolet light may also be used.

Abstract: A multizone test device for the determination of analyte from a liquid test medium upon contact with the liquid test medium and a labeled reagent comprising a chemical group having a detectable physical property. The test device preferably comprises multilayers including a reagent layer incorporated with an immobilized reagent and a detection layer incorporated with an immobilized form of a binding substance for the labeled reagent. The immobilized reagent and the labeled reagent comprise specific binding partners which will bind to each other dependent upon the amount of analyte present. Labeled reagent which does not become bound to the immobilized reagent in the reagent layer migrates into the detection layer and becomes bound to and immobilized by the immobilized binding substance therein.

Abstract: A multizone test device for the determination of analyte from a liquid test medium upon contact with the liquid test medium and a labeled reagent comprising a chemical group having a detectable chemical property. The test device preferably comprises multilayers including a reagent layer incorporated with an immobilized reagent and a detection layer incorporated with an immobilized form of an interactive detection reagent for the labeled reagent. The immobilized reagent in the reagent layer and the labeled reagent comprise specific binding partners which will bind to each other dependent upon the amount of analyte present. Labeled reagent which does not become bound to the immobilized reagent in the reagent layer migrates into the detection layer and interacts with the immobilized interactive detection reagent therein which results in the localized generation of a detectable reaction product which preferably is also immobilized in the detection zone.

Abstract: A multilayer analytical element exhibits improved precision in the assay of total lactate dehydrogenase (LDH). The element also provides reduced susceptibility to total protein and hemoglobin interferences in the assay. The element contains a porous spreading layer composed of a particulate structure. A fluorinated surfactant is also used in the assay. This surfactant has one or more fluorocarbon moieties provided, that when the surfactant has more than one such moiety, they are substantially linear. The surfactant can be incorporated in the element or added at the time of the assay.

Abstract: The present invention provides a process for the preparation of a reagent paper for immunological analysis, wherein a fiber fleece of a cellulose/synthetic fiber mixture, in which the weight ratio of cellulose/synthetic fiber is 1 to 90/99 to 10, is activated by treatment with periodate, the so activated fiber fleece is loaded with an acid-treated protein and non-bound protein is removed.The present invention also provides a reagent paper for immunological analysis, wherein it comprises a fiber fleece of a cellulose/synthetic fiber mixture, in which the weight ratio of cellulose/synthetic fiber is from 1 to 90/99 to 10.Furthermore, the present invention is concerned with the use of a fiber fleece of a cellulose/synthetic fiber mixture, wherein the weight ratio of cellulose/synthetic fiber is 90 to 1/10 to 99, as reagent carrier for heterogeneous immunological analysis.

Abstract: A container for determining antibodies or antigens in a biological liquid by the formation of specific antibody-antigen complexes, in which one partner element is initially associated with suspended magnetic particles that are subsequently regrouped against a collecting area of a first side wall of the container when the container is positioned within a magnetic field that extends through that area of the side wall. To prevent the particles from sliding down when the magnetic field is eliminated and to allow effective pipetting, the lower part of the side wall is adjacent to a planar surface formed at an obtuse angle to said side wall and tangent to a concave bottom surface that is itself tangent to a second side wall of the container located opposite to the first side wall.

Abstract: A liquid recovery device includes a receptacle, a swab for transferring a sample to a liquid in the receptacle, and a wringing unit to remove the liquid from the swab after the sample is transferred. The wringing unit has a sleeve with a closure in one end. A shaft of the swab extends through a passageway in the closure. When the swab in the receptacle is raised by upward movement of the shaft, an absorbent pad on the lower end of the shaft enters the passageway and is compressed. The compression of the pad wrings liquid therefrom which drips back into the receptacle. The device may be used in a method to prepare solutions of the sample in a minimum amount of liquid.

Abstract: This invention relates to devices and to methods, diagnostic reagents and kits embodying such devices for use in ligand/anti-ligand assays and the qualitative or semi-quantitative detection of a substance of interest thereby through use of light or photon detecting systems such as reflectometers, colorimeters, fluorimeters and the human eye. Such devices, methods and kits have applications in the biologic research and medical fileds for assaying drugs, hormones, peptides, proteins, enzymes, nucleic acids, antibodies, haptens, antibiotics, viri, infectious agents, tumor markers and the like, in the laboratory, the physicians' office, the veterinarian's office and the home.

Abstract: An immunoassay procedure utilizing a formazan-labeled primary antibody to detect the presence of an antigen is disclosed. The formazan-labeled antibody is dissolved in a test fluid suspected to containing the antigen. A dipstick having a first section on which primary antibodies are bonded and a second section free of primary antibodies and antigens and blocked to prevent bonding of primary antibodies and antigens is immersed in the test fluid and removed after a select period of time. A difference in color between the first and second sections indicate the presence of the antigen.

Abstract: The invention relates to a new method of immunological analysis for serum amyloid A protein (SAA) and serum amyloid P-component (SAP), kits therefor and a method of purification of SAA and SAP. These methods are based on the efficient binding of SAP to a plastic surface and to carriers bearing nitrated phenyl groups in the presence of calcium and related bivalent ions, and of SAA to a plastic surface and to carriers bearing nitrated phenyl groups with or without calcium ions. The method of immunological analysis allows for rapid and reliable screening of serum samples with a high sensitivity. SAA and SAP play a key role in the diagnosis and management of inflammatory diseases.

Abstract: A composition of a polysaccharide with a detectable material appended thereto and a 1,3-dione having a methylene group between the two carbonyls of the 1,3-dione, which methylene group has at least one ionizable hydrogen, provides accurate results in assays of hydrolyzing enzymes such as amylase. The composition can be incorporated in the reagent zone of a dry test element having a reagent zone and a registration zone.

Abstract: A method for conducting a ligand assay in an inert porous medium wherein a binding material is immunologically immobilized within the medium, which includes the steps of immunologically immobilizing a binding material within a finite zone of the medium, applying an analyte to the zone containing the immobilized binding material, applying a labeled indicator to the zone which becomes immobilized within the zone in an amount which can be correlated to the amount of analyte in the zone, applying a solvent to substantially the center of the zone to chromatographically separate the unbound labeled indicator from the zone, and measuring the amount of labeled indicator remaining in the zone.

Abstract: Dry chemistry reagent system, kit and method for detection of an analyte such as glucose, cholesterol, urea, antigen or antibody. The reagent system is a porous membrane or bibulous film having a porosity gradient from one planar surface to the other. In the membrane are uniformly distributed an indicator, a flow control agent and a reagent cocktail. The membrane is also modified by a conditioning agent.

Abstract: A method for detecting the presence of antibody or antigen in a liquid sample suspected of containing the antibody or antigen. To a test panel comprising a nitrocellulose carrier having stably bonded thereto a microsized spot consisting of either a primary ligand for that antibody or an antibody for that antigen, is added sufficient liquid containing non-specific globulin for the material of the spot, to block adjacent binding sites. Then a small liquid drop of the sample suspected of containing the antibody or antigen is added. After incubation of the panel, in tests for detecting an antibody, a drop of liquid containing labeled antiglobulin, which is an anti-immunoglobulin for that antibody, is added. In tests for detecting an antigen, the specific antibody-enzyme conjugate is added. After further incubation wash solution is added to the spot, and the test panel is assayed for presence of the label.

Abstract: A heterogeneous specific binding assay method for determining the amount of a suspected analyte in an aqueous test medium wherein a reaction mixture is formed by combining the test medium with assay reagents including a labeled reagent, an immobilizable component, and a binding substance which causes the immobilizable component to precipitate. Free and bound species of the labeled reagent are formed as a function of the amount of the analyte in the test medium. One of the free and bound species of the labeled reagent is immobilized by binding of the immobilizable component with the binding substance. The immobilized labeled reagent is seperated from labeled reagent which has not been immobilized, and the amount of label in the labeled reagent in one of the separated fractions is determined and related to the amount of analyte in the test medium.

Abstract: Method for carrying out immunoassays, in which method an antibody (or antigen) labeled with a tracer so as to be fluorescent is attached onto an antigen (or antibody, respectively) present at the inside wall of the measurement vessel, a liquid denser than the sample is added to the measurement vessel, which said denser liquid displaces the liquid from underneath, and both the excitation radiation is passed into the sample and the fluorescent radiation is collected to the detector through the wall or the bottom of the measurement vessel.

Abstract: A device is disclosed for use in a chromatographic system wherein a component of a mixture is partitioned between a liquid phase and an immobile phase. The device comprises at least one strip of a bibulous material. In the chromatographic system the component traverses at least a portion of the strip. The strip generally has a longitudinal edge substantially corresponding to the direction of traverse of the component. The longitudinal edge has the characteristic of substantially the same rate of traversal by the component along this edge when compared to the rate of traversal of the component along the body of the strip. The strips are prepared from a sheet of a bibulous material by non-deformative or non-compressive cutting of the sheet. The preferred cutting means is a laser beam.

Abstract: A device is disclosed for use in a chromatographic system wherein a component of a mixture is paritioned between a liquid phase and an immobile phase. The device is comprised of a chromatographic material. In the chromatographic system the component traverses at least a portion of the chromatographic material. The device generally has at least one longitudinal edge substantially corresponding to the direction of traverse of the component. The longitudinal edge includes means for controlling the shape of the front of the traversing component.

Abstract: The use of the ability of immunologically non-specific peptide linked amino acid containing compounds to combine with anti-antibodies or rheumatoid factor to provide for a method of detecting rheumatoid factor and for a method of immobilizing circulating immune complexes from fluids for the purpose of detection or removal thereof from body fluids, such as serum or blood.

Abstract: Vesicles comprising a matrix of lipid membranes prepared from lipid materials are useful in biomedical studies and immunoassays. A labeled species is encapsulated within the vesicles and released when the vesicles are lysed with a surface active agent. The outer surface of the vesicles is essentially free of the labeled species. Immunoassays can be carried out in solution or with a dry analytical element.

Abstract: A cap for a container in which immunoassays are performed includes a liquid absorbing material accessible to liquid in the container.

Abstract: Monoclonal antibodies which react specifically with a complementary rheumatic fever associated antigen on human B-lymphocytes derived from hybridoma cell line HB8783, process for preparing such antibodies, the use of antibodies for detecting rheumatic fever in mammals and test kit containing the antibodies.

Abstract: A device for carrying out chemical or clinical testing of a liquid sample, for example a urine sample, by a specific binding assay, said device comprising a test component (2) which has a sensitized solid surface (2a) carrying an immobilized component of a specific binding pair relevant to the assay, and a handling piece (1), and characterized in that the test component (2) bearing the sensitized surface (2a) is removably mounted in spaced relationship with a removably mounted accessory component (4) carrying an accessory solid surface (5), and in that there is a space (4a) between the sensitized surface (2a) and the removable accessory component (4) to act as a container for sample liquid, so that when the device is contacted with a sample liquid source or immersed in liquid which is to provide the test sample, liquid of the sample can enter the space (4a) to contact the sensitized surface (2a), and the accessory surface (5) acts to retain and contain sample liquid in contact with the sensitized surface (2a)

Abstract: A method and device for determining the presence of an analyte in a sample suspected of containing the analyte is disclosed. The method involves contacting a test solution containing the sample and a first member of a specific binding pair with an end portion of a strip of bibulous material capable of being traversed by the test solution through capillary action. The first member of a specific binding pair is capable of binding the analyte. The strip contains a second member of a specific binding pair integral therewith for concentrating and non-diffusively binding the first sbp member at a small situs on the strip separated from the end portion of the strip. The detectible signal is produced in relation to the presence of the analyte in the test solution. The test solution passes through the situs as the test solution traverses the bibulous material.

Abstract: The new method an products recognize human serum albumin, differentiating blood and tissue from human sources from blood and tissue of other animals. The method and products are particularly useful in forensic investigations. First, mice are injected with purified human serum albumin, spleen cells from the mice are fused with cells from a murine myeloma. Resulting hyberdomas are screened on human serum albumin coated plates. Subcloning, stabilizing by culture and continued assays for anti-human albumin activity produces products which recognize and differentiate blood or tissue samples from samples of other species.

Abstract: A device for performing a plurality of immunochemical assays simultaneously comprises a waste reservoir about which are positioned at least two assay tubes connected in series by conduits formed in the base and top of the reservoir structure. A compound syringe is insertable into an opening formed through the top of the waste reservoir, the syringe being held in place by a receiving structure formed in the base of the reservoir and connected to the entrance end of the series of assay tubes. The various compartments of the compound syringe are emptied in sequence to cause the flow of sample and assay reagents to flow through the assay tubes. The device is structured to allow for the reflow of sample through the tubes if desired.

Abstract: A method of rapid determination of the isotype class for a panel of monoclonal antibodies is described. The assay comprises adsorbing on a solid support medium antibodies directed to specific immunoglobulin heavy and light chains. Once such isotype-specific antibodies are bound to the nitrocellulose paper, the treated strips can be incubated with the monoclonal antibody of interest. Upon formation of a complex between the specific iso-type antisera and the monoclonal antibody, the complex is visualized by reaction with a chromogenic substance. In the preferred embodiment of the invention, the treated nitrocellulose strips are stored in kit form. Using these prepared strips, the isotyping assay can be performed in less than two hours with a minimum of technical manipulation and expenditure of reagents.

Abstract: A method for preparing a blush polymer coating composition containing an immunologically reative species comprises milling the species and the other materials used in the composition to uniformly disperse the species therein. This coating composition can be used to prepare analytical elements for determining analytes (e.g. creating kinase-MB) whereby the effects of potential interferents are immunochemically removed. By milling the immunologically reactive species, e.g. antisera, into the coating composition, the resulting element has improved stability resulting in improved keeping in high humidity environments.

Abstract: The invention relates to a process for the immunoassay of a substance, such as an antigen, a hapten or an antibody.This process comprises the following stages:(1) contacting a sample containing the substance to be assayed with a labelled immunoactive reagent specific to said substance, the immunoactive reagent quantity being such that the substance to be assayed is in excess compared with that labelled immunoactive reagent;(2) contacting at least part of the thus obtained reaction medium with a solid phase, to which is fixed an immunoactive reagent specific to the substance to be assayed;(3) separating the reaction medium from the solid phase; and(4) determining the labelled immunoactive reagent content of the solid phase.This process is more particularly applicable to the assaying of lipoprotein and in this case use is made of an antibody labelled by an enzyme, such as the Raifort peroxidase. It is also possible to assay .alpha.-foetoprotein by using monoclonal antibodies.

Abstract: Disclosed are novel chemiluminescent compounds and their method of use in luminometric immunoassays. The compounds, comprising salts of phenanthridinium esters, are particularly useful in sandwich immunoassays.

Abstract: A multilayer analytical element for analysis of analyte in a liquid sample comprising a liquid sample-spreading layer, a reagent layer containing a diazonium salt, and a liquid-impermeable light-transmissive support, being laminated in this order, in which said reagent layer contains a sulfonic acid group-containing polymer having at least 10 molar % of a repeating unit selected from those consisting of a sulfoalkyl group and sulfophenyl group. The analytical element can be an element comprising a porous reagent layer containing a diazonium salt and the liquid-impermeable light-transmissive support, being laminated in this order.

Abstract: An antigen-covered substrate is irradiated with ultraviolet light through a mask after which the exposed areas are rendered no longer antigenic. The unexposed areas retain their antigenic behavior and are available for the occurrence and detection of an immunological reaction.

Abstract: A heterogeneous, competitive binding immunoassay is conducted with a dry analytical element. The immunoassay is useful for determining a ligand (e.g. a therapeutic drug) and includes contacting a finite area of the element spreading layer with a sample of a liquid in the presence of a labeled ligand analog and an immobilized receptor. An immobilized ligand-receptor complex is formed within the finite area. Simultaneously, the uncomplexed ligand migrates horizontally away from the immobilized complex which remains in the center of the finite area. At least five seconds after the completion of the contacting, the amount of immobilized complex is measured in the center of the finite area.

Abstract: An apparatus responsive to optical changes in a waveguide when the latter is contacted with an analyte capable of reacting with a specific reactant thereto attached to the surface of said guide involves, for containing the analyte, an interchangeable round bottomed cuvette temporarily held by a suitably shaped carrier in working relationship with the optical components of the apparatus, this arrangement ensuring a correct optical orientation thereof relative to said component whatever the exact positioning of the cuvette.

Abstract: A homogeneous specific binding assay device, a method for its preparation, and a method for its use in determining a ligand, such as antigen, hapten, or antibody, in, or the ligand binding capacity of, a liquid sample. The test device comprises a solid carrier member, such as a fibrous web matrix, e.g., paper, or a polymeric film or gel, incorporated with reagents for a homogeneous specific binding assay system which produces a detectable response, usually an electromagnetic radiation signal, that is a function of the presence or amount of the ligand in or the ligand binding capacity of the sample. Useful homogeneous specific binding assay systems include those involving enzyme substrate labels, enzyme prosthetic group labels, and enzyme labels. The detectable response preferably is a luminescent, fluorescent, spectrophotometric, or colorimetric response, which is measurable by visual observation or instrument means.

Abstract: Viruses are detected by means of an immunoassay method in which an extended solid phase coated with antiviral antibody is employed to bind and remove virions from a specimen by forming an immuno-complex with antigens of said virions, a mobile solid phase comprising a dispersion of microspheres coated with the antiviral antibody is used to bind said microspheres to antigens associated with said immuno-complex, and the presence of bound microspheres is detected. The detection sensitivity is amplified by the ability to more readily detect the microspheres, which may be dyed or labelled. The extended solid phase advantageously may be in the form of a dipstick which can be easily contacted with the specimen. A virus detection kit provides the extended solid phase and mobile solid phases, each coated with antiviral antibodies.

Abstract: A device is disclosed into which a test solution can be added and at least the first step of a specific binding assay can be carried out. The device comprises a two compartment tube containing a removable rod having at one end a plurality of filaments coated with a specific binding partner for the analyte to be determined.

Abstract: An integral element for biological reaction comprising at least two layers consisting essentially of:a composite porous biological reaction layer comprising a fibrous material and a particulate material to which an active substance capable of participating in a biochemical reaction is fixed, anda porous layer of a fibrous material,in which:(1) the weight ratio between the particulate material and the fibrous material ranges from 1:20 to 1:0.3 on dry basis; and(2) the particulate material is contained in an amount ranging from 1 to 60 g/m.sup.2.

Abstract: A procedure for the immobilization of proteins on polystyrene surfaces which includes a pre-treatment of the polystyrene surface with a bis-diazonium compound of the general formula I where ##STR1## R1 stands for a hydrogen atom, a halogen atom, an alkyl group, an alkoxy group or a nitro group and whereR2 stands for a hydrogen atom, a halogen atom or an alkyl group and where X stands for an anion and the subsequent adsorption of the protein on the surface pretreated.Proteins immobilized by its procedure may be used in immunoassays.

Abstract: A method for the early diagnosis of Bordetella diseases based on the detection of Bordetella adenylate cyclase and the ability of this enzyme to catalyze the formation of cyclic adenosine monophosphate (cAMP). A sample secretion is taken from a suspected victim of a Bordetella disease (the most common of which in humans is whooping cough) and incubated under conditions to promote the formation of cAMP, which may then be measured as evidence of the presence of the disease. A sample of nasopharyngeal secretions is maintained in a nutrient medium pending assay. An adenylate cyclase assay is made by incubating the sample with adenosine triphosphate (ATP) and the calcium binding protein calmodulin to generate cAMP. The cAMP is measured by any of several known available methods.

Abstract: A method and device for detecting an antigenic material in which the device comprises a test utensil having an indentation in which two reagent spots are placed, the first body being a dyed substrate having a coating of an antibody or antibody-like material thereon and the second of the two reagent spots comprising a dyed test-inert material or a dyed substrate with a coating of a normal animal serum, the dye employed in the second reagent spot having a different color than that employed in the first spot. When a liquid test sample is added to the indentation, the dyed substrate particles or components are suspended or solubilized, and the resulting suspension gives the appearance of a third color. A positive agglutination test is indicated by the formation of at least one spot having the color of the first dyed substrate against a background having the color of the second dyed substrate.

Abstract: Disclosed herein is an assay useful for the determination of an analyte in whole blood. In particular, this assay is useful for the quantitative determination of peroxide-generating analytes, such as glucose or cholesterol, in whole blood. This assay utilizes a multizone element consisting essentially of a support having thereon, in order and in fluid contact, a registration zone and a reagent/spreading zone. The reagent/spreading zone has a void volume and average pore size effective to accommodate whole blood, and contains an interactive composition necessary for the analysis. Such composition is capable of providing, upon interaction with the analyte, a dye which can be spectrophotometrically detected at a wavelength greater than about 600 nm.

Abstract: Chemical analysis sheets comprising a reagent layer, a porous spreading layer and a cover layer provided with a small opening are disclosed. The cover layer prevents rapid evaporation of moisture to ensure a complete reaction between the chemical reagent and the ingredient tested for.

Abstract: The present invention relates to the carrying out of immunochemical reactions in a test tube having a bottom in the shape of an inverted prism or truncated prism, in such a way that the lower edge of the tube forms a strip having a length which is at least equal to one-quarter of the distance between two opposite walls, or where appropriate to a quarter of the diameter of the test tube, as a result of which both the sensitivity and the readability are improved.

Abstract: A solid-phase immunoassay support is provided by treating a test tube liner such as a preformed soft gelatin capsule half with a coupling solution comprising a fixative, a bifunctional coupling agent and a bioactive protein which selectively reacts with the substance which is the subject of the immunoassay. The support is particularly applicable to the radioimmunoassay (RIA) technique for determining the presence and concentration of minute amounts of protein antigens in biological fluid samples and can be readily inserted in an appropriately sized test-tube for easy and quick assays.

Abstract: A process for `unmasking` delta antigen in the blood of an animal, known or caused to be infected with the antigen. The process involves treating serum from the animal with a surfactant and optionally with an antibody--antigen dissociating agent. The blood derived delta antigen is used as a diagnostic agent in the detection and determination of different classes of antibodies to hepatitis D. virus (delta agent) by enzyme-immunoassay and radio-immunoassay.

Abstract: A method is provided for determining the concentration of pregnanediol glucuronide (PG) in a woman's urine which is characterized by utilization of the reagent 20.alpha.-hydroxy-4-pregnen-3-one (20-.alpha. reagent) in a form in which it reacts with antibodies binding to PG. The method is adaptable to a visual color indication test which can be performed by the woman herself as well as by laboratory analysis. The method can be used to define the period in which conception can occur, to define a post-ovulation safe period in which conception is prevented, and as an early pregnancy indicator.