Abstract: A device for performing an enzyme-labelled binding assay comprises an absorbent material and a developing solution, wherein the absorbent material is provided with a plurality of reagent zones including an indicator reagent zone, and is capable of transporting the developing solution by capillary action sequentially through each reagent zone, and wherein the indicator reagent zone includes a reagent capable, directly or indirectly, of immobilising an enzyme-labelled reagent in an amount dependent upon the assay result, characterised in that the developing solution includes a signal producing substrate for the enzyme. The substrate moves slower through the absorbent material than the enzyme-labelled reagent or any compound of the enzyme-labelled reagent formed in the assay. The absorbent material is suitably in the form of an elongate strip provided with transverse reagent zones. The device is useful for performing immunoassays including immunometric assays and dual analyte assays.

Abstract: An immunoassay element comprising at least one layer containing a leuco dye coating composition comprising:______________________________________ Dry Weight Component Ratio (Range) ______________________________________ a) Triarylimidazole leuco dye 55-80 b) Antioxidant 7-40 c) Poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) Alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________

Abstract: A biological sample such as feces, sputum, cervical tissue, pleural fluids, exudates, cytologic specimens, or the like, is tested for the presence or absence of: ova; parasites; microorganisms; inflammatory, neoplastic tissue cells; or other target materials which are indicative of infestation, disease or infection. The sample is mixed with a buffer fluid and placed in a transparent tube which contains a volume-constricting cylindrical insert for gravimetric separation of components of the sample. The mixture is centrifuged, and the annular space between the insert and tube bore is examined under magnification for the presence of the target materials.

Abstract: A colorimetric test strip useful for analysis of free chlorine is provided. In a preferred embodiment, 3,3',5,5'-tetramethylbenzidine is the colorimetric indicator. Beneficially, the carrier for the indicator has been treated to have a pH that eliminates chloramine interference. Advantageously, the indicator in free base form and a suitable water-soluble buffer may be deposited on the carrier using a combined solution of indicator and buffer.

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: 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: The present invention relates to a method for peptide C-terminal fragment sequence analysis, in which the fragment collection is carried out on an allylamine group-derivatized polymer membrane or on allylamine group-derivatized glass fiber filter paper; the collected C-terminal fragment is immobilized thereon using a water-soluble carbodiimide etc.; and the obtained immobilized product is subjected directly to amino acid sequence analysis. The present invention also relates to an apparatus for collecting a peptide fragment. According to the method of the present invention, peptides which are rich in hydrophobic groups in their C-terminus and are therefore difficult to trap with polyvalent ion carriers, currently used in the gas-phase sequencer, can be completely analyzed up to their C-terminus. Also, amino acid sequence analysis can be made even when the amount of C-terminal fragments is very small.

Abstract: The present invention provides chromatographic assay devices that can perform multiple assays simultaneously in the same test strip, as well as methods for their use. One of the assays can be an immunological assay to detect an antigen, such as human chorionic gonadotropin, while another assay can be a serological assay to detect an antibody, such as anti-rubella antibody. An assay device according to the present invention can comprise: (1) a first opposable component including at least one chromatographic medium having a specific binding partner to the first analyte and a specific binding partner to the second analyte immobilized thereto in separate, discrete, non-overlapping zones; and (2) a second opposable component including an absorber.

Abstract: A patient's health is diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more groups of particles such as lyposomes or plastic beads of different densities for each group. Each group of density-defined particles carries antigens or antibodies which are specific to a complement antigen or antibody which may be in the blood sample being tested, and which are indicative of the patient's health. A label-tagged antibody which is specific to all bound antibody/antigen couples is added to the blood sample so as to form labelled antibody+antigen-antibody complexes (AAAC) in the blood sample. Upon centrifugation, the complexed particles will settle out in different areas in the tube according to the respective density of the particles, and the degree of label emission of the particle layers can enable qualitative or quantitative analyses of the blood sample to be made.

Abstract: A hemoglobin sampler for use with stool samples for clinical tests and diagnoses of the digestive tract diseases in mass screening, etc. by securely sampling and collecting occult hemoglobin with water content from the stool samples without being hindered by the undigested solid content of stools. The sampler has a core member consisting of a porous fiber bundle made up of a plural number of synthetic fibers bundled in the longitudinal direction thereof, a rod of a suitable length provided with a thermosetting synthetic resin sheath at the outer periphery of the core, one end of the rod forming a sample absorbing member with a suitable surface area and small diameter made up of the above mentioned porous fiber bundle. The sampler can quantitatively sample occult hemoglobin with water from stool samples of various properties, thereby offering an easy sample method for the subject and stable specimen for tests.

Abstract: A support for biological molecules comprising a porous inorganic matrix and particles of a water-insoluble polymer, and a biologically active support comprising a porous inorganic matrix and particles of a water-insoluble polymer "sensitized" by biological molecules. The supports are prepared by bringing the matrix into contact with an aqueous dispersion of optionally "sensitized" polymer particles, and the use of such supports in biological application.

Abstract: The present invention includes novel digoxin assays employing a capture reagent, involving a first binding member conjugated to a polymeric anion substance, and a solid phase material containing a reaction site comprising a polymeric cation substance having a nitrogen content of at least about two percent. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: An analytical device determines the analytes in a liquid sample. This device includes a layer of flat material which has a sample application area and a detection area thereupon. The detection area includes a reagent for determining the analyte, and the absorbent sample application area and the absorbent detection area are disposed within a liquid impermeable boundary. The layer of flat material also includes an absorbent connector which is disposed such that the sample application area and the detection area are connected by the absorbent connector. The liquid impermeable boundary and the absorbent connector prevents liquid from being transported between the sample application area and the detection area, except through the absorbent connector.

Abstract: An improved device is used for performing solid-phase chemiluminescent immunoassays. The device comprises a container having a fibrous matrix and a porous absorbent material. An improvement in the device is the use of light absorbing material as the absorbent material or as a light barrier between the fibrous matrix and the absorbent material. A second improvement comprises a fibrous matrix of binderless fiber matrix, such as glass fiber. The invention improves the direct measurement of the chemiluminescent signal from a solid surface by reducing background signal. The device is disposable and is suitable for manual use or for use with an apparatus having programmed instructions. The device is designed to be employed in a variety of solid-phase diagnostic assays such as sandwich or competitive binding assays. The device is also designed for use with microparticle capture or ion capture methods of separating the immunochemical reaction products.

Abstract: A stack of a plurality of substantially identical cup-like vessels pre-incorporated with reagent on the inside, each of the vessels occupying at least about 50% of the depth of the next adjacent vessel to maximize stacking density. Because the pre-incorporated reagent overlaps the occupied depth portion of the vessel and therefore runs a risk of being dislodged, the wall of the vessel is constructed to provide a gap between the inside surface bearing the reagent, and the outside surface of the occupying, nested vessel, that is at least 0.025 mm.

Abstract: In a diagnostic apparatus system, a one piece porous substrate is provided in a container. The substrate serves both to extract an antigen in or on a top layer thereof with the remainder of the substrate serving as a reservoir. The pores in the top surface of the substrate are microscopic for entrapment of microspheres carrying antibodies. A target antigen in a test sample attaches to the antibodies when the test sample is poured through the top layer. The pores in all but the top layer of the substrate have a much greater pore size to comprise tile reservoir portion of the substrate.

Abstract: A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member having a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.

Abstract: On a slab-like board formed of a transparent material is closely attached a wedge-shaped transparent cover member provided with a recess in a central inner portion, thereby to form a clearance. The height of the clearance between the recess and the board is configured to decrease continuously or in steps. When an immunological active substance such as a monoclonal antibody is caused to sensitize carrier particles F, and a reagent having the carrier particles F dispersed into a liquid medium mainly composed of the water is mixed with a specimen, the reaction will occur in which the flocculate is formed from plural carrier particles. When this reaction liquid is poured into the clearance through the opening, the reaction liquid penetrates in the direction having a narrower vertical spacing due to surface tension. A single carrier particle unflocculated can move deep within the recess because it is small in diameter, but the flocculate G is trapped on its way and can not move because of its size.

Abstract: The present invention relates to a vial which can contain metered quantities of a chemical reagent. The vial has its lower or discharge end closed by a breakable diaphragm from which there outwardly extends a flat tang housed and retained in a seat provided within a hollow element. The hollow element is mounted to a hollow body by ribs which enable it to be rotated relative to the hollow body in order to cause the diaphragm to be broken by the tang.

Abstract: The present invention includes a sleeve for use with a device for collecting and transporting biological specimens. The sleeve comprises a tubular member for containing the bottom portion of the collection device and a lever so as to exert pressure to the collection device so as to break the ampoule, The sleeve provides an environment to maintain the substantial viability of a specimen during transport in a collection device.

Abstract: The invention addresses an analysis element for the determination of an analyte according to the principle of a heterogeneous immunoassay. Said analysis element is made of a chromatographic porous carrier material and has a reaction zone, at least two detection zones and absorptive zones following said detection zones. The reaction zone contains analyte-specific and labelled binding partners which are present in a number of soluble compartments which are close together, but nevertheless spatially separated. The detection zones are adjacent to the reaction zones and contain an immobilized binding reagent for one of the binding partners present in the reaction zone. At least one detection zone contains a binding reagent for the analyte-specific unlabelled binding partner.

Abstract: The present invention relates generally to test articles and assays for the detection of analytes in biological fluid samples. More particularly, the present invention relates to test articles an assays which employ dyed microorganisms as visual labels to detect suspected analytes.

Abstract: Immunodiagnostic tests in which enzymes or antibodies are bound to porous carrier materials can be carried out by employing as porous carrier materials macroporous polymer membranes which are prepared by(a) dispersing an insoluble filler in a solution which contains at least two incompatible polymers in amounts which lead to phase separation in the solution, resulting in a homogeneous casting solution, and(b) applying this solution to a support and carrying out a precipitation coagulation.

Abstract: The present invention relates to an apparatus for determining the presence or absence of a target analyte in a liquid sample, comprising:(i) a container capable of accommodating the liquid sample and having a transparent portion; and(ii) an insertion member which is capable of being inserted into the container comprising;a porous member which has a main surface and a reverse surface and which has on the main surface a substance capable of specifically binding to the target analyte; andan absorbent bonded to the reverse surface of the porous member;the porous member being supported in the insertion member whereby, when the insertion member is inserted into the container, the main surface can be observed from the outside of the container through the transparent portion of the vessel and the liquid sample is absorbed into the absorbent through the porous member.According to the analyzer of the present invention, the presence or absence of a target analyte in a sample can be easily determined.

Abstract: Methods and devices are provided for carrying out assays with minimal technical training where quantitative visual determinations may be made. The devices provide for a flow-path where a sample receiving element is moved from a sample receiving position to a position where it serves to bridge a transport element and a measurement element, so that the sample may be transported from the sample element to the measurement region. Labelled conjugates are provided which migrate a distance into the measurement region related to the amount of analyte in the sample.

Abstract: A diagnostic device in the form of a blood glucose monitoring strip of the dip-and-read variety, and which has a first, outer test area which is chemically identical with a second, interior test area. A blood sample is tested in the first area. The first area is torn off and discarded. Then, another, similar test is conducted employing the remaining, second, interior test area. A line of perforation divides the first and second areas. Notches may be defined in the outer ends of both test areas to facilitate reading of the blood impregnated samples with the use of a suitable photometric machine, for example.

Abstract: A quantitative test device is manufactured using a feedback loop which allows one to modify continuously the dimensions of a reading scale printed on the device. The quantitative test device is manufactured by attaching the critical component of a two-component dye system to minute particles such as microcrystalline cellulose, silica, or latex, which particles are suspended in a solution of a polymeric binder. Additional non-immobilized components of the reaction system of the test device are optionally added to the polymer solution. The suspension of dyed particles in polymer solution is applied to a fabric as a coating, using conventional coating machines, to obtain a homogeneous distribution of immobilized dye throughout the fabric.The device includes a measurement zone which is made from a film support made of a material having a lower melting point than the filter cloth fabric used in the measurement zone was used.

Abstract: A laminated assay device for use in determining the presence or amount of an analyte in a sample involving a bibulous assay strip having a sample application zone, a reagent zone and a pair of liquid impervious barriers defining a measurement zone extending from and in fluid communication with the application zone. The measurement zone has a volume measuring the amount of sample required for the assay. A substantially nonabsorbent first supporting film extends across and is laminated to the front surface of the assay strip, while a substantially nonabsorbent second supporting film extends across and is laminated to the back surface of the assay strip. The assay strip is impregnated with the members of a signal producing system which, upon reaction with a component in the sample, produce a detectable signal.

Abstract: A sample container holder is provided for gripping a sample container which contains a sample. The sample container holder comprises a body having a bore for receiving a sample container. A flexible element is disposed within the bore. A fluid passage is operatively connected with the flexible element for supplying a fluid to the flexible element such that, when the sample container is received in the bore in the body of the sample container holder, the flexible element engages the sample container with a conforming, cushioning compression of sufficient magnitude to resist removal of the container from the bore.

Abstract: A biologic sample such as feces, sputum, cervical tissue, pleural fluids, exudates, cytologic specimens, or the like, is tested for the presence or absence of: ova; parasites; microorganisms; inflammatory, neoplastic tissue cells; or other target materials which are indicative of infestation, disease or infection. The sample is mixed with a buffer fluid and placed in a transparent tube which contains a volume-constricting cylindrical insert for gravimetric separation of components of the sample. The mixture is centrifuged, and the annular space between the insert and tube bore is examined under magnification for the presence of the target materials.

Abstract: A sample solution is dripped on an injection region with a pipette. The sample solution immediately spreads in a reaction region by a capillary phenomenon. The sample solution is left for a predetermined period of time to bind a biological associated material in the sample solution with a specific affinity material bound on the inner surface of the reaction region. After the reaction, the outer surface portion of a support member is pushed against a reaction vessel main body to deform the support member, thereby bringing the sample solution into contact with a water absorbent member at a removal region. The sample solution is absorbed by the water absorbent member and is removed from the reaction region. A cleaning solution is dripped on the injection region in an appropriate amount to perform B/F separation and is allowed to spread in the reaction region. The cleaning solution is absorbed and removed by the water absorbent member. The biological associated material bound to the reaction region is assayed.

Abstract: The invention concerns a method for the determination of an analyte in a sample liquid by a reaction proceeding in several steps which are separated from one another in time and a suitable reaction vessel for this method.

Abstract: This invention relates to an improved assay device and assay for detecting or quantitating the presence or absence of a substance in a sample. The device has multiple layers comprising a permeable layer (a) having a capture reagent attached to less than the entire membrane, a selectively permeable layer (b) which does not allow assay reagents to pass through (b) and an absorbent layer (c). Layer (b) is in communication with layers (a) and (c). Layer (b) has at least one hole extending therethrough and the hole or holes are directly below the capture reagent in layer (a). The area of the hole or the combined area of the holes is less than the area covered by the capture reagent. This invention also relates to a method of reducing background color development in an absorbent layer of an assay device.

Abstract: A hollow, elongated, micropipette, which is specially adapted for use in spectrometers and which has an inner wall on which a coating containing a reagent has been deposited, is provided. The reagent is selected from among those that interact with one or more compounds in a sample solution, which is introduced into the micropipette, in order to permit the compounds to be detected by virtue of light absorption or emission by the complexes formed upon interaction of the reagent with the compound of interest in the sample.Upon introduction of the sample solution into the micropipette, a sufficient amount of the reagent in the coating dissolves in the solution and reacts, either directly or indirectly with a compound or compounds of interest in the solution to render such compound detectable and to permit quantification of the concentration of the compound in the sample.

Abstract: A method and apparatus for performing assays in a single step which does not require the user to perform a washing step, does not require the user to add any reagent or other solution other than analyte sample fluid to the apparatus, and does not require the user to come into contact with the apparatus at any point during the assay procedure after the fluid suspected of containing a particular ligand is added to the apparatus. The apparatus for performing the assay consists of a single container with at least three ports disposed through different planes in the body of the apparatus beneath which labelled antiligand (the first port), unlabelled antiligand (the second port), and unlabelled ligand (the third port) are disposed. Said labelled antiligand is complementary to both the analyte of interest and the unlabelled ligand, the latter of which serves as a control display for comparison of any color changes mediated by the label visible through the second port.

Abstract: The invention pertains to an immunoassay method for determining the presence of volatile organic compounds in aqueous, soil and air samples by simultaneously collecting and testing a sample volume suspected to contain such organic compounds. As a major problem in the assay of such materials is their rapid evaporation, the present immunoassay is specifically designed to eliminate or minimize the evaporation of the volatile organic analyte during sample handling as well as during the assay process itself. The immunoassay method is based on an assay vessel which has a lower portion, in which the immunoassay actually takes place, and an inert upper portion, which can hold a sufficiently large volume of sample to prevent or minimize evaporation of the organic compound from the smaller volume in the lower portion.

Abstract: Microcentrifuge tube having a container having a round opening and a frictionally seated lid hingedly connected by a fixed-hinge to the container, the lid having an upper lid surface and being sized and shaped to cover and seal the opening to maintain the inside of the tube free of any contaminant. The lid has a lid extension extending upwardly from the lid surface and outwardly away from the hinge in such a manner which allows the lid to be unseated and moved from the opening of the container when mechanical pressure by a user's finger is applied to the lid. The lid further has a guard portion extending downward from a portion of the lid and configured and arranged adjacent the container to act as a finger guard to prevent a user's finger contacting the container.

Abstract: The invention describes an assay device and assembly for detecting an analyte in a liquid sample. Each assay device in the assembly includes structure defining a well, a ligand-coated particle, and a flexible particle retaining structure for holding the particle in a captured position within the well.

Abstract: An analysis element for the determination of an analyte in a liquid sample, especially for medicinal uses. A carrier layer (2) contains, in a reagent domain (4), a reagent applied in a defined pattern by an ink-jet process. The pattern comprises several sets (A, B, C) of compartments (11-20), the compartments (e.g. 11, 13, 15, 17, 19) of the same set (e.g. A) having the same chemical composition, the compartments (11, 13, 15, 17, 19 or 12, 16, 20) of different sets (A or B) containing different reagents and the compartments of different sets being arranged in alteration so that the compartments containing different reagents are close together but nevertheless spatially separated.

Abstract: The present invention is a method for the detection of creatinine in an aqueous solution, particularly urine, which involves contacting the solution with a soluble cupric salt, a hydroperoxide and an oxidizable indicator which provides a detectable response in the presence of oxygen free radicals and a pseudoperoxidase. The invention is predicated on the discovery that cupric ions form a complex with creatinine which complex exhibits peroxidase like activity.

Abstract: A method of holding a container with a container holder comprises the following steps. The container is received within a bore on the container holder, and a fluid is conveyed through a fluid passage operatively connected with a flexible element within the bore such that the flexible element engages the container to retain the container within the bore.

Abstract: There are described a device and method for doing confined reactions such as PCR amplification and detection, wherein solids (e.g., beads) used to obtain separation between bound and "free" label reagents, are transferred from region to region, specifically through a wash liquid so as to wash off the "free" label reagent from the solids. Separate chambers have dividers that are overcome by piercing or by liquification, to create passageways for the transfer of the solids. The passageways remain contained within the device.

Abstract: Methods and device are provided where a device comprising an absorbing nib, an external deformable container and an internal container having a frangible barrier are provided, where the nib and internal container comprise reagents which are interactive with a sample for measuring an analyte.

Abstract: An immunochromatographic assay device for the detection of an analyte in a liquid sample, the device including a housing that contains an opening for the application of the liquid sample and multiple liquid permeable materials located in the housing that are adapted to receive, treat and facilitate the movement of the sample through the housing; preferably, a first liquid permeable material is adapted to receive the liquid sample; a second liquid permeable material is positioned under the first liquid permeable material; a third liquid permeable material is positioned above the second liquid material; means are provided to prevent liquid communication between the first and third liquid permeable materials; a wicking material, in fluid contact with the third liquid permeable material receives the sample; and reagents are positioned in the housing that display the results of the immunoassay.

Abstract: A patient's health is diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more groups of particles such as lyposomes or plastic beads of different densities for each group. Each group of density-defined particles carries antigens or antibodies which are specific to a complement antigen or antibody which may be in the blood sample being tested, and which are indicative of the patient's health. A label-tagged antibody which is specific to all bound antibody/antigen couples is added to the blood sample so as to form labeled antibody+antigen-antibody complexes (AAAC) in the blood sample. Upon centrifugation, the complexed particles will settle out in different areas in the tube according to the respective density of the particles, and the degree of label emission of the particle layers can enable qualitative or quantitative analyses of the blood sample to be made.

Abstract: A method is provided for rapidly determining during a saliva specimen collection procedure the presence of an amount of saliva, and for verifying that the sample obtained is in fact saliva. Color indication by dye markers and/or enzymatic activation of color indicators provides an indication that at least a predetermined amount of saliva has been applied to an absorbent and the enzymatic reaction indicates that saliva is contained in the sample collected.

Abstract: A new apparatus and method for immunoassays. A gold sol bead is held in a funnel member. First antibodies are associated with the gold sol bead. When the sample contacts the gold sol it dissolves the bead. A second antibody is impregnated on an immunosorbent surface. When the dissolved gold sol passes this surface, any antigen already reacted with the first antibody present reacts with the second antibody forming a gold: first antibody: antigen: second antibody: immunosorbent complex. The gold sol acts as the visible label.

Abstract: The present test device provides a merocyanine protein error indicator compound. Merocyanine compounds are a new class of protein error indicators, providing an analytical tool useful in the detection of protein in a sample.

Abstract: A method for improving recovery of cells from liquid suspension by centrifugation. The method comprises coating the interior of centrifuge containers with a solution comprising an amphipathic compound prior to introduction of the cell suspension and centrifugation. The method is particularly suited for recovery or concentration of rare cells from dilute suspensions, for example when rare cells are isolated from a sample by sorting on a flow cytometer.

Abstract: A method and device for measuring the binding affinity of a receptor to a ligand. According to one aspect of the invention, arrays of polymers are synthesized or immobilized on a substrate (212). The array of polymers is exposed to a fluorescently-labelled receptor in solutions of varying concentration. The fluorescence intensity of the labelled receptor is measured by way of, e.g., a photon counter using a confocal microscope (316). Binding affinity is determined through analysis of the relationship between fluorescence intensity and the solution concentration of the receptor. On-rates are measured as a kinetic increase in surface fluorescence intensity, and the on-rate constant rate extracted from fits to the data.