Abstract: A closure and a device for use with a closure are described. The closure includes a first member having an interrupted beveled edge, a second member having an undercut edge, and optionally a base member to which the second member is fixed. The first member is adapted to be received with the interrupted beveled edge retained by the undercut edge. A test device can include such a closure and can also include a hinge between the first and second members. Test elements, such as a chromatographic medium, an absorber, an applicator, or a sample application zone, can be disposed on the first member and/or the base member and can be brought into opposition by closing the first member with the closure. The beveled edge is interrupted by one or more uncut portions or bridges. A testing device according to the present invention can perform a number of types of immunoassays, including unidirectional assays, bidirectional assays, and assays employing a split flow path.

Abstract: An assay device for the performance of assays for analytes, particularly those of biological interest, provides for improved efficiency and sensitivity by reducing background. The assay device performs an immunochromatographic assay and also provides a wash to remove unbound labeled specific binding partner and thereby reduce the background. Assay devices according to the present invention can use either a directly visible label such as a metal sol label or an enzyme label. One embodiment of assay devices according to the present invention is particularly suitable for assay of analytes in whole blood samples. The present invention also encompasses test kits and methods of use of the assay devices.

Abstract: A chromatographic assay device for use with immunoassays allows rapid and convenient assays of analytes of biological interest, and permits extractions to be carried out in situ, avoiding the use of separate extraction vessels. The device has a wide dynamic range and avoids interference from particulates or colored components. In one form, the device comprises: (1) a first opposable component comprising a sample preparation zone adapted to receive a sample to be assayed; and (2) a second opposable component comprising a chromatographic medium. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label.

Abstract: A chromatographic assay device for use with immunoassays allows rapid and convenient assays of analytes of biological interest, and permits extractions to be carried out in situ, avoiding the use of separate extraction vessels. The device has a wide dynamic range and avoids interference from particulates or colored components. In one form, the device comprises: (1) a first opposable component comprising a sample preparation zone adapted to receive a sample to be assayed; (2) a second opposable component comprising a chromatographic medium; and (3) a conductive barrier attached to the second opposable component. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label. Other variations of the device vary the arrangement of components to provide optimal chromatography for a variety of analytes.

Abstract: A chromatographic assay device for use with immunoassays allows rapid and convenient assays of analytes of biological interest, and permits extractions to be carried out in situ, avoiding the use of separate extraction vessels. The device has a wide dynamic range and avoids interference from particulates or colored components. In one form, the device comprises: (1) a first opposable component comprising a sample preparation zone adapted to receive a sample to be assayed; (2) a second opposable component comprising a chromatographic medium; and (3) a conductive barrier attached to the second opposable component. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label. Other variations of the device vary the arrangement of components to provide optimal chromatography for a variety of analytes.

Abstract: A chromatographic assay test device for use with immunoassays. The test device has a sample collection member pivotally coupled to a test strip receiving member. The sample collection member has a window for applying a test sample to a pad accessible through the window and the pad is repositionable to an inverted position to contact a chromatographic member inserted into the test device. The chromatographic member is then brought into opposition to the sample collection member thus improving test performance by reducing the manipulation of samples. The test device is constructed from five interconnected panels which are die cut from SBS cardboard. The first panel has a window for inserting a test strip and the second panel has a window for viewing the test strip during the test procedure. The third panel has the repositionable pad section. The fourth panel has a window for applying the test sample and the fifth panel covers the test sample window.

Abstract: A chromatographic assay device for detection and/or determination of an analyte in a competitive immunoassay gives a semiquantitative or quantitative indication of analyte concentration in a single assay device while also giving a positive indication that flow has occurred properly through the device. In one form, the device comprises: (1) a first opposable component including a sample preparation zone and an absorber; and (2) a second opposable component including a first chromatographic medium with capture and detection zones, a second chromatographic medium with a comparison zone, and a comparison label. In another form, the second opposable component includes one chromatographic medium with capture, detection, and control zones. Test kits incorporating the devices and methods for their use are also disclosed.

Abstract: An assay device for detection and/or determination of an analyte in a test sample uses a barrier containing an aperture to control the application of reagents to the device for greater reproducibility of results. In its simplest form, the device comprises: (1) a chromatographic medium having a first end, a second end, and first and second surfaces, and having a specific binding partner for the analyte immobilized thereto in a detection zone; (2) at least one absorber in operable contact with at least one of the first and second ends; and (3) a substantially fluid-impermeable barrier adjacent to the first surface of the chromatographic medium, the barrier having at least one aperture therethrough for application of liquid to the chromatographic medium, the barrier at least partially blocking application of liquid to the chromatographic medium.

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: Improved fecal occult blood test having a matrix such as paper printed or impregnated with guaiac. The improvement comprises increasing the sensitivity while maintaining or improving the specificity of the test by employing an alcoholic-peroxide developing solution which contains an enhancing agent. The enhancers comprise phenolic type compounds such as esters of parahydroxybenzoic acids.

Abstract: An extraction vial includes a reservoir portion having generally parallel walls, a neck portion defining an opening into the reservoir portion and a channel surrounding the opening, a nozzle portion integral with reservoir portion at a second end of the reservoir, a sealing closure that closes the nozzle, a base integral with the sealing closure and including a support surface adapted to support the vial in an upright position, and a cap received and removably maintained within the channel. An extraction liquid may be contained within the vial for extracting sample from a carrier. The vial may be used by adding the carrier to the extraction liquid within the vial, closing the vial with the cap, agitating the vial to release sample from the carrier, and removing at least the sealing closure or, preferably, the sealing closure and base whereby extraction liquid can be expelled from the vial.

Abstract: Improved fecal occult blood test having a matrix such as paper printed or impregnated with guaiac. The improvement comprises increasing the sensitivity while maintaining or improving the specificity of the test by employing an alcoholic peroxide developing solution which contains an enhancing agent. The enhancers comprise phenolic type compounds such as esters of parahydroxybenzoic acids.

Abstract: A specimen slide in accordance with the present invention comprises a front panel including a test material placement side and a portion of a test sheet, the test material placement side including at least one aperture which is configured to accept a test sample through the aperture onto the test sheet, and a back panel including a developing side through which the opposite side of the test sheet is exposed. An indicating means is located on the developing side portion of the test sheet within proximity to, but not directly on, the portion of the test sheet directly opposite to the aperture.

Abstract: A solid phase binding member for the detection of an analyte in a test sample is described. The binding member comprises: (1) a solid support having micropores; (2) a polymer reversibly water-soluble before its application to the solid support; and (3) a ligand covalently attached to the polymer, the ligand interacting specifically with the analyte. The solid support can have micropores throughout or on its surface, and can be rayon, paper, fabric, plastic, agarose or polyacrylamide beads, glass, microcrystalline cellulose, or acid-treated plastic. The polymer can be carrageenan or sodium alginate. The ligand can be an antibody, a univalent antigen-binding fragment of an antibody, an antigen, a hapten, an enzyme, a hormone, or a single-stranded nucleic acid. Methods of use of the binding member are also described involving incorporation into a test device. The test device can be a dip stick, a hollow vessel, a slide, or a porous bead.

Abstract: A modular multi-channel automated medical analyzer device is disclosed, characterized by use of an ion selective electrode and/or enzymatic electrode/wash cell system which permits rapid analysis of various substances of interest contained within undiluted body fluids such as whole blood, serum and/or plasma. The ion selective electrode and/or the enzymatic electrode are disposed upon a probe which automatically axially reciprocates downwardly in a simple manipulative motion between an open-ended reference wash cell and a sample cup bearing the body fluid specimen to be analyzed. The wash cell includes an inlet port and one or more outlet ports through which is circulated an aqueous solution bearing a known concentration of the substance to be measured to provide a reference calibration medium as well as a probe washing medium.

Abstract: A modular multi-channel automated medical analyzer device is disclosed, characterized by use of an ion selective electrode and/or enzymatic electrode/wash cell system which permits rapid analysis of various substances of interest contained within undiluted body fluids such as whole blood, serum and/or plasma. The ion selective electrode and/or the enzymatic electrode are disposed upon a probe which automatically axially reciprocates downwardly in a simple manipulative motion between an open-ended reference wash cell and a sample cup bearing the body fluid specimen to be analyzed. The wash cell includes an inlet port and one or more outlet ports through which is circulated an aqueous solution bearing a known concentration of the substance to be measured to provide a reference calibration medium as well as a probe washing medium.

Abstract: An improved enzymatic electrode and electrode module specifically adapted for use in a medical analyzer device is disclosed which permits rapid analysis of substances of interest contained within undiluted body fluids such as whole blood, serum and/or plasma. The enzymatic electrode is in fluid communication with an axially reciprocating probe which selectively transports either a quantity of a buffer aqueous solution or a calibrant aqueous solution presented at a wash cell or a body fluid specimen disposed within a sample cup to an active enzyme bearing membrane positioned adjacent the enzymatic electrode.

Abstract: A method and device for separating blood into fluid and cellular fractions for diagnostic tests. The whole blood is introduced to a carrier containing a layer of carbohydrate which results in the rapid separation of the fluid from the cellular fractions. In a preferred embodiment, the device is fabricated in a sandwich design containing layers of carbohydrate and reagent material between two layers of plastic.

Abstract: A method and device for collecting and testing fecal occult blood which permits multiple analyses of a single fecal sample. The device is a combination of a sampler for collecting the fecal matter and a test slide. The fecal sampler comprises a pocket-like wipe pad for obtaining direct anal stool smears. An insert is disposed in the pocket of the wipe pad. The slide has a profiled opening similar to the design of the wipe pad. This opening acts as a receptacle for the pad when the fecal smear is transferred to the guaiac specimen receiving sheet of the slide. When the slide is closed the insert can be removed from the wipe pad. This design permits an analysis to be done on the specimen receiving sheet of the slide together with a second confirmatory test for human hemoglobin on portions of the insert. The fecal material on the insert is physically removed from the guaiac specimen receiving sheet.