Abstract: A diagnostic test kit that provides an integrated system for accurately detecting a test analyte over a broad range of possible concentrations is provided. One feature of the integrated system is that it is capable of indicating whether an analyte is within the “hook effect” region. Based on this indication, a technique may be selected for correlating a measured signal intensity to an analyte concentration or range of concentrations. For example, when it is determined that the test sample falls outside the “hook effect” region, the analyte concentration may be determined using one portion of a dose response curve. On the other hand, when it is determined that the test sample falls within the “hook effect” concentration, the analyte concentration may be determined using another portion of the dose response curve. Alternatively, the sample may simply be diluted for re-performing the assay.

Abstract: A method of analyzing a sample for one or more analytes of interest includes: providing an element having a base layer; a layer containing streptavidin; a spreading layer, wherein the streptavidin may or may not be in the spreading layer; providing immunocomponents and labeled immunoreactants which may be in the spreading layer or may be combined with the sample; dispensing the sample, and optionally the immunocomponents and a labeled immunoreactant onto the spreading layer at three or more areas, wherein each center of the three or more areas is substantially equidistance to the center formed by the three or more areas, and wherein each area contacts an adjacent area such that wash fluid flow in any direction will contact sample; washing the sample and label by directing the wash fluid at the center formed by the three or more areas, whereby the wash fluid equally flows over each of the three or more areas; and taking a measurement at each three or more areas to determine the presence or concentration of the

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample are described. The assay design prevents interference by reagents used for such removal with the HDL quantification reaction or with other assays carried out on the same sample. If desired, removal of non-HDL lipoproteins and assay of HDL cholesterol can be carried out without interruption of the assay.

Abstract: A method and device for detecting analytes in a test sample. Embodiments include methods for quantitatively detecting analytes within a range of concentrations. In an embodiment the method includes a lateral flow test strip with multiple test areas for capturing a labeled receptor to provide a detectable signal.

Abstract: An assay device and method for measuring the concentration of LDL-associated cholesterol in a blood-fluid sample are described. The method employs selective precipitation of VLDL and chylomicrons and immunoseparation of HDL from a blood fluid sample. The assay device allows the assay to be performed entirely in a flow strip format.

Abstract: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: A system and an apparatus for use in detecting a target microorganism or agent is disclosed which involves a solid support carrying a binding partner specific for the particular microorganism or agent and the solid support being characterised in that it defines means for protecting the binding partner from being dislodged or scraped off the solid support by physical means. The provision of protection against the binding partner being dislodged from or scraped off the solid support improves the reliability of tests such as immunoassays being conducted with the solid support and also enables such tests to be automated. Modules and machines for use with the solid support, and the automated conduct of tests are also disclosed.

Abstract: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.

Abstract: A method for the determination of a target analyte in a sample, said method comprising: a) applying a liquid sample suspected of containing said target analyte to a solid support capable of allowing lateral flow of liquid there through, which support has diffusibly arranged thereon, (i) either (a) a labeled binding partner for said analyte or (b) a labeled analogue of said analyte, and (ii) a labeled control reagent; b) allowing the sample, labeled binding partner for said analyte or a labeled analogue of said analyte and labeled control reagent to flow through a detection zone on said solid support; c) allowing the sample, labeled binding partner for said analyte or a labeled analogue of said analyte and labeled control reagent to flow through a control zone; and d) detecting the labeled density in the detection zone and the label density in the control zone and comparing these densities.

Abstract: Monoclonal antibody that specifically binds to alpha-amylase and is useful for detecting weather damage (i.e. pre-harvest sprouting) in cereal grain.

Abstract: The invention relates to a device for detecting one or several analytes in a sample, characterized in that it comprises one or more reaction chambers and/or one or more reagent application channels, and one or more capillary systems and one or more negative vessels. The invention also relates to a method for detecting one or more analytes in a sample fluid by visualization of agglutination, characterized in that a) the sample fluid is brought into contact with a reagent, b) the reaction mixture is exposed to the effects of gravitation or magnetism, wherein the reaction mixture is strained through the capillary system of the inventive device with a negative vessel connected to the inventive device, and c) the reaction between the analyte and the reagent is determined. The invention also relates to one such method wherein the reaction mixture is brought into contact with another reagent during step b).

Abstract: A reagent kit that is used for determining a characteristic of tissue obtained from a patient is described. The reagent kit comprising expression measurement reagents for measuring expression level of cyclin-dependant kinase (CDK) and activity measurement reagents for measuring activity value of CDK. The expression measurement reagents comprise first reagents and second reagents, and the activity measurement reagents comprise third reagents and fourth reagents. In the reagent kit, a first reagent set of the first and third reagents is stored under a first storage condition relating to temperature, and a second reagent set of the second and fourth reagents is stored under a second storage condition relating to temperature.

Abstract: Disclosed is a test device and a method for qualitatively and/or quantitatively measuring the concentration of an analyte in a biological fluid sample. The test device includes a housing defining a sample port, a test well containing a stirrer and a conjugate, and a test strip disposed within the housing. The test well is also defined by being located between the sample port and the test strip. Fluid flows from the test well onto the test strip, which has a trapping zone which binds the analyte and allows for its detection. A control zone may also be included. The test device is generally adapted to use a sandwich assay. Also disclosed is a system comprising the test device and a signal sensing device; and a method for using the test device.

Abstract: Disclosed is a device, for detecting an analyte in a sample, comprising a sample pad for collecting the sample, a test strip coupled to the sample pad, and a housing enclosing and allowing visualization of the test strip. The sample pad can include one or more markings for determining the amount of sample collected. The device can also include a run fluid container that fits over the sample pad and forms an air-tight seal around the housing. Further, the device can include a second sample pad/test strip combination for detection of a second analyte. Also disclosed are methods for detecting an analyte in a sample using the device.

Abstract: Antibodies having specific binding for the parent THC (?9-THC) and its major metabolites are provided which present a significant increase in sensitivity of immunoassays such as lateral flow immunoassays and ELISA for THC. The present invention also provides a rabbit hybridoma producing the antibody as a monoclonal antibody, a recombinant antibody, further molecularly engineered recombinant antibodies against parent ?9-THC and its metabolites and cell lines producing the recombinant antibodies. The invention also provides applications of the antibody in immunoassays, particularly lateral flow immunoassays, specifically applications in detecting THC in body fluids, particularly saliva, and kits for determining the presence of THC.

Abstract: Disclosed is a diagnostic testing device that may be used to detect one or more analytes in a sample. The device comprises a receptacle and a holder for a test strip. The test strip may be, for example, a lateral flow test strip. The device and holder permit analysis of a sample, wherein the device is substantially sealed during testing and detection of results. To use, the holder containing a test strip is inserted into the receptacle containing sample to be analyzed. Capillary flow along the test strip is initiated by contact of the sample with the distal end of the test strip. The receptacle is such that results of the assay may be detected visually or using standard instrumentation such as by measuring light absorption or reflectance.

Abstract: This invention relates to a device for the simultaneous qualitative or quantitative determination of several analytes in a liquid sample. The device comprises a membrane with a charging zone, for the application of the liquid sample, at least two indicator zones which can interact with the analyte(s) and at least one absorption region, which accepts the fluid after passing through the indicator zones, whereby the indicator zones lie between the charging zone and an absorption region, characterized in that the flow directions (flow tracks) are essentially parallel from the application zone through each indicator zone to an absorption region and at least two different flow tracks are present.

Abstract: A Plasma or serum separation membrane that enables omitting centrifugal separation, is free from hemolysis attributed to destruction of red blood cells and realizes easy and rapid separation of plasma or serum from blood; and a filter apparatus including the plasma or serum separation membrane. In particular, a plasma or serum separation membrane being a membrane for separation of plasma or serum from blood and having a void ratio of 30% or below; and a filter apparatus comprising a filter member capable of attaining movement of plasma swifter than movement of blood cells and a plasma or serum separation membrane connected in series with a rear side of the filter member.

Abstract: The present invention provides a new sensitive direct sandwich assay for determining the presence of COMP in a clinical sample. Two monoclonal antibodies directed against separate antigenic determinants of the COMP molecules are used in the assay. The invention also relates to three particularly advantageous monoclonal antibodies per se that are directed against human COMP. Cell cultures manufacturing these antibodies have been deposited according to the Budapest Treaty at Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, and have been assigned accession numbers DSM ACC2406, DSM ACC2408 and DSM ACC2418, respectively. A diagnostic kit comprising at least two of these monoclonal antibodies also constitute a part of the present invention.