Abstract: A flow-through assay for detecting the quantity of an analyte residing in a test sample is provided. The flow-through assay contains a porous membrane that is in fluid communication with probe conjugates that contain a specific binding member and a detectable probe. The porous membrane also defines a detection zone and a calibration zone. The calibration zone contains a polyelectrolyte substantially non-diffusively immobilized on the porous membrane. The polyelectrolyte is capable of generating a detectable calibration signal that can be readily compared (visually, quantitatively, and the like) to a detection signal to determine the amount of analyte in the test sample.

Abstract: A method of measuring the rate of binding of a binding substance and an analyte, for example in an assay such as an immunoassay, uses an initial step of performing ultrasonication sufficient to disrupt binding between the binding substance and the analyte. After cessation of the ultrasonication, measurements are taken to determine the rate of binding at cessation of said ultrasonication or at a predetermined time thereafter. The ultrasonication results in knowledge of the precise time of the start of the binding reaction which provides a better rate measurement.

Abstract: An analytical strip and a detecting method using the analytical strip are provided. The analytical strip includes a substrate having a channel thereon. The channel has a first region, a second region and a third region, which are arranged successively. A first antibody is localized in the first region. A saccharide and a peroxidase are localized in the first or second region. A second antibody for recognizing a different epitope of an identical antigen with the first antibody is immobilized in the second region. A substrate reagent including a saccharide oxidase is localized in the third region.

Abstract: Providing an absorption pad which shows remarkable water absorptivity and can shorten a detection time when employed for an immunoassay apparatus. A water absorption pad for the immunoassay apparatus, containing 50% by weight or more of silicon-containing particles wherein a moisture absorptivity is 30% or less at a humidity of 60% or less and a moisture absorptivity is 40% or more at a humidity of 90% or more, a strip for an immunoassay using said absorption pad as a suction part, and an immunoassay apparatus including said strip for the immunoassay.

Abstract: A membrane array used to detect one or more analytes from a small sample of fluid with high sensitivity is provided. The membrane array can be employed in various analytical devices and is especially useful for identifying analytes from whole blood with minimal or negligible background interference.

Abstract: [PROBLEMS] To reduce the amount of, for example, a capturing antibody to be employed without lowering detection sensitivity. At the same time, to enable the achievement of intense color development or light emission in a determination area even in the case where only a small amount of a labeled antibody is accumulated. To lower the detection limit in the sandwich method. To enlarge the dynamic range in the competition method. [MEANS FOR SOLVING PROBLEMS] A method of analyzing a test substance by an immunological analysis method by using the test substance, a support having a determination area, on which one member selected from a capturing antibody capable of binding specifically to the test substance and a capturing antigen capable of binding specifically to the test substance has been immobilized, and a labeled antibody capable of binding specifically to the test substance, wherein a label having a sensitizing effect has been immobilized on the determination area of the support.

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 and Zellkulturen GmbH, and have been assigned accesion 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.

Abstract: This invention is directed to a lateral flow assay for detecting the presence of an analyte in a liquid test sample. The lateral flow assay represents an improvement in the ability to accurately and with high fidelity to detect the presence or absence of a target analyte in a liquid sample, in part, by encompassing a reference region of immobilized, non-diffusible analyte that allows for detection of any factors that interfere with the interaction and binding of the analyte to the labeled capture reagent. Any influences on the interaction and binding of the analyte that is free in solution in the liquid test sample to its complementary labeled reagent will be encountered in parallel in the binding between the immobilized analyte in reference region to the labeled reagent as it diffuses through the reference region. In one embodiment, the lateral flow assay of the invention is a urine-based human Chorionic Gonadotropin (hCG) assay.

Abstract: A method to facilitate recovery troponin I and/or troponin T from a sample comprising addition of troponin C to the sample or to a surface from which the troponin I and/or troponin T are recovered.

Abstract: The present invention relates to test devices, and in particular devices capable of detecting the presence or absence of an analyte in a sample, such as a liquid sample. Also provided are methods of using such devices for quantitative or qualitative measurement of one or more analytes in a liquid sample.

Abstract: A method for rapid collection and assay of oral fluids is disclosed. The method comprising the steps of: (a) placing an assay device into an oral cavity, (b) removing said assay device from said oral cavity; and (c) determining the presence or absence of at least one analyte.

Abstract: The invention relates to a device for simultaneously, qualitatively or quantitatively identifying a number of analytes in a liquid sample. The device comprises a membrane with: a charging zone for applying the liquid sample; at least two indicator zones, which can interact with the analytes, and at least one absorption area, which absorbs the liquid after passing the indicator zones, whereby the indicator zones are located between the charging zone and an absorption area. The invention is characterized in that the flowing directions from the charging zone through the respective indicator zones to an absorption area (flow paths) are essentially parallel, and at least two different flow paths exist. The invention also relates to a method for identifying a number of analytes or the derivatives thereof in a liquid sample.

Abstract: An electroporation cuvette is constructed with electroporation electrodes arranged in non-parallel relation to form a gap whose width varies with the location within the cuvette, plus a pair of positioning electrodes that are arranged to cause electrophoretic migration of biological cells within the cuvette according to cell size. Once the cells, suspended in a solution of the impregnant, are distributed in the cuvette by the positioning electrodes, electric field pulses are generated by the non-parallel electroporation electrodes. Because of their distribution in the cuvette, the various cells will experience voltage differentials across their widths that approach uniformity regardless of cell diameter, since the larger cells will be positioned at locations where the gap between the electrodes is greater and the smaller cells at locations where the gap is relatively small while the voltage drop across the entire gap is uniform along the length of the cell.

Abstract: An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Abstract: A object of the present invention is to provide an immunochromatography method that makes it possible to rapidly detect an ultratrace amount of an analyte that has been impossible to analyze by conventional immunochromatography methods. The present invention provides an immunochromatography method, which comprises developing an analyte and a labeling substance which is modified with a first binding substance against the analyte in a mixed state on a porous carrier and capturing the analyte and the label at a reaction site on the porous carrier having a second binding substance against the analyte or a substance capable of binding to the first binding substance against the analyte, so as to detect the analyte, wherein the labeling substance having an average particle size of 1 ?m or more and 20 ?m or less is detected.

Abstract: An immunochromatoassay method that allows high detection sensitivity measurement. The method including the steps of: permeating an analyte solution that includes a visibly labeled second binding substance that specifically binds to a detection target substance into a test area of a chromatography medium provided with a first binding substance that specifically binds to the detection target substance, simultaneously with or after the permeation of the analyte solution into the test area, permeating a visual recognition aid solution into the chromatograph medium, the solution having a refractive index whose refractive index difference ?n from that of the chromatograph medium is ?0.1??n?0.1, and visually observing the test area while the visual recognition aid solution is permeated in the test area.

Abstract: A method for patterning a one or more biomolecules on a substrate that includes coating the substrate with a coating of the one or more biomolecules, applying a laser to the coating, and ablating a portion of the one or more biomolecules with the laser in a predetermined pattern.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: As a result of investigating the optimum conditions of methods for immobilizing proteins that interact with sugar chains onto a substrate, it was revealed that coating the surface of a slide glass with GTMS enables immobilization at a higher S/N ratio than conventionally possible. Moreover, by using a substrate to which a rubber with a number of holes was affixed to form a number of reaction vessels, and further by spotting lectins onto the substrate and washing with PBST, the weak interactions between sugar chains and lectins were successfully detected with improved sensitivity. In addition, by introducing an evanescent excitation-type scanner, it became possible to detect the interactions between lectins and sugar chains without washing away the probe solution.

Abstract: According to the biosensor and the blood component analytical method of the present invention, in a biosensor that is made of a single layer or plural layers of a porous material as shown in FIG. 1, having a reagent holding part and utilizing chromatography, a cell shrinkage reagent is carried on at least part of the reagent holding part, or at least part of a chromatographically developed part that is upstream of the reagent holding part. According to the biosensor having the above-mentioned structure and the blood component analytical method, even when whole blood is a sample, a high-accuracy blood component analysis cart be performed easily and quickly with less cost.