Abstract: The present invention features compositions and methods for the detection or measurement of oxalate in a sample. Such compositions include test devices that provide for the rapid and accurate detection of oxalate in a sample from a biological fluid. Advantageously, the compositions can be used to monitor the oxalate levels of a patient at a point of care (e.g., at the patient's home, clinic, physician's office, or other clinical setting).

Abstract: Test cells have a first sorbent strip with a sample receiving location and defining a first migration path, a distinct second sorbent strip which receives buffer solution and at least partially defines a second migration path distinct from and elongated relative to the first migration path, conjugate supported by the second strip, a test site located at a junction of the first and second strips and having an immobilized ligand-binding mechanism, and a divider which directs a first amount of the buffer to the first strip to move the sample to the test site and a second amount to the second strip to move the conjugate to the test site. The first and second migration paths have first and second lengths chosen so that ligand in the sample reaches the test site and binds to the immobilized ligand-binding mechanism prior to the conjugate reaching the test site.

Abstract: The present invention relates to a device for detecting a fungal contamination in an internal environment, to the use thereof and also to a method for detecting a fungal contamination in an internal environment using such a device.

Abstract: A reaction unit containing a bottom part and a top part for pipetting a liquid, wherein the bottom part contains a reaction cavity with a permeable filter grid insert and the top part contains a reaction cavity which can be fixed on said bottom part and contains a cavity or covering for receiving a magnet.

Abstract: A process for producing a bioreactor using viable immobilized biological material. The process produces a siliceous layer capable of biomass immobilization and selectively cutting off of macromolecules having a molecular weight higher than a selected threshold. The process includes the steps of: (a) supplying a gas flow of a gas carrier saturated by a mixture of silicon alkoxides selected from the group comprising (1) Si(OR)4, (2) SiH(OR)3, (3) R?Si(OR)3 and (4) R?SiH(OR)2 wherein R and R?, equal or different each other, are alkyl and/or aryl groups, wherein said gas flow is prepared by bubbling the gas carrier into a liquid mixture of said alkoxides in the ratio of (1) 40-85/(2) 0-60/(3) 0-60/(4) 0-60 (% v/v), preferably in the ratio of (1) 40-85/(2) 0-50/(3) 0-50/(4) 0-50 (% v/v), more preferably in the ratio of (1) 50-80/(2) 0-20/(3) 5-30/(4) 5-30 (% v/v), at a temperature of from 20 to 180° C., preferably of from 20 to 100° C.

Abstract: The present invention relates generally to an assay device with improved tolerance to mishandling and/or use by the user. More particularly, the invention relates to an assay device with reduced susceptibility to flooding.

Abstract: Provided are a water toxicity detecting apparatus and a method using sulfur particles.

Abstract: The invention provides a device and method for the rapid identification of patients suspected of having thalassemia. The invention provides a test strip for the aqueous detection of thalassemia related proteins in whole blood. The test strip includes antibodies specific to the gamma 4, (?4) protein and provides easy visual discrimination between a positive result and a negative result. The invention can be used in remote or clinical settings.

Abstract: A lateral flow, membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes phosphorescence to detect the signals generated by excited phosphorescent labels. The labels may have a long emission lifetime so that background interference from many sources, such as scattered light and autofluorescence, is practically eliminated during detection. In addition, the phosphorescent labels may be encapsulated within particles to shield the labels from quenchers, such as oxygen or water, which might disrupt the phosphorescent signal.

Abstract: The present invention relates to microfluidic devices and methods for manipulating and analyzing fluid samples. The disclosed microfluidic devices utilize a plurality of microfluidic channels, inlets, valves, filter, pumps, liquid barriers and other elements arranged in various configurations to manipulate the flow of a fluid sample in order to prepare such sample for analysis.

Abstract: A method for measuring glycated hemoglobin includes hemolyzing a blood sample with a hemolysate; reacting the hemolyzed blood sample with bead conjugates in which beads are conjugated with glycated hemoglobin binding materials; measuring the amount of total hemoglobin in the reacted blood sample; isolating normal hemoglobin from the glycated hemoglobin conjugated with the bead conjugates; measuring the amount of glycated hemoglobin isolated from the normal hemoglobin; and determining the percentage of the glycated hemoglobin in the blood sample on the basis of the measured amounts of total hemoglobin and glycated hemoglobin. The isolation of normal hemoglobin is performed by absorbing the normal hemoglobin using an absorption pad that is a porous pad having pores, each of which has a size greater than the size of the normal hemoglobin and smaller than the size of the bead.

Abstract: A sensor substrate includes a base and fibrous projections on an upper surface of the base. The fibrous projections have fixed ends fixed to the upper surface of the base and free ends opposite to the fixed ends, respectively. The fibrous projections provide a fixed end-side region including the fixed ends and a free end-side region including the free ends. The total surface area at which the fibrous projections in the fixed end-side region is larger than that in the free end-side region.

Abstract: An article for determining a minimum inhibitory concentration of antibiotics. The article has a strip of paper in which the strip of paper is permeable to air so as to prevent air bubbles from forming at a point of contact with a microbial culture medium. The strip of paper has a predetermined concentration gradient of an antibacterial agent graded on a scale of fifteen dilution units. The antibacterial agent on the strip of paper is releasable slowly from the strip of paper. The scale of fifteen dilution units can he expressed on a color scale and can be expressed in ?g/mL. The strip of paper is impregnated with the antibacterial agent.

Abstract: Provided is a diagnostic apparatus. The diagnostic apparatus includes a microfluidic chip including first and second measurement parts for respectively measuring an amount of hemoglobin and an active degree of an enzyme within a blood sample. The second measurement part of the microfluidic chip analyzes the active degree of the enzyme within the blood sample using voltammetry.

Abstract: The present invention relates generally to the field of analysis, for example biological analysis.

Abstract: The invention concerns methods of quantification of an analyte, A, in a test sample by means of a single immunochromatographic device, such as a lateral flow device (LFD).

Abstract: Disclosed is a lateral flow capillary device and uses thereof comprising a unipath bibulous capillary flow matrix and at least two reservoirs each in fluid communication with the capillary flow matrix wherein a reservoir contacts the capillary flow matrix through a passage having a rim pressing the matrix. The pressure that the rim applies on the matrix prevents leakage of liquids out of the capillary flow matrix at the reservoir/ matrix interface, allowing accurate sequential draining of liquid from the reservoirs.

Abstract: The systems of the invention include test cells with a first sorbent material defining a first flow path for a solution, a second sorbent material defining a second flow path distinct from the first flow path for a sample, and a test line or test site with immobilized antigens or antibodies or other ligand binding molecules such as aptamers, nucleic acids, etc. located at the junction of the first and second sorbent materials. The first and second sorbent strips touch each other at the test site location.

Abstract: A sequential solid phase immunoassay and system is disclosed. The immunoassay utilizes the secondary antibody method for the detection of antibodies in a membrane-based test. The system comprises a test strip including a nitrocellulose membrane having an immobilized antigen in a capture zone on the membrane and a stabilized liquid secondary antibody conjugate. The sequential solid phase immunoassay is performed in a sequential manner with the addition of a fluid specimen being followed by the addition of the stabilized liquid secondary antibody conjugate. The sequential procedure using the system includes allowing the fluid specimen containing antibodies specific to the antigen to pass laterally from the test strip first end through the capture zone. The immobilized antigens in the capture zone capture antibodies specific to the antigen. The stabilized liquid secondary antibody conjugate then binds to the captured antibodies and can be detected visually or by a machine or reader.

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: Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics and kits are provided.

Abstract: The present invention relates generally to the field of cell culture, which is a laboratory process used primarily for the growth, propagation, and production of cells for analysis and the production and harvesting of cell products. The present invention comprises functionalized and/or engineered hydrogel microcarriers that exhibit any or all of the following properties: controllable buoyancy, ferro- or paramagnetism, molecular or fabricated reporting elements, and optical clarity. The microcarriers are used in a bioreactor that employs external forces to control said microcarrier kinetic energy and translational or positional orientation in order to facilitate cell growth and/or cellular analysis. The bioreactor can be part of an automated system that employs any or all of the following; a microcarrier manufacturing method, a monitoring method, a cell culture method, and an analytical method.

Abstract: A detection system in a portable assay reader device is enabled or activated after a user applies a manual force to a portion of the reader device, to an object supporting the assay test strip, or to the assay test strip itself. The movement moves a switch from an open state to a closed state. The closed state enables a detection system to monitor one or more test regions in the assay test strip for a reaction. The detection system can include one or more imagers, one or more electrical detectors, one or more magnetic detectors, or one or more optical detectors that monitor the one or more test regions for applicable visible, electrical, magnetic, or optical reactions, respectively. The one or more imagers or detectors transmit data to a processing device to determine the results of a test.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: This invention relates to a device for detecting fungal contamination in an interior environment, including: a concentration module (MC); a separation module (MS) including a chromatographic microcolumn; and a detection module (MD), characterized in that it includes at least one first solenoid valve (E3) upstream of the detection module (MD) enabling either to direct a flow containing target molecules toward the detection module (MD), or to direct a flow filtered by a first means for filtering (Tx1), enabling the detection module (MD) to be cleaned when the flow does not contain the target molecules. The invention also relates to a control interface of the device.

Abstract: Devices and methods for the detection of target molecules are disclosed. Devices and methods for detecting food-borne target molecules are also disclosed.

Abstract: The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.

Abstract: A test element and method for detecting an analyte with the aid thereof is provided. The test element is essentially disk-shaped and flat, and can be rotated about a preferably central axis which is perpendicular to the plane of the disk-shaped test element. The test element has a sample application opening for applying a liquid sample, a capillary-active zone, in particular a porous, absorbent matrix, having a first end that is remote from the axis and a second end that is near to the axis, and a sample channel which extends from an area near to the axis to the first end of the capillary-active zone that is remote from the axis.

Abstract: A biosensor article including a substrate having polymer modified surface, the polymer comprising the formula (I) where (x), (y), (z), R, R?, R?, S, W, and X, are as defined herein. Methods for making the biosensor article or cell culture article, and methods for performing an assay of, for example, a bioentity, a ligand thereof, or both, with the biosensor article are also disclosed.

Abstract: A method of preparing a dry stick test device for determining an analyte in a milk sample by chemical assay. At least one reagent pad is provided by impregnating a first porous material with an aqueous solution including a reagent capable of reacting with the analyte, a derivative of the analyte or an indicator compound for the analyte to provide a detectable signal when in a moistened state. The reagent pad is dried. A development pad is provided by impregnating a second porous material with an aqueous solution including at least one controlling compound which, when in a moistened state, is capable of providing a condition required for the reagent to react with the analyte to provide the detectable signal. The impregnated second porous material is dried. The first porous material is immobilized with the second porous material, on a solid support, to obtain the dry stick test device.

Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: A diagnostic test kit for detecting the presence or quantity of an enzyme or enzyme inhibitor is provided. The diagnostic kit utilizes reactive complexes to facilitate the detection of the enzyme or enzyme inhibitor. The reactive complexes include a substrate joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter and specific binding member. In one embodiment, for example, a peptide, protein, or glycoprotein substrate is joined to a reporter (e.g., dyed latex particle) and specific binding member (e.g., biotinylated compound). In this embodiment, the substrate provides a cleavage target for a proteolytic enzyme. Specifically, upon contacting the reactive complexes, the proteolytic enzyme cleaves the substrate and releases the reporter and/or specific binding member. The signal exhibited by the released reporters may then be used to indicate the presence or quantity of an enzyme or enzyme inhibitor within the test sample.

Abstract: A test sensor includes a base, a lid and a channel for receiving a fluid sample. The channel includes a reagent. The test sensor also includes a tip portion extending from at least one of the base and lid. The tip portion prevents or inhibits moisture or contaminants from entering the channel and affecting the reagent. The test sensor further includes a detachable area located adjacent the tip portion. The detachable area is formed so as to assist movement of the tip portion or removal of the tip portion from the remainder of the test sensor. The movement or removal of the tip portion exposes the channel for receiving the fluid sample.

Abstract: Biological samples of mammary fluid or components thereof are obtained using a breast pump device coupled with an absorbent paper or membrane, optionally facilitated by administering oxytocin to the subject. The breast pump device stimulates expression of mammary fluid and provides for collection of diagnostic samples on the absorbent paper or membrane to evaluate breast disease, including cancer. The biological sample may include fluid containing one or more of cells or cellular components, proteins, glycoproteins, peptides, nucleotides or other desired constituents comprising a breast disease marker. Absorbent paper or membrane, and methods relating to the paper or membrane, and a breast pump device are also provided.

Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen, thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.

Abstract: The present disclosure relates to a carbon dioxide detector having a borosilicate substrate. It may also have a carbon dioxide responsive indicator solution disposed on the borosilicate substrate. The carbon dioxide detector may be part of a carbon dioxide detector system also including an air intake operably connected to the housing to allow air to reach the carbon dioxide detector. The carbon dioxide detector may include a borosilicate substrate and a carbon dioxide responsive indicator solution disposed on the borosilicate substrate. This detector may be part of a further system, such as a resuscitation system. The detector may be made by wetting a borosilicate substrate with a carbon dioxide responsive indicator solution and drying the indicator solution to immobilize it and form a dried carbon dioxide detector. It may be used to detect the concentration of carbon dioxide in an air sample by exposing the detector to the sample.

Abstract: An apparatus (1) for analyzing a contaminated surface has a transfer device (2) with a mount (3) and a porous disk-shaped medium (5) having a contact side (6) arrangeable on the contaminated surface. The mount (3) is bindable to the medium on its side (8) facing away from the contact side (6) via a first fixing edge (7a). An analytical device (11) is bindable to the medium (5) on its contact side (6) via a second fixing edge (7b) to remove the medium (5) from the mount (3). The first fixing edge (7a) is bindable to the medium (5) via a first adhesive bond and the second fixing edge (7b) is bindable to the medium (5) via a second adhesive bond. The first adhesive bond is breakable by a lower application of force than the second adhesive bond.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a microcontroller block disposed in the housing; and a phase-shift-based hematocrit measurement block. The phase-shift-based hematocrit measurement block includes a signal generation sub-block, a low pass filter sub-block, an analytical test strip sample cell interface sub-block, a transimpedance amplifier sub-block, and a phase detector sub-block. In addition, the phase-shift-based hematocrit measurement block and microcontroller block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter and the microcontroller block is configured to compute the hematocrit of the bodily fluid sample based on the measured phase shift.

Abstract: A test element for determining a body fluid is provided. The test element, in particular for determining the blood glucose level, includes a detection region which is charged with a reagent sensitive to the body fluid. A function element is arranged in or adjacent to the detection region for detecting at least one status parameter for the detection region, such that the functional element can be evaluated by means of a status measurement. A method for measuring the test element is also disclosed.

Abstract: A simple membrane assay method for detecting or quantitating an analyte in a specimen sample using an assay device equipped with a membrane bound with a capture-substance to capture the analyte, including the steps of filtering a specimen sample using a filter, dropping the filtrate onto said membrane and detecting the presence of the analyte in said specimen sample, as well as a simple membrane assay kit for detecting the presence of an analyte in a specimen sample, including (1) a filter tube, and (2) an assay device equipped with a membrane bound with a capture-substance to capture the analyte. The method or the kit can decrease the occurrence of false positivity and can provide a highly accurate detection of the analyte such as pathogen and antibody in a specimen collected in a medical scene or by an individual.

Abstract: Methods for measuring the amount of two or more analytes of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods involve determining a ratio of a detected amount of a single analyte of interest, to the sum of a detected amount of each of the analytes of interest plus a detected amount of a control, wherein the amount of each analyte of interest is directly or inversely related to the ratio for each analyte of interest.

Abstract: Disclosed herein are biosensors for the detection of airborne biomolecules. The biosensors include a housing, a sensing component, and optionally a sample capture component. The biosensors may utilize a gel-based detection platform.

Abstract: A general methodology for the development of highly sensitive and selective sensors that can achieve portable, low-cost and quantitative detection of a broad range of targets using only a personal glucose meter (PGM) is disclosed. The method uses recognition molecules that are specific for a target agent, enzymes that can convert an enzyme substrate into glucose, and PGM. Also provided are sensors, which can include a solid support to which is attached a recognition molecule that permits detection of a target agent, wherein the recognition molecule specifically binds to the target agent in the presence of the target agent but not significantly to other agents as well as an enzyme that can catalyze the conversion of a substance into glucose, wherein the enzyme is attached directly or indirectly to the recognition molecule, and wherein in the presence of the target agent the enzyme can convert the substance into glucose. The disclosed sensors can be part of a lateral flow device.

Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for a membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Abstract: A biochemical assay is provided comprising a substrate being capable of binding at least a target analyte and eventually other constituents contained in a biological sample, a test zone on the substrate for sample application, a non-immobilized conjugate reagent provided in the test zone for labeling the analyte, the conjugate reagent being capable of specific binding to the analyte but remaining unbound to the substrate, and a flow path for transporting a washing liquid through the test zone and washing an excess of unbound conjugate reagent away from the test zone. The test zone is also a detection area for detecting the labeled analyte.

Abstract: Dipsticks and other assay devices suitable for the assay of haptens are disclosed. Also disclosed are blocking agents for use in such devices.

Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: An optic light guide test sensor comprises a light guide, a reagent-coated membrane, and a mesh layer. The reagent-coated membrane and the mesh layer are attached to the light guide at an output end of the light guide. The light guide test sensor is adapted to be used to test the level of an analyte in a biological fluid sample when used with a readhead. A method of manufacturing the light guide test sensor involves providing a plurality of light guides, providing a strip of reagent-coated membrane, and providing a strip of mesh layer. The reagent-coated membrane and mesh layer are attached to the light guides by ultrasonic welding. The reagent-coated membrane and mesh layer may also be attached to the light guides by adhesive.