Abstract: A multilayered optical sensing patch, for the measurement of conditions, such as pH, oxygen level, etc, within containers, is provided. The multilayered optical sensing patch of the present invention is comprised of a heat sealable polymer substrate layer, and a polymeric sensing membrane later attached thereto. The polymer sensing membrane layer is formed of a porous polymer support membrane, and an optical sensing composition (comprising a reactive indicator) covalently bonded thereto. The heat sealable polymer substrate layer is capable of being securely bonded to the inner layer of bioreactor bags, as well as the porous polymer support substrate layer. Further, the porous polymer support membrane layer provides a firm supporting structure for the polymeric sensing layer, thereby protecting the optical sensing composition disposed therein from degradation/damage.

Abstract: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.

Abstract: In one aspect, this disclosure provides a substrate for determining the concentration of an analyte within a sample. The substrate includes a conductive region and a recognition layer, the conductive region including at least one particle and having a first surface operatively coupled with the recognition layer, the recognition layer comprising at least one recognition molecule. The distance between the first surface of the conductive region and the recognition molecule is selected such that when the analyte is bound to the recognition layer the combination of the at least one particle and the analyte exhibits at least one of the following effects when radiation is directed through the conductive region and the recognition layer: (i) a particle plasmon effect, (ii) a particle bulk interband absorption, (iii) analyte molecular absorption, and (iv) absorption by the analyte-particle combination.

Abstract: A biochip substrate capable of realizing the high detection accuracy by restricting a nonspecific adsorption or bonding of a substance to be detected, when used for a detection or analysis of protein, nucleic acids and the like. The biochip substrate is for fixing a biologically active substance on a surface of a solid substrate, and characterized in that it has a layer comprising a polymer compound obtained by copolymerizing an ethylenically unsaturated polymerizable monomer having an alkylene glycol residue, an ethylenically unsaturated polymerizable monomer having a functional group for fixing a biologically active substance and an ethylenically unsaturated polymerizable monomer having a cross-linkable functional group, on the surface of the substrate.

Abstract: A leak detection device (10) comprising a first membrane (12), the first membrane (12) containing at least one indicator chemical (16) responsive to anaerobic conditions, wherein the first membrane (12) is at least in part semi-permeable such that it allows passage of oxygen therethrough substantially in only one direction.

Abstract: Carriers or holders for holding microfluidic devices are provided. Some of the carriers that are provided include a hydration control device and/or a source of controlled fluid pressure to facilitate use of the carrier in conducting various types of analyses.

Abstract: An optical measurement apparatus is provided for conducting a test by efficiently reading color development of a reagent after reaction by optical measurement. To the above end, an optical measurement apparatus is provided which is to be used with at least one test instrument mounted to the apparatus. The test instrument includes a carrier provided with at least one reagent retaining portion which retains a reagent, and a sample is applied to the carrier. The optical measurement apparatus includes a reader for reading color development of the reagent retaining portion, and a controller for performing driving control of the reader and determination. The controller performs the determination by utilizing data obtained by a reading operation P to read the color development of the reagent performed after the lapse of a reaction completion period Tr1-Tr6 from the mounting of the test instrument, and the reaction completion period depends on the reagent.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: An analytical test element is provided having a surface comprising a chemical detection layer on which a spreading net is disposed, the spreading net being configured to provide for the planar distribution of a liquid sample on the detection layer. The spreading net generally comprises a filament structure coated with a metallic layer that is oxidized at least on one or more surface portions thereof facing the detection layer.

Abstract: In one embodiment the present invention provides a blood analyte meter that is user-friendly and easy to use. In accordance with an embodiment of the present invention an analyte measurement device, for use with a test strip for determining the amount of an analyte in a sample, displays a hierarchy of information or options to a user. The hierarchy of information or options may include, among other information or options, subroutines that are performable by the processor of the device, stored data related to past tests performed by the user, and alarm features of the device. A user scrolls through and selects individual options or pieces of information by rotating and translating a rotatable user interface around and along an axis of rotation.

Abstract: The invention relates to an analytical test element for analysis of a liquid sample. The analytical test element may contain a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening. At least one test field may be arranged in the channel, spaced apart from the inlet opening. The test element comprises a sample application site which is closed with a seal and which is designed in such a way that, when the seal is opened, the sample application site and the inlet opening of the channel are simultaneously open to the outside environment of the test element. The test element can then receive the liquid sample inside the channel via the sample application site and inlet opening, for analysis in the test field. The invention also relates to a test element magazine and to a system for analysis of liquid samples with at least one test element.

Abstract: The invention relates to compositions comprising a hydrogel matrix, where the matrix comprises poly(ethylene glycol) dimethyacrylate (PEGDMA), an acrylate, such as methacrylic acid (MAA) and methyl methacrylate (MMA), as well as 2-hydroxy-2 methyl propiophenone (HMPP).

Abstract: The present invention provides a colorimetric gas detector comprising a substrate bearing a material that can react with a gas in an atmosphere being monitored and wherein the reaction causes the material to change the radiation at which the material absorbs or radiates radiation (the color-change material). The material is located in at least one discrete area of the substrate. By providing the color change material in discrete areas, the amount of such material can be reduced and different types of color-change material can be included on a common substrate to detect two or more gases simultaneously.

Abstract: A liquid delivery apparatus is provided for depositing liquid materials onto prescribed areas. The apparatus includes a sensing and delivery pin and a photo sensor. The apparatus is sized to deliver a droplet of liquid material to the surface of a target area without coming into contact with the target surface. The apparatus is also capable of drawing geometric features, such as lines and grids of liquid material. The photo sensor measures the intensity of light during a processing cycle. Measured reflected-light intensity can be compared in real-time to a reference curve which is based on test process cycles representing the light intensity expected when the process proceeds in the preferred fashion to produce a normal spot having an expected droplet size. The light intensity measurements can also be fitted with a mathematical function such as an asymmetric double sigmoidal curve.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. 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: Methods for quantitatively measuring the amount of an analyte of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods comprise sandwich assays, and utilize an internal calibration reaction that closely mimics the reaction of test particles by the use of a two-step reaction.

Abstract: Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.

Abstract: An optical detection field, wherein a diamond-like carbon thin film containing therein fluorine is formed on a surface facing an existence region of a substance.

Abstract: The invention provides a reagent reservoir system and disposable reaction cassettes using the same. In one aspect, such system comprises a chamber in which dried reagent, particularly lyophilized reagent, is constrained to remain in a defined region of the chamber by a retaining member that obstructs passage of such reagents to other regions of the chamber where they may escape hydration or activation.

Abstract: It is intended to provide a target substance detection element wherein a target substance capturing body for capturing target substances is immobilized with good orientation in a desired region on the surface of the target substance detection element, a method for producing the target substance detection element, and a detection method using the target substance detection element.

Abstract: Devices and methods for the detection of antigens are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

Abstract: The present invention relates to the field of detection of components in gas phase, and in particular to detection of nitric oxide exhaled as a component of breath, using a liquid crystal assay format and a device utilizing liquid crystals as part of a reporting system.

Abstract: An object of the present invention is to provide a metal particle with which a highly-sensitive testing method can be conducted, and a testing method using such metal particle. The present invention provides a metal particle, which is produced by coating a metal particle labeled with a molecule binding to an analyte with a mixture of two or more types of water-soluble polymer having a mercapto group, a dithiol group or a sulfide group and differing in molecular weight.

Abstract: The invention concerns coated test elements and in particular test elements comprising a capillary gap which have a hydrophobic structured coating at least in the area surrounding the capillary gap.

Abstract: A sheet of sensors and a method of manufacturing such sheet of sensors. The sheet is configured with (A) a tessellated zipper pattern of identically shaped elements defining (i) a right longitudinal column consisting of a base portion of a right set of elements, (ii) a left longitudinal column consisting of a base portion of a left set of elements, and (iii) an intermediate longitudinal column consisting of alternating tab portions of the right and left elements, and (B) a continuous longitudinal strip of functional material positioned only within the intermediate column.

Abstract: The present invention relates to a class of fluorescent, organic nanofibrils, and particularly the films comprising entangled piling of these nanofibrils exhibiting effective quenching of their fluorescence upon exposure the vapor of explosives. The invention also relates to a sensor and a method for sensing the explosives vapor and other volatile organic compounds, including the explosives taggants through the modulation of the fluorescence of the nanofibril film and the electrical conductivity of the nanofibrils. The invention also relates to a development of synthetic methods, protocols and techniques that leads to production of various arylene-ethynylene macrocycle (AEM) molecules, which consist of a shape-persistent, toroidal scaffold in planar conformation, with minimal ring strain and highly tunable ring sizes (from 0.5 nm to above 10 nm).

Abstract: According to one embodiment of the present invention, an optical-based test sensor for use in the determination of an analyte in a liquid sample is disclosed. The test sensor includes a base, a polymer carrier, and a test membrane. The base has a capillary channel formed in a surface of the base that is adapted to move a liquid sample from an inlet to a reaction area formed in the base. The polymer carrier has a lower surface adhered to the surface of the base and is disposed over at least a portion of the capillary channel. The test membrane, which contains a reagent, is adhered to the lower surface of the polymer carrier and extends from the polymer carrier into the reaction area.

Abstract: A paint that warns of radiological or chemical substances comprising a paint operatively connected to the surface, an indicator material carried by the paint that provides an indication of the radiological or chemical substances, and a thermo-activation material carried by the paint. In one embodiment, a method of warning of radiological or chemical substances comprising the steps of painting a surface with an indicator material, and monitoring the surface for indications of the radiological or chemical substances. In another embodiment, a paint is operatively connected to a vehicle and an indicator material is carried by the paint that provides an indication of the radiological or chemical substances.

Abstract: A system for warning of corrosion, chemical, or radiological substances. The system comprises painting a surface with a paint or coating that includes an indicator material and monitoring the surface for indications of the corrosion, chemical, or radiological substances.

Abstract: A method is provided for producing an analytical element comprising at least one test field for analyzing a liquid sample, wherein provision is made for a carrier on which a polymer fabric is arranged. At least one portion of the polymer fabric is irradiated with UV laser light and thereby hydrophobized.

Abstract: Articles for testing a coagulation process in whole blood.

Abstract: Methods of manufacturing test strips are disclosed. Embodiments include laminating a two piece covering layer over a substrate with a series of cavities, wherein the two pieces are separated by a gap, the gap forming a vent opening for the cavities. Other embodiments include covering the sample receiving chamber with a cover thinner than the cover covering the body of the test strip, the thicker body cover absorbing more force than the chamber cover to reduce the possibility of adhesives squeezing out from under the chamber cover. The present invention also provides an advantageous method of mass-producing the inventive test strips without having to align the slot or vent opening laterally with respect to the test strips and without having to punch a vent opening. The method is also well suited to mass production by roll processing techniques.

Abstract: The invention relates to a method and an immunological test kit for predicting the risk of transplant rejection by detecting anti-AT1 receptor auto-antibodies in biological materials of a patient to be examined, e.g. by an immune reaction with the AT1 receptor or functionally analogous peptides or proteins thereof. The invention is also directed to the use of the AT1 receptor or functionally analogous peptides or proteins in order to predict (diagnose) the risk of transplant rejection. Said risk exists if anti-AT1 receptor auto-antibodies can be detected in such biological materials, e.g. in body fluids or tissues.

Abstract: Disclosed is a cuvette for taking a measurement on a liquid, comprising a monolithic cuvette body with a cavity (4) in the form of a narrow gap that is formed between two at least approximately parallel wall surfaces (15, 16) and is delimited by an inner wall (5, 6, 11) and a drawing edge (2) which is open towards the surroundings and from which the liquid is drawn into the cavity (4) forming a measurement zone (13) under the effect of a capillary force.

Abstract: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.

Abstract: The invention provides devices, test kits and methods for removing target agents from a sample. The device contains one or more porous matrices having pore sizes larger than 10 ?m, and a plurality of particles impregnated therein. The target agents attach the device and are removed from the sample.

Abstract: A sample acquiring device for volumetric enumeration of white blood cells in a blood sample comprises a measurement cavity for receiving a blood sample. The measurement cavity has a predetermined fixed thickness. The sample acquiring device further comprises a reagent, which is arranged in a dried form on a surface defining the measurement cavity. The reagent comprises a hemolysing agent for lysing red blood cells in the blood sample, and a staining agent for selectively staining white blood cells in the blood sample. A system comprises the sample acquiring device and a measurement apparatus. The measurement apparatus comprises a sample acquiring device holder, a light source, and an imaging system for acquiring a digital image of a magnification of the sample. The measurement apparatus further comprises an image analyser arranged to analyse the acquired digital image for determining the number of white blood cells in the blood sample.

Abstract: A biochip substrate capable of realizing the high detection accuracy by restricting a nonspecific adsorption or bonding of a substance to be detected, when used for a detection or analysis of protein, nucleic acids and the like. The biochip substrate is for fixing a biologically active substance on a surface of a solid substrate, and characterized in that it has a layer comprising a polymer compound obtained by copolymerizing an ethylenically unsaturated polymerizable monomer having an alkylene glycol residue, an ethylenically unsaturated polymerizable monomer having a functional group for fixing a biologically active substance and an ethylenically unsaturated polymerizable monomer having a cross-linkable functional group, on the surface of the substrate.

Abstract: The invention concerns test elements, in particular diagnostic test elements, for determining the presence or concentration of biological, medical or biologically or medically effective substances including nucleic acids, proteins, viruses, microorganisms and cells, characterized in that these test elements contain nanofibers.

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 and apparatus for use in a flow through assay process is disclosed. The method is characterised by a “pre-incubation step” in which the sample which is to be analyzed (typically for the presence of a particular protein), and a detection analyte (typically one or more antibodies bound to colloidal gold or a fluorescent tag) which is known to bind to the particular protein may bind together for a desired period of time. This pre-incubation step occurs before the mixture of sample and detection analyte come into contact with a capture analyte bound to a membrane. The provision of the pre-incubation step has the effect of both improving the sensitivity of the assay and reducing the volume of sample required for an assay. An apparatus for carrying out the method is disclosed defining a pre-incubation chamber for receiving the sample and detection analyte having a base defined by a membrane and a second membrane to which a capture analyte is bound.

Abstract: Provided among other things are breach or contamination indicating elastomeric articles for indicating a breach or contamination by a selected chemical or group of chemicals, the article having an exterior and interior and comprising: (1) an indicating layer that comprises (a) a carrier polymer, and (b) a plurality of microcapsules wherein each microcapsule comprises a dye and a shell, wherein the plurality of microcapsules is dispersed in the carrier polymer and the polymer shell releases the dye in the presence of the selected chemical(s); and (2) an elastomeric layer selected to resist permeation by the selected chemical(s), which resistant layer is to the interior or exterior side of the indicating layer.

Abstract: A mammalian disease detecting system used to provide a visual indication of a possible disease state includes particles made of a material that is substantially clear or transparent to permit the easy visual detection of blood in urine of a mammal. The system also includes additives to permit visually detection of possible disease states or infections in mammals, such additives being of the type that are not reactive with the particular material.

Abstract: Embodiments of a method for demonstrating hair damage comprises eluting protein fragments from a hair sample with an aqueous solution, adding a protein indicating reagent to the aqueous solution to provide a visual indicator corresponding to an amount of protein fragments eluted, and comparing the visual indicator to a scale to determine an amount of eluted protein fragments present in the aqueous solution.

Abstract: A system for detecting biomaterials that are suspected to be present in a medium that contains multiple materials. A hydrated substrate has water molecules entrapped within molecular spaces between polymeric chains of the substrate. The hydrated substrate also has detection material, which has a specific affinity for a target material. The entrapped water molecules provide a source of water for the detection material such that a change in charge occurs when the target material and detection material coalesce. A display unit detects the change in charge and provides an indication that the target material is present when the change in charge is detected.

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: An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a “fill to here” line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called “dose hesitation”.

Abstract: An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a “fill to here” line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called “dose hesitation”.

Abstract: An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a “fill to here” line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called “dose hesitation”.