Abstract: The present invention provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.

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.

Abstract: The invention is directed towards methods and compositions for identifying the amount of ammonium acid in a buffered oxide etching composition. In buffered oxide etching compositions it is very difficult to measure the amount of ammonium acid because it has varying equilibriums and it is toxic so it hard to handle and sample. When used to manufacture microchips however, incorrect amounts of ammonium acid will ruin those chips. The invention utilizes a unique method of spectrographically measuring the ammonium acid when in contact with added chromogenic agents to obtain exact measurements that are accurate, immediate, and safe.

Abstract: A dehydration sensor having a stable, printable, buffered-ink composition that enables one to miniaturize the detection zone and permits both buffer and indicator dye to be applied in the same area of a detection zone, without need for a conventional, large buffer pad region.

Abstract: A portable tester to detect one or more analytes from explosives, drugs, or household chemicals, comprising: a plurality of chemical disposable, detachable reagent reservoirs storing reagents to induce a series of color reactions, wherein developed color depends on sequences of applied reagents to respective pads on a support base, reaction times and temperatures on said pad to create one or more color bar codes for a specific analyte. The tester comprises a piezoelectric dispenser coupled to each respective reservoir to dispense a mist of reagent onto respective test pads to increase sensitivity and reduce reaction heat and time; wherein piezoelectric dispenser is processor controlled to control dispensing time and volume in each step.

Abstract: Devices, systems, and methods for the collection of biological samples. In at least one exemplary embodiment, a device comprises a collection medium having top and bottom surfaces and a predetermined size and shape, the top surface comprising a position marker and at least one binding site operable to bind a biological sample, a protective facing substantially impermeable to the biological sample, the protective facing coupled to the top surface of the collection medium and having a size and shape substantially similar to the predetermined size and shape of the collection medium. The protective facing being sized and shaped to define a first void positioned to allow for the transfer of the biological sample through the protective facing and onto the at least one binding site of the collection medium, and a second void positioned to expose the position marker for alignment of the collection medium.

Abstract: The present invention is related to a diagnostic test kit for detecting luteinizing hormone (LH) in a biological sample at a concentration relative to a threshold concentration of LH. The device can include a release medium formed of a first material and including a labeled conjugate with a detectable label and a first binding member reactive with a first epitope of LH and a capture medium formed of a second, different material, in fluid communication with the release medium. The capture medium includes a result site having immobilized thereon a capture component capable of directly or indirectly binding LH that is bound to the labeled conjugate. The device is calibrated such that color development at the result site occurs only when the LH concentration of the liquid sample is greater than the threshold concentration.

Abstract: The present invention is an improved apparatus for sample analysis. The apparatus employs an assay component containing a membrane having one or a plurality of analyte-specific binding agents attached thereto, a means for absorbing liquid, and a piston means for drawing analytes through said membrane into said means for absorbing liquid. The apparatus is configured to be portable and provide a detector for detecting binding of an analyte to an analyte-specific binding agent, a plurality of data acquisition components, and a computer for integrating, analyzing and storing the detected analyte specific binding and acquired data.

Abstract: Provided is a strip-assembled immunochromatographic disc, containing: a base, a lid engaged with the base and a draining piece disposed between the strips on the base and the lid, wherein a sampling opening is disposed on the lid directly facing to the draining piece, and the said sampling opening intercommunicates to a draining groove provided on the inner side of the lid which is formed by a plurality of draining channels; several strip stages are provided on the base with their location and number corresponding to those of the draining channels provided on the lid, and the edge of the draining piece laps to the sample pads of the strips carried on the stage adjacent to one end of the sampling opening. Also provided is a method of performing multiplexed immnochromatographic detection using the strip disc to accomplish the detection of multiple target analytes in one sample in an assay.

Abstract: A device and a process are proposed for separating constituents of a sample fluid, wherein the sample fluid is supplied by capillary force to a receiving region (7) for metering, stopping or delaying the sample fluid and the sample fluid is pre-treated with a soluble chemical (13) in the receiving region (7) before the sample fluid is supplied to a separating device (5) for separating off constituents of the sample fluid.

Abstract: A wetness indicator material may be used on a substrate to form a wetness sensor. The sensor may show either the presence or absence of an aqueous-based fluid or water-containing medium, such as vaginal fluid or urine in a personal hygiene article. The wetness sensor may be incorporated into the article. The wetness indicator material includes a standard colorant that does not change color when wetted. The standard colorant increases the range of hues exhibited by the wetness indicator material.

Abstract: A biomedical testing sheet comprises: a substrate with calligraphy paper material, wherein the substrate comprises a wax pattern layer, which is a part of a surface of the substrate coated by a waxy material, and penetrated and diffused by the waxy material, and the wax pattern layer comprises one or more carrying units for carrying one or more droplets of liquids to be measured. The lotus effect substantially prevents diffusion of the liquids and reagents on the carrying units, and reduces the required amount of liquids to be measured and the amount of agent.

Abstract: The present invention relates to a quantitative assay device and a method for the 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 two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.

Abstract: The invention provides reagents and methods for lateral flow assays and quantitative capture or determination of components, including cells, in a sample. In one aspect, reagents and methods for diagnostic assay are provided. In one embodiment an assay for determining T cell numbers, particularly a CD2+ CD4+ T cell assay is provided. A manufacturing method for producing rapid diagnostic assays in a decentralized manner is also described. The method generates net economic advantages over conventional diagnostic manufacturing practices.

Abstract: It is an object of the present invention to provide a measurement kit for developing a first developing solution and a second developing solution from different directions to suppress background noise, and an immunochromatography kit. The present invention provides a measurement kit, which comprises a first developing member for supplying a first developing solution and a second developing member for supplying a second developing solution, wherein the developing direction of the first developing solution is allowed to intersect with the developing direction of the second developing solution, so that development is carried out by developing the first and second developing solutions in different developing directions, and a water absorbent portion is established on the downstream of each of the developing directions.

Abstract: Disclosed is a single-use disposable article for determining the concentration of thiol compounds in a sample of fluid, and a description of how to make and use the article.

Abstract: Disclosed is an assay device for use in the determination of the presence of at least one analyte of interest in a liquid sample; the device comprising a reaction zone in which a reagent reacts with the analyte of interest and a bibulous member which, when contacted with the liquid sample, draws liquid therefrom towards the reaction zone; the bibulous member comprising means to change color when wetted by the sample.

Abstract: A test tape device is disclosed herein for use with a replaceable analytical tape cassette, where the device includes a housing having a cassette compartment covered by a cassette door and a housing opening for sample application, a protective cover that can be moved between a closed position covering the housing opening and a release position allowing access to the housing opening and a door lock for retaining the cassette door in the closed position, wherein the protective cover is coupled with the door lock via an interlocking mechanism, such that the door lock can only be unlocked in the release position of the cover.

Abstract: Described here are systems, devices, cartridges, methods, and kits for detecting or quantifying at least two different analytes using at least two different techniques, in a single sample. The cartridges typically comprise at least two test sites and the location of at least one test site is not dependent on a corresponding measurement device. The systems generally comprise a device, memory, and a processing module. The device comprises a light source, an array detector, and a port configured to accept at least a portion of a cartridge. The processing module is configured to perform an image analysis of the cartridge. The methods comprise the steps of acquiring calibration information, acquiring an image of the cartridge, performing an image analysis, and cycling through specific detection or quantification techniques corresponding to the techniques required by the test sites. Computer readable media are also described.

Abstract: The invention relates to a flow through system for quantifying a target component in a liquid. The flow through system comprises a flow-through device comprising a flow path comprising a marker section, a capture section downstream to said marker section, and at least two quantification sections. The marker section comprises a non-immobilized marker. The capture section comprises a capture zone with an immobilized capture agent, and the at least two quantification sections comprise a pre-capture quantification section placed downstream to the marker section and up stream to the capture section, and a post-capture quantification section placed downstream to the capture section. The system further comprises a quantification unit for each of said quantification sections. The quantification unit(s) being arranged to quantify marker containing components and/or particles passing through said respective quantification sections.

Abstract: A sterilization indicator system and method of using the system to determine efficacy of a sterilization process. The system includes a vial having a first compartment containing spores of one or more species of microorganism; a second compartment containing a growth medium with a disaccharide, an oligosaccharide or a polysaccharide in which the vial is free of monosaccharide; an enzyme, capable of acting upon the monosaccharide to yield reaction products and electron transfer, disposed on two or more electrodes adapted to carry an electrical signal resulting from the electron transfer, the pair of electrodes positioned to contact the combined contents of the first compartment and the second compartment during incubation; and an apparatus linked or linkable to the electrodes and adapted to detect and measure the electrical signal resulting from electron transfer when the enzyme acts upon the monosaccharide.

Abstract: The problem is to provide a multilayer analysis element for analyzing liquid samples, having improved adhesive force between a transparent support and a detection layer even by handling at the time of processing, while maintaining basic performances such as sensitivity and storage performance. The multilayer analysis element for analyzing liquid samples is characterized in that at least a detection layer containing a substance that generates a detectable change by a gaseous substance, a liquid blocking layer that selectively permeates the gaseous substance, and a spreading layer are integrally adhesion laminated in this order on a transparent support, and the detection layer contains an adhesive polymer and a water-insoluble vinyl polymer.

Abstract: A cholesterol-level measuring apparatus including a portable body having a cholesterol level detecting means for identifying a cholesterol level in a blood sample, and a display screen communicatively coupled to the cholesterol level detecting means for illustrating a learned cholesterol level in the blood sample. Notably, the cholesterol level detecting means includes a disposable test strip having a color-changing reactive reagent that changes color in response to the learned cholesterol level in the blood sample.

Abstract: The present invention provides an immunochromatographic device, which contains the following (a) and (b): (a) a first device part holding a first insoluble carrier used for developing a complex formed with an analyte and a labeling substance comprising a metal labeled with a first binding substance that can bind to the analyte and capturing the analyte and the labeling substance at a reaction portion containing a second binding substance that can bind to the analyte, and (b) a second device part holding a second insoluble carrier used for developing a liquid and a third insoluble carrier used for absorbing a liquid, in such a way that the first insoluble carrier does not come into contact with the second insoluble carrier and the third insoluble carrier.

Abstract: Disclosed is a method for measuring thrombin generation in a whole blood sample. The whole blood sample may be applied forthwith, without prior processing. The blood cells and blood plasma in the whole blood sample are separated by (lateral) flow migration. Also disclosed is an assembly of a sample support and a device dedicated to measure thrombin generation in a whole blood sample. Advantageously, the sample support comprises a separator medium allowing separation of whole blood into blood cells and blood plasma by means of (lateral) flow migration.

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: The disclosure provides low cost, portable three-dimensional devices for performing multiplexed assays. The devices comprise at least two substantially planar layers disposed in parallel planes, wherein one of the layers is movable relative to each other parallel to the planes to permit the establishment of fluid flow communication serially between the two layers.

Abstract: A lateral flow device includes a sample compressor and a test strip comprising a diverting zone. The diverting zone, which may include a barrier and/or a gap or ditch, stops or impedes flow. Flow is reinitiated and diverted into an alternate plane by compression of a sample compressor. Flow returns to the original, lateral plane, at the end of the diverting zone.

Abstract: A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

Abstract: The present invention relates to a test strip for determining and/or quantifying a property of a sample, such as the concentration of an analyte, the pH, the viscosity, or the specific gravity of a fluid specimen. More particularly, the present invention relates to an improved test strip and scale for determining and/or quantifying a property of a sample, such as the concentration of an analyte, the pH, the viscosity, or the specific gravity of a fluid specimen.

Abstract: An analyzing apparatus contains an image detection unit and an analysis unit. The image detection unit contains a view field area that covers at least a reaction area and a background area in a test piece. The reaction area exhibits a reaction color when exposed to a test substance in a specimen. The analysis unit detects the test substance based on the reaction color and determines, during detection of the test substance, whether a state of the background area falls within an acceptable range set for the test substance.

Abstract: A point-of-care, screening kit for use by a heath care worker to create custom test strips for screening the bodily fluids of an individual for various, medical conditions includes: (a) a plurality of reagents (12), (b) a substrate (18) configured to: i) receive one of the reagents and react with it so as to cause it to acquire a first characteristic color, and, ii) upon the addition of the individual's bodily fluid to the substrate, acquire, as a result of the formulation of each of the reagents, a second, dichotomous characteristic color when the individual has a specific one of the various, medical conditions.

Abstract: A device for assay can evenly develop solution, and performs highly accurate and sensitive measurement. A first device part (10) maintains a second insoluble carrier (12) and a third insoluble carrier (13) in such a manner that they overlap with each other at a detection portion (14) of a first insoluble carrier (11). These three carriers (11), (12) and (13) are housed not in contact with each other. A pressing unit (18) having a pressing surface (18a) that is parallel to the detection portion (14) is provided on an inner surface of the second device part (20) facing the detection portion (14). The pressing surface (18a) is displaced by being pressed toward the detection portion (14), and presses, from the upper side of the first insoluble carrier (11), the second insoluble carrier (12) and the third insoluble carrier (13) onto the first insoluble carrier (11). The first device part (10) and the second device part (20) are joined together.

Abstract: The present invention is related to a diagnostic test kit that assesses ovarian reserve by measuring Follicle Stimulating Hormone (FSH) in a liquid sample. The sample can be deposited on a first portion of the device for transport to a second portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a test site, in fluid communication with the release medium and formed of a second, different material.

Abstract: The present invention relates to a color-changing composition and a multiple-component material including a substrate and a printed layer on the substrate. The printed layer includes a color-changing composition to indicate a change in condition, such as a change in wetness. The color-changing composition includes a matrix-forming component, a leuco dye, a Lewis Acid, a neutral surfactant and an organic solvent.

Abstract: The present invention provides devices, in particular lateral flow devices, for detecting a target analyte on a surface, in which the elements of collection and detection are integrated. The present invention also provides methods of use thereof.

Abstract: In a chromatography quantitative measuring apparatus, a beam applied from a light source to a chromatography test strip is formed into an elliptical shape by an optical means such as a cylindrical lens, a variation in absorbance that accompanies elution of a marker regent is detected while the elliptical beam is applied between a marker reagent hold part and a detection part, and a measurement is automatically started in a prescribed period of time since the detection of variation. According to the chromatography quantitative measuring apparatus so configured, non-uniform coloration is reduced by shaping the beam elliptically with the optical means, whereby the accuracy of quantitative analysis is enhanced, and the apparatus can be operated easily.

Abstract: Methods, compositions, and systems for detecting explosives is disclosed and described. A sensor for detecting explosives can comprise a porous hydrophilic material modified with a series of ? conjugated molecules with the general structure: [EW]-[CS]-[PED] wherein EW is an electron withdrawing group, CS is a conjugated system, and where PED is a pre-electron donating group. The porous hydrophilic material is capable of detecting hydrogen peroxide by reacting the aryl boronate group (or other Pre-ED groups) with the hydrogen peroxide to provide a fluorescent change.

Abstract: A device for assay can evenly develop solution, and performs highly accurate and sensitive measurement. A first device part (10) maintains a second insoluble carrier (12) and a third insoluble carrier (13) in such a manner that they overlap with each other at a detection portion (14) of a first insoluble carrier (11). These three carriers (11), (12) and (13) are housed not in contact with each other. A pressing unit (18) having a pressing surface (18a) that is parallel to the detection portion (14) is provided on an inner surface of the second device part (20) facing the detection portion (14). The pressing surface (18a) is displaced by being pressed toward the detection portion (14), and presses, from the upper side of the first insoluble carrier (11), the second insoluble carrier (12) and the third insoluble carrier (13) onto the first insoluble carrier (11). The first device part (10) and the second device part (20) are joined together.

Abstract: The present invention relates to test strips that are photo and thermally stable, optically transparent and offer virtually specific absorptiometric sensing of nitrite in natural waters. The process of which is as follows: 1) The entrapment of xanthene dye specifically rhodamine 6G in sol-gel glass. This entrapment is done by delicate balance of coulombic interactions, hydrogen bonding and molecular imprinting effect. 2) In particular, rhodamine 6G entrapped sol-gel layers are formed by first preparing a sol by sonicating a mixture of tetraethoxsilane, water and ethanol for 30 minutes and hydrolysed to form gel by drop wise addition of hydrochloric acid. 3) This gel is further sonicated for 30 minutes after addition of dye and then aged for 15-20 h to obtain dye entrapped sol-gel glass and 4) This is then manually cast as sol-gel films on glass substrates to obtain test strips.

Abstract: Methods and assay for the portable colorimetric detection of an antioxidant in a food sample. According to one aspect the method comprises the steps of providing a colorimetric reagent comprising a plurality of ceria nanoparticles immobilized to a support, contacting the colorimetric reagent with the food sample, and detecting an optical property of the colorimetric reagent, wherein a change in the optical property of the colorimetric reagent is associated with the presence of antioxidant in the food sample, and further wherein the change in the optical property of the colorimetric reagent is dependent upon the concentration of the antioxidant in said food sample.

Abstract: Embodiments of the invention relate to portable detection apparatus, comprising one or more detector regions adapted to visually indicate the presence or amount of an analyte in a beverage. The detection apparatus is shaped substantially the same as a consumer product.

Abstract: This invention relates generally to methods and apparatus for desorption and ionization of analytes for the purpose of subsequent scientific analysis by such methods, for example, as mass spectrometry or biosensors. More specifically, this invention relates to the field of mass spectrometry, especially to the type of matrix-assisted laser desorption/ionization, time-of-flight mass spectrometry used to analyze macromolecules, such as proteins or biomolecules. Most specifically, this invention relates to the sample probe geometry, sample probe composition, and sample probe surface chemistries that enable the selective capture and desorption of analytes, including intact macromolecules, directly from the probe surface into the gas (vapor) phase without added chemical matrix.

Abstract: A method and devices analyze for the presence of cyanide in samples using colorimetric analysis of samples after contacting with cobinamide or monocyanocohinapmide.

Abstract: Disclosed is an assay device for the determination of the presence and/or extent if an analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole detection zone capable of immobilizing a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole detection zone capable of immobilizing a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

Abstract: In a chromatography quantitative measuring apparatus, a beam applied from a light source to a chromatography test strip is formed into an elliptical shape by an optical means such as a cylindrical lens, a variation in absorbance that accompanies elution of a marker regent is detected while the elliptical beam is applied between a marker reagent hold part and a detection part, and a measurement is automatically started in a prescribed period of time since the detection of variation. According to the chromatography quantitative measuring apparatus so configured, non-uniform coloration is reduced by shaping the beam elliptically with the optical means, whereby the accuracy of quantitative analysis is enhanced, and the apparatus can be operated easily.

Abstract: An apparatus is provided for sensing an analyte in a fluid.

Abstract: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

Abstract: A diagnostic test device comprising at least one membrane disposed in any of one, two, and three dimensions; at least one test sample fluid input port that receives and transfers at least one test sample fluid and onto the at least one membrane; at least one contiguous fluid flow manifold within the at least one membrane to multiplex or distribute the at least one test sample fluid; at least one contiguous fluid flow channel that operatively connects the at least one membrane to the at least one contiguous fluid flow manifold; at least one analyte assay test zone disposed within the at least one contiguous fluid flow channel; and at least one chemical capturing reagent disposed within the at least one analyte assay test zone, wherein multiple analyte assay test results are simultaneously obtained and in parallel in the diagnostic test device.

Abstract: The invention is directed towards methods and compositions for identifying the amount of hydrofluoric acid in a buffered oxide etching composition. In buffered oxide etching compositions it is very difficult to measure the amount of hydrofluoric acid because it has varying equilibriums and it is toxic so it hard to handle and sample. When used to manufacture microchips however, incorrect amounts of hydrofluoric acid will ruin those chips. The invention utilizes a unique method of spectrographically measuring the hydrofluoric acid when in contact with added chromogenic agents to obtain exact measurements that are accurate, immediate, and safe.