Abstract: A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Abstract: The current invention is directed towards a device that useful for studying cell migration. It is preferred that the device is configured to study stem cell, particularly hematopoetic stem/precursor cell homing. The device allows for detailed analysis of the various phases of the multiphase homing process. There are also provided herein, novel methods of using the device, including, but not limited to, dissection of the homing process under microenvironmental conditions mimicking healthy conditions, diseased conditions, inflammatory conditions, drug treatment conditions and experimental conditions.

Abstract: Methods and immunoassays for diagnosing a bite or sting of a venomous organism in a patient having symptoms consistent with such a bite or sting are provided. A sample of venom is collected from the area of the suspected bite or sting using a swab and then contacted with an antibody that specifically binds to an antigenic site on venom present in the sample. Binding is then detected. The invention is illustrated by examples showing diagnosis of brown recluse spider bite, distinguishing it from other diagnoses with which it is often confused. This extremely sensitive test can detect venom antigens down to about 20 picograms even after the sample has been shipped and stored for periods of up to three weeks during the summer.

Abstract: A molecular sensor includes a membrane layer having parallel pores extending through the membrane layer and incorporating therein probe molecules that bind with corresponding target molecules when present in the pores, electrodes, and an ionic solution in contact with the electrodes and the pores, wherein the electrodes are energized to induce an electrical current in the solution through the pores, wherein the electrical current induces an electrical parameter in the electrodes that is indicative of a through-pore electrical impedance of the pores, wherein the through-pore electrical impedance is increased when there is probe-to-target molecule binding in the pores relative to when there is an absence of such binding.

Abstract: A method and apparatus are provided for processing a nucleic acid. The apparatus includes a disposable self-contained processing module that contains the nucleic acid and substantially all of the fluids to effect a nanoparticle hybridization test, a pump coupled to the processing module, a valving system disposed between the pump and processing module and a control system coupled to the pump and valving system causing the processing fluids to interact with the nucleic acid to effect a sandwich hybridization test using nanoparticles.

Abstract: It is an object of the present invention to provide a method for simply mixing two or more types of liquids in a porous carrier.

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 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 for identifying one or more ligands. The first and second sorbent strips touch each other at the test site location. The test cell may be used to test for pregnancy, HIV (including different HIV antigens or peptides), tuberculosis, prion, urin-analysis/drug, cardiac markers, cancer markers, Chagas, Chlamydia, dental bacteria (SM/LC), influenza A, influenza B, adenovirus, rotavirus, strep A, other bacteria or viruses, etc., and veterinary applications such as CPV, FIV, FeLV, heartworm, etc., although it is not limited to those applications.

Abstract: A sample analysis device is provided in which a target component to be analyzed is prevented from being contaminated by a sample itself, which can be formed in an appropriate size, and which has excellent operability. In a sample analysis device 1 in which a sample is to be held in a porous sheet 13, supporting films 11 and 12 are stuck on front and rear faces of the porous sheet 13, respectively, and a sample supply hole 14 is formed in a part of the supporting films.

Abstract: A new class of biosensors and methods for making and using same are disclosed. The biosensors are multi-layered membrane composites, where at least one layer is prepared by the layer-by-layer process and at least one layer is responsive to changes is a property of a biological system such as changes in the concentration of an atom, ion, molecule or molecular assembly. Because the biosensors are multi-layered, a single biosensor is capable monitor a number of different properties of a biological system simultaneously. The biosensors are monitored by systems that impinge an excitation waveform on the biosensors and analyze a reflected and/or a transmitted resultant waveform. Additionally, the biosensors can be associated with field activated electronic components so that implantable, self-contained analytical devices can be constructed and monitored by field generators, where data is transmitted to an analyzer after field activation.

Abstract: A method of scanning a sample plate surface mask in an area adjacent to a conductive area using mass spectrometry is disclosed. The method comprises the steps of providing a sample plate including a mask applied with a rough surface to the electrically conductive surface to produce a sample site comprising a central portion formed from the electrically conductive surface and a marginal portion of the mask, preparing an analyte comprising mixing a biomolecule with an organic solvent, an aqueous solution, and a matrix selected from the group of ?-cyano-4-hydroxycinnamic acid and3,5-dimethoxy-4-hydroxycinnamic acid; applying the analyte to the sample site; forming at least one crystal of the analyte in an area on the mask adjacent to the conductive area, and scanning the area on the mask adjacent to the conductive area with a laser beam.

Abstract: Device for immunochromatography comprise a test strip comprising a sample application member, a label holding member and a chromatography membrane, a first case member and a second case member. Detection kits and methods for testing an analyte substance are also described.

Abstract: A microchamber including a glass substrate which is transparent to a specific wavelength, an absorbent region which absorbs the specific wavelength, and a melting substance region which does not absorb the specific wavelength, is solid at room temperature and melts when heated, which regions are layered on the glass substrate. The absorbent region, is irradiated with a focused light beam of the specific wavelength and locally heated in the vicinity of the converging rays, so that the melting substance region is locally melted at a portion adjacent to the absorbent region, thereby forming a cavity as the focused light beam moves. Accordingly, the shape of the microchamber can be arbitrarily changed in accordance with the process of cell culture.

Abstract: The invention provides methods used to analyze the contents of a biological sample, such as blood serum, with cascade Raman sensing. A fluorescence producing nanoporous biosensor having probes that bind specifically to known analytes is contacted with a biological sample and one or more bound complexes coupled to the porous semiconductor structure are formed. The bound complexes are contacted with a Raman-active probe that binds specifically to the bound complexes and the biosensor is illuminated to generate fluorescent emissions from the biosensor. These fluorescent emissions generate Raman signals from the bound complexes. The Raman signals produced by the bound complexes are detected and the Raman signal associated with a bound protein-containing analyte is indicative of the presence of the protein-containing compound in the sample. The invention methods are useful to provide a protein profile of a patient sample. The invention also provides detection systems useful to practice the invention methods.

Abstract: An analytical test strip includes a substrate and a reagent layer disposed on a portion of the substrate. The reagent layer includes an enzymatic reagent ink comprising an amount of hydrophobic silica material, an amount of surfactant; and an amount of enzyme. The amounts of the hydrophobic silica material and the surfactant in the enzymatic reagent ink is predetermined using a first relationship and a second relationship. The first relationship is between wetability of a representative hydrophobic silica material and at least a first calibration characteristic of an analytical test strip that includes an enzymatic reagent ink containing the representative hydrophobic silica material. In addition, the first relationship defines a minimum wetability that provides an acceptable first calibration characteristic. The second relationship defines wetability of a mixture of the hydrophobic silica material and the surfactant across a range of relative amounts of the hydrophobic silica material and the surfactant.

Abstract: A method for manufacturing an array plate for biomolecules includes coating a surface of a substrate with a hydrophobic material to form a hydrophobic layer having initial hydrophobic properties, etching the hydrophobic layer through an etch mask placed thereon to form a hydrophilic binding site, removing the etch mask, and processing the remaining region of the hydrophobic layer to recover the initial hydrophobic properties. A method for manufacturing a biochip using this array plate, includes processing the surface of the hydrophilic binding site of the array plate to increase an affinity of biomolecules to the hydrophilic binding site, and applying a solution containing biomolecules to the surface of the hydrophilic binding site.

Abstract: In a biosensor having a developing layer for developing a sample solution, including a reagent part immobilized to a portion of the developing layer and a marked reagent part which is held in a dry state by a portion of the developing layer, and is dissolvable by developing the sample solution, and qualitatively or quantitatively analyzing an analyte in the sample solution by measuring the amount of the marker reagent bound to the reagent immobilization part; wherein plural reagent immobilization parts exist, and the respective reagent immobilization parts have different affinities for the analyte in the sample solution or the marker reagent, whereby a prozone phenomenon can be detected. Further, a biosensor with a high precision of measurement, which has a wider dynamic range for the concentration of the analyte in the sample solution, can be provided.

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

Abstract: An analytical device has a housing that encloses a multi-substrate chip having a reference marker and a plurality of substrates, wherein the housing is configured such that the reference marker and the substrates are illuminated by respective light sources at different angles. Further contemplated analytical devices include a housing with a cavity in which a multi-substrate chip having a plurality of substrates is at least partially disposed, wherein at least one of the plurality of substrates is coupled to a carrier via a crosslinker that is disposed in a matrix.

Abstract: Provided are methods and devices for separating particulate analytes or aggregates of analytes from a fluid, after the separation medium of the device is saturated with the fluid. The endpoint indicating completion of the separation is determined by saturation; therefore, no precise metering of the fluid sample is necessary. The separated analyte of interest can be detected, quantitated or its migration measured in the separation medium. The measured property of the analyte can then be correlated with a parameter of interest. In some embodiments, the device can be marked to directly read the value of the parameter of interest. In one embodiment, the fluid is blood and the device includes a volumetric capillary reservoir for collecting the blood, a separation paper or indicator strip, and graduations for correlating the migration of red blood cells with hematocrit or hemoglobin concentration.

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

Abstract: A biochemical sensor capable of detecting a prescribed target substance in a specimen in a short time period with high sensitivity and measuring the amount thereof has a surface and a rear surface, and channels formed from the surface to the rear surface, allowing influx of the specimen. An inner circumferential surface of the channels is formed of porous material. The porous material carries, in its pores, functional substance having a function of forming a reactant by the interaction with the target substance.

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

Abstract: Microfluidic devices having active features such as valves, peristaltic pumps, and mixing portions are fabricated to have a thin elastomeric membrane over the active features. The active features are activated by a tactile actuator external to the membrane, for example, a commercial Braille display. The display may be computer controlled, for example by simple text editor software, to activate individual Braille protrusions or a plurality of protrusions to actuate the active portions of the microfluidic device. Integral devices can incorporate the tactile actuators in a single device, but still external to the membrane.

Abstract: A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a scavenging zone that contains a capture reagent for the analyte of interest. The capture reagent may capture a quantity of the analyte that is less than or equal to a predefined base quantity of the analyte, such as a quantity considered “normal” for a particular test sample. Thus, the capture reagent is able to prevent some of the analyte from being detected. In this manner, the sensitivity of the assay device may be reduced in a simple, inexpensive, yet effective manner.

Abstract: A test strip configured for the detection of an analyte in a fluid sample and methods for manufacturing and for using the same. The test strip comprises a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween. The first flow matrix comprises a detection composition movably bound thereto, wherein the detection composition when exposed to the analyte produces at least one detectable product and wherein the first and second solid matrices are selected so as to accumulate the at least one detectable product at the interface between the two matrices, when the fluid sample travels from the first flow matrix to the second flow matrix.

Abstract: The present invention relates to a lateral flow assay and system, including a test strip, for detection and quantification of analytes in samples, such as samples containing cells and fluid, where the assay is volume independent, and the sample size is less than about 100 ?l, where the test strip includes a first membrane such as a sample filter, that is in capillary contact with an optional second membrane, such as a fluid collector, the second membrane, if present is in capillary contact with an optional third membrane, such as a conjugate pad containing a mobilizable detectable agent, or with a fourth membrane, which is a chromatographic strip, which optionally contains a mobilizable detectable agent, all such membranes being in fluid contact with a fifth membrane, such as a buffer pad, a sixth membrane, such as an absorbent pad, optionally a seventh membrane, which is also an absorbent pad, a capture band for capturing the analyte and at least one control band, or alternatively, the chromatographic strip

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: Test strips designed to prevent or reduce false results when measuring the condition of a sample are provided. The test strips can be used for analysis of samples by methods including electrical and optical measurements. The reagent test strips and methods are particularly suited for use in the detection of blood coagulation.

Abstract: The present invention provides a test strip and a detecting method thereof. The test strip comprises a first sheet, a second sheet a first filter and a second filter. The first sheet comprises a bulge portion deposited substantially in the center thereof. The second sheet comprises a depression in alignment with the bulge portion to form a sealing space. The first filter is disk-shaped and deposited in the sealing space. The first filter is used to receive a biological sample. The second filter is ring shaped and disposed in the sealing space and under the first filter to receive the biological sample coming from the first filter. The first filter comprises sodium azide, sodium dihydrogen phosphate, and urea, and the second filter comprises sodium azide, phenol red, and urea.

Abstract: A method for preparing a rubbed substrate structure suitable for use in a liquid crystal assay device, includes reacting a biochemical blocking compound that includes at least one reactive group with an activated modified surface of a support, the activated modified surface of the support having at least one functional group capable of reacting with the reactive group of the biochemical blocking compound, wherein a covalent bond is formed between the biochemical blocking compound and the support producing a support with a surface comprising the biochemical blocking compound. The method also includes rubbing the surface having the biochemical blocking compound to produce a rubbed surface that possesses features that drive uniform anchoring of liquid crystals when the liquid crystals contact the rubbed surface.

Abstract: Removal of abundant proteins from a sample enhances detection and resolution of less abundant proteins in the sample such as in two-dimensional gel electrophoresis. The removal is accomplished by immunosubtraction of several high abundance, interfering or contaminating proteins simultaneously.

Abstract: A diagnostic test kit for detecting the presence or absence of a protease (e.g., aminopeptidase) within a test sample is provided. The test kit comprises a substrate that is capable of being cleaved in the presence of the protease to release a compound. The kit also comprises a lateral flow device that comprises a chromatographic medium. The chromatographic medium defines a detection zone within which is contained a first reagent (e.g., diazonium ion) that is capable of reacting with the compound to form a second reagent (e.g., aromatic azo compound). The second reagent exhibits a color that is different than the color of the first reagent. The lateral flow device also includes an absorbent material located adjacent to the chromatographic medium, the absorbent material receiving the test sample after flowing through the chromatographic medium.

Abstract: Described herein are various embodiments of a test strip, which may be capable of measuring an analyte. The test strip may include a working electrode and a reference electrode where the reagent formulation is disposed on the working electrode. The reagent formulation may be coated onto the test strip. The reagent formulation includes an enzyme, a ruthenium hexamine mediator, and a solution for dissolving the enzyme and the ruthenium hexamine mediator. The reagent formulation may be coated onto the test strip. The reagent formulation includes an enzyme, a ruthenium hexamine mediator, and a solution for dissolving the enzyme and the ruthenium hexamine mediator. The ruthenium hexamine has a concentration range from about 15% to about 20% (weight of mediator/volume) of solution. The enzyme may be either glucose oxidase and glucose dehydrogenase.

Abstract: A test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid is provided, as well as methods for making and using the test strip. This test strip is commercially usable, for example, in a diagnostic device at a point of care for detection of analytes in whole blood.

Abstract: A chromatographic test device comprising, in the order of passage of a sample containing blood cell components and liquid components, a label holding member provided with a labeling substance capable of binding specifically to an analyte contained in the liquid components, a blood cell separation member for separating predetermined blood cell components in the sample from the liquid components, and a chromatographic carrier carrying a capturing substance capable of binding specifically to the analyte.

Abstract: The present invention relates to an aqueous coating composition for coating a photoresist pattern comprising a polymer containing amino group. The present invention also relates to a process for manufacturing a microelectronic device comprising providing a substrate with a photoresist pattern, coating the photoresist pattern with the novel coating material reacting a portion of the coating material in contact with the photoresist pattern, and removing a portion of the coating material which is not reacted with a removal solution.

Abstract: A biosensor is provided with a development layer for developing an inspection target solution, that has a reagent immobilization part where an antibody for a measurement target in the inspection target solution is immobilized and a reagent holding part which marks in a dry state and holds an antibody which can be eluted by development of the inspection target solution in parts of the development layer. The biosensor measures a bonding amount of the marker reagent bonded to the reagent immobilization part, thereby qualitatively or quantitatively measuring components to be measured in the inspection target solution, and is further provided with a space forming material that forms a cavity part, which is a space into which the inspection target solution flows, between the development layer for developing the inspection target solution and the space forming material.

Abstract: A protease detection product (1) for detecting a protease enzyme in a sample. The protease detection product (1) comprises a medium (2) providing a liquid flow path; a labelled component (6) located on the liquid flow path; a capture component (12) located downstream of the labelled component (6) and immobilisation means (8) for immobilising the intact labelled component. The labelled component (7) comprises a base element (8) connected to releasable element via a protease-sensitive linker peptide (9). The releasable element comprises a label (10). The capture component (12) is capable of binding the releasable element.

Abstract: An indicator device for determining the efficacy of an antimicrobial treatment process. The indicator device includes an active agent encapsulated in an encapsulation component. The encapsulation components preferably takes the form of an electrospun nanofiber including a polymer.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

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: In order to realize a sensor that is capable of promptly and accurately supplying a small amount of a liquid sample to a filtration part even if the sensor is not held substantially horizontally, this invention provides a sensor having means for supplying a liquid sample to the filtration part by capillary action.

Abstract: A biochemical analysis unit has a flow-through area in which plural spot areas are arranged, and probes are spotted onto the spot areas. The biochemical analysis unit is set into a chamber of a reaction vessel. A reaction solution containing a target is supplied through an inlet into the chamber. A flow rate is adjusted such that the pressure loss may be 80 kPa when the reaction solution flows through the flow-through area. When the pressure loss is increased, the reaction solution flows through the flow-through area after equivalently spreading into a lower side of the chamber. Thus the flowing speed is decreased.

Abstract: A diagnostic assay device that directs an applied sample to the analytical membrane of a directed flow device. The device has a sample receiving port defined by layers of built-up material on one end of the test strip. The port contains the sample and specifically directs it to the membrane in a controlled fashion. Additional features include configuration of the housing in a general C-shape with the test strip spanning the opening of the C-shape to allow access by a reader device. A preferred method employs superparamagnetic particles to label the target analytes for detection and measurement by means of an electromagnetic reader device.

Abstract: Disclosed herein is a fully-integrated, disposable biochip for point-of-care testing of clinically relevant parameters. Specifically, in accordance with an embodiment of the present invention, the biochip is designed for POCT (point-of-care-testing) of an array of metabolic parameters including partial pressure of oxygen, Glucose, and Lactate concentration from venous blood samples. The biochip is fabricated on a low-cost plastic substrate using mass manufacturing compatible fabrication processes. Furthermore, the biochip contains a fully-integrated metallic micro-needle for blood sampling. The biochip also uses smart passive microfluidics in conjunction with low-power functional on-chip pressure generators for microfluidic sequencing. The design, configuration, assembly and operation of the biochip are ideally suited for a disposable biochip specifically targeted towards POCT applications.

Abstract: Disclosed herein is a dry fluorescence biosensor strip for rapid detection of a target analyte present in bodily fluids. The dry fluorescence biosensor strip comprises a sample receptacle and a dry detection membrane. The sample receptacle receives a sample of one of the bodily fluids. The dry detection membrane detects presence of the target analyte in the received sample based on fluorescence induced on the dry detection membrane. Fluorescent signals are emitted from the dry detection membrane on induction of fluorescence. A fluorometer quantifies measurable properties of the target analyte based on the emitted fluorescent signals. The dry fluorescence biosensor strip may further comprise a filtration membrane for filtering the received sample. The filtered sample migrates from the filtration membrane to the dry detection membrane. The dry detection membrane may then detect presence of the target analyte in the filtered sample.

Abstract: An assay device, analytical instrument and assay method for determining the presence or amount of an analyte in a fluid is disclosed. The device is a one-step lateral flow dry reagent immunoassay with one, two or more zones along a transverse axis of the device, each zone can contain or be preceded by diffusively or non-diffusively bound reagents. The invention measures an indicator in one or two test zones for each analyte to determine its presence or concentration. The signal reagent (indicator) may be a particle such as a colored latex or colloidal gold. The assay quantitation may be read by an instrument.

Abstract: This invention relates to assays for an analyte in a liquid sample such as a body fluid. More particularly, the invention relates to a method and apparatus for the detection of a ligand in a body fluid such as urine or blood, which includes an immobilization zone for interfering agents in a sample.