Abstract: The present invention relates to a biosensor specifically detecting a protein kinase A (PKA), and a diagnosis kit comprising the biosensor. In particular, the present invention relates to a biosensor for detecting a PKA comprising a cantilever, and a protein kinase inhibitor (PKI) immobilized on the surface of the cantilever; and a kit for diagnosing diseases caused by the increase of the activity of a protein kinase, comprising a sample, the biosensor, and a quantification manner.

Abstract: This invention focuses on the marriage of solid-state electronics and neuronal function to create a new high-throughput electrophysiological assay to determine a compound's acute and chronic effect on cellular function. Electronics, surface chemistry, biotechnology, and fundamental neuroscience are integrated to provide an assay where the reporter element is an array of electrically active cells. This innovative technology can be applied to neurotoxicity, and to screening compounds from combinatorial chemistry, gene function analysis, and basic neuroscience applications. The system of the invention analyzes how the action potential is interrupted by drugs or toxins. Differences in the action potentials are due to individual toxins acting on different biochemical pathways, which in turn affects different ion channels, thereby changing the peak shape of the action potential differently for each toxin.

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 ate also disclosed.

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: The present invention discloses a device for monitoring chemotaxis or chemoinvasion. The present invention further provides a flexible assay system and numerous assays that can be used to test biological interactions and systems. Laminar flow gradients are employed that mimic gradient situations present in vivo.

Abstract: Devices and methods for performing assays on materials, particularly biological materials, are provided. The devices and methods make use of self-sealing members, which can be applied to a flat surface to form wells to facilitate immobilization of materials on the flat surface, then removed to yield a flat surface that facilitates the performance of processes on and/or detection of the immobilized material.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: A process and device are disclosed to determine the activity of enzymes in liquids in a largely automatic manner. The device for carrying out this process has a column (1) with a chromatographic carrier for treating a measurement sample. The carrier is mixed with a substance capable of binding to an enzyme inhibitor present in the measurement sample and that corresponds to at least one enzyme. A measurement sample supply (2) is associated to one end of the column (1). A valve/pump arrangement (7, 11, 14, 15) for filling at least one test tube (5) with a carrier and at least part of the measurement sample is connected downstream of the column (1), in the flow direction of the measurement sample. The carrier is dissociated into cleavage products by the action of the enzyme. The rise in concentration per unit of time of at least one of the cleavage products of the carrier is sensed during an incubation time.

Abstract: An evanescent-field sensor system and method of using the system to detect either liquid- or airborne biological pathogens, chemical agents, and other harmful or toxic species is provided. The sensor system involves 1) an evanescent-field sensor having a substrate surface with at least a partial bio- or chemo-responsive layer, which forms a part of a serially renewable sensing region; 2) an optical interrogation apparatus for monitoring the bio- or chemo-responsive layer; and 3) an air-fluid delivery system. The optical interrogation apparatus has a light source, an optical delivery system, and a detection instrument or device. The air-fluid delivery system includes either macro or micro-fluidic passages designed to convey biological or chemical analytes to a sensing region.

Abstract: Device and method for sterility testing, in particular of pharmaceutical products, includes a closed sterility test system having at least two test containers, in each case having an integrated test filter, an outlet connecting branch arranged below the test filter and an inlet connecting branch which is arranged above the test filter and can be connected with a tube connection via a sampling device to a sample container. The tube connection of the test container in each case has a distributing component via which a fixed tube connection to an associated nutrient medium container is formed and can be used to feed an associated nutrient medium to the test container.

Abstract: The invention is directed to novel IC chips containing substances used particularly in bioassays. Furthermore, the invention is directed to assay methods and kits using these chips.

Abstract: A substrate for testing a carrier liquid for biomolecules using SPR or other techniques provides a metallic island surrounded by a hydrophobic layer, the islands being a location for the attachment of probe molecules. The hydrophobic layer may also be a dielectric material providing improved sensitivity in SPR imaging.

Abstract: In a method for analysis biomolecules (3) attached to a solid surface of a substrate (1) are used for detecting the presence of analytes (4) in a sample by binding of the analytes to the biomolecules. The biomolecules (3) are attached directly to the surface of the substrate together with biomolecule-repellent molecules (5), which cover the surface between the biomolecules (3) to prevent nonspecific binding of analytes (4) and other biomolecules. The invention relates also to a biosensor where biomolecules (3) are attached directly to the substrate (1) together with biomolecule-repellent molecules (5), which cover the surface between the biomolecules (3) to prevent non-specific binding of analytes (4) and other biomolecules. The biomolecules (5) can be self-assembled hydrophilic polymers. One example of using the invention is immunological analysis using surface plasmon resonance (SPR).

Abstract: The invention provides methods and compositions for the detection and/or quantification of a microbial contaminant, for example, a bacterial endotoxin or a glucan, in a sample. In particular, the invention provides a test cartridge useful in the practice of hemocyte lysate-based assays for the detection and/or quantification of a microbial contaminant in a sample. In addition, the invention provides methods of making and using such cartridges. In addition, the invention provides a rapid, sensitive, multi-step kinetic hemocyte lysate-based assay for the detection and/or quantification of a microbial contaminant in a sample. In addition, the invention provides a glucan-specific lysate that can be used in a variety of assay formats, including, for example, a test cartridge, optionally configured to perform a kinetic assay.

Abstract: An apparatus comprising one or more piezoelectric mass sensors for use in diagnostic and analytic processes, in particular for immunochemical detection of diagnostically relevant analytes in real time, is described. Each piezoelectric mass sensor comprises a piezoelectric crystal with a receptor surface which has immobilized thereon a lawn of recombinant antibodies comprising single VH chain or single-chain Fv (scFv) polypeptides specific for a particular antigen. Binding of antigen to the recombinant antibodies results in a change in mass on the receptor surface which is detected as a change in resonant frequency. In a preferred embodiment, the receptor layer is a precious metal such as gold which facilitates self-assembly of the recombinant antibodies into a lawn on the receptor surface via a cysteine residue at the carboxy terminus of the attachment polypeptide.

Abstract: It has been found that a urine test for ovarian reserve can be provided which is equivalent in sensitivity to current laboratory methods which determine ovarian reserve based on FSH levels in serum. A lateral flow device for indicating ovarian reserve is disclosed. The device has an application zone for receiving a urine sample, a labelling zone containing label which binds to FSH in the sample, and a detection zone where FSH-bound label is retained. The detection zone has a threshold value which corresponds to a serum FSII level of between 5-20 mIU/ml (e.g. 10 mIU/ml). A test result above the threshold value indicates diminished ovarian reserve.

Abstract: A device for monitoring leukocyte migration is provided. The device generally includes a plurality of chambers, each chamber including a channel in which leukocyte migration mediators or endothelial cells are disposed therein. The device is fabricated in the footprint of a standard microtiter plate. The invention also provides a method of using the device to monitor leukocyte migration in the presence of physiological shear flow and therefore simulate physiological conditions of a blood vessel in vivo. The invention further provides a method of using the device to high-throughput screen a plurality of test agents.

Abstract: The present invention provides methods, compositions, and kits for rapid detection of analytes in a sample. Surprisingly, it has been found that bulking materials having non-sugar sweeteners effectively enhance chromatographic detection methods by providing component stability and controlled release. Thus, the novel components and methods disclosed herein provide a completely new modality of chromatographic analyte detection.

Abstract: A simple easy to manufacture analytical device capable of performing membrane based immunoassays on batch of samples within 3 to 10 minutes wherein the method permits focused application of samples, costly labeled immunoassay and signal amplification reagents, said device includes an antibody-immobilized micro porous membrane, breadth corner layer of which is directly attached to a semi-rigid liquid-impervious body with water insoluble adhesive; absorbent body is provided separately and is not attached to analytical device during manufacture, absorbent body is wetted and is placed proximal to the lower surface of the membrane thereby forming networks of capillary channels with the absorbent body; flow of samples or reagents is always kept downwards and focused without application of any force to the absorbent body and the use of disposable adsorbent body permits stepwise addition of signal amplification reagents for ultra sensitive detection of diagnostically important molecules by visual examination of the m

Abstract: Method for the detection and enumeration of viable microorganisms. A liquid that comprises one or more markers incorporated in a liquid sol-gel precursor, is provided. A transparent slide is coated with a thin uniform layer of the liquid sol-gel precursor composition. The microorganisms are separated from liquid sample to be analyzed by passing the sample through a filter, and then bringing the filter into close contact with the sol-gel coated slide. The filter is co-incubated with the sol-gel coated slide for a period of time and at a temperature suitable to promote uptake of the markers by the microorganisms. The gel-coated slide irradiated with an external energy source, so as to generate detectable signals emitted from the markers uptaken by the microorganisms. Image of the detectable signals emitted from the microorganisms are acquired, and analyzed using a computer system, in order to provide the identification and enumeration of the microorganisms.

Abstract: Method and reagent composition for covalent attachment of target molecules, such as nucleic acids, onto the surface of a substrate. The reagent composition includes epoxide groups capable of covalently binding to the target molecule. Optionally, the composition can contain photoreactive groups for use in attaching the reagent composition to the surface.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: A method and kit for detecting Trichomonas vaginalis infection in a human subject are disclosed. In the method, a body-fluid sample such as a vaginal swab sample or urine is obtained from the subject and contacted with an antibody specific against a Trichomonas adhesin peptide, forming an antibody-adhesin peptide complex if the subject is infected with Trichomonas. The presence or absence of the complex establishes, with a reliability of at least 80%, in the case of a vaginal swab sample, and with a reliability of at least 40% in the case of a urine sample, the presence or absence, respectively, of Trichomonas infection in the subject. A preferred test kit employs a dry-strip, sandwich assay, format.

Abstract: Methods for testing a fecal sample for the presence of hemoglobin, comprising performing a chemical fecal occult blood test on the sample and then performing an immunochemical fecal occult blood test on a portion of the sample exposed to the chemical reagents used in the chemical fecal occult blood test.

Abstract: The present invention provides methods, compositions, and kits for rapid detection of analytes in a sample. Surprisingly, it has been found that bulking materials having starch reagents effectively enhance chromatographic detection methods by providing component stability and controlled release. Thus, the novel components and methods disclosed herein provide a completely new modality of chromatographic analyte detection.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: The present invention provides an optical assay apparatus that includes a light source module and an optical sensor. The light source module produces light having a range of propagation angles. The sensor includes a light adjusting portion and an assay sensing portion. The light adjusting portion receives the light produced by the light source module and provides light having a propagation angle that is substantially constant to the assay sensing portion. In one embodiment, the sensor may be coupled with the light source module by an interrogation module which includes a window in which a waveguide is integrated. In another embodiment, the sensor and interrogation module are mounted in an automated assay platform that provides two-dimensional or three-dimensional movement of the sensor so that it can be sequentially immersed in solutions required to perform a particular assay protocol.

Abstract: Multiwell plate applications are describe for use with a plurality of fibres having an extraction phase coated thereon in combination with a positioning device. The device and method described are able to perform adsorption of components of interest from a biological system in high volume.

Abstract: Arrays of protein-capture agents useful for the simultaneous detection of a plurality of proteins which are the expression products, or fragments thereof, of a cell or population of cells in an organism are provided. A variety of antibody arrays, in particular, are described. Methods of both making and using the arrays of protein-capture agents are also disclosed. The invention arrays are particularly useful for various proteomics applications including assessing patterns of protein expression and modification in cells.

Abstract: Methods, articles, and kits for obtaining elevated concentrations of a substance from a sample that has become bound, for example by providing a positive test result in an immunoassay or other binding assay. The concentrated substance is optionally subjected to further processing or analysis, for example to confirm the identity of the substance, such as a pathogenic organism in a food sample.

Abstract: A chromatographic assay device for the analysis of an analyte in a liquid sample has a proximal sample application zone and a distal test zone. The test zone contains a first ligand capable of binding with the analyte to form an analyte-ligand complex. The device also includes a spatially distinct reservoir containing a labeled reagent capable of binding to the analyte-ligand complex; an absorbent sink which is positioned to be capable of drawing the contents of the spatially distinct reservoir through the test zone; and structures for contacting the spatially distinct reservoir with the chromatographic medium so that the labeled reagent migrates from the reservoir to the absorbent sink, and thereby through the test zone to determine the presence or absence of the analyte. The device is used in a method for detecting analyte.

Abstract: An immunoassay cassette, apparatus, and method for detecting an analyte in a liquid body-fluid sample are disclosed. The cassette has a body and a support mounted on the body, for movement relative to the body to first and second transfer positions. Sample supplied to a sample well in the cassette body is transferred to a reagent reservoir on the cassette body, by moving the support to its first transfer position. Here the sample reacts with a first reagent composition in the reservoir effective to form a modified sample. The modified sample is then transferred to a reagent strip on the support by moving the support to its second transfer position. The reagent strip has a transfer zone at which sample material is transferred to the strip, a second reagent composition effective to react with the modified sample to form a detectable analyte-dependent product, and a detection zone located downstream at which the detectable product can be observed.

Abstract: An immunoassay cassette, apparatus, and method for detecting an analyte in a liquid body-fluid sample are disclosed. The cassette has a body and a support mounted on the body, for movement toward and away from a sample transfer position. Sample supplied to a sample well in the cassette body is taken up by a reagent reservoir containing a first reagent composition effective to form a modified sample. The support provides a reagent strip having a transfer zone that is brought into contact with the reservoir, when the support is in the transfer position, a detection zone located downstream of the transfer zone, and a second reagent composition effective to react with the modified sample to form a detectable analyte-dependent product. By controlling movement of the support, volume and rate of sample flow from the reservoir to the strip can be controlled to optimize and/or standardize sample-transfer conditions in the assay.

Abstract: An assay system has a chamber that receives a test strip onto which a sample comprising an analyte has been placed. The chamber is in gaseous communication with a piezoelectric material that generates an electrical signal in response to a pressure change in the chamber that is caused by a reaction between the analyte and a reagent.

Abstract: The invention is directed to a method and device for simultaneously testing a sample for the presence, absence, and/or amounts of one or more a plurality of selected analytes. The invention includes, in one aspect, a device for detecting or quantitating a plurality of different analytes in a liquid sample. The device includes a substrate which defines a sample-distribution network having (i) a sample inlet, (ii) one or more detection chambers, and (iii) channel means providing a dead-end fluid connection between each of the chambers and the inlet. Each chamber may include an analyte-specific reagent effective to react with a selected analyte that may be present in the sample, and detection means for detecting the signal. Also disclosed are methods utilizing the device.

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 analysed, (typically for the presence of a particular protein), and a detection analyte (typically an antibody 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: Methods and compositions are provided for detecting biomolecular interactions. The use of labels is not required and the methods can be performed in a high-throughput manner. The invention also provides optical devices useful as narrow band filters.

Abstract: The present invention relates to a method and system for the in vivo determination of the presence and/or concentration of biological and/or chemical substances in body lumens. The system of the invention comprises a solid support, the support being inserted into a body lumen and having immobilized thereon at least one reactant capable of reacting with the substance resulting in an optical change; and a detecting unit, in communication with the support, capable of detecting a reaction resulting in an optical change between the reactant and the substance.

Abstract: Supports for immobilizing molecules, particularly biomolecules, methods of making such supports, kits, and biomolecular hybridization assay devices are disclosed. The methods, supports and devices include forming a triamine layer on at least a portion of a substrate and attaching a compound to a portion of the substrate.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).

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

Abstract: A measurement method is provided, which enables to obtain a two-dimensional image with better quantitative-ability by suppressing the influence of the charge-up, when the two-dimensional secondary ion image is obtained for a biological material fixed on a substrate having a high resistivity by utilizing a TOF-SIMS method in a certain wide area. A two-dimensional image having considerably high positioning resolution-ability can be obtained by the procedure in which the pulsed primary ion beam is irradiated at a spot, and the pulse-wise spot-applications of the primary ion beam and the simultaneous detection of the secondary ion generated from the irradiated primary ion beam proceed along with a discontinuous scanning pattern, and eventually the results of these secondary ion measurements are reconstructed into a two-dimensional image in line with the aforementioned discontinuous scanning pattern.

Abstract: The present invention relates to a structure and manufacturing process of a nano device transistor for a biosensor. The structure, the manufacturing process and the related circuit for a carbon nano tube or nano wire transistor biosensor device are provided. The refurbished nano device is used for absorbing various anti-bodies so as to detect the specific antigens or absorbing various biotins. Therefore, the object of the present invention to detect the specific species for bio measurement can be achieved.

Abstract: An apparatus for separating and detecting motile spermatozoa in a liquid sample, comprises: a separation vessel including (i) an inlet port, (ii) an outlet port arranged to be opened, (iii) a separation medium into which motile spermatozoa in the sample can flow via the inlet port, and (iv) an actuator operable to open the outlet port for allowing the separation medium to flow out of the vessel through the outlet port; and a spermatozoa detection device including (i) an application zone in communication with the outlet port, (ii) a detection zone, in which presence of spermatozoa can be detected, and (iii) a reagent zone containing a reagent which is capable of reacting with spermatozoa to facilitate detection of the spermatozoa in the detection zone, with the application zone, the detection zone and the reagent zone being arranged to permit capillary flow of spermatozoa from the application zone to the detection zone.

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: The present invention provides antibodies which specifically bind early conception factor, which can be found in body fluids of animals including but not limited to the cow, cat, dog, horse, human, sheep, and pig. The invention provides methods for detecting conception or the absence of conception in an animal, the latter being recognized by the absence of early conception factor in a suitable body fluid collected from the animal. Apparati for detecting early conception factor in a body fluid from an animal comprising the antibodies which specifically bind early conception factor are also provided.

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 involve providing a solid phase apparatus comprising a membrane having an application point, a sample capture zone, and a control capture zone, where the sample capture region is between the contact region and the control capture zone; and providing a sample collection apparatus comprising a population of analyte binding particles or a population of analyte coated particles. In the assays, a fluid sample is introduced into the sample collection apparatus, and the resultant mixture is applied to the application point of the membrane. The fluid allows transport components of the assay by capillary action to and through the sample capture zone and subsequently to and through the control capture zone. The amount of analyte in the fluid sample is related (e.g.

Abstract: The present invention relates to film-immobilized capture particles, and substrates coated with film-immobilized capture particles. In particular, the present invention provides microarrays for detecting the presence or absence of a target in a sample employing film-immobilized capture particles. In preferred embodiments, the present provides very high density arrays that allow simultaneous analysis on a number of samples.

Abstract: The present invention describes methods and cassettes for cell-based toxin detection and organ localization. The cassettes includes an array containing cells and a matrix of openings or depressions, wherein each region of the substrate enclosed by the opening or depression in the matrix forms a domain individually addressable by microfluidic channels in the device.

Abstract: The invention discloses an on-spot hydrophilic enhanced slide/microarray. The preparation method relates to a hydrophobic copolymer prepared by blending, grafting or co-polymerization of a hydrophobic material and a compound bearing functional groups such as anhydride, imide, cyclic amide, and cyclic ester, and application of the hydrophobic copolymer onto an organic or inorganic substrate. The resulting slide has the properties of on-spot hydrophilic/hydrophobic dynamic conversion, as well as on-spot hydrophilic enhancement for the preparation of high-density and high-efficiency bio-chip/microarray.