Abstract: Detection apparatus for use in the detection of the presence of a selected pathogen in a sample are disclosed. Such apparatus include: a substrate with a detection region on a surface thereof, the detection region having microstructures including grooves formed therein that will align liquid crystal material in contact therewith, the width and depth of the grooves being in the range of 10 &mgr;m or less; a blocking layer on the surface of the detection region of the substrate that does not disrupt the alignment of liquid crystal material in contact therewith, the blocking layer blocking nonspecific adsorption of pathogens to the surface; and a binding agent on the surface of the detection region of the substrate, the binding agent specifically binding the selected pathogen.

Abstract: The present invention is directed to the use of deposited thin films for chemical or biological analysis. The invention further relates to the use of these thin films in separation adherence and detection of chemical of biological samples. Applications of these thin films include desorption-ionization mass spectroscopy, electrical contacts for organic thin films and molecules, optical coupling of light energy for analysis, biological materials manipulation, chromatographic separation, head space adsorbance media, media for atomic molecular adsorbance or attachment, and substrates for cell attachment.

Abstract: A method of making strip for testing for the presence of an analyte generally comprises providing a support member which includes a spreading layer and a reagent layer, and a capillary in communication with the support layer and spreading layer for transporting a sample of body fluid thereto.

Abstract: A device and method allow for detecting the presence of microorganisms in clinical and non-clinical specimens. The device, a sensor, provides an environment to culture microbial organism colonies from a fluid sample, and a means to facilitate microbial detection and quantification, either manually or with an instrument. The sensor has a microorganism immobilization matrix layer and a sensor layer. Detected microbial colonies are immediately available for further testing. The sensor provides an area for accepting a fluid sample, a mechanism to immobilize the fluid sample on an interior surface of the plate, nutrients to facilitate growth of microorganisms in the sample, and a sensor for allowing the detection and/or enumeration of microorganism colonies within the sample.

Abstract: The invention relates to sensor compositions comprising a composite array of individual arrays, to allow for simultaneous processing of a number of samples. The invention further provides methods of making and using the composite arrays. The invention further provides a hybridization chamber for use with a composite array.

Abstract: The present invention involves an optical assay device and method of use for the detection of an analyte of interest in a sample that conveniently allows control of the flow characteristics of the sample through the device without significant user intervention. The optical assay device includes a base having an absorbent material, and a member having an optically active test stack that is rotatably coupled to the base for rotation between a lowered position and a raised position. In the lowered position, the optically active test stack contacts the absorbent material for drawing the sample through the surface. In the raised position, the optically active test stack does not contact the absorbent material.

Abstract: The present invention provides systems, methods, screens, reagents and kits for optical system analysis of cells to rapidly determine the distribution, environment, or activity of fluorescently labeled reporter molecules in cells for the purpose of screening large numbers of compounds for those that specifically affect particular biological functions.

Abstract: Microfabrication methods and devices in which microscale structural elements are provided in an intermediate polymer layer between two planar substrates. Preferred aspects utilize photoimagable or ablatable polymer layers as the intermediate polymer layer.

Abstract: A catcher, having an immunological epitope, is fixed to a detection zone of a spreading layer. A marker, capable of easy detection, has an inmmunological epitope. The marker and bispecific antibodies are soluble so that they can move on the spreading layer. The bispecific antibodies include a first bispecific antibody, having specificity for the detectable material in the fluid sample and the marker, and a second bispecific antibody, having specificity for the detectable material in the fluid sample and the catcher. Pore sizes and particle diameters are set so that the reaction product in which the marking elements and the particles are bonded are caught at a catching section. The concentration of the marking elements and the particles are increased to improve detection sensitivity. The result is an inexpensive and simple detection apparatus being highly-sensitive for the immunological detection of a detectable material, without wasting valuable antibodies.

Abstract: The invention relates to a method for determining an analyte by means of binding reactions, which method comprises: i) applying the sample to an application zone for sample (ASZ) on a flow matrix in which transport of components present in the sample can take place (transport flow), the flow matrix further exhibiting: a) optionally an application zone (AR*Z) for a binding reactant (Reactant*=R*) which is analytically detectable; b) a detection zone (DZ), which is located downstream of ASZ and exhibits an additional binding reactant (Capturer) firmly anchored to the matrix, and in which a complex (signal complex) containing the Capturer and the analyte and/or Reactant* is formed during the reaction, and ii) detecting the signal complex in the detection zone, the measured signal being used for determining the analyte.

Abstract: A method for determining and diagnosing inflammatory enteric disease using an immunochromatographic test device having a multiplicity of test zones. The method tests for the presence of at least one enteric pathogen and at least one of certain inflammatory enteric disease markers. The enteric pathogens tested for can be any number of enteric pathogens such as the pathogens E. coli O157, Campylobacter, Salmonella, Listeria, Shigella, and Yersinia. The inflammatory enteric disease markers tested for are fecal lactoferrin, a bacteria marker, a virus marker, and a protozoa marker. Positive results for any one of the pathogens indicates that pathogen as the cause of the inflammatory enteric disease. Positive results for fecal lactoferrin indicate an inflammatory condition of the intestines. Positive results for the bacteria, virus, protozoa markers indicate respectively a bacterial, viral, or protozoan cause of infection as the cause of the disease.

Abstract: A process for preparing arrays of two or more heterogeneous catalysts, heterogeneous catalyst precursors, or combinations thereof in a body having preferably parallel through-channels. In this process, a solution, emulsion or dispersion of elements present in the catalyst, catalyst precursor, or combination thereof, is first prepared, and is used to simultaneously or successively coat the channels of the body to produce freshly impregnated moist channels. These channels are then treated and reacted with one or more reactive gases, and the coated body is optionally heated in the presence or absence of inert or reactive gases.

Abstract: A system for the rapid characterization of multi-analyte fluids, in one embodiment, includes a light source, a sensor array, and a detector. The sensor array is formed from a supporting member into which a plurality of cavities may be formed. A series of chemically sensitive particles are, in one embodiment positioned within the cavities. The particles may be configured to produce a signal when a receptor coupled to the particle interacts with the analyte. Using pattern recognition techniques, the analytes within a multi-analyte fluid may be characterized.

Abstract: One-step enzyme immunoassays in which enzyme-antibody conjugate or label and enzyme substrate are separated until separation of bound and free enzyme conjugate or label is complete. This separation is accomplished by using variable flow paths, immobilization of substrate at the test line, placement of substrate in a sac or association with a particle label, enzyme product chemical capture, delay zone dissolution and protected enzyme substrates.

Abstract: A method for detecting a microorganism in a test sample is described. The method involves distributing microvolumes of a sample to a plurality of microcompartments of a culture device, incubating for a time sufficient to permit at least one cell division cycle of the microorganism, then detecting the presence or absence of the microorganism in the microcompartments. Also disclosed are devices for carrying out these methods.

Abstract: A rubbed substrate structure for use in a liquid crystal assay device, includes: a biochemical blocking compound chemically immobilized on a surface of one side of a support forming a biochemical blocking layer; and a biomolecule recognition agent deposited on the side of the support containing the biochemical blocking layer. The biomolecule recognition agent includes a recognition site capable of selectively recognizing a target species to be detected by the liquid crystal assay device. Additionally, the surface of the side of the support containing the biochemical blocking layer is rubbed such that it possesses features that drive a uniform anchoring of liquid crystals when the liquid crystals contact the side of the support containing the biochemical blocking layer.

Abstract: A chromatography assay device and method for use with whole blood samples utilizing a red blood cell separating agent to aggregate red blood cells and permit plasma or serum to flow by capillary action and a neutralizing agent to neutralize any effects the red blood cell separating agent may have on the device and method.

Abstract: Rigid frame (10) for holding thin, flexible tray top (82) of injection-molded multiwell tray (81) planar. Multiwell tray (81), such as a titre or PCR plate, includes apertures (86) spaced apart in peripheral wall (85). Frame wall (20) of frame (10) includes a plurality of barbs (41) spaced apart on interior surface (40). Apertures (86) and barbs (41) cooperate to retain tray (81) within tray (10).

Abstract: A test piece for use in biological analyses includes a plurality of different known specific binding substances disposed in predetermined positions on a substrate. The specific binding substances are disposed on a plurality of surfaces provided by the substrate and arranged in the direction of thickness of the substrate.

Abstract: The present invention provides high-density arrays including mask layers and methods of manufacturing the same. The arrays are formed on a polymeric substrate and include a mask layer. Various linking agents, linking agent coatings, and/or reactants may be provided on the mask layer. Where present, the linking agents and reactants preferably operate together to capture a desired analyte which can then be detected based on an electromagnetic signal, e.g., fluorescence, that is emitted by the analyte in response to excitation energy incident on the array. With the mask layer in place, the signal-to-background ratio provided by the arrays can be increased.

Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises a flavin-dependent enzyme that has specificity for the analyte, a flavin cofactor if, and only if, a flavin is not bound to the enzyme, a tetrazolium dye precursor, an electron transfer agent, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring glucose in whole blood.

Abstract: A device for culturing microorganisms and its use are described. The claimed device comprises a substrate having a top side, a pedestal mounted on the top side of the substrate and comprising a non-absorbent culture surface, a flexible cover sheet attached to the substrate and comprising a bottom surface, the cover sheet being configured to cover the culture surface, and a culture medium deposited on one or more surfaces selected from: the culture surface, and the cover sheet bottom surface. An aqueous sample is spread and contained by the claimed device without additional equipment or manipulation by the end user.

Abstract: A device and method for filtering a biologically derived sample and for mixing the sample with a reagent, comprising a fluid container defining a reservoir compartment and including a container outlet, a filter and a fluid flow-through matrix disposed in a flow path between the reservoir compartment and the container outlet. Water-soluble, dried reagent is retained on the matrix. Means is provided for urging sample in an aqueous liquid in the reservoir compartment through the filter and matrix and out the container outlet. Pressure is applied to the sample in an aqueous liquid in the reservoir compartment to cause the sample to flow in liquid through the filter and matrix and out of the container for analysis.

Abstract: A multilayer analytical element for determining a level of an analyte on a substrate and adapted for use with hydrogen peroxide and an affinity-enzymatic compound of formula A-C-B, wherein A is a detecting agent having affinity for the analyte, B is an enzymatic visualizing agent consisting of peroxidase and C is a binding agent linking the detecting and visualizing agents together. The multilayer analytical element of the invention comprises a solid support and a hydrophilic layer thereon, the hydrophilic layer being formed of gelatin, polyvinyl alcohol or a mixture thereof and containing a developing agent and a hydrophobic color-producing agent in a total amount of 5 to 30 weight %, the developing agent and the color-producing agent being present in a weight ratio of 1:0.3 to 1:3.0.

Abstract: A device and method are provided for isolating and culturing microorganisms from a bulk fluid sample. The device comprises a container having therein a polymeric immobilization layer having interstitial spaces between polymer chains such as a gel matrix. The interstitial spaces are of an average size less than an average size of microorganisms to be separated from the sample and cultured. A bulk fluid sample is applied to the immobilization layer where fluid is absorbed by the layer and microorganisms remain on the surface of the layer. After culturing, microorganism colonies are readily accessible on the surface of the layer for harvest and testing. The immobilization layer may contain one or more of nutrients for microorganism growth, lytic agents, lytic enzymes, antibiotics, antibiotic neutralizers, indicators, detergents and selective agents. An adjacent support layer may be above and/or below the immobilization layer.

Abstract: The present invention provides high-density arrays including mask layers and methods of manufacturing the same. The arrays are formed on a polymeric substrate and include a mask layer. Various linking agents, linking agent coatings, and/or reactants may be provided on the mask layer. Where present, the linking agents and reactants preferably operate together to capture a desired analyte which can then be detected based on an electromagnetic signal, e.g., fluorescence, that is emitted by the analyte in response to excitation energy incident on the array. With the mask layer in place, the signal-to-background ratio provided by the arrays can be increased.

Abstract: The present invention relates to methods for fabricating solid supports. More specifically, the present invention features methods for fabricating solid supports for in situ synthesis and for carrying out large numbers of reactions. The present invention also features solid supports with in situ synthesized long polynucleotides.

Abstract: The present invention relates to microstructures which a fabricated from a cast or molded polymer material, such as polydimethylsiloxane (PDMS). The invention describes and claims methods and compositions from which a variety of microstructures may be prepared. The microstructures are particularly useful for use in assays and reactions in the relating to biological assays, including applications in medical diagnostics. Such assays and reactions included, but are by no means limited to, polynucleotide sequencing and polynucleotides analysis, including analysis of single nucleotide polymorphisms, and for polynucleotide amplification such as PCR. The microstructures of the invention may contain many features that are useful for such applications. For example, the microstructures may comprise wells or channels for biological fluids and/or reagents, as well as pumps and valves for directing such fluids, e.g., in a biological assay.

Abstract: Bioelastomers are disclosed for use in methods of binding compounds including immunoassay methods, in biosensors and methods or regenerating biosensors, and in methods for targeting the delivery of a compound to a particular location within an animal subjects. In general, the bioelastomer is conjugated to a binding compound, which is in turn used to bind a compound of interest. For targeted compound delivery, the bioelastomer is conjugated to the compound to be delivered.

Abstract: A device and method allow for detecting the presence of microorganisms in clinical and non-clinical specimens. The device, a sensor, provides an environment to culture microbial organism colonies from a fluid sample, and a means to facilitate microbial detection and quantification, either manually or with an instrument. The sensor has a microorganism immobilization matrix layer and a sensor layer. Detected microbial colonies are immediately available for further testing. The sensor provides an area for accepting a fluid sample, a mechanism to immobilize the fluid sample on an interior surface of the plate, nutrients to facilitate growth of microorganisms in the sample, and a sensor for allowing the detection and/or enumeration of microorganism colonies within the sample.

Abstract: The present invention relates to a sintered porous polymeric material useful as membrane in an analyte detection device, such as a lateral flow device, flow through device, or a dipstick device. The invention encompasses an analyte detection device that comprises such a sintered porous polymeric material and method of analyte detection using such a device. Specific sintered porous polymeric materials encompassed by the invention are surface activated and further coated with one or more layers of a variety of materials.

Abstract: The present invention provides a test strip having a first layer comprising a wicking member and a second layer comprising a capillary transfer plane member. The capillary transfer plane has a plurality of capillary transfer passages. The capillary transfer passages can comprise various shapes to control sample flow rate. Located above one or more of the capillary transfer passages are a plurality of test strips. Another aspect of the present invention provides a sample testing device, which includes a housing having a one or more openings, and a test strip as described above, wherein a sample application area of the test strip is accessible through one of the openings in the housing, and each of the testing members is viewable through one of the openings of the housing.

Abstract: A chromatographic assay or test device for detection and/or determination of an analyte in a test sample, comprises a base member, and a chromatographic medium located in or on said base member, the base member being provided with a receptacle to receive an applicator having the sample applied thereto, and the applicator being movable when located in said receptacle between a first position in which the applicator is out of fluid contact with the chromatographic medium, and a second position in which the applicator is in fluid contact with the chromatographic medium so as to apply a sample on the applicator to the chromatographic medium. In an alternative aspect, the test device comprises a base member, and a second member, at least one of the base member and the second member including a chromatographic medium, and the second member being slidably movable with respect to the base member from a first position to a second position.

Abstract: The present invention describes novel methods for making a substrate for selective cell patterning, and the substrates themselves, wherein the method comprises contacting reactive hydroxyl groups on the surface of a substrate with a hydroxyl-reactive bifunctional molecule to form a monolayer, and using stencils to deposit cell repulsive or cell adhesive moieties in controlled locations on the cell culture substrate. Methods comprising selective differentiation of stem cells to create tissue specific and organ-specific cell substrates, as well as the cell substrates themselves are also provided.

Abstract: An improved rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a post-filter unit capable of receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can specifically bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The post-filter unit comprises a label zone permeated with a dried indicator reagent which is capable of being placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

Abstract: An array bundle is provided for creating multiple arrays for testing. The array bundle is adapted to be cut transversely to form a series of identical arrays of cells. In one embodiment, the array bundle is used in detecting predetermined components from sample mixtures.

Abstract: A method of determining the gender of a bird in ovo comprises detecting the presence or absence of an elevated level of a sex-related hormone in the extra-embryonic fluid of the bird egg, and then determining the gender of the bird within the egg from the presence of an elevated level of a sex-related hormone therein. Preferably, the sex-related hormone is an estrogen. Further preferred are methods in which the extra-embryonic fluid is allantoic fluid. The method is preferably carried out on chicken eggs prior to or during transfer of the eggs from incubator to hatcher.

Abstract: Disc assay devices and methods for the detection and enumeration of microorganisms are disclosed. The devices and methods include a plurality of discs attached to a substrate and a reflector on one surface of each of the discs to reflect electromagnetic energy of selected wavelengths after the energy has passed through the disc. The reflector may be useful to improve the accuracy of detection and/or enumeration of target microorganisms on the assay devices. A system for detecting and/or enumerating target microorganisms on disc assay devices is also provided.

Abstract: Device for assaying an analyte, comprising a labelling zone, where a label can bind to the analyte, in communication with a capture zone, wherein the pore size of the capture zone is such that label which is not bound to the analyte can migrate therethrough, whereas label which is bound to the analyte cannot. During migration from the labelling zone (large pore size) to the capture zone (small pore size), unbound label can pass into and through the capture zone, whereas bound label will be captured at the junction of the labelling zone a the capture zone. The device relies upon the label being smaller than the analyte, such that free label is not retarded by the capture zone. It is particularly suitable for assying analytes such as spermatozoa, which are large in comparison with a label such as a labelled antibody.

Abstract: The present invention provides a well-less filtration device that includes a pre-filter layer; a support layer; and at least one layer of solid phase extraction medium disposed between the pre-filter layer and the support layer. At least a portion of the pre-filter layer, support layer and solid phase extraction medium are ultrasonically welded together to form a pattern of filter cells and land areas with the land areas being disposed between the filter cells. The filter cells of the device may be arranged to conform to a standardized array format.

Abstract: A test piece for use in biological analyses includes a plurality of different known specific binding substances disposed in predetermined positions on a substrate. The specific binding substances are disposed on a plurality of surfaces provided by the substrate and arranged in the direction of thickness of the substrate.

Abstract: Technological preposition of the present invention is a liquid processing method making use of a pipette device which sucks a liquid containing a target high molecular substance from inside of a vessel through a chip detachably set on a sucking port or a discharging port of a liquid sucking/discharging line and transfers this liquid or target high molecular substance to the next target processing position for the purpose to execute such works as quantifying, separating, taking out, pipetting, clarifying condensing, and diluting a liquid or a target high molecular substance contained in a liquid and also such works as extracting, recovering, and isolating the target high molecular substance by means of sucking and discharging a liquid with a pipette device and controls by a magnetic body over magnetic particles and/or a filter combined according to the necessity, and the chip can isolate the target high molecular substance by having the substance attracted onto magnetic particles or with a filter set on each c

Abstract: Provided is a system for identifying a hydrogen gas producing organism. The system includes a sensor film having a first layer comprising a transition metal oxide or oxysalt and a second layer comprising a hydrogen-dissociative catalyst metal, the first and second layers having an inner and an outer surface wherein the inner surface of the second layer is deposited on the outer surface of the first layer, and a substrate adjacent to the outer surface of the second layer, the organism isolated on the substrate.

Abstract: The simultaneous synthesis of diverse organic compounds is performed in stackable modules which are moveable among nesting sites located on work station platforms. The reactor module includes a block adapted to receive an array of tube-like reactor vessels. The vessels are sized to optionally accept porus polyethelyene mircocannisters with radio frequency transmitter tags. Each vessel has a bottom port connected to an outlet tube. A valve block located below the reactor vessels simultaneously controls discharge through the outlet tubes. The valve block includes plates with aligned, relatively moveable sets of rib surfaces which act through Teflon encapsulated silicone O-ring cord sections to simultaneously close rows of outlet tubes.

Abstract: The present invention provides high-density arrays including mask layers and methods of manufacturing the same. The arrays are formed on a polymeric substrate and include a mask layer. Various linking agents, linking agent coatings, and/or reactants may be provided on the mask layer. Where present, the linking agents and reactants preferably operate together to capture a desired analyte which can then be detected based on an electromagnetic signal, e.g., fluorescence, that is emitted by the analyte in response to excitation energy incident on the array. With the mask layer in place, the signal-to-background ratio provided by the arrays can be increased.

Abstract: A chemical sensor includes an enzyme layer, a diffusion layer and an analyte barrier layer positioned over the diffusion layer. Apertures are formed by microfabrication in the analyte barrier layer to allow controlled analyte flux to the diffusion layer.

Abstract: Test strip device for accepting a liquid sample and forming an even fluid front across the test strip. When the sample is applied to a contacting surface, it runs down the surface where it collects between the contacting surface and a slope surface. As the sample collects, it evenly reaches fluid flow contact with an absorbent membrane. As a result, the sample forms an even fluid front across the membrane, improving the performance of the test strip device. Methods for using the device to accept a sample and to detect an analyte in the liquid sample are also provided.

Abstract: A test card for drugs of abuse has a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips extend longitudinally from top to bottom at the card and are fastened side by side in parallel on one or both sides of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. The test card thus provides for the simultaneous detection of multiple analytes. Processes are also disclosed for making the drug test card with test strips on one and both sides of the card.

Abstract: An apparatus for measuring the ability of ameboidally mobile cells to migrate has a deposit of active substance in the form of a plate, a membrane filter disposed on the deposit and one or more vessels on the filter. The vessel or vessels have a base opening, for a liquid which contains ameboidally mobile cells. The base opening in the vessel bears against the membrane filter. A surface area of the membrane filter is at least 1.6 times as large as the area of the base opening in the vessel.

Abstract: A chromatographic test strip comprising a solid support having at least a first portion and a second portion with said portions being in the same plane so as to permit capillary flow communication with each other. The sample is added to the first portion. The first portion also may comprise a tracer portion having a tracer movably supported therein. The tracer consists of a visible particulate marker. In the second portion, a binder is immobilized. The test strip is useful in a variety of immunoassays.