Abstract: A new design for a static diffusion cell for use in a diffusion sampling apparatus to be used in conjunction with automated or manual sampling is disclosed. The diffusion cell of present invention provides to an improved and efficient diffusion assay system.

Abstract: Microfluidic methods and devices for heterogeneous binding and agglutination assays are disclosed, with improvements relating to mixing and to reagent and sample manipulation in systems designed for safe handling of clinical test samples.

Abstract: A reconfigurable sample preparation device includes a rotary plunger device having a hollow body and a coupling device, provided above one end of the rotary plunger, and accommodating a sample. The device also includes at least one sealed reagent module. When the rotary plunger is rotated on the coupling device, a film of the reagent module is pierced, mixing the sample with a substance from the reagent module.

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

Abstract: An integrated device for diagnostic analyses used to verify the presence of bacteria in at least a biological sample mixed with a eugonic culture medium in liquid form, to classify at least the type of bacteria, and to test a series of antibiotics, selected from a group of characteristic antibiotics at least for the type of bacteria identified, identifying those effective to determine the antibiotic therapy. The device comprises, inside an integrated structure, first containing means provided with containing elements in which the biological samples to be analyzed are distributed, second containing means comprising recipients or micro-plates thermostated with wells containing a eugonic culture medium in liquid form in which a first fraction of the biological samples to be analyzed is dispensed, and a first recipient and second recipients or plates with a relative first well and second wells in which a further fraction of the biological samples which resulted positive to the analysis is dispensed.

Abstract: A container assembly for storing, treating, transporting and stabilizing a biological sample includes a container, a cap and a sample holder removably received in the container. The sample holder can be a platform-like device dimensioned to be supported on a ledge formed in the side wall of the container. The sample holder includes a central cavity for receiving the sample and immersing the sample in the stabilizing agent in the container. In another embodiment, the sample holder has a closure member for closing the open top end of the cavity. The container includes a liquid reagent in an amount sufficient to treat the biological sample. The biological sample is retained in a predetermined containment area of the container to maintain the biological sample immersed in the reagent without regard to the orientation of the container.

Abstract: The invention provides a method of monitoring the response of platelets to a COX1 inhibitor such as aspirin. The method involves collecting platelet-containing mammalian blood treated with a COX 1 inhibitor; mixing the blood with a COX 1-dependent platelet agonist, such as arachidonic acid, monitoring extracellular ATP in the agonist-activated blood to generate a measurement, and comparing the measurement to a standard value. Devices, systems, and kits for carrying out the method are also provided.

Abstract: The introduction of genetic material or molecules of biological interest into cells is a procedure with an increasing interest both for experimental and application purposes, so that electroporation is a widely used technique, but the electroporation of single adhering cells is still impaired. The present application describes an apparatus for the electroporation of any kind of cell adhering to a substrate at any stage of development, where an electrical signal can be driven and applied to a single adhering cell in culture in order to obtain its electroporation. The method to electroporate a single adhering cell with the apparatus of the invention is also described.

Abstract: A device and methods for monitoring status of at least one cell, wherein the cell has a membrane forming a substantially enclosed structure and defining an intracellular space therein. In one embodiment of the present invention, the device includes a first substrate having a first surface and an opposite second surface, a second substrate supported by the first substrate, the second substrate having a first surface, an opposite second surface, a body portion between the first surface and the second surface, a first side surface and an opposite second side surface, wherein the body portion defines a first passage between the first side surface and the second side surface and an opening on the first surface of the second substrate and in fluid communication with the first passage, and sidewalls positioned above the first surface of the second substrate.

Abstract: An automated analyzer for performing multiple diagnostic assays simultaneously includes multiple stations in which discrete aspects of the assay are performed on fluid samples contained in sample vessels. The analyzer includes stations for automatically preparing a sample, incubating the sample, preforming an analyte isolation procedure, ascertaining the presence of a target analyte, and analyzing the amount of a target analyte. An automated receptacle transporting system moves the sample vessels from one station to the next. A method for performing an automated diagnostic assay includes an automated process for isolating and amplifying a target analyte, and, in one embodiment, a method for real-time monitoring of the amplification process.

Abstract: Device and method for detecting the presence of known or unknown toxic agents in a fluid sample. Targets in the sample are bound to releasable receptors immobilized in a reaction region of a micro- or nano-fluidic device. The receptors are selected based on their affinity for classes of known toxic agents. The receptors are freed and the bound and unbound receptors separated based on differential electrokinetic mobilities while they travel to a detection device.

Abstract: Disclosed herein is a device comprising a pair of bellows pumps configured for efficient mixing at a microfluidic scale. By moving a fluid sample and particles in suspension through an aperture between the paired bellows pump mixing chambers, molecular collisions leading to binding between the particles and ligands in the sample are enhanced. Such devices provide an alternative for mixing that does not use a vent and can be used with a variety of particles in suspension such as magnetic beads to capture or purify useful cells and molecules.

Abstract: Systems, methods and apparatus provide flexible and efficient high throughput electroporation systems. An electrical pulse may be transmitted to any number of channels of a multi-channel sample plate. Drivers can provide the selection of which channels to transmit the electrical pulse. To provide efficient transitions between electrical pulses, discharge circuits provide efficient means achieve a desired voltage.

Abstract: The invention relates to an assay method and a fluid microsystem for carrying out said assay method, in particular, for carrying out miniaturized affinity tests in a micro-array format. According to said invention, a liquid phase comprising at least one type of detectable high-molecular weight soluble substance, for example a labeled reaction partner or product of an affinity reaction is displaced by the hydraulic effect of a high-molecular weight osmotic agent on an ultrafiltration membrane towards a miniaturized measuring chamber defined thereby. The fraction of the detectable high-molecular weight substance(s) is concentrated in the measuring chamber, while the dissolved low-molecular weight components are removed with the solvent through the membrane pores, thereby making it possible to attain a high detection sensitivity.

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: A method of separating a cell-containing sample into a substantially cell-depleted portion, and a cell-containing portion comprising at least one of a stem cell, a lymphocyte, and a leukocyte comprises a step in which the sample is received in a vessel with at least one flexible wall. In another step, an additive and particles are added to the sample, wherein the additive substantially binds to the at least one of the stem cell, lymphocyte, and leukocyte, and the particles and wherein the particles substantially bind to the at least one of the stem cell, lymphocyte, and leukocyte, and the additive, thereby producing a cell-containing network. In a further step, the network is separated from the substantially cell-depleted portion by applying a magnetic force.

Abstract: The invention relates to fluidics as used in medical and diagnostic equipment and relates further to means for purifying, abstracting, filtering, detecting and/or measuring analytes in liquid samples.

Abstract: The invention relates to methods and devices enabling simultaneous detection of several biological threat agents, including viruses and bacteria. The device includes a plurality of chambers and conduits which can be manually operated to so that reagents and sample are passed through the device and nucleic acid hybridization membranes to permit detection by the naked eye. The device has minimal logistical requirements since it is self-contained and includes all the reagents required to process a sample suspected of containing a variety of biological threat agents, it does not require electrical or other external sources of energy, it is disposable, and it can operated by a soldier or responder without microbiological training or expertise.

Abstract: Disclosed herein is a device comprising a pair of bellows pumps configured for efficient mixing at a microfluidic scale. By moving a fluid sample and particles in suspension through an aperture between the paired bellows pump mixing chambers, molecular collisions leading to binding between the particles and ligands in the sample are enhanced. Such devices provide an alternative for mixing that does not use a vent and can be used with a variety of particles in suspension such as magnetic beads to capture or purify useful cells and molecules.

Abstract: A microscale method for the characterization of one or more reaction variables that influence the formation or dissociation of an affinity complex comprising a ligand and a binder, which have mutual affinity for each other.

Abstract: The invention relates to a device for detecting one or several analytes in a sample, characterized in that it comprises one or more reaction chambers and/or one or more reagent application channels, and one or more capillary systems and one or more negative vessels. The invention also relates to a method for detecting one or more analytes in a sample fluid by visualization of agglutination, characterized in that a) the sample fluid is brought into contact with a reagent, b) the reaction mixture is exposed to the effects of gravitation or magnetism, wherein the reaction mixture is strained through the capillary system of the inventive device with a negative vessel connected to the inventive device, and c) the reaction between the analyte and the reagent is determined. The invention also relates to one such method wherein the reaction mixture is brought into contact with another reagent during step b).

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 microchip for capillary electrophoresis is provided. The microchip comprises an injection channel and a separation channel configured to receive a sample through a sample well disposed on a first end of the separation channel; wherein the injection channel and the separation channel intersect to form a ‘T’ junction. The microchip further comprises a first valve disposed adjacent to the ‘T’ junction and on the separation channel and a second valve disposed at the ‘T’ junction. The second valve is a two-way valve. A sample plug is injected into an area between the ‘T’ junction and a second end of the separation channel.

Abstract: Disclosed is a microfluidic assay system and methods that apply flow injection analysis to permit dispersion monitoring. A solution containing a reagent that binds an analyte and a tracer is delivered via pressure-driven flow into the receiving end of the injection channel of the system of the invention. A sample fluid suspected of containing the analyte is delivered into the upstream end of the input channel under conditions permitting flow of the sample fluid toward the downstream end of the assay channel and permitting dispersion of the reagent into the sample fluid. The amount of tracer present in the fluid as it passes over the reference region and the capture region and the amount of binding between the analyte and the capture region are detected. The amount of binding detected between the analyte and the capture region is correlated to the amount of tracer detected in the reference region.

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 rapid assay concentration device. In one form, the device includes a substrate and a plurality of elongated membranes on the substrate. At least one capture zone is formed in each membrane. Each capture zone is responsive to the presence of a target chemical in the fluid. Capture zones on different membranes have different threshold levels of response to the chemical. In a method for monitoring temporal changes of analyte levels in a source multiple test devices are provided, with each device including a plurality of regions. Each region is responsive at a different sensitivity level to indicate presence of the analyte. A source sample is brought into contact with a first of the test devices to determine whether the source contains a level of analyte sufficient to induce a response thereto in one or more of the test unit regions.

Abstract: A microfluidic assay device for determining the presence or absence of an analyte within a fluid test sample is provided. The present invention provides a technique for achieving continuous flow in a microfluidic device by using at least one input channel, an analysis zone, and a plurality of wicking channels disposed about the perimeter of the analysis zone. In one embodiment, for example, the wicking channels extend radially from the analysis zone. As a result of the particular configuration of the microfluidic device, an assay may performed in a “single step” without the need for active forces, such as a pressure source, electrokinetic force, etc., to induce flow of the fluid test sample through the device. Likewise, flow rate is controlled so that the dwell time of the fluid test sample within the analysis zone is long enough to allow for the desired reactions and/or detection.

Abstract: Featured are devices and systems embodying one or more electrically-addressable-solid-state nanopores useful for sensing and/or characterizing single macromolecules as well as sequencing DNA or RNA. In one aspect of the present invention, there is featured a linear or 2-D electrically-addressable array of nanopores, where the nanopores are located at points of intersections between V-shaped grooves formed in an upper surface of the insulating member and a V-shaped groove formed in a lower surface of the insulating member. In another aspect of the present invention the solid-state nanopore of the present invention the width and/or length of the nanopore is defined or established by sharp edges of cleaved crystals that are maintained in fixed relation during the formation of the insulating member including the nanopore.

Abstract: Nanochannel arrays that enable high-throughput macromolecular analysis are disclosed. Also disclosed are methods of preparing nanochannel arrays and nanofluidic chips. Methods of analyzing macromolecules, such as entire strands of genomic DNA, are also disclosed, as well as systems for carrying out these methods.

Abstract: A method of separating a cell-containing sample into a substantially cell-depleted portion, and a cell-containing portion comprising at least one of a stem cell, a lymphocyte, and a leukocyte comprises a step in which the sample is received in a vessel with at least one flexible wall. In another step, an additive and particles are added to the sample, wherein the additive substantially binds to the at least one of the stem cell, lymphocyte, and leukocyte, and the particles and wherein the particles substantially bind to the at least one of the stem cell, lymphocyte, and leukocyte, and the additive, thereby producing a cell-containing network. In a further step, the network is separated from the substantially cell-depleted portion by applying a magnetic force.

Abstract: The present invention includes devices, systems, and methods for assaying cells using cell-substrate impedance monitoring. In one aspect, the invention provides cell-substrate impedance monitoring devices that comprise electrode arrays on a nonconducting substrate, in which each of the arrays has an approximately uniform electrode resistance across the entire array. In another aspect, the invention provides cell-substrate monitoring systems comprising one or more cell-substrate monitoring devices comprising multiple wells each having an electrode array, an impedance analyzer, a device station that connects arrays of individual wells to the impedance analyzer, and software for controlling the device station and impedance analyzer. In another aspect, the invention provides cellular assays that use impedance monitoring to detect changes in cell behavior or state. The methods can be used to test the effects of compounds on cells, such as in cytotoxicity assays.

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: A method of manufacturing a microfluidic device is described. A substrate having at least one device thereon is provided, wherein the device includes at least one channel. Next, a region beside the channel is heated, and then the substrate is pulled to neck the region such that at least one capillary connecting with the channel is formed. The present invention also provides a microfluidic device including a substrate and at least one capillary. In particular, the substrate has at least one device thereon, and the device has at least one channel. The capillary is connected with the channel, wherein the substrate and the capillary are a unity structure such that the interface between the capillary and the channel is dead-volume free.

Abstract: A new design for a static diffusion cell for use in a diffusion sampling apparatus to be used in conjunction with automated or manual sampling is disclosed. The diffusion cell of present invention provides to an improved and efficient diffusion assay system.

Abstract: A device for measuring an extracellular potential of a test cell includes a substrate having a well formed in a first surface thereof and a first trap hole formed therein. The well has a bottom. The first trap hole includes a first opening formed in the bottom of the well and extending toward a second face of the substrate, a first hollow section communicating with the first opening via a first connecting portion, and a second opening extending reaching the second surface and communicating with the first hollow section via a second connecting portion. The first connecting portion has a diameter smaller than a maximum diameter of the first hollow section, greater than a diameter of the second connecting portion, and smaller than a diameter of the test cell. The device can retain the test cell securely and accept chemicals and the test cell to be put into the device easily.

Abstract: A device for detecting cells and/or molecules on an electrode surface is disclosed. The device detects cells and/or molecules through measurement of impedence changes resulting from the cells and/or molecules. A disclosed embodiment of the device includes a substrate having two opposing ends along a longitudinal axis. A plurality of electrode arrays are positioned on the substrate. Each electrode array includes at least two electrodes, and each electrode is separated from at least one adjacent electrode in the electrode array by an expanse of non-conductive material. The electrode has a width at its widest point of more than about 1.5 and less than about 10 times the width of the expanse of non-conductive material. The device also includes electrically conductive traces extending substantially longitudinally to one of the two opposing ends of the substrate without intersecting another trace. Each trace is in electrical communication with at least one of the electrode arrays.

Abstract: The invention provides a method of monitoring the response of platelets to a COX1 inhibitor such as aspirin. The method involves collecting platelet-containing mammalian blood treated with a COX 1 inhibitor; mixing the blood with a COX 1-dependent platelet agonist, such as arachidonic acid, monitoring extracellular ATP in the agonist-activated bl>>d to generate a measurement, and comparing the measurement to a standard value. Devices, systems, and kits for carrying out the method are also provided.

Abstract: The invention relates to methods for preparing and performing quantitative PCR analyses, a new sealing device and a new use. According to the invention, a sample vessel containing the samples to be analyzed is sealed by placing a planar sealing device on the vessel to cover the samples and applying pressure on the sealing device in order to deform the sealing device so as to form a light-refracting geometry individually for the samples to be analyzed. The invention offers a convenient way of sealing the vessel and forming analysis-improving optical lenses over the samples simultaneously.

Abstract: A culture flask 10 comprises two or more internal chambers 18-21 defining a plurality of parallel surfaces of different sizes and means for fluid communication 24 between the chambers 18-20.

Abstract: A method and apparatus are provided for preparing a test sample for detecting a predetermined target nucleic acid. The method includes the steps of providing a test probe comprising an oligonucleotide attached to a nanoparticle and providing a hybridization unit containing the test sample and the test probe, wherein said hybridization unit further includes a target sample substrate and a distribution manifold coupled to a first side of the substrate. The method further includes the steps of clamping a processing fluids manifold to the distribution manifold of the hybridization unit, denaturing the test sample and preparing the test sample for detecting the predetermined target nucleic acid by pumping a plurality of processing fluids between the processing fluids source manifold and distribution manifold to hybridize the test probe and predetermined target nucleic acid to the target sample substrate, to wash the hybridized sample and to amplify a detectable parameter of the hybridized sample.

Abstract: Reaction vessel 1 for assaying of a subject substrate molecule comprises a translucent narrow tube 2 which has a liquid feed port 4 at one end, and which is intended to be packed with microparticles 5 as solid phase support on which a reagent molecule is bound thereto, in which said reagent is capable of binding to, adsorbing, or showing affinity with the subject substrate molecule, and a effluent collecting tube 3 in which a liquid absorbing member 13 is provided inside for absorbing the liquid poured into the narrow tube, and which is connected to the narrow tube 2 at its downstream via a communicating passage 11, and a current-controlling mechanism for controlling liquid current in the narrow tube so as to hold the liquid in the narrow tube 2 during a predetermined time.

Abstract: A tube and float system for use in separation and axial expansion of the buffy coat includes a transparent or semi-transparent, flexible sample tube and a rigid separator float having a specific gravity intermediate that of red blood cells and plasma. The float includes a main body portion of reduced diameter to provide a clearance gap between the inner wall of the sample tube and the float. One or more protrusions on the main body portion serve to support the flexible tube. During centrifugation, the centrifugal force causes the diameter of the flexible tube to expand and permit density-based axial movement of the float in the tube. The float further includes a pressure relief system to alleviate pressure build up in the trapped red blood cell blood fraction below the float, thereby preventing red blood cells from being forced into the annular gap containing the buffy coat layers.

Abstract: A container is provided for cell growth by artificial cultivation of selected biological material in a growth liquid for use in an oscillating incubator. The container has a circular bottom with rounded corners joining a sidewall that is inclined at an angle toward a longitudinal axis of the container to define a container volume. The bottom has six equally spaced baffles extending inward from the corners and upward toward a large diameter opening of the container centered on the longitudinal axis. The baffles have a triangular cross-sectional shape with an included angle of about 28–40°, and a height measured parallel to the longitudinal axis of about 15–25% of the usable container volume. The baffles end before the longitudinal axis. The container and baffles are blow molded of a polymer suitable for blow molding. An air permeable filter is placed over the container opening, with the filter having an adhesive on one side to stick to the container.

Abstract: The invention relates to a bioreactor for cultivating microorganisms, as well as a method for its production. The invention is characterized in that the bioreactor (1) comprises two identically constructed base elements (2,3) that are constructed in trough shape and consist of a bottom part (4) and four side parts (5) arranged on a bottom part (4) and having an inside depth T1. The base element (2,3) consists of a light permeable material. The identically constructed base elements (2,3) are arranged on each other so as to exactly cover each other. A flow guide device is arranged inside the identically constructed base elements (2,3).

Abstract: A chromatographic lateral-flow assay system for rapid, high sensitivity method of detecting low levels of ligands in body fluids, with few false positives and few false negatives. The lateral-flow assay may have a membrane strip in ribbon form, which increases detection on the order of 2 to 10 fold over the conventional chromatographic specific binding assay techniques by placing a dried or lyophilized conjugate in colloidal spheres opposite side of the lateral flow membrane strip. A chromatographic specific binding assay strip device, comprising: a laminate strip having a first side and an opposite second side; a conjugate pad or membrane disposed on said first side of said laminate; a sample receiving pad or membrane strip and reservoir pad or membrane disposed on said second side of said laminate; and a detection pad or membrane strip disposed between the sample pad or membrane and the reservoir pad or membrane on said second side of said laminate.

Abstract: Disclosed is an inspection apparatus that includes a cartridge including a container which is at least partially structured with an elastic member, the container including inside thereof a plurality of rooms to contain solution and a passage to connect the plurality of rooms; and a housing which is arranged with a liquid feeding device which conducts inspection of the solution by applying external force to the elastic member to move the solution in the passage or in at least one of the rooms, wherein the housing is sealed air-tightly from outside air, and the housing is a safety cabinet to which a sterilization filter is provided at an outlet passage thereby that communicates from inside to external of the housing.

Abstract: An article for holding a liquefied sample for the quantification of biological material in the sample includes a device having a reaction chamber enclosing a volume therein, the reaction chamber having an upper opening through which a liquefied sample can be poured and a plurality of discrete non-permeable compartments, each of the compartments having an upper rim and being configured and dimensioned to hold separate aliquots of a liquefied sample therein; and a gasket lid removably secured to the top of the device, the gasket lid being configured and dimensioned for sealing the upper rim of each compartment to prevent liquid communication between the compartments.

Abstract: A thermal cycling method and device is disclosed. The device comprises a sample chamber whose temperature can be rapidly and accurately modulated over a range of temperatures needed to carry out a number of biological procedures, such as the DNA polymerase chain reaction. Biological samples are placed in containers each comprising a reservoir and a reaction portion, wherein the reaction portion has a small volume. The small volume reaction portion permits the rapid and accurate temperature modulation. With an optically transmissible reaction portion, DNA amplification may be monitored by fluorescence during PCR.

Abstract: A simplified Polymerase Chain Reaction (PCR) sample preparation apparatus and method of using a PCR sample preparation for both liquid and dry samples. A portable apparatus comprising a handle removably attached to a wand assembly. The handle includes a cover and a swab with an absorbent material. The wand assembly includes a buffer container for a buffer that is ruptured by a spike when the holder is inserted into the wand assembly. The apparatus may include a waste container removably attached to a tube comprising a plunger, a safety clip to prevent the plunger from depressing, and a port for introduction of a liquid sample. A filter on the waste container collects a specimen of the liquid sample for preparation as described above.

Abstract: A novel hybridization device that improves the efficiency and consistency of microarray hybridization reactions by achieving a greater degree of internal mixing of target solution. The device provides a gasket-and-cover-type chamber wherein solution mixing is achieved by the creation of a multitude of microbubbles. One or more of the inner walls that define the chamber contain bubble-rupturing elements that extend into the chamber and terminate in sharp edges. They are typically located on opposite sides of a rectangular chamber and are pointed in a direction opposing bubble movement. Their interference with larger bubbles causes their breakup into microbubbles which travel separate and distinct paths as a result of external agitation and thereby provide improved solution mixing that results in a uniform distribution of target molecules to the probe molecules bound to the substrate. The sensitivity and consistency of the hybridization reaction is significantly increased.