Abstract: Fluid flow devices include a small plate (2), at least one flow channel (20) formed into this small plate, at least one storage channel (221-226) extending from this connection channel, and a set of valves (V1-V6), each of which is suitable for allowing or stopping the flow of fluid in a corresponding storage channel.

Abstract: A sterilization test pack, including a base comprising a pair of recessed compartments, wherein the recessed compartments are arranged in a non-concentric relationship and are in fluid communication with each other; a cover attached to the base and forming a sealed enclosure for the recessed compartments; an external channel providing the only fluid communication between the sealed enclosure and an external environment; a selected sterilization indicator in a first of the recessed compartments; and a chemical integrator and/or a chemical indicator in a second of the recessed compartments, in which the external channel is configured to allow only restricted flow of a gaseous sterilization medium into the recessed compartments and the base and cover are otherwise impenetrable by the gaseous sterilization medium.

Abstract: A sample processing vessel may include a branch segment and at least two tracks. The at least two tracks may be fluidly isolated from one another by a permanent seal. The tracks may be segmented by breakable seals. The branch segment may be temporarily isolated from the tracks by breakable seal(s) and put in fluid communication with the tracks once those seal(s) are broken, such that fluid received by the branch segment is divided into portions that pass into both tracks.

Abstract: Systems and methods are provided for analyzing particulates. A liquid having a plurality of particulates substantially linearly ordered in a streamline can be externally controlled to provide flow in first and second directions, where, generally, the first direction is opposite to the second direction. A target particulate can be measured from the plurality of particulates at or near a measurement area while the liquid flows in the first flow direction. The flow direction can be reversed and measured at the measurement area while flowing in the second direction. The particulates substantially retain the same linear order during at least one cycle, a cycle being defined by movement in the first direction followed by movement in the second direction.

Abstract: This invention relates to a technique for adjusting the temperature of a liquid held on an analyzing instrument (1) to a target value. The invention provides a temperature control method wherein thermal energy is supplied to liquid (10) by passing a magnetic flux across an analyzing instrument (1) for raising the temperature of the liquid. The invention also provides an analyzing instrument (1) and analyzing apparatus (X) which are suited to raising the temperature of a liquid (10) using a magnetic flux.

Abstract: A microfluidic valve system is disclosed that includes a matrix, a hydrophilic acceptor region a hydrophilic transfer region, and a hydrophobic gap between the acceptor region and the transfer region.

Abstract: Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.

Abstract: A device and method is provided for performing a high throughput assay. The device includes a plate structure having a plate and a plurality of microfluidic structures positioned thereon. Each microfluidic structure defines a channel having an input and an output. At least one of the input and the output of the channel of each of the plurality of mircofluidic structures includes a first plurality of ports. In operation, the channels are filled with fluid and pressure gradients are generated between the fluids at the inputs and the fluids at the outputs of the channels. As a result, fluid flows through the channels toward the outputs.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in competitive analyte immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads opsonized for leukocytes; and (b) performing a competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: A test module for performing a genetic diagnostic assay, the test module having an outer casing dimensioned for hand-held portability, the outer casing having a receptacle for a biological sample containing target nucleic acid sequences, an array of chambers containing probes for hybridization with the target nucleic acid sequences to form probe-target hybrids, a flow-path extending from the inlet to the probes, and, a reagent reservoir containing a reagent for addition to the sample in the flow-path upstream of the probes, wherein, each of the chambers contains less than 270 picograms of probe and the reagent reservoir has a volume less than 1000,000,000 cubic microns.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in an analyte immunoassay, and in particular in non-competitive immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads; and (b) performing a non-competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: An analytical strip including a substrate and a channel structure is disclosed. A substrate has a flat surface and the channel is formed on the flat surface according to a predetermined pattern. The surface of channel structure is not lower than the surface of the substrate. The channel has a hollow-matrix conformation and the channel is more hydrophilic than the flat surface of the substrate is. The strip also contains a reaction material formed in the hollow-matrix.

Abstract: A test module for biochemical processing and analysis, the test module having an outer casing dimensioned for hand-held portability, the outer casing having a receptacle for receiving biochemical liquid, and, a reagent reservoir containing a reagent for addition to the biochemical liquid for use in chemical analysis of the biochemical liquid, wherein, the reagent reservoir has a volume less than 1000,000,000 cubic microns.

Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: A microfluidic device includes a sample chamber accommodating a sample, a first sample distribution unit connected to the sample chamber and receiving the sample, a sample transfer unit connected to the first sample distribution unit and forming a path for transferring the sample, and including a first connection unit connected to the first sample distribution unit and a second connection unit, wherein the distance from the center of rotation to the second connection unit is greater than the distance from the center of rotation to the first connection unit, a second sample distribution unit connected to the second connection unit and receiving the sample transferred via the sample transfer unit after filling the first sample distribution unit, and first and second analysis units respectively connected to the first and second sample distribution units and analyzing ingredients of the sample.

Abstract: A microfluidic cartridge with solution reservoir-pump chamber is disclosed. The microfluidic cartridge comprises a channel-chamber layer, a sealing layer, a printed circuit board bound with magnetoresistive biochip. The channel-chamber layer includes at least a waste reservoir, a reaction-detection chamber, a solution reservoir-pump chamber and a plurality of micro-channels. Said solution reservoir-pump chamber realizes both functions of solution reservoir and pump chamber in a single structure. Said sealing layer is sealed with said channel-chamber layer to form an integrated microfluidic system with at least a waste reservoir, a reaction-detection chamber, a solution inlet, a solution reservoir-pump chamber and a micro-channel. Said solution reservoir-pump chamber in the present invention consists of elastic objects inside for sealing and pumping. Under pressure, said elastic object propels solution in the reservoir into said reaction-detection chamber via channels of said plurality of micro-channels.

Abstract: The present invention relates to microfluidic devices and methods for manipulating and analyzing fluid samples. The disclosed microfluidic devices utilize a plurality of microfluidic channels, inlets, valves, filter, pumps, liquid barriers and other elements arranged in various configurations to manipulate the flow of a fluid sample in order to prepare such sample for analysis.

Abstract: My newly created invention consists of a means to test Synthetic Cannabanoids, By a urinalysis cup which a new reagent patch is added to the other patches being tested for drugs such as Marijuana, cocaine, methamphetamines, opiates and Heroin but not limited to the said illegal drugs. An equivalent would be a Saliva test that gives immediate results but is more expensive, hence the UA cup is more economical. The Synthetic Cannabanoid drug stays in your blood stream for approximately three days, so the need to detect it is substantial as it has proven very harmful to users as it mimic's marijuana but can be far more potent then THC, The active ingredient in Marijuana. The parent drugs of the synthetic Cannabanoids are JWH-018, JWH-073, and JWH 250 respectively and not intended to limit them to these chemicals for the purpose of testing for Synthetic Cannabanoids.

Abstract: A delivery apparatus for selectively delivering one or more liquid reagents into a reaction or test chamber (2), especially of an assay apparatus, the apparatus comprising: one or more respective storage chambers (5,6) for containing the one or more liquid reagents and arranged generally above the reaction or test chamber (2); and a plunger element (4) arranged and operable for insertion into the mouth of a selected storage chamber so as to displace a selected reagent from therewithin into the reaction or test chamber (2) generally therebelow by gravitational liquid overflow from the mouth of the chamber. The apparatus may conveniently be provided as a discrete delivery unit, with the storage chambers (5,6) prefilled with the selected reagents.

Abstract: A reaction vessel having a reaction chamber for holding a sample is fabricated by producing a housing having a rigid frame defining the minor walls of the chamber. The housing also defines a port for introducing fluid into the chamber. At least one sheet or film is attached to the rigid frame to form at least one major wall of the chamber. In preferred embodiments, two sheets or films are attached to opposite sides of the rigid frame to form two opposing major walls of the chamber, the major walls being connected to each other by the minor walls.

Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: The invention relates to an analytical test element for analysis of a liquid sample. The analytical test element may contain a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening. At least one test field may be arranged in the channel, spaced apart from the inlet opening. The test element comprises a sample application site which is closed with a seal and which is designed in such a way that, when the seal is opened, the sample application site and the inlet opening of the channel are simultaneously open to the outside environment of the test element. The test element can then receive the liquid sample inside the channel via the sample application site and inlet opening, for analysis in the test field. The invention also relates to a test element magazine and to a system for analysis of liquid samples with at least one test element.

Abstract: An integrated meter system for determining information related to an analyte of a fluid sample includes a meter including a housing and a plurality of test sensors. Each of the plurality of test sensors includes a penetrating member, a testing portion, and a channel. The channel is adapted to receive the fluid sample. The test sensors are removably located within the housing. At least one of the test sensors is removably connected to an adjacent test sensor. The integrated meter system also includes a test-sensor advancement mechanism that is configured to advance the test sensors.

Abstract: Provided is a microfluidic device that can automatically perform various types of biological blood analysis. In the microfluidic device, a specimen is centrifugally separated and the centrifugally separated specimen is diluted into various dilution ratios. Also, at least two reagents that are required for one reaction and that need to be separately stored are stored in separate chambers, and they are mixed when a reaction is needed. Thus, various conventional blood analyzing reagents can be used as they are or after being minimally processed in the microfluidic device.

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: A device and method is provided for performing a high throughput assay. The device includes a plate structure having a plate and a plurality of microfluidic structures positioned thereon. Each microfluidic structure defines a channel having an input and an output. At least one of the input and the output of the channel of each of the plurality of mircofluidic structures includes a first plurality of ports. In operation, the channels are filled with fluid and pressure gradients are generated between the fluids at the inputs and the fluids at the outputs of the channels. As a result, fluid flows through the channels toward the outputs.

Abstract: Intrusion of foreign matters from the outside of a reaction container plate and environmental contamination onto the outside are prevented. The reaction container plate (1) comprises a container base (3) having a reaction container (5), a channel base (11) having an introduction hole (11b) above the reaction container (5) and arranged on the surface of the container base (3), and a channel cover (13) arranged on the channel base (11) in order to form in cooperation with the surface of the channel base, an introduction channel (15) passing above the introduction hole (11b). The channel (13) is formed to be enclosed. The introduction hole (11b) does not allow liquid to pass under an introduction pressure state in the channel (15) where the liquid is introduced into the channel (15) but allows the liquid in the channel (15) to pass to the reaction container (5) side under a pressurized state where the inside of the channel (15) is pressurized higher than the introduction pressure.

Abstract: A cartridge for conducting a chemical reaction includes a body having at least one flow path formed therein. The cartridge also includes a reaction vessel extending from the body for holding a reaction mixture for chemical reaction and optical detection. The vessel comprises a rigid frame defining the side walls of a reaction chamber. The frame includes at least one channel connecting the flow path to the chamber. The vessel also includes flexible films or sheets attached to opposite sides of the rigid frame to form opposing major walls of the chamber. In addition, at least two of the side walls are optically transmissive and angularly offset from each to permit real-time optical detection of analyte in the reaction chamber.

Abstract: A cartridge assembly is adapted to be used in a sensor-dispensing device. The cartridge assembly comprises an end cap, a disposable cartridge and a sealing mechanism. The end cap includes one opening. The disposable cartridge comprises an outer and inner cartridge. The inner cartridge contains sensors arranged in a stack therein. Each of the sensors carries a reagent sufficient to produce a signal in response to the analyte concentration in a fluid. The outer cartridge forms an opening of sufficient dimensions to permit a sensor to pass through the opening. The outer cartridge includes a holding mechanism that holds at least one of the sensors in place during movement of the inner cartridge. The sealing mechanism is adapted to form a substantially moisture-tight seal.

Abstract: A use composition monitor determines the concentration of peracid and/or peroxide in a use composition using a kinetic assay procedure. A sample mixture containing a sample of the use composition, a diluent and at least one reagent is prepared and analyzed using, for example, an optical detector. A reduced-turbulence optical detector can be used to improve collected response data. A reduced-turbulence optical detector can include a cell body disposed about a length of transparent tubing. The cell body positions one or more emitter/receiver pairs about the transparent tubing. Thus, tube junctions are eliminated and sample flow within the tube is substantially turbulence free.

Abstract: The enumeration of cells in fluids by flow cytometry is widely used across many disciplines such as assessment of leukocyte subsets in different bodily fluids or of bacterial contamination in environmental samples, food products and bodily fluids. For many applications the cost, size and complexity of the instruments prevents wider use, for example, CD4 analysis in HIV monitoring in resource-poor countries. The novel device, methods and algorithms disclosed herein largely overcome these limitations. Briefly, all cells in a biological sample are fluorescently labeled, but only the target cells are also magnetically labeled. The labeled sample, in a chamber or cuvet, is placed between two wedge-shaped magnets to selectively move the magnetically labeled cells to the observation surface of the cuvet. An LED illuminates the cells and a CCD camera captures the images of the fluorescent light emitted by the target cells.

Abstract: The present invention relates to a technique for moving a mobile component such as a sample and a reagent, in an analyzing article. A method of analyzing a sample according to the present invention includes a first movement step of moving a mobile component from a fluid entrance port (61) to a first goal (511) in a passage (51), and a second movement step of moving the mobile component from the first goal (511) to a second goal (512) in the passage (51), in an analyzing article (Y1). The analyzing article (Y1) further includes a branch passage which branches from the first goal (511), and a first opening for releasing gas from within the branch passage. The first movement step is carried out by establishing communication between inside and outside of the branch passage via the first opening.

Abstract: A cassette for preparing a sample is disclosed herein. The cassette includes a housing, which encloses the structures and the processes used to prepare the sample.

Abstract: A microfluidic apparatus having a substrate including a channel through which a fluid is conveyed, a fluid container in which at least one kind of fluid is accommodated and which is disposed on the substrate so as to allow the fluid to flow toward the channel, and a fluid flow controller which controls a flow of the fluid toward the channel from the fluid container.

Abstract: A reusable bio-analysis cartridge that includes a built-in mechanism to track various parameters and usage data. The tracking mechanism includes a non-volatile rewritable memory “smart-key” that is associated with the cartridge to provide automatic tracking dedicated to the cartridge. The key may be physically coupled to the cartridge with good high voltage insulating properties. When the cartridge is used in an instrument, the associated key is inserted into an I/O interface to communicate with the instrument. The instrument may be configured to “authenticate” the cartridge and conduct an integrity check to determine if the particular cartridge has the correct properties (e.g., gel-chemistry, serial no., Patient I.D.) for the particular sample analysis to be conducted. Further, the instrument may communicate/record information concerning usage of the cartridge (e.g., usage history, test parameters, and perhaps test results).

Abstract: A test sample collection device includes a generally elongated sample collection section for collecting and holding a test sample, a handle member having a top half, a bottom half, a test strip located between the top and bottom halves, and an opening formed by the top and bottom halves, and a cap. Prong members fit within the opening of the handle member for releasably connecting the sample collecting section to the handle member. The cap is releasably mounted on the sample collecting section and covers the sample collecting section. Flexible extension members on the cap are used to release the sample collecting section from the handle member. The collecting section includes a plurality of fins and slots for assisting in collecting the test sample. The device also includes windows for magnified viewing of test results and for indicating whether a sufficient amount of the sample has been collected.

Abstract: The invention relates to analysis of samples (for example, blood, urine, saliva, or swab). Some embodiments include a diagnostic testing platform. The platform may permit the analysis of a plurality of different samples with no or only minor modifications made to the platform. This platform may also reduce the number of steps performed by a user, and offer increased sensitivity and precision. The platform may be integrated with a low-cost instrument and provide an accurate digital analysis of the reaction.

Abstract: A microfluidic chip comprises a substrate and a channel or multiple channels in the substrate. Each channel includes a tortuous path section or multiple tortuous path sections. A receptor for the detection of an analyte can be immobilized in a tortuous path section, for example by adsorption. Different receptors can be immobilized in different tortuous path sections of each channel or in different channels for simultaneous detection of multiple analytes. The chip is especially useful for running immunoassays, particularly ELISA.

Abstract: A microfluidic valve device includes a microfluidic chip including a substrate having a channel, a valve disposed within the channel and configured to change a conductance of the channel, with the valve having an inner channel formed therein, and an oscillator configured to generate a traveling wave. The valve is moved by generating the traveling wave to open and close the channel.

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: The invention relates to a reaction vessel, a reaction vessel liquid introducing device, a liquid introducing and reaction measuring device, and a liquid introducing device, and is directed to being able to perform temperature control of a liquid stored within the reaction vessel with a high accuracy and faithful responsiveness. The reaction vessel comprises: a storage chamber in which a liquid is storable, that has an opening part; a reaction chamber that is formed thinner or narrower than the storage chamber; and at least one flow passage that communicates between the storage chamber or the exterior and the reaction chamber. The reaction vessel is formed such that it is connectable to a liquid introducing section provided externally, and the liquid can be introduced into the reaction chamber by connecting to the liquid introducing section.

Abstract: A testing device is provided which is able to distribute a liquid sample to a plurality of reaction sections by a simple operation without using a tip dispenser, and also achieves individually independent reaction systems without causing reaction sections to be in communication with each other due to a liquid sample. The testing device has a transparent molded body which includes: a storage chamber for injecting/holding a liquid sample; a reaction chamber for causing a reaction of the sample; a receiving chamber for sucking and receiving the sample, with the storage chamber and the reaction chamber being in communication with each other via a distributing flow path, and the reaction chamber and the receiving chamber being in communication with each other via a sucking flow path; and a liquid reservoir between the reaction chamber and the receiving chamber.

Abstract: A medical device, such as a vascular access device, is disclosed for providing access to a medical fluid flow path for the introduction or withdrawal of medical fluids to and from the flow path. The access device includes an indicator for providing a visual indication when the access device has been exposed to an antiseptic agent.

Abstract: An oral fluid collection and transfer device comprises a collection device (10) and a test cartridge (100). The collection device includes a frame or chassis (14), and an absorbing pad (12) for absorbing oral fluid and which is secured around part of the frame with part of the frame protruding from the pad. A collapsible cover (16) covers the absorbing means and has apertures (68) for the ingress of oral fluid into contact with the absorbing pad. A cap (18) covers the part of the frame protruding from the absorbing pad. The cap and the cover latch together to surround the frame and the absorbing pad. The device also includes a fluid adequacy indicator (20) in the form of an electrical circuit with an LED (66) which is completed when the absorbing means has absorbed a predetermined volume of oral fluid.

Abstract: Methods and devices are provided for controlling a fluid flow over a sensing surface within a flow cell. The methods employ laminar flow techniques to position a fluid flow over one or more discrete sensing areas on the sensing surface of the flow cell. Such methods permit selective sensitization of the discrete sensing areas, and provide selective contact of the discrete sensing areas with a sample fluid flow. Immobilization of a ligand upon the discrete sensing area, followed by selective contact with an analyte contained within the sample fluid flow, allows analysis by a wide variety of techniques. Sensitized sensing surfaces, and sensor devices and systems are also provided.

Abstract: Method of enriching specific cells from cellular samples are disclosed, comprising contacting in solution a cellular sample with affinity-tagged ligands (ATLs) each comprising a first ligand linked to an affinity tag, wherein the ligand selectively binds a cellular marker of the rare cells and the affinity tag can be selectively captured by a capture moiety, wherein the affinity tags do not comprise a magnetic particle; and flowing the sample through a microfluidic device comprising the capture moiety to selectively retain ATL-bound cells. Methods for enriching circulating tumor cells, and devices for enriching specific cells from cellular samples are also disclosed.

Abstract: An implantable medical device is provided for use with an external detector to detect an analyte in vivo. In one embodiment, the device consisting essentially of a substrate; a plurality of discrete reservoirs located in the substrate, each reservoir having at least one opening; a reacting component contained in each reservoir; and at least one non-degradable barrier layer covering each reservoir opening, the barrier layer being permeable to an analyte to be detected, wherein the reacting component remains inside the reservoirs and can react with the analyte to be detected, and wherein the device is adapted for implantation into the body of a patient.

Abstract: A device for collecting, testing and storing fluids includes a container and a removable cap. Body fluids, such as urine, are collected in the container. The cap defines a test strip holder that receives one or more drug test strips and an adulteration strip. An opening defined through a bottom of the cap provides fluid communication between the container and the cap. When tilted, fluid from the container enters the cap through the hole. A variety of plugs may be employed to block the opening and thereby prevent fluid communication between the container and the cap after fluid has entered the cap. The remaining uncontaminated and untested body fluid is stored in the container and thus made available for further confirmation testing. Associated methods for collecting, testing and storing fluids with a single device are also provided. A method of manufacturing the foregoing test device is also provided.

Abstract: A microfluidic device for preparing a mixture, has a mixer. The mixer includes a plurality of chambers, each chamber having a volume of at most 1 microliter, a first plurality of channels, each channel fluidly connecting 2 chambers, a plurality of chamber valves, each chamber valve controlling fluid flow out of one of the plurality of chambers, and a first plurality of channel valves, each channel valve controlling fluid flow through one of the first plurality of channels.

Abstract: A process challenge device (PCD) for determining the effectiveness of a microbial deactivation process that uses a vaporous deactivating agent (e.g., vaporized hydrogen peroxide) as a deactivating agent. The PCD includes first and second layers that are joined together to form (1) a chamber dimensioned to receive a biological and/or chemical indicator, and (2) first and second conduits fluidly connecting the chamber with a region outside the PCD. Each conduit has one end in communication with the region outside the PCD and another end in communication with the chamber. A removable seal member seals the biological and/or chemical indicator inside the chamber.