Abstract: A porous media, a housing containing a porous media and methods for fabricating the housing containing a porous media are provided. The porous media is composed of varying amounts of sorptive binding particles in combination with polymer particles, for example silica particles mixed with polyethylene beads. The porous media is sintered into target housings, for example pipette tips, for use in desalting, purifying and separating biomolecules in target samples. The porous media is also formed into porous media discs via pressure and heating for insertion into housing devices.

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

Abstract: This invention provides methods and compositions for testing for pregnancy and non-pregnancy in ungulates and non-hoofed ruminates. The tests provided by this invention are useful during a time that coincides with the estrus cycle during which breeding occurs or the first estrus cycle after breeding of a non-pregnant animal. The tests provided by this invention are useful in estrus and ovulation synchronization programs, with pregnancy testing useful at a time allowing for resynchronization of non-pregnant animals within the first estrus cycle. The tests provided by this invention assay for the presence, absence, or level of a selected IFN-?-induced protein in a sample from a female animal. The tests of this invention are useful for testing cells, blood, plasma, serum, cells, milk, nasal secretions, ocular secretions, vaginal secretions, urine, and saliva samples. The tests provided by this invention are immunoassays.

Abstract: Hollow particles for use in various types of assay devices are provided. Due to their hollow or voided structure, the particles may exhibit a variety of beneficial properties. For instance, hollow particles are generally lightweight, and thus, relatively inexpensive in comparison to other types of particles. Hollow particles may also form a stable system without requiring refrigeration or rotation. In addition, hollow particles may possess enhanced light diffraction capabilities, which may be particularly beneficial in certain types of assay devices, e.g., diffraction-based assay devices.

Abstract: A device for biochemical processing and analysis of a measured sample volume of a sample is described. The device is characterised in that it consists of a sealed vessel (1) and that it comprises at least one thin pierceable membrane (2) through which a capillary tube (3) containing said measured sample volume of a sample can pass into said sealed vessel (1). Said sealed vessel (1) further contains at least one biochemically reactive substance (4) and a liquid (6). A method, wherein the device according to the invention is used for analysis, is also described.

Abstract: The present invention provides an analyte detection system for detecting a target analyte in a sample. In particular, the invention provides a detection system capable of one-step amplification of the detection signal by incorporating a secondary flow path that can deliver reagents to a reaction zone. Methods of using the detection system to detect analytes in samples, particularly biological samples, and kits comprising the detection system are also disclosed.

Abstract: An apparatus for detection of an analyte of interest in a solid, semi-solid, or liquid biological sample, using a lateral flow assay test strip, is described. The apparatus minimizes sample handling and manipulation upon introduction of the sample into a sample-receiving chamber and transfer of the sample to a test chamber containing the assay strip.

Abstract: An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample are described. The assay design prevents interference by reagents used for such removal with the HDL quantification reaction or with other assays carried out on the same sample. If desired, removal of non-HDL lipoproteins and assay of HDL cholesterol can be carried out without interruption of the assay.

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

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

Abstract: A membrane array used to detect one or more analytes from a small sample of fluid with high sensitivity is provided. The membrane array can be employed in various analytical devices and is especially useful for identifying analytes from whole blood with minimal or negligible background interference.

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

Abstract: A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a detection zone and compensation zone within which are immobilized capture reagents. The present inventor has discovered that the presence of a compensation zone may enable the detection of an analyte over extended concentration ranges. In particular, the compensation zone facilitates the binding of probes that would otherwise bind within the interior of assay device or that would exhibit “self-quenching”.

Abstract: There is described an affinity-chromatography assay system comprising with an immobilized component containing a bio-reagent and a flowable component containing a complimentary bio-reagent characterized in that the immobilized component is supported on a dip strip or planar surface and the flowable component is adapted to flow down the dip strip of high density. There is also described a method of conducting an affinity-chromatography assay which comprises the use of such an assay system.

Abstract: The invention is an electronically processed single-step test device for detecting the presence of a preselected analyte in a fluid. The device includes a hollow rectangular outer casing, disposed within co-joined upper and lower sections of the casing are assay material, an electronic processing system, and a LCD display. The LCD display is observable through a viewing window. The assay material is a sorptive material including a fluid sample application region in the form of a sample wick in fluid communication with a test strip. The test strip includes an analyte capture region adjacent to a light shield. The electronic processing system includes red and green LEDs which are alternately pulsed or energized over predetermined periods of time to determine if fluid test results show a marker or markers in the capture region indicative of the presence of a preselected analyte in the fluid. If so, Yes+ is displayed on the LCD. If not, No? is displayed on the LCD.

Abstract: A device for the determination and/or the detection of erythrocyte blood groups from a whole blood sample, and a process that implements this device, as well as a kit for the determination and the detection of blood groups are disclosed.

Abstract: Methods and devices for isolating nucleic acids from a mixture containing such nucleic acids and extraneous matter are provided. In one embodiment, the method of the invention comprises passing the mixture through a glass frit under conditions effective to separate the nucleic acids from the extraneous matter. In a more specific embodiment, the glass frit is a sintered glass frit.

Abstract: A cell isolating device and method is provided to concentrate or isolate cells with specific characteristics from a mixture of different cell types. One embodiment may comprise two subtypes of antibodies that are directly conjugated to biotin (Abb) and conjugated to a fluorescent molecule (Abf). The conjugated antibodies (Abb+Abf) bind to the target cells in a mixed cell suspension. The cell suspension is then passed over an immobilized avidin or streptavidin substrate on a glass microscope slide. The biotinylated target cells adhere to the avidin/streptavidin substrate, while the unbound cells are washed off and collected in a wicking member. Captured cells on the avidin/streptavidin substrate may then be visualized directly using a fluorescent microscope or detected and enumerated via an on-board fluorescent detection device.

Abstract: Disclosed is a test device and a method for qualitatively and/or quantitatively measuring the concentration of an analyte in a biological fluid sample. The test device includes a housing defining a sample port, a test well containing a stirrer and a conjugate, and a test strip disposed within the housing. The test well is also defined by being located between the sample port and the test strip. Fluid flows from the test well onto the test strip, which has a trapping zone which binds the analyte and allows for its detection. A control zone may also be included. The test device is generally adapted to use a sandwich assay. Also disclosed is a system comprising the test device and a signal sensing device; and a method for using the test device.

Abstract: Disclosed is a device, for detecting an analyte in a sample, comprising a sample pad for collecting the sample, a test strip coupled to the sample pad, and a housing enclosing and allowing visualization of the test strip. The sample pad can include one or more markings for determining the amount of sample collected. The device can also include a run fluid container that fits over the sample pad and forms an air-tight seal around the housing. Further, the device can include a second sample pad/test strip combination for detection of a second analyte. Also disclosed are methods for detecting an analyte in a sample using the device.

Abstract: Systems and methods are provided for immobilizing nucleic acid amplicons and protein antigens on a test device. Amplicons comprising a synthetic binding unit and a detectable label are generated and immobilized at predetermined locations on a test device by specific binding interactions between the synthetic binding unit and a synthetic capture unit located at the predetermined locations. The synthetic binding unit may include a unique design such that during amplification, a region of the synthetic binding unit is not subject to the amplification reaction, and thus the amplicon remains single stranded and available for binding to the synthetic capture unit during the capture process. In certain embodiments, the synthetic binding unit and a synthetic capture unit include synthetic nucleic acid analogs that do not interact with native nucleic acids or enzymes that act thereon. In one embodiment the synthetic binding unit and synthetic capture unit comprises puranosyl RNA (pRNA).

Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: A Plasma or serum separation membrane that enables omitting centrifugal separation, is free from hemolysis attributed to destruction of red blood cells and realizes easy and rapid separation of plasma or serum from blood; and a filter apparatus including the plasma or serum separation membrane. In particular, a plasma or serum separation membrane being a membrane for separation of plasma or serum from blood and having a void ratio of 30% or below; and a filter apparatus comprising a filter member capable of attaining movement of plasma swifter than movement of blood cells and a plasma or serum separation membrane connected in series with a rear side of the filter member.

Abstract: This invention relates to a device for the simultaneous qualitative or quantitative determination of several analytes in a liquid sample. The device comprises a membrane with a charging zone, for the application of the liquid sample, at least two indicator zones which can interact with the analyte(s) and at least one absorption region, which accepts the fluid after passing through the indicator zones, whereby the indicator zones lie between the charging zone and an absorption region, characterized in that the flow directions (flow tracks) are essentially parallel from the application zone through each indicator zone to an absorption region and at least two different flow tracks are present.

Abstract: A quantitative sampler of pathogens in exhaled air is provided. The quantitative sampler includes an air inputting pipe for a sampled individual to blow exhaled air; a check valve unit for preventing the exhaled air from reversely flowing; an aerosol filtering unit having an aerosol filtering material for collecting aerosol particles in the exhaled air; and an air flow meter for measuring if total accumulated volume of the exhaled air reaches a predetermined sampling volume defined as a concentration denominator of exhaled pathogens. The quantitative sampler can be used to collect the aerosol particles, and then moves the aerosol filtering material out of the aerosol filtering unit followed by separating genetic substances in the aerosol particles from the aerosol filter, so that a real-time qPCR can be reacted by using the genetic substances for obtaining a quantitative concentration of the exhaled pathogens.

Abstract: The present invention provides a fluid collection and drug testing device that includes a fluid collector, to collect a fluid sample, and a housing to test and retain the fluid sample. The housing includes a collection chamber, having an open end to receive the fluid collector, at least one membrane test strip, in fluid communication with the collection chamber, to indicate the presence or absence of at least one test drug, and an immunoassay-based fingerprint acquisition pad, in fluid communication with the collection chamber, to positively identify the test subject and associate the test subject with the fluid sample.

Abstract: A three-dimensional fluidic assay device or sensor is described. The sensor has a porous substrate with a first face or plane defined along x-y coordinate axes, and a second face remote in a z-direction from the first face. The first face contains a sample deposition zone and the second face has at least one detection zone, such that when a fluid sample is deposited in the sample deposition zone, fluid is transported by means of capillary action along the z-direction to the detection zone and manifests a signal development. An absorbent article, such as a diaper or feminine hygiene product, having such a three-dimensional sensor integrated across the thickness of the absorbent article, from an inner layer to an outer layer, is also described.

Abstract: A rapid immunoassay method and apparatus for detecting foot and mouth disease virus are disclosed. The method and test device permit pen-side testing of animals and provide test results within a relatively short time period. In a preferred embodiment, the method and apparatus provide a means for differentiating between FMDV-infected and FMDV-vaccinated animals.

Abstract: The present invention relates to a forensic test strip and method for the detection of semen. This strip is comprised of a paper element coated with reagents which react to the presence of acid phosphatase (AP), an enzyme found in semen, and is sandwiched between a clear plastic cover and an opaque plastic backing. This assembly is peeled apart, the paper element exposed to a source of semen, and the clear cover replaced. A positive test is characterized by a bright purple color, which easily can be seen through the clear cover. An adhesive backing is provided, which allows an investigator conveniently to affix the test strip directly to a notebook.

Abstract: This invention provides a simple detection method with excellent sensitivity and specificity, which allows prompt detection of an analyte by allowing a labeled reagent to effectively react with the analyte in the process of treating an analyte-containing specimen, such as during removal of impurities, a detection apparatus, and a detection kit. This method for detecting an analyte in specimens comprises steps of: bringing a labeled reagent containing a ligand that specifically binds to the analyte into contact with a specimen; and supplying the mixture of the specimen and the labeled reagent to a solid-phase support onto which a capture reagent that specifically binds to the analyte has been immobilized, wherein the step of bringing the specimen into contact with the labeled reagent is carried out at a site that is not on the solid-phase support and that is detached from the solid-phase support.

Abstract: The invention provides for devices and methods for detecting an organism causing a urinary tract infection. In a preferred embodiment, detecting the organism causing a urinary tract infection follows a preliminary indication of a urinary tract infection by a urinary monitoring device to monitor for the presence or absence of markers indicative of a urinary tract infection. The invention also provides for methods of using such devices.

Abstract: The invention provides a dipstick and a kit comprising the dipstick, for testing for the presence of a plurality of different targets in a sample solution which comprises: a dipstick having a plurality of different capture zones and, immobilised to each capture zone, a different capture moiety, each capture moiety capable of capturing a different target; and, separately, a plurality of different detection probes, each detection probe capable of binding to a different target and each detection probe being labelled with or enabling the formation of a detection signal so that the presence of each target is indicated by the formation of a signal at the capture zone for that target; wherein the target for at least two of the capture moieties is a disease causing micro-organism or a marker indicating the existence of a disease, disorder, or condition of the host from which the sample solution was derived, and wherein at least two of the capture moieties are capable of binding to different components or markers of t

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

Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample and indicating to the user the presence or absence of the analyte through the formation of a recognizable symbol during the assay. In one embodiment, the present invention provides test strips having a matrix including a sample application zone, a reagent zone, and a detection zone. Within the detection zone are located positive and negative control areas, and an analyte binding area. The positive control area contains one or more components that exhibit a first color when dry and a second color when wetted. When the assay is conducted, the positive control area is wetted by the assay fluids and turns to a second color, thereby functioning as a positive procedural control. When analyte is present in the sample, it binds at the analyte binding area, which interacts with the positive control area to form a second recognizable symbol at the detection zone.

Abstract: The use of a high power and an incoherent light source to reduce noise associated when investigating unknown molecules in Surface Plasmon Resonance (SPR) systems. High power and incoherent light sources can improve resolution and accuracy of SPR system measurements.

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: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

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

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

Abstract: A rapid immunochromatographic assay system is provided for measuring the amount of glycated albumin in a blood sample relative to the total level of albumin in the sample. The assay system is comprised of a disposable cassette that contains the test strips and testing reagents, and a measurement device that automatically reads, calculates and displays the test results over a period of time. The test cassette contains two test strips that are used to measure glycated albumin and total albumin respectively. The strips are contiguous beneath the single sample application well so that the same sample is tested simultaneously by both test strips. Part of the sample will migrate thru the glycated albumin test strip where it will react with the glycated albumin test reagents to yield a glycated albumin result, while part of the sample will migrate thru the total albumin test strip where it will react with the total albumin test reagents to yield a total albumin result.

Abstract: A self-contained apparatus using a gravitationally encouraged, interrupted, downward, diffusive and programmed flow of fluid to provide for rapid confirmatory immunological testing (“RCIT”) in, for example, a clinical, point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a source of conjugate having mobilizable binding members such as immunographic antigens or antibodies specific to the condition being tested conjugated to a detectable label such as colloidal gold. The specimen is premixed with a first measured, reactive mix buffer solution carried within an openable tank. The specimen and solution are temporarily held within an incubation reservoir formed behind a dam made from porous, diffusive material.

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

Abstract: A self-contained device using a gravitationally encouraged, interrupted downward and programmed flow of fluid to provide for rapid confirmatory immunological testing (“RCIT”) in a point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a colloidal conjugate of antigens or antibodies pathogenically specific to the condition being tested and premixed with a first measured, reactive mix buffer solution carried within an openable tank. Alternately, the buffer solution is preformulated to carry the colloidal conjugate in suspension. The premixture flows out of the first chamber toward chromatographic test strips having a single layer of uniformly dispersed porous matrix material such as polyethylene and inclined in a downward flow orientation. The flow is interrupted by a holding reservoir which is drained by siphoning, gravity and capillary forces. The delayed and regulated flow provides an incubation time for a better affinity binding of the specimen.

Abstract: A chromatography device includes a sample introducing portion for introducing a sample in a liquid state and provided at an upstream side of a flow of the sample, a developing means including a creatinine detecting portion, at which a creatinine detection reagent for detecting creatinine in the sample is provided, and a substance-to-be-detected detecting portion, at which a substance-to-be-detected detecting reagent for detecting a substance included in the sample is provided, and a liquid absorbing portion for absorbing liquid included in the sample in order to allow the sample to flow to a down stream side towards the liquid absorbing portion, wherein the sample introducing portion, the developing means and the water absorbing portion are provided on a board in this order from the upstream side to the downstream side in order to quantify the substance, which is included in the sample and which is to be detected.

Abstract: The present invention relates to a dry reagent assay device having at least one test zone and at least one reference zone, which provides an internal mechanism for assuring correct and reliable assay procedures and reagent qualities. In one embodiment, the present invention relates to an assay device having at least one test zone for detecting at least one analyte in a sample by reacting the sample with a labeled indicator reagent, and a reference zone for receiving unreacted labeled indicator reagent.

Abstract: The invention relates to devices for performing single step assays for the determination of the presence or absence of an analyte in a liquid sample, and methods of determining the presence or absence of such analytes using such devices. Devices disclosed comprise a labeled analyte-binding reagent reversibly-immobilized on a non-porous solid material, which solid material is in physical contact with a dry porous carrier bearing an immobilized analyte-binding reagent. Also provided are quantitative assay devices.

Abstract: Near-infrared molecular assays can be used to detect small quantities of a molecule of interest in vivo or in vitro using laser dyes. A hand-held portable device is provided which can rapidly read small quantities of selected molecular tags in tissues of fish or other animals in the field. The device is composed of four components: (1) a light source, such as a laser diode; (2) a sample holder; (3) an optical system; and (4) a detector.

Abstract: A diagnostic and testing apparatus and related methods for the use of the same are disclosed which derive and use antibodies to equine albumin and equine hemoglobin in testing apparatus, kits, and methods for detecting and localizing gastric and colonic ulcers or bleeding in horses. Fecal droppings from a horse to be tested are placed in a container together with a buffered liquid solution and mixed thoroughly, following which several drops of liquid from the container are placed into a test kit. Visual markers in the test kits signify the detection of the indicators equine hemoglobin and equine albumin, which are respectively indicative of the presence of gastric and/or colonic ulcers or bleeding.