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: Disclosed is a diagnostic testing device that may be used to detect one or more analytes in a sample. The device comprises a receptacle and a holder for a test strip. The test strip may be, for example, a lateral flow test strip. The device and holder permit analysis of a sample, wherein the device is substantially sealed during testing and detection of results. To use, the holder containing a test strip is inserted into the receptacle containing sample to be analyzed. Capillary flow along the test strip is initiated by contact of the sample with the distal end of the test strip. The receptacle is such that results of the assay may be detected visually or using standard instrumentation such as by measuring light absorption or reflectance.

Abstract: Antibodies having specific binding for the parent THC (?9-THC) and its major metabolites are provided which present a significant increase in sensitivity of immunoassays such as lateral flow immunoassays and ELISA for THC. The present invention also provides a rabbit hybridoma producing the antibody as a monoclonal antibody, a recombinant antibody, further molecularly engineered recombinant antibodies against parent ?9-THC and its metabolites and cell lines producing the recombinant antibodies. The invention also provides applications of the antibody in immunoassays, particularly lateral flow immunoassays, specifically applications in detecting THC in body fluids, particularly saliva, and kits for determining the presence of THC.

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: 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: The invention provides for a urinary monitoring device to monitor for the presence or absence of markers indicative of a urinary tract infection (UTI). The invention also provides for methods of using such a device.

Abstract: Disclosed is an assay device to determine the presence of at least one analyte of interest in a liquid sample, the device comprising means for generating a first signal (the ‘test’ signal) which indicates the presence and/or amount of analyte of interest in the sample; and means for generating a second signal, the generation of which second signal indicates both (a) the test has been successfully conducted, and that (b) sufficient time has elapsed following contact of the assay device with the liquid sample for the test to be read and the first signal to have been properly generated.

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 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: 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: A test strip configured for the detection of an analyte in a fluid sample and methods for manufacturing and for using the same. The test strip comprises a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween. The first flow matrix comprises a detection composition movably bound thereto, wherein the detection composition when exposed to the analyte produces at least one detectable product and wherein the first and second solid matrices are selected so as to accumulate the at least one detectable product at the interface between the two matrices, when the fluid sample travels from the first flow matrix to the second flow matrix.

Abstract: The present invention relates to an apparatus for use in an assay comprising: (a) at least one first receptacle comprising a fluid inlet and a fluid outlet, (b) a porous membrane, and (c) at least one analyte-specific binding agent, characterised in that said at least one analyte-specific binding agent is immobilised on the underside of said porous membrane relative to the fluid inlet; and to methods of performing said assay.

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: A system for treating a blood sample (700) having an analyte of interest comprises a strip (200) having a membrane (218), respective portions (216, 220 and 222, or 300) which are provided for receiving the sample, for lysing cells of the sample to liberate hemoglobin, and for capturing glycated hemoglobin. The latter two portions (220 and 222, or 300) of the membrane are treated with lysing and capture agents, respectively. A portion of the strip (214 or 230 or 240) is provided for holding an eluting agent and for releasing the agent upon a release condition. A system for detecting analyte comprises an optical subsystem (550) that is aligned with the strip to provide a signal corresponding to an amount of analyte, and an electronic subsystem (650) for processing the signal (560) to provide a result, such as an amount or percentage of glycated hemoglobin.

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: 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: 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.

Abstract: This disclosure teaches a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, haptens, and carbohydrates by lateral flow techniques. In one embodiment of the disclosure, a test sample is added to the test strip, which then migrates to the site of the immobilized allergens, thereby forming a first antibody IgE-allergen complex. A chase release buffer is added upstream to or from the site of the labeled anti-IgE antibodies, which is itself upstream from the sample site. The anti-IgE antibodies migrate downstream to the site of immobilized first complex, thereby forming a second complex indicating the presence of class specific IgE antibodies in the test specimen. In another embodiment of the disclosure, a liquid form of the labeled anti-IgE antibodies can be added to the test strip after the first complex has been formed.

Abstract: A rapid diagnostic test system includes a lateral-flow strip for performing a binding assay. The lateral-flow strip contains a binding agent having a deposition density that varies periodically along at least a portion of the lateral-flow strip. The test system further includes an imaging system that is used to capture an image of the portion of the lateral-flow strip.

Abstract: A biosensor is provided with an area in which a reagent having bleaching action is carried in a state where it can be dissolved, at least in a part of a sample application area to which an inspection target solution is applied or the downstream of the sample application area in the direction of the inspection target solution permeating, in a development layer. In the so-constituted biosensor, a colored component in the inspection target solution can be faded by the bleaching reagent, so that the color in parts other than a reactive area is reduced in consequence, whereby a visual judgment is possible and a more accurate measurement result in which a reading error by a measuring device is extremely suppressed can be obtained.

Abstract: A novel method for detecting the concentration of a metabolite in a fluid sample is provided. Devices for the detection of the analyte are also provided. In particular, a device for determining the concentration of 11-dehydro thromboxane in a urine sample and comparing it to a set of standardized quartile concentrations is provided. A concentration of urinary 11-dehydro thromboxane that falls within the fourth quartile is indicative of a greatly increased risk of a recurrent cardiovascular event.

Abstract: The present invention is to provide a simple membrane assay method for detecting or quantitating an analyte in a specimen sample using an assay device equipped with a membrane bound with a capture-substance to capture the analyte, comprising the steps of filtering a specimen sample using a filter, dropping the filtrate onto said membrane and detecting the presence of the analyte in said specimen sample, as well as a simple membrane assay kit for detecting the presence of an analyte in a specimen sample, comprising (1) a filter tube, and (2) an assay device equipped with a membrane bound with a capture-substance to capture the analyte. The method or the kit can decrease the occurrence of false positivity and can provide a highly accurate detection of the analyte such as pathogen and antibody in a specimen collected in a medical scene or by an individual.

Abstract: Hydrophobic coating compositions are provided as are processes to coat articles with the compositions. Extremely hydrophobic coatings are provided by the compositions. Durable, weatherable and scratch-resistant coatings are provided by compositions comprising a fluorinated component and an adhesion promoter compound. The adhesion promoter compound can include an alkoxy group, a furfuryl-containing ring structure, and a reactive group.

Abstract: Methods, compositions, and apparatus for detecting the presence of caffeine in a liquid sample are provided. In certain embodiments, an internally referenced competitive assay allows a very precise determination of a threshold value of caffeine for use in semiquantitative types of ligand-receptor assays. By using a detection means that participates in two assays, sensitivity is doubled in the maximum sensitivity range and the range can be adjusted to match the predicted concentration range of an analyte. This format and the materials described herein allow the assay to complete within three minutes. In addition, this format accommodates common attributes of liquid samples for detecting caffeine, such as the inclusion of milk or sugar in a coffee-type beverage.

Abstract: An immunoassay device has a housing defining a first opening for receiving a solution and a second opening through which a liquid sample is deposited, a strip of sorbent material having a test site with immobilized antigen or antibody for the ligand to be tested, and a filter for filtering the sample. The filter is located at the second opening and directly above the test site. The sorbent material defines a horizontal flow path in the housing for the solution from the first opening to the test site. In use, the sample is first applied via the filter to the test site, and then, after the ligand has been captured, a buffer added through the first opening is used to cause a secondary specific binder conjugated to a marker to migrate horizontally by capillary action to the test site where it can bind to the already captured ligand. This immunoassay offer several advantages over the traditional chromatographic immunoassays.

Abstract: The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

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 device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids.

Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: Rare cells are separated from a sample fluid by a positive selection or negative selection antibody by centrifuging in a tube containing a harvesting float. The harvesting float has an axial passage and a density to settle in the sample fluid and expand the layer of the target component. The positive selection antibody is preferably coupled to a particulate carrier, such as a microbead, to attach to the target component. The negative selection antibody forms a complex or conjugate with a contaminating component. In the positive separation, the particulate carrier is recovered in the axial passage of the float.

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

Abstract: Water soluble analytical agents for chlorine analysis of water are delivered into a sample from a support that is beneficially moved in the sample to assist delivery and mixing. Beneficially, an immediate photometric analysis of free chlorine is provided, and variability of measurements is reduced. Advantageously, the analysis is a touch-free chlorine analysis.

Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Abstract: A device for collecting oral liquids includes a lateral flow chromatography strip having a collection member. The collection member is separated from the remainder of the chromatography strip by a liquid impermeable removable barrier which prevents liquid in the collection member from entering the chromatography strip. Once adequate oral liquid has been collected (as indicated by a sample sufficiency indicator), the barrier is removed to allow oral liquids to flow through the strip. The liquids interact with binding partners in the strip to provide test results, such as an indication that an analyte of interest is present in the liquid. The strip may be contained in a housing with an access opening through which the removable barrier may be manipulated, and windows through which test results may be viewed. This device avoids reflux of reagents from the strip into the mouth of a test subject during use.

Abstract: Diagnostic in-vitro devices for use in the assaying of biological fluids are provided which include cover plates or backing strips which exhibit hydrophilic properties to assist in transport of the biological fluid or retention of same within the device. Exemplary diagnostic devices include lateral flow devices, microfluidic devices and microtiter plates. The devices may also be comprised of low fluorescent material in order to facilitate any diagnostic determination by use of fluorescent emissions. Hydrophilic properties may be imparted to the cover plates or backing strips by physical or chemical treatment thereof. The cover plates or backing strips may exhibit heat sealable or pressure sensitive properties.

Abstract: An assay device, analytical instrument and assay method for determining the presence or amount of an analyte in a fluid is disclosed. The device is a one-step lateral flow dry reagent immunoassay with one, two or more zones along a transverse axis of the device, each zone can contain or be preceded by diffusively or non-diffusively bound reagents. The invention measures an indicator in one or two test zones for each analyte to determine its presence or concentration. The signal reagent (indicator) may be a particle such as a colored latex or colloidal gold. The assay quantitation may be read by an instrument.

Abstract: This invention relates to assays for an analyte in a liquid sample such as a body fluid. More particularly, the invention relates to a method and apparatus for the detection of a ligand in a body fluid such as urine or blood, which includes an immobilization zone for interfering agents in a sample.

Abstract: Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.

Abstract: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution layered above particulate layers. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: A non-continuous immunoassay device which includes two or more separated pads for immunoassay analysis, and is capable of controlling the migration speed of a mobile phase between the separated pads, and an immunoassay method using the same are disclosed. The immunoassay device includes a first pad receiving a mobile phase; a second pad which is spatially separated from the first pad by a predetermined distance, and to which the mobile phase migrates; an upper case for covering the upper parts of the first pad and the second pad; a lower case for covering the lower parts of the first pad and the second pad; and a connecting member which is formed on at least one of the upper case and the lower case, and located between the first pad and the second pad to form a passage for moving the liquid sample.

Abstract: An immunochromatographic test device of the present invention comprises: a sample receiving member for receiving a sample; a label holding member for holding a labeling substance to bind to an analyte contained in the sample; and a chromatographic membrane having a detection zone at which an immobilization substance to bind to the analyte is immobilized, wherein the sample receiving member disposed to cover the label holding member and in contact with the chromatographic membrane, and the chromatographic membrane is spaced apart from the label holding member.

Abstract: A test kit for immunochromatography comprising a test strip and a test tube is described. The test strip comprises a detection zone for detecting an analyte in a sample. The test tube accommodates the test strip. The test tube comprises an indicator at a position corresponding to the detection zone of the test strip which is inserted into the test tube.

Abstract: A gunpowder particle test kit for determining gunpowder residue includes a transparent sleeve having a closed end and an open folded end sealed with a clip forming a sealed cavity carrying a test strip and a crushable ampoule carrying a diphenylamine solution. The test strip has an adhesive area on a front surface. An opaque label is provided on a rear surface on the sleeve opposite the adhesive area. In use, the clip is removed to open the cavity, the test strip removed and applied to possible residue areas on a subject. The strip is returned to the cavity; the clip reapplied to seal the cavity. Thereafter, the ampoule is crushed to release the solution, which develops a distinctive coloration observable against the label to indicate the presence of possible gunpowder residue.

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: There is provided a lateral flow assay device for detecting the presence or quantity of an analyte residing in a test sample where the lateral flow assay device has a porous membrane in communication with a wicking pad. The porous membrane has a detection zone which has a chromophore configured to chemically react with an analyte or a secondary trigger or a reaction product from the analyte and a trigger generating reagent(s), to generate a visually detectible signal. Additional chrmophore zones may be located downstream from the first chrmophore zone to generate signals of varying color. Scavenging zones may be included between chromophore zones to attenuate the signal by reacting with the analyte without generating a visually detectable signal.

Abstract: An immunoassay device has a housing defining a first opening for receiving a solution and a second opening through which a liquid sample is deposited, a strip of sorbent material having a test site with immobilized antigen or antibody for the ligand to be tested, and a filter for filtering the sample. The filter is located at the second opening and directly above the test site. The sorbent material defines a horizontal flow path in the housing for the solution from the first opening to the test site. In use, the sample is first applied via the filter to the test site, and then, after the ligand has been captured, a buffer added through the first opening is used to cause a secondary specific binder conjugated to a marker to migrate horizontally by capillary action to the test site where it can bind to the already captured ligand. This immunoassay offer several advantages over the traditional chromatographic immunoassays.

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