Abstract: A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, a

Abstract: The present invention aims to provide an assay reagent and an assay for accurately measuring KL-6, in particular, an assay reagent and an assay for accurately measuring KL-6 in samples containing a rheumatoid factor and/or a nonspecific substance other than the rheumatoid factor. KL-6 in samples that contain a rheumatoid factor and/or a nonspecific substance other than the rheumatoid factor can be accurately measured using an immunoassay reagent comprising a solution at a pH of 4.0 to 5.5 containing a rheumatoid factor interference inhibitor and a solution of an insoluble carrier on which anti-KL-6 antibodies are immobilized.

Abstract: The invention relates to a system for collecting a biological sample comprising a container having at least one open end, a closure fitting on or in said at least one open end, a holding element connected to said closure and a solid matrix on which said biological sample is deposited, and optionally at least one processing agent, wherein said solid matrix is at least partially transferable into a liquid or dissolved state by changing at least one physico-chemical property of the environment of said matrix without disintegration of the biomolecules comprised in said biological sample deposited on said matrix.

Abstract: It is an object of the present invention to provide a measurement kit for developing a first developing solution and a second developing solution from different directions to suppress background noise, and an immunochromatography kit. The present invention provides a measurement kit, which comprises a first developing member for supplying a first developing solution and a second developing member for supplying a second developing solution, wherein the developing direction of the first developing solution is allowed to intersect with the developing direction of the second developing solution, so that development is carried out by developing the first and second developing solutions in different developing directions, and a water absorbent portion is established on the downstream of each of the developing directions.

Abstract: Methods, apparatuses, and systems for collecting samples using hybrid porous materials that include an organic material and an inorganic material. A method for sample collection includes contacting a hybrid porous material and a biological sample to the porous material. The hybrid porous material includes an inorganic material and an organic material. The method includes placing the porous material with the attached sample in a liquid medium, wherein the sample is separated from the porous material in the liquid medium to form a separated sample, and collecting the separated sample in the medium.

Abstract: A collection device for use in connection with off-device testing of collected samples. The device includes a first panel having one or more apertures for receiving samples, a second panel opposite the first panel, and a removable tab having a first portion and a second portion. The first portion is aligned with at least one of apertures on the first panel and constructed such that depositing the sample through the at least one aperture causes the sample to be directly deposited on the first portion of the tab, and the second portion includes a sample-free grasping area accessible from an exterior of the device for removing the tab. A method of obtaining a sample is also disclosed.

Abstract: Methods, devices, and kits are provided herein for the accurate and rapid detection of disease causing microbes in a sample by the detection of microbial components of which correlate to the presence of the microbe. Kits include a first binding agent operatively coupled to an immobilized support; and a second binding agent operatively coupled to one or more pH indicating moieties wherein the first and second binding agents bind with sufficient specificity to the microbial component to permit detection of that component which correlates to the presence of the microbe in the sample.

Abstract: Modified branched polymers are combined with bioactive agents which are one member of a binding pair for use in an assay.

Abstract: A test strip dispenser that has a housing that defines a dispensing opening is provided. A cylindrical body engages the housing and is capable of rotating about an axis to rotate relative to the housing. A test strip engages an outer surface of the cylindrical body and is carried by the cylindrical body about the axis. Alignment of the test strip with the dispensing opening causes the test strip to fall off of and out of engagement with the outer surface and through the dispensing opening.

Abstract: Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics and kits are provided.

Abstract: Analytes in a sample are resolved by retentate chromatography in a procedure involving adsorbing the analytes on a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.

Abstract: A devise for fecal occult blood test comprises a first and a second casings, a sampling portion extending from the first casing, a specimen processing portion, at least a testing portion and a packing cylindrical member. The packing cylindrical member is coupled between the first and second casings when unused and dismantled therefrom when used. After sampling via a specimen collecting portion of the sampling portion, the specimen collecting portion is drawn into the first casing to reduce the device size. The first and second casings are fixedly coupled together in a specimen processing position thereof to mix specimens with a liquid of the specimen processing portion into a testing liquid, and then in a specimen testing position thereof to disperse onto the testing portions for testing and directly display test results. The present invention advantages high accuracy, rather hygiene, significant size reduction, real-time testing-result display and convenient use.

Abstract: The invention provides a method for continuously detecting glucose concentration in a sample, including: (a) providing a biosensor comprising a transducer and a polysaccharide covered on the surface of the transducer; (b) providing a carbohydrate binding protein solution, wherein the carbohydrate binding protein has at least one receptor, and the receptor is capable of binding to the polysaccharide and glucose; (c) mixing a sample and the carbohydrate binding protein solution to form a mixture; (d) contacting the mixture with the biosensor; (e) detecting the amount of carbohydrate binding proteins bound to the polysaccharide by the biosensor, wherein glucose concentration of the sample is inversely proportional to the amount of carbohydrate binding proteins bound to the polysaccharide; and (f) refreshing the surface of the biosensor with a high concentration glucose solution.

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: A lateral flow test system together with methods for its use in the detection of one or more analytes, or components, of interest within a sample, such as a biological sample, is provided. The system comprises a liquid formulation of a gold conjugate and a lateral flow assay device that does not include a conjugate pad having conjugate dried thereon.

Abstract: Systems and methods are disclosed to automatically detect the presence of a substance on a test swipe by capturing a background image of the test swipe; applying one or more test chemicals to a test swipe; adjusting the temperature of the test swipe to a predetermined temperature range; controlling a variable speed fan to avoid fogging the camera's lens; capturing an in-situ image of the test swipe after the application of chemical at the predetermined temperature range; subtracting the background image from the in-situ image; generating a difference value from the two images; and searching a known database to identify the substance.

Abstract: An electrochemical immunosensor system with reduced interference, comprising: a first immunosensor that generates an electrochemical signal based on the formation of a sandwich between an immobilized antibody, a target analyte and a labeled antibody, wherein a portion of the signal arises from non-specific binding of the labeled antibody in the region of the first immunosensor, and a second immunosensor that acts as an immuno-reference sensor and generates a signal that is the same as or predictably related to the degree of non-specific binding which occurs in the region of the first immunosensor, and has an immunocomplex between an immobilized antibody and an endogenous or exogenous protein that is in the sample and that is not the target analyte.

Abstract: A membrane strip biosensor device using a fluid mobile conductive composition of ferromagnetic particles bound to a conductive polymer bound to a capture reagent is described. The biosensor device is designed to detect analytes at low concentrations in near real-time with an electronic data collection system and can be small. The device can be used to detect pathogens, proteins, and other biological materials of interest in food, water, and environmental samples.

Abstract: The invention provides methods for treatment of acute coronary syndrome and prediction of adverse cardiac events on the basis of elevations of catalytic iron in biological fluid of a human subject. An embodiment of the invention provides a method for early detection of acute coronary syndrome (ACS) in a human subject at the time of presentation of the chest pain. The method includes analyzing a test sample of the biological fluid for amount of catalytic iron and detecting acute coronary syndrome in the human subject.

Abstract: The present invention is directed to methods for extracting markers from biological samples, and to systems, devices, kits and reagents for use in such methods. The invention is also to methods, kits, reagents and compositions for measuring a plurality of different organism types in a sample. One of the specific advantages of the present invention is the ability to simultaneously extract more than one microorganism or viral particle marker in one volume from a single sample containing a complex biological matrix.

Abstract: The invention concerns coated test elements and in particular test elements comprising a capillary gap which have a hydrophobic structured coating at least in the area surrounding the capillary gap.

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: An apparatus and methods for binding an analyte of interest in a sample are provided. The apparatus comprises a substrate with an exposed surface with an compound, that is electrostatically charged or capable of forming hydrogen bonds, provided bound to the solid substrate. A recombinant single chain antibody (scFv) molecule specific for the analyte of interest, having one or more amino acids with charged or hydrogen-bond forming sidechains in a linker polypeptide portion, is bound to the layer on the solid substrate. When the analyte of interest is present in the sample the scFv binds the analyte to the solid substrate. The apparatus can be used with an immunoglobulin layer to detect Fc receptors, so as to detect microorganisms such as Staphylococcus aureus having protein A or protein G.

Abstract: The present invention relates to a novel IL17RLP protein which is a member of the interleukin (IL)-17 receptor family. In particular, isolated nucleic acid molecules are provided encoding the human IL17RLP protein. IL17RLP polypeptides are also provided as are vectors, host cells and recombinant methods for producing the same. The invention further relates to screening methods for identifying agonists and antagonists of IL17RLP activity. Also provided are diagnostic methods for detecting immune system-related disorders and therapeutic methods for treating, diagnosing, detecting, and/or preventing immune system-related disorders.

Abstract: An analytical strip and a detecting method using the analytical strip are provided. The analytical strip includes a substrate having a channel thereon. The channel has a first region, a second region and a third region, which are arranged successively. A first antibody is localized in the first region. A saccharide and a peroxidase are localized in the first or second region. A second antibody for recognizing a different epitope of an identical antigen with the first antibody is immobilized in the second region. A substrate reagent including a saccharide oxidase is localized in the third region.

Abstract: This invention is directed to a lateral flow assay for detecting the presence of an analyte in a liquid test sample. The lateral flow assay represents an improvement in the ability to accurately and with high fidelity to detect the presence or absence of a target analyte in a liquid sample, in part, by encompassing a reference region of immobilized, non-diffusible analyte that allows for detection of any factors that interfere with the interaction and binding of the analyte to the labeled capture reagent. Any influences on the interaction and binding of the analyte that is free in solution in the liquid test sample to its complementary labeled reagent will be encountered in parallel in the binding between the immobilized analyte in reference region to the labeled reagent as it diffuses through the reference region. In one embodiment, the lateral flow assay of the invention is a urine-based human Chorionic Gonadotropin (hCG) assay.

Abstract: The invention relates to a device for simultaneously, qualitatively or quantitatively identifying a number of analytes in a liquid sample. The device comprises a membrane with: a charging zone for applying the liquid sample; at least two indicator zones, which can interact with the analytes, and at least one absorption area, which absorbs the liquid after passing the indicator zones, whereby the indicator zones are located between the charging zone and an absorption area. The invention is characterized in that the flowing directions from the charging zone through the respective indicator zones to an absorption area (flow paths) are essentially parallel, and at least two different flow paths exist. The invention also relates to a method for identifying a number of analytes or the derivatives thereof in a liquid sample.

Abstract: A object of the present invention is to provide an immunochromatography method that makes it possible to rapidly detect an ultratrace amount of an analyte that has been impossible to analyze by conventional immunochromatography methods. The present invention provides an immunochromatography method, which comprises developing an analyte and a labeling substance which is modified with a first binding substance against the analyte in a mixed state on a porous carrier and capturing the analyte and the label at a reaction site on the porous carrier having a second binding substance against the analyte or a substance capable of binding to the first binding substance against the analyte, so as to detect the analyte, wherein the labeling substance having an average particle size of 1 ?m or more and 20 ?m or less is detected.

Abstract: An immunochromatoassay method that allows high detection sensitivity measurement. The method including the steps of: permeating an analyte solution that includes a visibly labeled second binding substance that specifically binds to a detection target substance into a test area of a chromatography medium provided with a first binding substance that specifically binds to the detection target substance, simultaneously with or after the permeation of the analyte solution into the test area, permeating a visual recognition aid solution into the chromatograph medium, the solution having a refractive index whose refractive index difference ?n from that of the chromatograph medium is ?0.1??n?0.1, and visually observing the test area while the visual recognition aid solution is permeated in the test area.

Abstract: According to the biosensor and the blood component analytical method of the present invention, in a biosensor that is made of a single layer or plural layers of a porous material as shown in FIG. 1, having a reagent holding part and utilizing chromatography, a cell shrinkage reagent is carried on at least part of the reagent holding part, or at least part of a chromatographically developed part that is upstream of the reagent holding part. According to the biosensor having the above-mentioned structure and the blood component analytical method, even when whole blood is a sample, a high-accuracy blood component analysis cart be performed easily and quickly with less cost.

Abstract: It is an object of the present invention to provide a measurement kit for developing a first developing solution and a second developing solution from different directions to suppress background noise, and an immunochromatography kit. The present invention provides a measurement kit, which comprises a first developing member for supplying a first developing solution and a second developing member for supplying a second developing solution, wherein the developing direction of the first developing solution is allowed to intersect with the developing direction of the second developing solution, so that development is carried out by developing the first and second developing solutions in different developing directions, and a water absorbent portion is established on the downstream of the developing directions.

Abstract: A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.

Abstract: Described are methods of visualizing biological samples using histological staining and invisible light (e.g., infrared or near-infrared) fluorescence.

Abstract: The subject invention is an immunoassay for the semi-quantitative test kit for determination of human chrionic gonadtropin (hCG) in fluid sample (such as urine) as an aid in the diagnosis of a certain stage of pregnancy. The test device includes five strips having each having a dipping end or sample ends where sample can be applied. Results are indicated by coloration of two bands across a clear area of the strips, one band being coated with a reagent such as hCG antigens and the other with a reagent such as goat/rabbit polyclonal antibody gold conjugate. The combination of color indications on the bands provides the test results.

Abstract: An analytical strip and a detecting method using the analytical strip are provided. The analytical strip includes a substrate having a channel thereon. The channel has a first region, a second region and a third region, which are connected sequentially. A first antibody is localized in the first region. A saccharide and a peroxidase are localized in the first or second region. A second antibody for recognizing a different epitope of an identical antigen with the first antibody is immobilized in the second region. An optical substrate and a substrate reagent including a saccharide oxidase are localized in the third region.

Abstract: A test strip and method for detecting an analyte present in a sample.

Abstract: Capture particles for harvesting analytes from solution and methods for using them are described. The capture particles are made up of a polymeric matrix having pore size that allows for the analytes to enter the capture particles. The pore size of the capture particles may be changeable upon application of a stimulus to the particles, allowing the pore size of the particles to be changed so that analytes of interest remain sequestered inside the particles. The polymeric matrix of the capture particles may be made of co-polymeric materials having a structural monomer and an affinity monomer, the affinity monomer having properties that attract the analyte to the capture particle. The capture particles may be used to isolate and identify analytes present in a mixture. They may also be used to protect analytes which are typically subject to degradation upon harvesting and to concentrate low an analyte in low abundance in a fluid.

Abstract: The present invention is directed to methods and apparatus for detection of one or more analytes. Analytes include agents or components of infectious agents such as pathogenic virus, as well as enzymes, proteins and biomarkers.

Abstract: Methods and immunoassays for diagnosing a bite or sting of a venomous organism in a patient having symptoms consistent with such a bite or sting are provided. A sample of venom is collected from the area of the suspected bite or sting using a swab and then contacted with an antibody that specifically binds to an antigenic site on venom present in the sample. Binding is then detected. The invention is illustrated by examples showing diagnosis of brown recluse spider bite, distinguishing it from other diagnoses with which it is often confused. This extremely sensitive test can detect venom antigens down to about 20 picograms even after the sample has been shipped and stored for periods of up to three weeks during the summer.

Abstract: The invention provides methods for early diagnosis or detection of acute coronary syndrome and prediction of adverse cardiac events on the basis of elevations of catalytic iron in biological fluid of a human subject. An embodiment of the invention provides a method for early detection of acute coronary syndrome (ACS) in a human subject at the time of presentation of the chest pain. The method includes analyzing a test sample of the biological fluid for amount of catalytic iron and detecting acute coronary syndrome in the human subject.

Abstract: The present invention provides immunoassays which are highly specific for detection in biological samples of methamphetamine and other drugs of abuse of the methamphetamine group such as ecstasy and other ecstasy class drugs. More particularly, competitive assays are provided comprising: (a) contacting said sample with (i) a pseudoephedrine/carrier conjugate in which pseudoephedrine is linked via its hydroxyl group to the carrier and (ii) an antibody which is capable of binding both one or more drugs of the methamphetamine group and said conjugate; and (b) determining whether the binding of said antibody to said conjugate is reduced by the presence of said sample, a reduction in binding being indicative that the sample contains a methamphetamine group drug.

Abstract: Methods for measuring the relative amount of two or more analytes of interest in a fluid sample, as well as kits useful in the methods, are disclosed. The methods involve assays that utilize a solid phase apparatus with a membrane having an application point and at least two sample capture zones having sample capture reagents; analyte binding particles or analyte coated particles; and assessment of a ratio of such particles arrested in capture zones, wherein the ratio is equal to, or inversely equal to, the relative amounts of the analytes of interest in the fluid sample.

Abstract: A capturing molecule having not less than two domains specifically binding to different sites of a target substance, wherein the not less than two domains comprise (1) a first domain having a hypervariable loop structure at a binding site to the target substance, and (2) a second domain having no hypervariable loop structure at a binding site to the target substance.

Abstract: The present invention relates to a test piece supplying device (1) comprising a container (4) for containing a plurality of test pieces, and also includes a movable body (3) moving relative to the container (4) with the test piece accommodated in a recess (30) so as to take the test piece out of the container (4). The container (4) includes a sweeping portion (41) for interfering with the test pieces, in the container (4), located above the test piece accommodated in the recess (30), when the movable body (3) moves relative to the container (4). When a warped test piece accommodated in the recess (30) is moved relative to the container (4), the interfering portion (41) flattens the test strip to be accommodated in the recess (30) so that the test piece is easily taken out of the container (4).

Abstract: A method of determining allergen activity in dust comprises: providing a dust sample; extracting from the dust sample at least one breakdown component or proteins or peptides; reacting the extracted at least one breakdown component with a colorimetric amine detection reagent such as TNBSA; and quantitatively measuring the intensity of any resulting coloration. The allergen activity may be gauged by the intensity of coloration.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: The present invention provides methods for detecting and quantifying metabolites in a biological sample by measuring the concentration of a test metabolite in the sample and comparing that concentration against the concentration of the reference metabolite; enabling accurate metabolite concentration measurements to determine aberrant drug usage patterns. Also disclosed is an analytical testing device and related computer-assisted products for detecting and quantifying metabolites in a biological sample efficiently and accurately.

Abstract: Monoclonal antibody that specifically binds to alpha-amylase and is useful for detecting weather damage (i.e. pre-harvest sprouting) in cereal grain.

Abstract: A reagent kit that is used for determining a characteristic of tissue obtained from a patient is described. The reagent kit comprising expression measurement reagents for measuring expression level of cyclin-dependant kinase (CDK) and activity measurement reagents for measuring activity value of CDK. The expression measurement reagents comprise first reagents and second reagents, and the activity measurement reagents comprise third reagents and fourth reagents. In the reagent kit, a first reagent set of the first and third reagents is stored under a first storage condition relating to temperature, and a second reagent set of the second and fourth reagents is stored under a second storage condition relating to temperature.

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.