Abstract: According to one embodiment of the present invention, an optical-based test sensor for use in the determination of an analyte in a liquid sample is disclosed. The test sensor includes a base, a polymer carrier, and a test membrane. The base has a capillary channel formed in a surface of the base that is adapted to move a liquid sample from an inlet to a reaction area formed in the base. The polymer carrier has a lower surface adhered to the surface of the base and is disposed over at least a portion of the capillary channel. The test membrane, which contains a reagent, is adhered to the lower surface of the polymer carrier and extends from the polymer carrier into the reaction area.

Abstract: A sequential solid phase immunoassay and system is disclosed. The immunoassay utilizes the secondary antibody method for the detection of antibodies in a membrane-based test. The system comprises a test strip including a nitrocellulose membrane having an immobilized antigen in a capture zone on the membrane and a stabilized liquid secondary antibody conjugate. The sequential solid phase immunoassay is performed in a sequential manner with the addition of a fluid specimen being followed by the addition of the stabilized liquid secondary antibody conjugate. The sequential procedure using the system includes allowing the fluid specimen containing antibodies specific to the antigen to pass laterally from the test strip first end through the capture zone. The immobilized antigens in the capture zone capture antibodies specific to the antigen. The stabilized liquid secondary antibody conjugate then binds to the captured antibodies and can be detected visually or by a machine or reader.

Abstract: A method of immobilising a biological molecule on a substrate comprises: (i) covalently attaching a substantially three-dimensional polysilane polymer to a substrate; and (ii) attaching a biological molecule onto and/or within the polymer. The method may additionally comprise the steps of coating the substrate (or the chemically protective layer) with a layer of radiation sensitive material, exposing the substrate to a source of radiation, and incubating the substrate in the presence of a first species of biological molecule.

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: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: A substrate for bioassay comprises a substrate and a group of reaction regions serving as a field where interaction between substances proceeds and formed in the substrate, and a group of information pits used to obtain positional information of individual reaction regions and/or substance information used in the reaction regions. The group of reaction regions and the group of information pits are not formed in the same substrate surface. A bioassay apparatus using the substrate and a method for making the substrate are also provided.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: Monoclonal antibodies, synthetic and biotechnological derivatives thereof (ScFv or others) are able to recognise the NGF high affinity receptor, TrkA, and act as NGF-antagonist molecules. Pharmacological compositions for therapy, gene therapy, diagnostics of neurological pathologies are also described. Transgenic animal models to study such pathologies are also described.

Abstract: The invention features a method of attaching a ligand that has a free carboxyl group to a solid support by adding an amino group to the ligand to form a ligand-amino derivative, converting the ligand amino derivative to a ligand sulfhydryl derivative, attaching the ligand sulfhydryl derivative to a protein to form a ligand-linker-protein conjugate, and applying the ligand-linker-protein conjugate to the solid support. The method is particularly useful for immobilizing small molecule ligands having a free carboxyl group, such as cloxicillin, to a lateral-flow test strip, in order to make a detection zone on the test strip that exhibits a clear signal and enhanced sensitivity.

Abstract: Devices and methods for the detection of target molecules are disclosed. Devices and methods for detecting food-borne target molecules are also disclosed.

Abstract: The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.

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: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: A microfluidic cartridge for isolating biological molecules having a capture chamber containing functionalized solid supports maintained in a fluidized state provides reduced pressure drops and bubble formation during microfluidic extraction. The cartridge may include an electric field lysis chamber and/or a chemical lysis chamber. The electric-field lysis chamber may comprise an electrically insulating structure arranged between two opposing planar electrodes.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

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: A diagnostic test tape for liquid samples is provided comprising a flexible transport tape and a plurality of test fields applied to the transport tape that are distributed in the longitudinal direction of the tape, where said test fields comprise a detection layer and a spreading net spanning the detection layer for a planar uptake of liquid sample, wherein the spreading net is formed from a lattice-like fabric comprising fabric threads that cross at right angles. In order to prevent the fabric from arching up under tape tension it is proposed that the fabric is oriented obliquely to the transport tape such that all fabric threads run obliquely to the longitudinal direction of the tape.

Abstract: Methods for measuring the amount of two or more analytes of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods involve determining a ratio of a detected amount of a single analyte of interest, to the sum of a detected amount of each of the analytes of interest plus a detected amount of a control, wherein the amount of each analyte of interest is directly or inversely related to the ratio for each analyte of interest.

Abstract: The present invention provides processes for determining the molecular weight of glatiramer acetate and other copolymers. The present invention further provides a plurality of molecular weight markers for determining the molecular weight of glatiramer acetate and other copolypmers which display linear relationships between molar ellipticity and molecular weight, and between retention time and the log of the molecular weight. The molecular weight markers also optimally demonstrate biological activity similar to glatiramer acetate or corresponding copolymers and can be used for treating or preventing various immune diseases. In addition, the subject invention provides pharmaceutical compositions for the treatment of immune diseases comprising a polypeptide having an identified molecular weight and an amino acid composition corresponding to glatiramer acetate or a terpolymer.

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: 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: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for a membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: Dipsticks and other assay devices suitable for the assay of haptens are disclosed. Also disclosed are blocking agents for use in such devices.

Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: The present invention provides an immunochromatographic device, which contains the following (a) and (b): (a) a first device part holding a first insoluble carrier used for developing a complex formed with an analyte and a labeling substance comprising a metal labeled with a first binding substance that can bind to the analyte and capturing the analyte and the labeling substance at a reaction portion containing a second binding substance that can bind to the analyte, and (b) a second device part holding a second insoluble carrier used for developing a liquid and a third insoluble carrier used for absorbing a liquid, in such a way that the first insoluble carrier does not come into contact with the second insoluble carrier and the third insoluble carrier.

Abstract: A method of controlling the flow of an aqueous fluid in a microfluidic device, which makes use of a fluid gate comprising a UCST (upper critical solubility temperature) polymer and which allows fluid to flow by raising the temperature of the fluid gate above the USCT. Also provided is a device incorporating such a fluid gate and the use of such a device to detect an analyte in an aqueous fluid sample.

Abstract: A new reaction apparatus including a capillary having an inner surface to which a probe molecule that specifically binds to an analyte is immobilized and achieving a highly efficient reaction using a small amount of a sample and a process of the reaction are provided. The reaction apparatus includes a capillary having an inner surface to which a probe molecule that specifically binds to an analyte is immobilized; a passage allowing a fluid discharged from one end of the capillary to flow to the other end of the capillary; a columnar magnetic body that is disposed in a fluid containing the analyte in the capillary and/or the passage in the state that the fluid fed in the capillary can circulate via the passage; end-fixing means for fixing one end of the columnar magnetic body in the capillary and/or the passage by a DC magnetic field; and end-moving means for moving the other end of the columnar magnetic body by an AC magnetic field such that the fluid circulates via the passage.

Abstract: A chemical analytic apparatus of the present invention is the one which proposes that a miniaturization, a making low-cost and portability are possible and also the operation of each process of separation, concentration and dilution of specimen is possible, and, which includes: an introduction means (S1) that introduces a droplet to which magnetic ultrafine particles are mixed into another liquid that differs from the droplet while maintaining a single droplet; a conveyance means by which the droplet that includes the magnetic particles is conveyed in another liquid of the introduction means by applying magnetic field externally to the magnetic ultrafine particles; and processing means (S2 to S6) by which operations for processing of chemical analysis are performed one by one in the process in which the droplet to which the magnetic ultrafine particles are mixed is conveyed by the conveyance means.

Abstract: Methods, materials, apparatus and systems are described for performing capillary flow assay. In one aspect, a system includes a sample collection unit to collect a sample liquid and a sample testing and storing unit to interface with the sample collection unit to test and store the collected sample liquid. The sample testing and storing unit includes a sample inlet shaped to receive the collected sample from the sample collection unit, and a sample well positioned below the sample inlet to retain at least a portion of the sample liquid. The sample testing and storing unit includes a sample housing unit to store a remainder of the sample liquid not retained in the sample well, and an analyte testing unit housing shaped to receive an analyte detecting unit to test a presence of a target analyte in the sample liquid.

Abstract: The invention concerns a method for increasing the dynamic measuring range of especially immunological test elements in particular immunological chromatography test strips that can be evaluated optically that are based on specific binding reactions. The invention enables the dynamic measuring range of test elements based on specific binding reagents, especially of immunological test elements to be shifted towards higher analyte concentrations without impairing the lower detection limit.

Abstract: A waveguide sensor capable of direct, real-time detection and monitoring of analytes in the vicinity of the waveguide surface without requiring the tagging or labeling of the analyte, is described. Analytic and numerical calculations have predicted that by locally detecting either changes in the evanescent field or changes in the light coupled out of the waveguide as a result of the presence of the analyte, high detection sensitivity will be able to be achieved.

Abstract: Packaged NERS-active structures are disclosed that include a NERS substrate having a NERS-active structure thereon, and a packaging substrate over the NERS substrate having an opening therethrough, the opening in alignment with the NERS-active structure. A membrane may cover the opening in the packaging substrate. In order to perform nanoenhanced Raman spectroscopy, the membrane may be removed, and an analyte placed on the NERS substrate adjacent the NERS-active structure. The membrane may be replaced with another membrane after the analyte has been placed on the substrate. The membrane may maintain the pristine state of the substrate before it is deployed, and the replacement membrane may preserve the substrate and analyte for archival purposes. Also disclosed are methods for performing NERS with packaged NERS-active structures.

Abstract: This invention provides devices and methods for detecting an analyte suspected to be present in a sample. The subject devices and methods are particularly useful for performing immunoassays on a variety of analyte, especially those present in a bodily fluid.

Abstract: An apparatus for the selective release of a bound species based on the presence of an analyte, the apparatus comprising: a first and second receptor species, the first receptor species linked with a bound species and configured to interact with an analyte to form a first intermediate complex, the bound species for causing increased porosity of a membrane of an in-contact analyte sensor apparatus to correspondingly increase exposure of a sensing element of the analyte sensor apparatus to allow for production of a detectable electrical signal which can be used to sense the presence of the analyte, the second receptor species for interacting with the first intermediate complex to form a second intermediate complex; and a cleaving species, the cleaving species configured to interact with the second intermediate complex to release the bound species for use in sensing the presence of the analyte.

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

Abstract: The present invention provides materials and methods that can serve as a prosthetic and/or, for tissue engineer applications, as a supporting matrix in the stabilization of the myocardium.

Abstract: Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: A method and apparatus for conducting specific binding assays are claimed. This invention relates to an initial non-receptor ligand interaction with nanoparticles or other solid phases followed by specific detection methods used for detecting biological, chemical or environmental entities. This invention employs an on-device ligand attachment to nanoparticles or other solid phase followed by the specific capture in discrete zones on the device. The ligand-bound complexes assemble on the ligand specific capture zone leading to a visible diagnostic result, if colored solid phases are employed.

Abstract: Provided are an immunochromatography kit that is highly sensitive and capable of multicoloration, and organic colored microparticles that are ideal as an element of the immunochromatography kit. Organic colored microparticles having an average grain size between 10 and 1,000 nm and a color intensity between 1.0 and 5.0 are prepared using cellulose as the starting material. When the organic colored microparticles are used as a label in an immunochromatography kit, the immunochromatography kit is of a high sensitivity than conventional technology. The immunochromatography kit is also capable of multicoloration and is useful for rapid diagnosis.

Abstract: Assays for detecting antibodies to pharmaceutical preparations, food allergens and environmental allergens are described.

Abstract: The disclosed invention relates to monoclonal antibodies (MAbs) which recognize human fatty acid synthase (hFAS) and are distinct from previously known anti-hFAS antibodies. Compositions, devices and kits comprising the MAbs are provided along with methods of using the MAbs in a variety of applications.

Abstract: The present invention is directed to polymeric matrices for the controlled release of a hydrophilic bioactive agent. Generally, the elution control matrix includes a polymeric matrix having a first polymer and a plurality of microparticles that include the hydrophilic bioactive agent. In one embodiment, the matrix includes a polymer comprising hydrophilic and hydrophobic portions. In another embodiment, the microparticles include a crosslinked hydrophilic polymer.

Abstract: The present invention is directed to immunoassays for detecting one or more target analytes in a fluid sample wherein the detection reaction occurs on a solid support and involves an amplification system. In particular, the invention is directed to making and using a test device having at least one site for detecting the presence of at least one target analyte, wherein a conjugate comprising dextran-polystreptavidin is immobilized at the test site(s) as a capture reagent for a complex containing the target analyze.

Abstract: An adhesive composition for use in devices and methods for measuring a presence or a concentration of a particular component, such as an antigen, in a sample, such as blood, are provided. In one exemplary embodiment of an adhesive composition, the composition includes an adhesive, water, a poloxamer, and an anticoagulant. The adhesive can include particular properties, such as being hydrophilic, pressure-sensitive, heat-activated, and/or water soluble. The adhesive is particularly useful because it can help improve the flow of sample a device. For example, when the device is an immunosensor, the adhesive can help prevent the blood from clotting in chambers of the immunosensor. This results in a more efficient and accurate determination of the concentration of the sample. Methods of making the composition and device in which the composition can be used are provided, as are methods of using the same.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: An assay device for testing of liquid samples for drugs of abuse has a transparent container for retaining a liquid sample. A backing member is within the container and is curved so that its front surface corresponds to the curvature of the container wall. Immunoassay test strips are on the front face of the backing and are visible through the container wall. Each test strip is enclosed in a transparent pocket which has a bottom opening through which the bottom portion of the test strip protrudes to contact the liquid sample within the container. The liquid then flows upwardly through the test strip to react with reagents within the test strip.

Abstract: Hydrophilic threads as platforms for inexpensive, low volume, portable diagnostic systems, and methods of making the same are described. A diagnostic system includes a hydrophilic loading thread having an inlet zone at a proximal end; a testing zone at a distal end; and an intermediate zone located between the inlet zone and the testing zone, wherein the testing zone does not directly contact the inlet zone. In another aspect, a diagnostic system includes (i) a hydrophilic loading thread that includes an inlet zone at a proximal end and an intermediate zone at a distal end; and (ii) one or more additional hydrophilic threads that contact the intermediate zone of the loading thread.

Abstract: An electronic sensor is provided for detecting the presence of one or more analytes of interest in a sample. The sensor preferably comprises a field effect transistor in which conductance is enhanced altered by analyte binding to receptors in the active region. An array of sensors may be formed to analyze a sample for multiple analytes.