Abstract: An immunity testing device formed of a thin sheet of material folded to three portions, and the two end portions; named “front cover”0 and “back cover”; fold back to different sides of the center part; named base seat; to provide protection on both sides of the base seat. Two absorbent sheets bridged with a test paper are fixed on the side of base seat that's facing the front cover. A hole is present at the position of the first absorbent sheet on base seat for specimen application. The front cover is disposed with observation cover plates at the position corresponding to the test paper and/or water-absorbing sheets for observation of test result as well as for preventing pollution before, and after use. The test paper is pre-embedded with antibodies/antigens to capture the corresponding antigens/antibodies in the test specimen as in Immunity method. The used testing device can be burned down to ensure environmental protection.

Abstract: A method to produce arrays of compounds for concurrent testing is described. Two formats are described using porous rods or porous sheet materials. In one format, the compounds of the array are immobilized onto porous rod elements. In the second format, the compounds are immobilized as lines on a sheet of porous material. In both cases, a bundle is formed by radial compression of the rods or spiral wrapping of the sheet. A sheath is applied to the bundle, and arrays are cut as slabs. Each synthesis or application step to create an array element is used to fabricate multiple arrays. Relatively high-density arrays can be produced with current printing technologies. The method is particularly suited to mass production of arrays.

Abstract: An improved homogeneous enzyme immunoassay process for quantitatively analyzing an antigen by determining the change in the enzymatic activity caused by a reaction between the antigen and an enzyme-labeled antibody. The antigen is reacted with an enzyme-labeled antibody, followed by the reaction with a second antibody capable of recognizing and binding to a different epitope and then with a third antibody capable of recognizing and binding to the second antibody. The enzymatic activity of the labeling enzyme is determined by a water-insoluble substrate. Using the water-insoluble substrate, steric hindrance is enhanced. A highly-sensitive analysis can be carried out by a simple operation even when the antigen has a molecular weight falling within an intermediate range, for example, a range of M.W. 10,000 to 70,000.

Abstract: Disclosed is a colorimetric sensor comprising polydiacetylene membrane liposomes, a polydiacetylene membrane film or fine particles coated with a polydiacetylene membrane, in which the polydiacetylene membrane is incorporated with a protein having a reduced molecular weight low enough not to cause color change in the polydiacetylene membrane. The examples of the reduced-molecular-weight proteins include an antibody Fab′ fragment, an antigenic protein of molecular weight of 100,000 or less, and a peptide consisting of 3-20 amino acid residue, which undergo an antigen-antibody reaction with an antigen or antibody contained in a sample. As the reduced-molecular-weight protein is also employed a combination of single-stranded DNA of 100 bases or less which hybridizes with single-stranded DNA contained in a sample to form a double-stranded DNA, and an antibody which reacts with said double-stranded DNA but does not react with the single-stranded DNA contained in the sample.

Abstract: The invention relates to surfaces coated with streptavidin and avidin for use in immunoassays, wherein the surfaces comprise a layer of streptavidin and avidin which are bonded on a surface of a solid supporting material through a biotinylated adhering agent.

Abstract: A method and apparatus for preparation of a substrate containing a plurality of sequences. Photoremovable groups are attached to a surface of a substrate. Selected regions of the substrate are exposed to light so as to activate the selected areas. A monomer, also containing a photoremovable group, is provided to the substrate to bind at the selected areas. The process is repeated using a variety of monomers such as amino acids until sequences of a desired length are obtained. Detection methods and apparatus are also disclosed.

Abstract: Starting from two non-miscible phases, i.e., a lipophilic and a hydrophilic phase, a surface-active substance and a recognition component, a micellar recognition system is built in a suitable manner and is incorporated into a layer structure. The micellar recognition system is provided in a single thin layer in which the recognition component is distributed homogeneously. Additional layers which may be provided about this layer, have an influence on the properties of the entire layer structure. On contact between the layer structure and the substance to be measured a recognition step takes place in the layer which is followed by a transducing step. In this way a measurement variable is produced by means of which information is obtained on the substance. The layer structures exhibit higher sensitivity, a lower detection threshold, short response time and special robustness with regard to sample interference.

Abstract: A method for determining whether a subject has had a stroke and, if so, the type of stroke which includes analyzing the subject's body fluid for at least four selected markers of stroke, namely, myelin basic protein, S100 protein, neuronal specific enolase and a brain endothelial membrane protein such as thrombomodulin or a similar molecule. The data obtained from the analyses provide information as to the type of stroke, the onset of occurrence and the extent of brain damage and allow a physician to determine quickly the type of treatment required by the subject.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilized on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating mea

Abstract: The subject invention relates generally to immunoassays for detection of antibodies by use chemiluminescent compounds. More particularly, the subject invention relates to chemiluminescent immunoassays to detect antibodies wherein a precomplex mixture is created and a two-step assay is performed resulting in a greater signal.

Abstract: An element and method for easily performing liquid assays are disclosed. The element uses capillary action to draw a predetermined volume of a liquid sample into a reaction chamber charged with reagent, where reaction between the liquid sample and the reagent is monitored.

Abstract: This invention relates to a lateral flow immunochromatographic assay device with an increased range of sensitivity without an increase in the clearance time or the occurrence of false positive results. The indicator reagent for the analyte is located in both a separate labeling reagent region and a discrete zone of the analyte detection region.

Abstract: Disclosed is a diagnostic device for the colorimetric detection of an analyte in a test fluid. The device is a dry reagent layer which is overcoated with a transparent, fluid permeable membrane. The membrane is made up of a combination of a water dispersible and a water soluble polymer. The membrane may contain a surfactant and a thickener.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating mea

Abstract: A process for selectively immobilizing viral glycoproteins on lectin-coated surfaces for use in solid phase immunoassays is disclosed. This method does not require that the virus or antigen be purified prior to immobilization. This method provides an inexpensive and effective immunoassay method to screen fluids for the presence of viral antibodies.

Abstract: The present invention provides a kit for the improved method for detection of panel-reactive antibodies in serum of a subject against HLA Class I antigens, which comprises an array of microbeads, each microbead presenting HLA antigens from a cell population presenting the same HLA antigens. In the method, serum from a subject is added to said array of microbeads then the mixture is incubated for a sufficient time for anti-HLA antibodies in the serum to bind to the HLA antigens presented on the microbeads. After removing serum components which do not specifically bind with the HLA antigens presented on said microbeads, the microbeads are incubated with a labeled ligand capable of specifically binding with anti-HLA antibodies bound to said HLA antigens. The labeled ligand which is not bound to said HLA antigens are removed and the presence of labeled ligand bound to said HLA antigens are detected by flow cytometry.

Abstract: The present invention relates to a method for biotinylating a desired subset of a larger population of proteins, wherein the subset of proteins is first selectively bound to a solid phase, thereby separating it from undesired proteins of the population, and then, still bound to solid phase, it is biotinylated. Unreacted biotin may then be washed from the solid phase, and the biotinylated protein may be uncoupled from the solid phase.

Abstract: A highly specific surface for biological reactions, which includes a support with at least one essentially compact layer of an organic compound. On the outside of the organic compound layer is an exposed group containing an ethylenic double bond, which has affinity for a molecule with biological activity under certain reaction conditions. The other elements of the organic compound layer are essentially inaccessible to the molecule with biological activity under the reaction conditions.

Abstract: A method and device are provided for the semi-quantitative and quantitative determination of an analyte in a sample. A non-competitive trap which can bind unreacted labelled receptor to analyte but has virtually no binding capabilities to receptor in the presence of analyte is used. Labelled receptor:analyte complex is trapped in a second trap. The relative amounts of unbound receptor in the non-competitive trap versus the amount of receptor:analyte complex in the second trap is a measure of the amount of analyte in the sample.

Abstract: The invention provides methods for separating bound label from unbound label within an assay mixture, for predispensing assay reactants in self-contained assay vessels, as well as for detecting the presence and/or amount of an analyte within a fluid sample. In addition, a reusable detection vessel for use therein and with specific binding assays in general is disclosed. In the methods, generally an analyte within a sample is detected or measured by forming an assay mixture containing sample, analyte binding components and label, placing the assay mixture in contact with an immisable primary layer, subjecting the assay mixture to conditions that separate the analyte bound with binding components and label from unbound binding components and label, and subsequently detecting bound label.

Abstract: A multilayer dry immunoassay element comprising 1) a spreading layer having a sample application area and a signal read area and 2) a separate receptor layer residing on 3) a radiation-transmissive support characterized in that the spreading layer contains a light absorbing material.

Abstract: A method to produce arrays of compounds for concurrent testing is described. Two formats are described using porous rods or porous sheet materials. In one format the compounds of the array are immobilized to porous rod elements. In the second format the compounds are immobilized as lines on a sheet of porous material. In both cases, a bundle is formed by radial compression of the rods or spiral wrapping of the sheet. A sheath is applied to the bundle and arrays are cut as slabs. Each synthesis or application step to create an array element is used to fabricate multiple arrays. Relatively high density arrays can be produced with current printing technologies. The method is particularly suited to mass production of arrays.

Abstract: Subject matter of the invention is a method of binding a biological material to a solid phase by providing a sample liquid containing the biological material in a sample vessel (A) having an inner contour (A17); then a hollow body (C) which has a contour (C12) that matches the inner contour (A17) is introduced into the sample vessel (A) while being closed with respect to the sample vessel by means of a porous matrix (C11); the sample liquid can enter the structural form (C) through the porous matrix (C11). This method is easy to automate and reduces the generation of aerosols.

Abstract: A chromatographic assay device for use with immunoassays allows rapid and convenient assays of analytes of biological interest, and permits extractions to be carried out in situ, avoiding the use of separate extraction vessels. The device has a wide dynamic range and avoids interference from particulates or colored components. In one form, the device comprises: (1) a first opposable component comprising a sample preparation means adapted to receive a sample to be assayed; and (2) a second opposable component comprising a chromatographic medium. The first and second opposable components can be brought into opposition so as to cause the sample preparation means to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label. Other variations of the device vary the arrangement of components to provide optimal chromatography for a variety of analytes, as well as to permit bidirectional chromatography.

Abstract: A spectrophotometric assay for the detection of acetaminophen in aqueous fluids can be carried out with a dry analytical element. The element comprises a support having thereon one or more reagent layers containing a first enzyme, aryl acylamidase, to cleave the amide bond of acetaminophen to produce p-aminophenol; a second enzyme, ascorbic acid oxidase, to oxidize the p-aminophenol so that it couples to a water soluble coupling agent to form a dye that is read at 670 nm. The assay is precise, accurate on serum and plasma samples, and relatively free from significant interferences. The element also allows measurement over a broad dynamic range.

Abstract: The invention is directed to a non-instrumented assay giving quantitative and/or qualitative results. Specifically, the invention is directed to an assaying process wherein a first portion of binder supported on substantially the entire length of a solid is contacted with a sample suspected of containing analyte. The binder is a binder for at least the analyte. The first portion is also contacted with a tracer. The process includes contacting a second binder portion also supported on the solid with tracer. The second portion is juxtaposed to the first portion and has a known amount of analyte thereon. The amount of analyte in the sample is determined by comparing the visibility of tracer in the first and second portions. In a preferred embodiment, a third binder portion supported on the solid juxtaposed to the second portion is contacted with tracer. The third portion has a known amount of analyte thereon. The amount of analyte in the third portion is different from the amount on the second portion.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: A method and device for detecting the presence, absence or amount of an analyte in a whole blood sample is disclosed. The device comprises four zones, a sample receiving zone, a labeling zone, a capture zone and an absorbent zone. The sample receiving zone contains an irreversibly immobilized reagent that allows for removal of substantially all red blood cells from the whole blood sample. Flow through the device is via capillary migration and all of the dissolved or dispersed components in the sample flow at substantially equal rates and with relatively unimpaired flow through the device. The method involves the use of the device for detection of analyte in a whole blood sample.

Abstract: For the qualitative or/and quantitative detection of a substance to be determined in a test sample with the aid of an immunoassay or nucleic acid hybridization assay the following components are used:a) a capture reagent which enables a specific detection of the substance to be determined by means of two different binding sites 1) if desired together with further test components and 2) is bound or is capable of binding to an active solid phase via a specific binding pair one partner of which is linked to the capture reagent and the second partner of which is coupled to an active solid phaseb) an active solid phase andc) an inactive solid phase which substantially corresponds to the active solid phase but to which the capture reagent cannot bind,wherein the test sample is either firstly brought into contact with the inactive solid phase alone and only later with the active solid phase, or is simultaneously brought into contact with the active and inactive solid phase during which the capture reagent and if des

Abstract: The present invention relates to a dry immunoassay analytical element for assaying a ligand, comprising a support bearing: (a) a label zone comprising an enzyme labeled ligand or an enzyme labeled receptor; (b) a spreading zone; (c) a receptor zone comprising a fixed concentration of an immobilized receptor for the ligand; and (d) a gravure zone comprising a diaryl telluride. A prefered embodiment of the present invention further comprises a vanadyl salt. The present invention further relates to a method for performing an assay using an element as described above.

Abstract: Starting from two non-miscible phases, i.e., a lipophilic and a hydrophilic phase, a surface-active substance and a recognition component, a micellar recognition system is built in a suitable manner and is incorporated into a layer structure. The micellar recognition system is provided in a single thin layer in which the recognition component is distributed homogeneously. Additional layers which may be provided about this layer, have an influence on the properties of the entire layer structure. On contact between the layer structure and the substance to be measured a recognition step takes place in the layer which is followed by a transducing step. In this way a measurement variable is produced by means of which information is obtained on the substance. The layer structures exhibit higher sensitivity, a lower detection threshold, short response time and special robustness with regard to sample interference.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: A chromatographic strip positive readout binding assay device and method suitable for quick, sensitive and reliable field testing for small molecules such as environmental contaminants, drugs of abuse, therapeutic drugs and hormones. The detectable label is not attached to either the analyte or to the analyte receptor. Low affinity binding pairs can be used in the positive readout binding assay.

Abstract: The present invention includes novel rubella assays employing a Rubella virus capture reagent and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing Rubella antibody may be contacted with the capture reagent to form a capture reagent/analyte complex. The complex is then contacted to the positively charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: The present invention provides a novel carbamazepine hydrazide compound suitable for covalent attachment to a polymer particle reagent, having the general formula ##STR1## The present invention also provides a novel carbamazepine acid compound suitable for attachment to proteins for the production of carbamazepine immunogens. The carbamazepine antigen of the present invention has the following general structure: ##STR2## where X is C=O, CH.sub.2 or SO.sub.2 ; Y is C=O, CH.sub.2, SO.sub.2 ; R is an alkyl and P is a protein or a hapten.

Abstract: A device for assaying haptens includes a solid support linked through a nucleic acid fragment to a reagent that can compete with the hapten for binding to antibodies that bind to the hapten. A process for assaying a hapten uses this device.

Abstract: A detection sheet capable of detecting an antigen or antibody in a biological fluid with a high sensitivity in a simple operation, as well as a detection kit and detection method using the detection sheet. The detection sheet comprises (a) a fibrous aggregate with carried particles of a calcium phosphate compound having an average particle diameter of about 0.01 to 200 microns and a Ca/P ratio of about 1.0 to 2.0, and (b) an avidin, streptavidin or avidin derivative from which carbohydrates have been extracted immobilized on said calcium phosphate compound. After a biotinylated antigen or antibody is bonded to the immobilized avidin, streptavidin, or avidin derivative of the detection sheet, the detection sheet is contacted with a test solution to thereby bond an antigen or antibody of the test solution to the detection sheet.

Abstract: A synthetic strategy for the creation of large scale chemical diversity. Solid-phase chemistry, photolabile protecting groups, and photolithography are used to achieve light-directed spatially-addressable parallel chemical synthesis. Binary masking techniques are utilized in one embodiment. A reactor system, photoremovable protective groups, and improved data collection and handling techniques are also disclosed. A technique for screening linker molecules is also provided.

Abstract: A "one step" device for the detection of analytein clinical assays is disclosed. A visible label comprising a visible moiety and a ligand that binds to or competes with analyte is contained in a fluid conducting membrane or prefilter; and the analyte and associated ligand are conducted by the flow of sample into a detection zone. The detection zone contains a capture reagent that binds to label or to analyte bound to label.

Abstract: A dry immunoassay analytical element for assaying a ligand, comprising a support bearing:1. an enzyme labeled ligand or an enzyme labeled receptor zone;2. a spreading zone; and3. a receptor zone containing a fixed concentration of an immobilized receptor for the ligand and the labeled ligand when present and the receptor is covalently bonded to polymeric beads having a diameter in the range of 0.1 to 5 .mu.m; characterized in that the element contains a diaryl telluride (DAT) compound and the zones can be in the same or separate layers.

Abstract: The present invention relates to a process for synthesizing on a single substrate a plurality of chemical compounds having diverse structures. The process involves the use of a bilayer photoresist to build up selected regions of the array in a step wise fashion.

Abstract: An analytical system for performing an immunoassay is provided wherein the system contains an element that uses capillary action to draw a sample into a reaction chamber charged with reagent containing an immobilized antibody or immobilized antigen, where reaction between the liquid sample and the reagent is monitored, and optionally contains a method for controlling the moment that transport of the sample from the sample well to the reaction chamber is initiated.

Abstract: Erythrocyte exclusion membranes suited for test strips of electrochemical sensors have a porous matrix and a mobile erythrocyte aggregating agent. The membranes typically comprise a water-insoluble hydrophobic polymer incorporating a hydrophilic polymer and with the erythrocyte aggregating agent. Such membranes can have a pore size which is several times larger than the diameter of erythrocytes, and allow rapid passage of plasma by holding back the erythrocytes as rouleaux at the surface of the membrane. The membranes are preferably made by forming in situ on a test strip using spray casting.

Abstract: The invention relates to a method of using a pair of leucine zipper peptides for in vitro diagnosis, in particular, for the immunochemical detection and determination of an analyte in a biological liquid. In one method, the first leucine zipper peptide is immobilized by attaching it to a solid support, the second leucine zipper peptide is coupled to a specific binding partner for the analyte, the two peptides are brought into contact, the sample of the biological liquid is brought into contact with the immobilized first peptide and the specific binding partner for the analyte, and the amount of analyte bound to the binding partner is determined. The leucine zipper peptides are preferably v-fos and c-jun.

Abstract: A method of separating bound labeled indicator from free labeled indicator in a layer of a test element for immunoassay. The method comprisesa) depositing sample containing a target immunoanalyte capable of binding to the labeled indicator or to an immobilized antibody in competition with the labeled indicator, onto an exterior surface of a test element in the presence of the labeled indicator andb) adding an amount of wash liquid to the exterior surface to form a pool of the liquid having a meniscus on the surface, the liquid penetrating the surface over an area bounded by a closed intersect edge formed between the pool meniscus and the surface, so that penetrating liquid can push free labeled indicator away from bound labeled indicator in a volume of the layer below the bounded area.

Abstract: The present invention relates to an enzyme reagent ticket for conducting diagnostic or serological tests. More particularly, the present invention relates to an enzyme reagent device which allows for a low-cost, disposable, rapid and convenient system for use in the determination of various components in test fluids, and to a diagnostic kit including the device according to the present invention for conducting certain immunochemical, diagnostic or serological testing.

Abstract: A method of dispensing wash solution to separate free from bound labels in a slide immunorate assay. The method comprises dispensing wash first as separate drops spaced to allow complete absorption prior to the next drop, followed by a time at which the rate of dispensed wash exceeds the rate of fluid uptake of the slide, to form a continuous stream. The first phase of this wash method provides a more complete separation of bound from free under the dispense tip than occurs if only a continuous stream is used throughout.

Abstract: An assay device for detection and/or determination of an analyte in a test sample uses a barrier containing an aperture to control the application of reagents to the device for greater reproducibility of results. In its simplest form, the device comprises: (1) a chromatographic medium having a first end, a second end, and first and second surfaces, and having a specific binding partner for the analyte immobilized thereto in a detection zone; (2) at least one absorber in operable contact with at least one of the first and second ends; and (3) a substantially fluid-impermeable barrier adjacent to the first surface of the chromatographic medium, the barrier having at least one aperture therethrough for application of liquid to the chromatographic medium, the barrier at least partially blocking application of liquid to the chromatographic medium.

Abstract: A method and device for detecting fetal membrane rupture by detecting only that insulin-like growth-factor-binding protein 1 (IGFBP-1) which is free of insulin-like growth factors 1 and 2 (IGF-1 and IGF-2) are disclosed. The method is based on the fact that the concentration of free IGFBP-1 in the blood serum is about 10 times lower than that of the IGFBP-1 bound to IGF-1 and IGF-2, while in the amniotic liquid which is contained in the amnion has more than 1000 times the concentration of free IGFBP-1 than the blood serum. Therefore, when even a small amount of amniotic liquid is contained in the vaginal secretion sample, this is clear evidence of the rupture of the fetal membrane having taken place. The method and the device make it possible to diagnose fetal membrane rupture with an extremely high accuracy. Because of the low concentration of the IGFBP-1 in the blood, the admixture of the blood serum to the sample does not affect the results of the test.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.