Abstract: A method of determining the concentration of a sample antigen in the presence of an interferant by(1) running two immunoassays on the sample: one assay where the interferant influences the binding of both the sample antigen and a labeled antigen and a second assay where the interferant influences the binding of the sample antigen but not the labeled antigen;(2) obtaining a plot of the possible sample antigen concentrations versus the possible interferant concentrations corresponding to the readout for the sample for each of the two immunoassays; and(3) determining the sample antigen concentration and the interferant concentration which correspond to the point that appears in both the immunoassays plots.

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 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: A method for the preparation of an immobilized protein ultrathin film reactor by immersing a solid support alternately into an aqueous solution of protein, and into an aqueous solution of polyion charged oppositely to said protein and preparing a structurally controlled ultrathin film of mono- or multi- protein layers on a said solid support with precision at molecular level. And a method for chemical reaction of a substrate by preparing an immobilized protein ultrathin film reactor composed of multiple layers of protein on a solid support by above mentioned method, and initiating a chemical change of the substrate molecules using obtained immobilized protein ultrathin film reactor.

Abstract: The invention is a method and device for collecting and processing a biological specimen for the analyses of nucleic acids. A device comprises a matrix to which cells and viruses adhere and a handle to manipulate the matrix. The devices are used to collect, dry, transport, store and process small amounts of blood or other tissue. The matrix of the device is transferred to a reaction tube and amplifying reagents added to it. Nucleic acid sequences and relative quantities are detected and analyzed from the same specimen. The relative amounts of amplified nucleic acid from one or more particular RNA sequences are compared to one another and to the amount of amplified nucleic acid from DNA sequences serving as an internal control for the number of biological units per specimen.

Abstract: The invention relates to multiplex ligase chain reaction (LCR). Two or more putative target sequences are selected. For each one, a set of four probes is used simultaneously to amplify the putative sequence if it is present in the sample. Preferably, all the amplicons are labeled with a common label/hapten and, for each different target, with a unique label/hapten. The invention also relates to an immunochromatographic strip device and method employing a diagonal array of capture spots.

Abstract: A dual particle immunoassay method and kit for detecting analyte in a sample in which the sample to be analyzed, a binding molecule specific for the analyte, and a particle coated with the analyte to be detected or coated with a second binding molecule are reacted and applied to a porous membrane. The competitive immunoassay utilizes an analyte-coated particle, whereas the sandwich immunoassay employs a second binding molecule-coated particle. All of the reagents except for the coated particle are able to pass through the porous membrane. Detectable particles coated with a binding substance that binds to the binding molecule, such as protein A protein G, second antibody reactive to the binding molecule, or a small synthetic affinity ligand, are reacted with coated particles retained on the membrane surface. The detectable particles will pass through the membrane if not complexed with the coated particle.

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: An assay device for detection or determination of an analyte in a sample uses opposable components and is suitable for assay of human chorionic gonadotropin and other protein or glycoprotein hormones.

Abstract: A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol.

Abstract: A method is disclosed for determining the presence or amount of analyte in a fecal sample. The method comprises the steps of (A) contacting the fecal sample with an extraction reagent comprised of at least one detergent and at least one buffer to form a mixture, (B) applying the mixture to an absorbent filter that is in proximity to or in contact with an immunoassay such that analyte present in the sample is transferred to the immunoassay, and (C) detecting the presence of analyte by said immunoassay. In a preferred embodiment, the immunoassay comprises a porous strip containing immunoreagents for detecting analyte.

Abstract: Sensor laminates for detection by immunoassay of target molecules in biological fluids wherein the sensor laminates contain a reactive substrate layer having a polymeric material treated to enhance binding to a ligand and methods of producing and using these sensor laminates are provided. Also provided are multi-sectioned fluid delivery devices for use with the sensor laminates in detection of target molecules in biological fluids.

Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromoionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromoionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.

Abstract: The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative.

Abstract: A test device which includes a housing having an immunochromatographic test strip therein is disclosed. The test strip is color-coded so that the presence or absence of a substance or substances in a fluid sample may be detected and identified. The strip also indicates the locations of the immunoreactions that will take place on the test strip by means of colored lines. Sample is applied onto the strip through a window and is spontaneously wicked up the test strip mobilizing a dye-microspherical antibody located in a first zone on the strip. The dye particles then move along the membrane strip by capillary action to a second zone. In the absence of specific antigen in the sample, the dye-microsphere particles attach to the antigen in the second and third zones through immunocomplexation, forming definite, visible lines. This is a negative test.

Abstract: An evaluating method of a testing element having an immobilized antigen or antibody on an immobilizing carrier thereof, which immobilized antigen or antibody has yet to react with another antigen or antibody, which involves contacting the testing element with a solution containing an antibody or antigen reactive with the immobilized antigen or antibody, specifically binding a labelling compound to the reactive antibody or antigen to thereby cause a color-developing reaction of the labelling compound, and determining an amount of the antigen or antibody immobilized on the testing element as a function of a level of produced color. Using this evaluation method, a quantitative determination of the immobilized antigen or antibody can be carried out, and thus the performance of the testing element for antigens or antibodies can be evaluated.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises (a) an upper support strip having a fluid receiving port and (b) a lower support strip having a color change viewing port and securely sandwiched therebetween (c) a spreading mesh screen for uniformly distributing the fluid, (d) a chemically treated separating layer for removing an undesirable element, e.g.

Abstract: An immunochemical assay device comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: A method and apparatus for the quantitative determination of an analyte in a liquid employs a liquid-permeable solid medium defining a liquid flow path. The medium includes a number of reactant-containing reaction zones spaced apart along the flow path and in which reaction occurs with the analyte or an analyte derivative (e.g., a labeled analyte) to result in the formation of a predetermined product. Detector means are employed to detect analyte, analyte derivative, reactant or predetermined product in the reaction zones, the number of such zones in which such detection occurs indicating the amount of analyte in the liquid.

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: An assay device for testing for the presence of an analyte in a sample liquid supported on a test surface, the device comprising a test stick having a handle portion to be held by a person performing the test and a mixing portion to contact the sample liquid, the mixing portion bearing a dried, pre-dosed reagent for the test, the dried reagent being reconstituted by contact of the mixing portion of the test stick with the sample liquid, and wherein the mixing portion is configured to provide a mixing surface to mix the reconstituted reagent with the sample liquid on the test surface.

Abstract: A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol.

Abstract: A method of assaying a preselected volume of sample on an chromatographic strip includes providing a sample receiving reservoir. This reservoir can receive a preselected volume of sample or a preselected volume of sample and reagent. The sample receiving reservoir has an overflow outlet. A moat is communicated to the overflow outlet of the sample receiving reservoir for receiving the sample or sample and reagent when the sample receiving reservoir is full. The mixed sample or sample and reagent fill the sample receiving reservoir, and discharge the excess sample through the overflow outlet to the moat. The sample receiving reservoir having the preselected volume of sample or sample and reagent is discharged on the chromatographic strip for assay. Provision is made for adding a density adding solute which is neutral to the chromatographic strip, the density adding solute occupying the sample receiving reservoir.

Abstract: Disclosed are devices and methods for performing an assay which determines the presence or quantity of an analyte in a fluid sample by detecting binding of the analyte to at least one immobilized analyte capture reagent and washing unbound material from the immobilized analyte capture reagent. The devices and methods an elongated solid phase flow matrix, including capillary channels capable of driving capillary fluid movement, and further including (i) a first region adapted for receipt of the fluid sample, (ii) a second region at which the analyte capture reagent is immobilized, (iii) a third region for application of a wash reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned intermediate to the first region and the third region and intermediate to the absorbent reservoir and the third region. The device also includes means to detect analyte bound at the second region.

Abstract: A capsule package and a touch-free method for water analysis. It allows for addition of dry ingredients and aqueous test reagent without any human intervention, and therefore substantially decreases the possibility for analysis error. Furthermore, it eliminates physical contact between the operator and the chemical reagent, thereby enhancing safety. Importantly, the packaging system allows for film protection of a water soluble membrane so that it is damage free prior to use.

Abstract: Methods and apparatus for the preparation and use of a substrate having an array of diverse materials in predefined regions thereon. A substrate having an array of diverse materials thereon is generally prepared by delivering components of materials to predefined regions on a substrate, and simultaneously reacting the components to form at least two materials. Materials which can be prepared using the methods and apparatus of the present invention include, for example, covalent network solids, ionic solids and molecular solids. More particularly, materials which can be prepared using the methods and apparatus of the present invention include, for example, inorganic materials, intermetallic materials, metal alloys, ceramic materials, organic materials, organometallic materials, non-biological organic polymers, composite materials (e.g., inorganic composites, organic composites, or combinations thereof), etc.

Abstract: An apparatus in the form of a test strip is useful for determining the presence of one or more components in a fluid sample. The test strip can be used by itself or in conjunction with an associated housing assembly. The test strip provides a rapid volume, timing and temperature independent visually readable strip for the semi-quantitative detection of a component, such as an analyte.

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 bi-directional chromatography.

Abstract: A slide having a portion thereof provided with transparent adhesive which adheres to a test sample. The slide and adhesive may be transparent. Specific types of infection and particularly fungal infections can be detected in the test sample using immunotest-methods. In a special embodiment the adhesive slide is fashioned with a peripheral lip or well to contain a test sample and a reagent.

Abstract: The present invention relates to a device for determining an analyte in a fluid sample in an assay. The device comprises a lid having a plurality of elements and a membrane. The elements have openings which allow passage of fluid to the membrane. The membrane is supported by the lid and covers the openings of the elements. The undersurface of the membrane is in contact with a porous wick which contains a first zone which includes binder attached to a particulate label and a second zone containing salt. The wick extends downward from the membrane and is in contact with the fluid sample.

Abstract: Disclosed is a test cell and a method for detection of a preselected ligand in a liquid sample such as a body fluid. The test cell includes an elongate outer casing which houses an interior permeable material capable of transporting an aqueous solution and defining a sample inlet, a test volume, and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet and is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site which includes a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path. The test site can be observed through a window of the casing.

Abstract: A test device, system and method, the device composed of an elongated, toothbrush-shaped, transparent, plastic housing and a lateral-flow test strip for the detection of an analyte, such as a beta-lactam in milk, in the housing, the housing having an expansion cavity to receive expanded, liquid-contacted, absorbing material in the test strip, and to control lateral flow rate and times in the test strip.

Abstract: A test kit is disclosed for analyzing a patient's saliva to determine the patient's risk of tooth decay, which contains: (a) a support; (b) an absorbent material in contact with said support and capable of removing saliva from the mouth and of absorbing the saliva; (c) a composition coated on said absorbent material, said composition soluble in saliva and capable of reaction inside the mouth of the patient with the saliva to reduce the pH of the saliva; and (d) a color scale for determining outside of the mouth of the patient the pH of the saliva absorbed by the absorbent material in which the composition is dissolved to measure the reaction of the composition with the saliva in the patient's mouth to determine the patient's risk of tooth decay.

Abstract: A device and related method for performing one or more immunoassays to detect the presence of respective analytes in a sample. The device involves the use of a unitary bibulous material providing one or more flow paths having a common origin site and a plurality of respective reagent zones providing the reagents necessary for performing a visual readout, competitive immunoassay for the presence of the respective analyte.

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 test strip for a rapid immunoassay containing specific immunochemical reagent zones (7, 8, 9) is described. The test strip (10) has a backing sheet (1) and attached thereto a receiving end pad (3) and at a distance therefrom a finishing end pad (5). A test membrane (2) is provided between said pads (3, 5). Said membrane (2) is positioned in parallel relationship to said backing (1) at a distance therefrom so that said backing (1) and said membrane (2) limit between themselves an air gap (4) which is open at its edges. Said gap (4) functions as a sheltered reaction chamber for the immunolgical reaction taking place as a liquid is made to flow through said membrane (2). The test strip is simple to manufacture by lamination and easy to use and it is suitable for both diagnostic and environmental immunoassays.

Abstract: An analytical device for use in determining the presence of an analyte species of interest in a liquid state includes a chromatographic membrane support along which the liquid may travel, a plurality of first detectable particles associated with a sampling region of the device at which the liquid is to be applied, the particles being capable of being moved along the support by the liquid travel and having immobilised thereon a first binding agent capable of forming a first complex with the analyte species, a threshold region provided downstream of the sampling region in the direction of liquid travel, the threshold region being provided with a second binding agent which is capable of binding to non-complexed first binding agent on the particles, and which is present in an amount, such that a detectable number of the particles only pass the threshold region if the amount of analyte species in the sample is above a predetermined level, and a detection region downstream of the threshold region in the direction o

Abstract: A multi-test panel with several test strips containing a separate and different immunochromatographic system, each strip being housed in a separate structure so that the structures may be joined together and interchanged, depending upon what substances within a fluid sample are being detected.

Abstract: A self-contained device is described that integrates nucleic acid extraction, specific target amplification and detection into a single device. This integration permits rapid and accurate nucleic acid sequence detection. The invention may be used, for example, in the screening for nucleic acid sequences which may be indicative of genetic defects or contagious diseases, as well as for monitoring efficacy in the treatment of contagious diseases.

Abstract: A molecular detection apparatus comprises a molecular receptor (20), a detection element (22) responsive to the molecular receptor (20), and a substrate (24) which supports the detection element (22). The molecular detection apparatus further includes a grasping member (26) and an elongated member (30) to couple the grasping member (26) to the substrate (24).

Abstract: A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

Abstract: Assays and kits for identifying fertile sperm samples (e.g. for use in an assisted reproductive technology or as an indication of an ineffective male contraception (vasectomy)) and sub-fertile sperm samples (e.g. as an indication of a potentially infertile male donor or an effective male contraception) are disclosed.

Abstract: Devices for use in heterogeneous ligand-receptor assays, having a porous member in contact with a nonabsorbent textured surface, where the surface texturing is such that a capillary network is formed when in fluid communication with the porous member. More particularly, these devices comprise:(a) a porous member having (i) at least one binding agent capable of immobilizing at least one target ligand on the porous member from a fluid sample in at least one zone and (ii) a means for detecting the presence or amount of said target ligand as a result of the assay process; and(b) a nonabsorbent member in fluid communication with the porous member, the nonabsorbent member forming at least one capillary with the porous member so that when sample, alone or in combination with other fluids, is added to the porous member, fluid is drawn through the porous member.

Abstract: A convertible stand and container is provided for specimen tubes and includes first and second sides each having proximate and distal portions. In a stand configuration the side proximate portions are releasably latched together and the side distal portions are folded double over the outsides of the proximate portions. A plurality of receiver proximate sections are formed between the side proximate portions. In a container configuration the side distal portions are releasably attached together and form receiver distal sections therebetween which align with the receiver proximate sections to provide receivers for containing the specimen tubes.

Abstract: A method for the repeated transfer of liquids from one of several storage containers into a transfer container wherein protective tips are placed onto a tip of a pipette in order to avoid contamination.

Abstract: Disclosed is an improved method for the detection of an analyte in a fluid test sample using a strip of a negatively charged matrix material having a zone containing mobile, labeled binding partner for the analyte and a separate zone for capturing the labeled binding partner as it is carried through this zone by the fluid test sample. The improvement involves combining the fluid test sample with a polyalkoxylated amine surfactant to control non-specific binding of the labeled binding partner to the negatively charged matrix material.

Abstract: This invention relates to a device comprising a hydrophobic solid support coated with a chemical that can capture bacterial lipopolysaccharides (LPS). This invention also relates to the use of such a device in an immunoassay for the detection of microorganisms. This invention also relates to the incorporation of such a device into a diagnostic kit.

Abstract: An immunoassay plate for an immune complex transfer immunoassay, comprising a well type solid phase and a dip stick type solid phase which can be inserted into said well type solid phase, wherein the dip stick type solid phase is coated with either substance (A) or (B) to be mentioned below and the well type solid phase is coated with the other, remaining substance, and these solid phases are used as the two solid phases to be used for an immune complex transfer immunoassay:(A): a substance having a reactive group which specifically binds to a functional group previously introduced onto a substance, which specifically forms an immune complex with a test substance(B): a substance having a reactive group capable of specifically binding to the test substance in the immune complex, a substance which specifically forms an immune complex with the test substance, or a functional group conjugated in advance with said substance, provided that the moiety which binds to the reactive group of (A) does not bind to the rea

Abstract: An assay device for the performance of assays for analytes, particularly those of biological interest, provides for improved efficiency and sensitivity by reducing background. The assay device performs an immunochromatographic assay and also provides a wash to remove unbound labeled specific binding partner and thereby reduce the background. Assay devices according to the present invention can use either a directly visible label such as a metal sol label or an enzyme label. One embodiment of assay devices according to the present invention is particularly suitable for assay of analytes in whole blood samples. The present invention also encompasses test kits and methods of use of the assay devices.

Abstract: A solid phase system for use in ligand-receptor assays, particularly immunoassays using monoclonal antibodies, is disclosed. The solid phase system comprises a porous matrix in which microspheres, bound with a receptor capable of capturing a target ligand, are entrapped. Preferably, the microspheres are entrapped within a discrete zone or zones of the porous matrix.