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 zone 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 zone to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label.

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 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 zone adapted to receive a sample to be assayed; (2) a second opposable component comprising a chromatographic medium; and (3) a conductive barrier attached to the second opposable component. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone 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.

Abstract: A cover receptacle assembly of plastics for use in laboratories, in particular for the polymerase chain reaction technique, comprising a tubular receptacle having a receptacle botton at one end and a receptacle opening at an opposite end, a cover for sealingly closing said receptacle opening, strap hinge means integrally and pivotally connecting said receptacle and cover with each other, and holding means for holding said cover in an intermediate position between an initial position wherein said cover is pivoted away from said receptacle opening for 180.degree. and a closing position wherein said cover closes said receptacle opening.

Abstract: A device for performing an enzyme-labelled binding assay comprises an absorbent material and a developing solution containing a substrate for said enzyme, wherein the absorbent material is provided with a plurality of reagent zones including an indicator reagent zone and is capable of transporting the developing solution by capillary action sequentially through the reagent zones, and wherein the indicator reagent zone includes a reagent capable, directly or indirectly, of immobilizing an enzyme-labelled reagent in an amount dependent on the assay result, characterized in that the absorbent material includes a reagent that prevents a signal formation except where enzyme-labelled reagent is immobilized at the indicator reagent zone. The absorbent material is suitably in the form of an elongate strip provided with transverse reagent zones. The device is useful for performing immunoassays, including immunometric assays and dual analyte assays.

Abstract: Laboratory vessels are coated on an operational surface thereof with a hydrophobic coating polymer or reactive monomer to form a coating having an exposed surface populated with 30% by area or more terminal trifluoromethyl groups. Laboratory vessels coated with such coating solutions are provided having extremely low surface energies and high resistance to solvent attack. Methods of forming hydrophobic coatings on laboratory vessels are also provided and include methods of forming exposed coating surfaces having populations of from about 30% by area to 100% by area trifluoromethyl groups. The hydrophobic coatings may be prepared from solutions, suspensions or powdered materials containing a fluoroalkyl ethylenically unsaturated monomer substantially free of any crosslinking, having from about 3 to about 20 carbon atoms, and containing at least one terminal trifluoromethyl group, or containing a polymerization product of such a monomer.

Abstract: A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member comprising a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.

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 zone adapted to receive a sample to be assayed; (2) a second opposable component comprising a chromatographic medium; and (3) a conductive barrier attached to the second opposable component. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone 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.

Abstract: A method and test device are disclosed for detecting under field conditions unidentified antigenic substances which are detrimental to human or animal health or welfare. A sample solution containing the suspected unidentified antigenic substance is added to the test device containing a known antigenic substance which is irreversibly attached to a solid support and suspended in a buffer solution along with an antibody specific to the known antigenic substance conjugated with a detecting agent. After incubation to bind the unknown antigenic substance to the conjugate, the solution contacts a white porous bibulous sheet incorporating a substrate for the detecting agent and a chromogen, which is part of the test device. If the identity of the sample antigen is the same as that on the solid support, a color reaction takes place.

Abstract: An assembly for use in biological assays containing an integral ceramic core and, partially abutting the core, a sheath. The ceramic core has a mean pore size of from about 1 to about 400 microns, an apparent porosity of from, about 25 to about 60 percent, a hydrophilic surface, a length of from about 10 to about 200 millimeters, and a wicking rate of at least about 20 millimeters per minute; the sheath has a wicking rate of less than 5 millimeters per minute.

Abstract: Centrifuged anticoagulated blood samples are analyzed under magnification in a centrifuge tube containing a layer-elongating insert, which tube is placed on a calibrated slide. The slide includes a slot in which the tube is placed. A calibrated scale is disposed adjacent to the slot for use in measuring various blood sample parameters, such as hematocrit, platelet count, and the like. Anemia and/or low platelet counts are indicative of potentially serious complications of malaria. Their detection will prompt a physician to consider the liklihood of serious illness due to malaria. The presence or absence of blood-borne parasites can also be determined using the procedures of this invention. Thus the device allows a blood sample to be analyzed for malarial parasites, and also allows measurement of hematicrit and platelet counts.

Abstract: An assembly for use in biological assays containing an integral ceramic core and, partially abutting the core, a sheath. The ceramic core has a mean pore size of from about 1 to about 400 microns, an apparent porosity of from, about 25 to about 60 percent, a hydrophilic surface, a length of from about 10 to about 200 millimeters, and a wicking rate of at least about 20 millimeters per minute; the sheath has a wicking rate of less than 5 millimeters per minute.

Abstract: A device and method for its use in diagnostic assays are provided. The device comprises at least one assay path, where an assay path includes a main flow path and at least one side reagent channel. The main flow path begins at a sample addition port, continues through a main reagent area into an incubation area and ends in a waste area. In fluid communication with the main flow path is at least one side reagent channel that begins at a liquid addition port, continues through a side reagent area and ends in said main channel at a region between the main reagent and waste areas, usually upstream from the incubation area. Agitation means may be included in at least one of the main and side reagent areas and/or the incubation area. At least one fluid interruption means located at various positions along the main and side reagent channels upstream from the incubation area provide for control over reagent interaction and fluid flow through the device.

Abstract: Non-invasive methods and kits are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin or an oxytocin analogue to a mammalian patient to stimulate expression of mammary fluid. The oxytocin is preferably administered intranasally and causes myoepithelial contraction of target alveolar-ductal tissues of the breast. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components.

Abstract: A test device for detecting or determining an analyte in a test solution includes an absorbent material having separate contact, competitive binding, and measurement portions. The contact portion is positioned for contact with and uptake of the test solution. The competitive binding portion has a binding material for the analyte non-diffusively bound thereto. The measurement portion has a receptor for the analyte and marker-encapsulating liposomes non-diffusively bound thereto. In a method for using the test device, a solution containing the analyte and the analyte-liposome conjugate is allowed to traverse the absorbent material from the contact portion through the competitive binding portion and on through the measurement portion of the absorbent material. The amount of marker in the measurement portion of the absorbent material, following traversal by the test solution, is then determined as a measure of the analyte in the sample.

Abstract: The present invention relates to a method for carrying out immunochemical reactions and to regenerable solid phases which can be used for this purpose. When use is made of precious metals, preferably gold, as the solid phase, and also of certain reducing agents or oxidizing agents, such as, for example, sodium borohydride and tetrabutylammonium hydroxide, with or without the addition of detergents, the solid phase can be employed repeatedly, following regeneration.

Abstract: A vessel for conducting blood cell agglutination assays is disclosed. A barrier retains reactants in an upper chamber during incubation, then, in response to a force, permits reagents to enter a lower chamber containing a matrix for separating agglutination.

Abstract: A device and method for quantitative determination of an analyte in a biological sample utilizes a non-transparent support medium for retaining a chromatogenic reaction product with the medium being exposed to a source of light for transmitting therethrough a scattered, uniform response light signal which is collected at a photosensitive device whereby the amount of the analyte is correlated to the intensity of the response light signal. The response light signal may be converted to a time-duration signal proportional to light intensity to facilitate the quantitative determination.

Abstract: A particularly efficient design for a nonbibulous lateral flow one step assay for an analyte in a biological sample is disclosed. In the improved device of the invention, three zones which are in nonbibulous lateral flow contact are employed: a sample receiving zone, a labeling zone, and a capture zone. The sample containing analyte is carried through the labeling zone and interacts with an assay label comprising visible moieties, preferably particles, which are coupled to specific binding reagent for analyte or to a competitor with analyte for a capture reagent. The flow continues into the capture zone where the visible moieties to which analyte or competitor are coupled are captured. Excess fluid is absorbed into an absorbent zone in contact with the capture zone. A positive result is obtained by visualizing the visible moieties in the capture zone.

Abstract: Binding assays are effected by introducing a specific binding reagent through a top absorbant membrane in parallel contact with a main absorbant membrane. By providing a parallel flow of liquid in the two membranes, and by controlling the flow of the diluted reagent from the top absorbant membrane into the main absorbant membrane, a controlled, uniform dilution of the reagent is obtained, leading to more accurate assay results.

Abstract: A particularly efficient design for a nonbibulous lateral flow one step assay for an analyte in a biological sample is disclosed. In the improved device of the invention, three zones which are in nonbibulous lateral flow contact are employed: a sample receiving zone, a labeling zone, and a capture zone. The sample containing analyte is carried through the labeling zone and interacts with an assay label comprising visible moieties, preferably particles, which are coupled to specific binding reagent for analyte or to a competitor with analyte for a capture reagent. The flow continues into the capture zone where the visible moieties to which analyte or competitor are coupled are captured. Excess fluid is absorbed into an absorbent zone in contact with the capture zone. A positive result is obtained by visualizing the visible moieties in the capture zone.

Abstract: Improved devices for collecting and analyzing samples of aqueous solutions, body fluids, sewage or fecal matter to be used in detecting microbes and microbial byproducts. A device in accordance with the invention comprises a body including an internal channel having an entryway, a solute chamber connected to the entryway, a solute-adding mechanism operatively connected to the solute chamber, a window in the body that allows viewing of a portion of the channel, and an aperture in the body that opens to the channel; a bendable tang connected to the body; and a sample collection unit attached to the tang.

Abstract: A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample.

Abstract: A test device for detecting or quantifying an analyte in a test sample includes an absorbent material having separate contact and measurement portions. The contact portion is positioned at or proximate to a first end of the absorbent material. The measurement portion has a receptor for a conjugate of an analyte analog and marker-encapsulating liposomes. In a method for using the test device, a binding material specific for the analyte is combined with the liposome-analyte analog conjugate and the test sample to form a test mixture. The mixture is incubated for a time sufficient to permit competition between any analyte present and the conjugate for the binding material. Following incubation, the mixture is allowed to traverse the absorbent material from the contact portion through the measurement portion of the absorbent material.

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 chromatographic assay test device for use with immunoassays. The test device has a sample collection member pivotally coupled to a test strip receiving member. The sample collection member has a window for applying a test sample to a pad accessible through the window and the pad is repositionable to an inverted position to contact a chromatographic member inserted into the test device. The chromatographic member is then brought into opposition to the sample collection member thus improving test performance by reducing the manipulation of samples. The test device is constructed from five interconnected panels which are die cut from SBS cardboard. The first panel has a window for inserting a test strip and the second panel has a window for viewing the test strip during the test procedure. The third panel has the repositionable pad section. The fourth panel has a window for applying the test sample and the fifth panel covers the test sample window.

Abstract: A diagnostic test, and a device for conducting the test, for assessing whether patient chest pain is cardiac in origin and for differentiating between unstable angina and myocardial infarction as a cause of patient chest pain is described. The diagnostic test comprises simultaneously detecting at least three selected cardiac markers with the use of at least three different monoclonal or polyclonal antibody pairs, each member of which is complementary to a different marker, which is released by heart muscle at varying stages after the onset of chest pain and is indicative of the cause of the chest pain.

Abstract: A diagnostic test, and a device for conducting the test, for assessing whether patient chest pain is cardiac in origin and for differentiating between unstable angina and myocardial infarction as a cause of patient chest pain is described. The diagnostic test comprises simultaneously detecting at least three selected cardiac markers with the use of at least three different monoclonal or polyclonal antibody pairs, each member of which is complementary to a different marker, which is released by heart muscle at varying stages after the onset of chest pain and is indicative of the cause of the chest pain.

Abstract: A device for combined bioaffinity assay and electrophoretic separation is provided, which comprises a capillary system having two stages, a first stage in which bioaffinity interactions of analyte molecules and molecular recognition elements are performed, and a second stage, in which electrophoretic separation of the analyte molecules and subsequent detection of the separated species is accomplished. Within the first capillary stage the molecular recognition elements are attached and immobilized to the inside capillary wall, for example, by adsorption or by covalent binding to the capillary material. The method for combined bioaffinity assay and electrophoretic separation comprises flowing an analyte through a capillary system having two stages. In a first capillary stage the analyte molecules are captured by respective molecular recognition elements present in that stage.

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 has a hollow outer casing and an assay material disposed within the casing. The outer casing defines: a urine inlet port; a viewing window; and at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material defining: 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 liquid sample between the urine sample application region and the analyte capture region. The drainage vent is located to permit excess urine entering the casing from the urine stream to exit the casing thereby to minimize hydraulic pressure induced flooding of the assay material disposed within the casing and to reduce the frequency of false test results.

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: Disclosed are assay systems, kits, 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. An elongated solid phase flow matrix includes: (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 liquid wash and/or detector reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned between the first region and the third region and between the absorbent reservoir and the third region. The device also includes means to detect analyte bound at the second region.

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: Centrifuged anticoagulated blood samples are analyzed under magnification in a centrifuge tube containing a layer-elongating insert, which tube is placed on a calibrated slide. The slide includes a slot in which the tube is placed. A calibrated scale is disposed adjacent to the slot for use in measuring various blood sample parameters, such as hematocrit, platelet count, and the like. Anemia and/or low platelet counts are indicative of potentially serious complications of malaria. Their detection will prompt a physician to consider the liklihood of serious illness due to malaria. The presence or absence of blood-borne parasites can also be determined using the procedures of this invention. Thus the device allows a blood sample to be analyzed for malarial parasites, and also allows measurement of hematicrit and platelet counts.

Abstract: A dry immunoassay analytical element, for assaying a ligand is disclosed. The element comprises, in the following order, (a) a layer containing a labeled ligand, (b) a bead spreading layer, c) a cross-linked hydrophilic polymer layer and d) a support; wherein(i) a fixed concentration of an immobilized receptor for the labeled ligand is located in a zone at the interface of layers (b) and (c); and(ii) the receptors are immobilized by being covalently bonded to polymeric beads that are smaller than the beads in layer (c).

Abstract: This invention relates to a lateral flow immunochromatographic assay device without a plastic housing. The assay includes a sample receiving region, analyte detection region and end region all made of porous material and capable of lateral flow. The analyte detection region includes labeling reagents, a capture reagent and a control reagent. The back of the porous material is laminated with a semi-rigid material with adequate mechanical strength. The top is partially covered with a thin plastic material so as to leave a portion of the sample receiving region exposed for sample application.

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: This invention relates to a diagnostic tests and devices for conducting such tests at the point of care or in a diagnostic laboratory for accurate, simple, and rapid assessment of chest pain. In particular, the invention relates to differential diagnosis of the origin of chest pain, e.g., whether the pain is cardiac in origin, and for differentiating between unstable angina ("UA"), myocardial infarction ("MI"), congestive heart failure ("CHF"), and other ischemic events affecting the heart, at early onset of patient chest pain. The invention further relates to diagnosis of the stage of the MI in a patient suffering from MI, and to prognosis of such a patient.

Abstract: A single use sampling and sample delivery device for a test kit includes a strip having a first part and a second part. The first part has a first side and a second side, each side having a surface to serve as a spatula for collecting and placing a sample into a test kit. The second part serves as a handle for manipulating the first part. The first part which contains the sample may be readily separated from the second part, then left in the container. Alternate embodiments of the device include addition of an adhesive coating or a foam and adhesive coating to the first part, both employing a release covering to protect the sample surface from contamination prior to use. The device may be individually packaged or supplied in a pack containing a plurality of strips.

Abstract: The present invention is directed to a new assay procedure and improved solid phase assay devices for use with a so-called physical developer. The invention provides a new assay procedure for detecting the presence of an analyte in a fluid sample using a tracer having a metal label which signal is enhanced by applying a physical developer. The assay is performed with a device having a support for a test area and having attached thereto a binder specific for the analyte to be detected. The assay comprises the steps of directing the fluid sample and the tracer through a porous medium into contact with the test area at a controlled flow rate to allow binding of the analyte with the binder and the tracer to the analyte, directing a physical developer through said porous medium to amplify the signal generated by the tracer, and separating the device to allow the test area to be read. The invention further relates to devices and immunoassay test kits for carrying out the improved immunoassay procedure.

Abstract: A device and related method for simultaneously performing a plurality of 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 read-out, competitive immunoassay for the presence of the respective analyte.

Abstract: The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.

Abstract: A disposable diagnostic device and method of its use are provided. The device comprises a housing containing first and second flow paths orthogonal to each other. The first flow path commences at a sample addition port and continues through a transport channel which feeds sample to an incubation area by means of capillary flow. The incubation area comprises a signal producing system and is underneath an optically-clear window. The first flow path terminates in a top waste reservoir which receives sample and wash fluid. The second flow path begins on one side of the incubation area at an inlet port over a side reagent reservoir. Liquid flows along the second flow path from the side reagent reservoir across the incubation area into the side waste reservoir. The incubation area may comprise agitation means for homogenous dispersion of reagent into liquid.

Abstract: A rapid and accurate test kit is discussed for the detection of antibodies to HIV in saliva. The identification of antibodies to HIV in the saliva of seropositive individuals is shown using a test kit that requires no special machinery or skill and can be conducted by a single person in the privacy of their own home.

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: Sensitive methods using a variety of biomarkers in oral saliva of humans and animals to detect measure, and quantify the presence of infectious and non-infectious agents and the functional status of living tissues in both (1) biomedical and (2) environmental applications. With in vivo biomedical applications, saliva samples are taken from human and animals and biomarker, such as enzyme or antibody levels, are measured. The extent of exposure to an agents is measured by the presence of specific chemical or biological constituents, by the degree of enzymes inhibition, or by the changes in the amount of the biochemicals in saliva. With in vitro environmental applications, enzymes or other biochemicals from animal or human saliva can be used to monitor the presence of toxic or reactive agents in tissue samples, urine, feces, milk, air, water, soil, or plants. The amount of toxicant in samples is estimated from a standard curve for that agent.

Abstract: A method for increasing the binding activity of specific binding members bound to a solid phase material, e.g., a particle, that has been sterically stabilized. This increase in binding activity is brought about by degrading a steric stabilizer on the surface of the solid phase material. The method involves both immobilizing a specific binding member on the surface of a solid phase material and degrading a steric stabilizer on the surface of that solid phase material. In the preferred embodiment, the method involves the immobilization of a specific binding member on the surface of the sterically stabilized solid phase material, with subsequent degradation of the steric stabilizer.

Abstract: This invention is directed to a ligand-receptor assay for determining the presence of at least one target ligand, capable of competing with a ligand analogue conjugate for binding sites available on a ligand receptor, said ligand analogue conjugate comprising at least one ligand analogue coupled to a colloidal gold particle, in a fluid sample suspected of containing said target ligand comprising the steps of:a. contacting said fluid sample with said ligand analogue conjugate and said ligand receptor to form a homogeneous reaction mixture, the relative amounts of said ligand analogue conjugate and said ligand receptor being selected such that in the absence of said target ligand and subsequent to substantially equilibrium binding in said reaction mixture, substantially all of said ligand analogue conjugate is bound to said ligand receptor such that no unbound ligand analogue conjugate is detected as a result of the assay method;b.

Abstract: An apparatus for collecting antigen, including an allergen exemplified by a dust-mite, dispersed in a motile fluid in a given environment that can be inserted in a section of a pipe of a standard vacuum cleaner hose. The apparatus includes a receptacle whose body is formed of nylon, typically with a pore size of from 15 to 60 .mu.m. The receptacle is coated with an antibody that retains the antigen in a contacting relationship. The apparatus is provided with a removable holder, which assists in locating the apparatus in the pipe of the vacuum cleaner. The apparatus can be used directly in an immunoassay for confirming the presence of, or quantifying, the antigen.

Abstract: A method is described for performing an affinity assay comprising contacting a sample to be assayed for the presence of an analyte with a dry reagent containing the analyte (hapten, antigen, antibody, receptor, or complementary polynucleotide) bound to a reaction cascade initiator, an antibody or other binding pair partner reactive with said analyte, and magnetic particles, to form an assay mixture in a reaction chamber, incubating the assay mixture, applying an oscillating or moving static magnetic field to the assay mixture, activating the reaction cascade initiator to initiate a reaction cascade, monitoring the response of the magnetic particles to the oscillating or moving static magnetic field to provide a time varying signal, and determining the analyte concentration of the sample by analysis of the time varying signal, as well as a kit for performing the assay and a diagnostic system for performing the assay.