Abstract: A portion of a hydrophobic membrane, having an unknown concentration of a first molecule in a sample bound to its surface, is incubated with a second molecule that selectively binds to the first molecule so as to allow determination of its concentration. The membrane is first coated with the first molecule and then dried to render the uncoated portion nonwettable with water. The labeled second molecule selectively binds to the first molecule in the absence of a blocking agent on the membrane.

Abstract: A method of assaying a human urine sample, by measuring a concentration of pyridinium crosslinks from which the concentration of total hydrolysed pyridinoline in the sample can be determined, is disclosed. In the method, a urine sample is reacted with an anti-Pyd antibody reagent which preferably has a ratio of reactivity toward native free pyridinoline and urinary pyridinoline peptides larger than 1,000 daltons in molecular weight, of greater than 10:1. By measuring the extent of immunocomplex formed by the reaction, the concentration of total hydrolysed pyridinoline in the sample can be calculated. Also disclosed are an antibody reagent and kit which can be used in the method.

Abstract: Monoclonal antibodies highly specific for human bone alkaline phosphatase, especially in the presence of human liver alkaline phosphatase, and their use in assays for human bone alkaline phosphatase are disclosed. A kit using the antibodies in an assay for human bone alkaline phosphatase is also disclosed.

Abstract: Contaminants in particulate materials may be separated and quantitated by contacting the particulate material with an immobilized biomolecule which specifically binds to the contaminant, separating the contaminant-immobilized biomolecule complex from the particulate material, and counting the bound contaminant. The method may be conveniently carried out when the biomolecule is immobilized on a magnetic particle. An apparatus for carrying out the method contains a receptacle for receiving a reaction vessel and magnets positioned such that magnetic particles contained in the reaction vessel will be drawn to and adhere to the sides of the reaction vessel when placed in the receptacle.

Abstract: The present invention relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of generic anti-hapten antibodies. Also disclosed are multi-analyte immunoassay methods. Reagents, devices, and kits using the anti-hapten antibodies are also disclosed. The present invention also relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of a dual antibody format.The present invention also relates to dyed erythrocytes, preferably fixed, which are coated with antibodies. Also disclosed is the use of these dyed erythrocytes in agglutination assays to detect and measure the presence of an analyte in a sample. The analyte can be a hapten, an antigen, or an antibody. Also included are agglutination assays, compositions and kits using these dyed and coated erythrocytes.

Abstract: A method of immunologically assaying intact human osteocalcin in a human assay sample is provided by using an antibody having an epitope in a region of an amino acid sequence 1 to 20 on the N-terminal side of human osteocalcin and an antibody having an epitope in a region of an amino acid sequence 36 to 49 on the C-terminal side of human osteocalcin. A reagent and a kit therefor are provided. Furthermore, a method of immunologically assaying the total amount of human intact osteocalcin in a human assay sample, and a reagent and a kit therefor are also provided. A monoclonal antibody and a polyclonal antibody are used for the assay. A process for producing these antibodies, and utilization of these antibodies is described.

Abstract: This invention relates to a method for the isolation of trophoblast (placental) cells from the blood of a pregnant mammal so as to provide the essential starting material, namely cells derived from the fetus, to enable genetic and/or biochemical information about the fetus to be obtained. In particular, this invention relates to the use of monoclonal antibodies specific for membrane protein markers on mammalian trophoblasts to isolate trophoblast cells from maternal blood. These cells may then be used to obtain fetal genetic and/or biochemical information early in pregnancy. The present invention is particularly relevant for detecting human fetal abnormalities.

Abstract: A hybridoma capable of producing monoclonal antibody for recognizing hCG-.beta. core region and hCG-.beta. subunit, which is obtained by cell fusion of an antibody producing cell of a mammal immunized with hCG-.beta. subunit and a lymphoid cell line, and the monoclonal antibody are disclosed. The monoclonal antibody can be used in an immunochemical determination method useful for diagnosis of cancers.

Abstract: Assay reagents, devices, methods and kits used in the analysis of low molecular weight analytes which by themselves are too small or unable to bind to two specific binding members at the same time. The invention involves the use of an analyte-substitute reagent (ASR) comprising at least two components, the first of which is identical to or an analog of the analyte to be determined, while the second is an unrelated ligand for which an antibody or other specific binding member can be obtained or produced.

Abstract: A device for performing an enzyme-labelled binding assay comprises an absorbent material and a developing solution, 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 each reagent zone, and wherein the indicator reagent zone includes a reagent capable, directly or indirectly, of immobilising an enzyme-labelled reagent in an amount dependent upon the assay result, characterised in that the developing solution includes a signal producing substrate for the enzyme. The substrate moves slower through the absorbent material than the enzyme-labelled reagent or any compound of the enzyme-labelled reagent formed in the assay. 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: A device for collecting a specimen, including (a) a test vessel for containing a solution containing an immunocomplex, which is a complex as a result of an antigen-antibody reaction between a specimen and a magnetic-labeled antibody containing a magnetic micro-particle and an antibody fixed to the micro-particle, (b) an external magnetic field generating device for generating a magnetic field, preferably a gradient magnetic field and applying it to the solution in the test vessel to effect local concentration of the immunocomplex to a predetermined position, (c) a magnetic member for collecting the immunocomplex at the position of local concentration, and (d) a moving mechanism for achieving relative movement between the magnetic member and the test vessel.

Abstract: Mechanical stresses and deformations are applied directly to cell surface receptors or molecules and measured using a system including a magnetic twisting device in combination with ferromagnetic microbeads coated with ligands for integrins or any other surface receptors. The system can be used diagnostically to characterize cells and molecules and to determine the effect of transformation and compounds, including drugs, on the cells and molecules. The system can also be used to induce cells to grow or alter production of molecules by the cells.

Abstract: A test method for determining the presence or absence of an antigen or antibody analyte in a sample. The sample is first reacted in a reaction vessel with magnetic carrier particles having immobilized thereon a substance which specifically binds to said analyte, thereby forming bound and unbound magnetic carrier particles. The bound and unbound magnetic carrier particles are then precipitated on a flat and substantially horizontal inside wall surface of said reaction vessel with a magnet provided outside the reaction vessel, such that a gradient magnetic field is formed in a plane perpendicular to a direction in which the bound and unbound magnetic particles are precipitated, thereby forming a precipitation image on the wall surface. Finally, the presence or absence of the analyte is determined by the shape of the precipitation image.

Abstract: Compositions useful in quantitating collagen peptides to determine the rate of bone resorption are prepared by treating bone with a protease, such as collagenase, and purifying the compositions so as to enrich them with peptides capable of binding to the monoclonal antibody MAb-1H11.

Abstract: A method is described for determining a hapten which method comprises (i) contacting the hapten with a binding partner of the hapten, whereby the hapten becomes bound to some of the binding partner, (ii) contacting the unbound binding partner with a secondary binding partner therefor, (iii) contacting the binding partner with an antibody which binds the binding partner which has bound thereto the hapten but which does not bind the binding partner which has bound thereto its secondary binding partner; and (iv) determining the amount of antibody bound to the binding partner. Kits for use in the method are also described.

Abstract: A magnetic separator for isolating magnetically-labeled substances of interest, such as immunological agents, from a non-magnetic test medium using a method of high gradient magnetic separation. The target substance is contacted with microscopic magnetic particles having a receptor for binding with the target substance. The test medium containing the magnetic particles is held in a non-magnetic container and placed into a gap within an arrangement of magnets for causing the magnetic particles to adhere to selected locations upon the interior wall of the container. The quantity of magnetic particles may be controlled to cause the magnetic particles collected upon the interior wall to form a monolayer. The magnets are arranged upon a yoke which may provide linear, surrounding multipolar, or partially surrounding multipolar configurations of magnetic pole faces about the gap.

Abstract: A method for the direct analysis of analyte indicative of marijuana exposure found in keratinized structures, e.g., hair, fingernails and toenails, which comprises preparing a mixture containing dithiothreitol or dithioerythritol, a protease suitable for the digestion of the keratin structure and a sample of the keratin structure; permitting the enzyme to at least substantially digest the sample of keratin structure to form a digest solution, followed by mixing the digest solution with a suspension of an ion exchange resin to remove an interfering, cross reacting substance naturally found in hair and finally subjecting the digest solution to analysis to determine the identity and amount of marijuana analyte in the keratin structure sample. To accelerate the method, cupric sulfate may be added to the mixture after degradation of the keratin sample in order to deactivate the activator. The enzyme may be a protease with papain, chymopapain, and proteinase K being preferred for use in the invention.

Abstract: A method for modifiying a liquid assay reagent to provide prolonged homogeneity thereof, particularly where the liquid assay reagent comprises microparticles for performing a heterogeneous immunoassay, is provided wherein the addition of an inert material to a liquid assay reagent achieves neutral density to thereby prolong the homogeneity thereof for extended periods of time. A method for the automated agitation of assay reagents to maintain the homogeneity thereof with an automated, continuous and random access analytical instrument is also provided. The automated mixing is accomplished by a back and forth motion of a carousel onto which assay reagent containers or packs are mounted with asymmetric pauses which can be completed within a short period of time. The carousel acceleration, velocity, distance moved, and pause-asymmetry are optimized to provide rapid assay reagent resuspension without foaming or bubble formation.

Abstract: The present invention provides devices for performing binding assays. Such devices comprise (i) a reaction vessel where unbound and immobilized magnetically-labeled reagent are produced in relation to the amount of said analyte in said test sample; (ii) a separation means for partitioning said immobilized magnetically-labeled reagent and said bound magnetically-labeled reagent; (iii) a magnetic field generator means for the application of a magnetic field to said magnetically-labeled reagent; and (iv) a measurement means to assess the effect of said magnetic field on said magnetically-labeled reagent as a measure of the presence or amount of said analyte in said test sample. The device provided by the instant invention can run, for example, direct indirect, competitive, inhibition and sandwich assay formats.

Abstract: The present invention provides assay methods for performing binding assays, wherein the detectable label is a magnetically responsive material. Direct and indirect, competitive and sandwich assay formats are used to partition the magnetically attractable label between a solid phase and a fluid phase in proportion to the presence or amount of analyte in the test sample. The magnetic responsiveness of the magnetically attractable label in one or both phases results in the exertion of a force upon the label. By determining the extent of the force or influence of the force exerted upon the label, the amount of the analyte in the test sample is determined.