Abstract: A method of assaying for an analyte which occurs at least partially bound as a complex with its soluble receptor or binding protein, the method comprising the steps of: i) mixing a biological fluid serum sample containing the analyte to be determined with a detergent for dissociating said complex, ii) mixing the sample from step i) with reagents, including a specific binding partner of the analyte for binding to the analyte, for performing a specific binding assay for the analyte, iii) and mixing the sample from step i) with a sequestrant for the detergent, whereby the binding of step ii) is performed in the presence of the sequestrant.

Abstract: Compositions are disclosed comprising (a) a metal chelate wherein the metal is selected from the group consisting of europium, terbium, dysprosium, samarium osmium and ruthenium in at least a hexacoordinated state and (b) a compound having a double bond substituted with two aryl groups, an oxygen atom and an atom selected from the group consisting of oxygen, sulfur and nitrogen wherein one of the aryl groups is electron donating with respect to the other. Such composition is preferably incorporated in a latex particulate material. Methods and kits are also disclosed for determining an analyte in a medium suspected of containing the analyte. The methods and kits employ as one component a composition as described above.

Abstract: In this disclosure, novel caanabinol-based tracers suitable for use in immunoassays that detect cannabinoids in a biological sample are disclosed. These cannabinol-based tracers are particularly useful in a continuous flow displacement immunoassay. The disclosure also describes the processes for synthesizing the novel tracers, and the application of these tracers in fluorescence immunoassays for detecting and quantifying cannabinoids in biological samples.

Abstract: Reagents and methods for the detection of Staphylococcus aureus are provided. The reagents contain an antibody that binds to a capsular polysaccharide of type 5 of Staphylococcus aureus, and can be used in methods for detection of oxacillin resistant Staphylococcus aureus that escapes detection by agglutination in the presence of fibrinogen and antibodies directed against protein A of Staphylococcus.

Abstract: The present invention provides biologically active linear polypeptides that possess a plurality of biologically active groups, methods employing such peptides to target molecules to cells, and methods employing such peptides for inhibiting the binding of cells to each other.

Abstract: Thrombotic or thromboembolic disease is detected or monitored by determining the presence or amount B in a urine sample.

Abstract: This invention provides a novel fluorescent particle including a core or carrier particle having on its surface a plurality of smaller polymeric particles or nanoparticles, which are stained with different fluorescent dyes. When excited by a light source they are capable of giving off multiple fluorescent emissions simultaneously, which is useful for multiplexed analysis of a plurality of analytes in a sample. The coupled complex particles carrying on their surface fluorescent nanoparticles, methods of preparing such polymer particles, and various applications and methods of using such particles are claimed.

Abstract: The invention concerns a method for the purification of a target substance from a biological sample by immobilizing the target substance on a solid phase by means of a high affinity binding pair and subsequently eluting it by adding a partner of the binding pair in a free form. In addition reagent kits for carrying out the method are disclosed.

Abstract: An improved method of making a series of bead or microsphere or particle populations characterized by subtle variation in a proportion or ratio of at least two fluorescent dyes distributed within a single bead of each population is provided. These beads, when excited by a single excitation light source are capable of giving off several fluorescent signals simultaneously. A set containing as many as 64 distinct populations of multicolored, fluorescent beads is provided and when combined with analytical reagents bound to the surface of such beads is extremely useful for multiplexed analysis of a plurality of analytes in a single sample. Thus, methods of staining polymeric particles, the particles themselves, and methods of using such particles are claimed.

Abstract: Protein arrays for the parallel, in vitro screening of biomolecular activity are provided. Methods of using the protein arrays are also disclosed. On the arrays, a plurality of different proteins, such as different members of a single protein family, are immobilized on one or more organic thinfilms on the substrate surface. The protein arrays are particularly useful in drug development, proteomics, and clinical diagnostics.

Abstract: The invention provides methods and devices for detecting the presence of one or more target analytes in a sample employing a channel having affixed therein one or more binding partners for each target analyte. Assays are carried out by transporting the sample through the channel to each successive binding partner so that target analyte present in said sample binds to the corresponding binding partner. The sample is then transported beyond the binding partner(s), followed by detection of any target analyte bound to each binding partner. In one embodiment, binding efficiency is increased by the use of segmented transport, wherein a first bolus or bubble of a fluid that is immiscible with the sample precedes the sample during transport and a second bolus or bubble of a fluid that is immiscible with the sample follows the sample. Many configurations are possible for the device of the invention.

Abstract: A pretreatment method for assaying a substance which comprises mixing a biological specimen with at least one pretreating agent selected from among surfactants and alkali agents, thus releasing binding proteins in the biological specimen from the substance to be assayed and, at the same time, inactivating the proteins by irreversible denaturation to thereby eliminate the effects of the binding proteins coexisting in the biological specimen.

Abstract: The invention relates to methods, kits and systems for determining an analyte in a liquid sample as well as the use thereof for concentration analysis and screening purposes. In one method, a specific binding partner to the analyte is permitted to compete with a conjugate containing the analyte or an analyte analogue for the binding to free analyte. The conjugate also contains a component that specifically binds to a solid support so that reacted and unreacted conjugate are bound thereto when the reaction solution is contacted with the solid support. The amount of analyte is then determined by measuring by a label-free mass-detection technique, such as surface plasmon resonance, the amount of binding partner immobilized on the solid support via the reacted conjugate. This is made possible by the binding partner having a considerably greater mass than the conjugate. Variants of this method are also disclosed.

Abstract: A method and apparatus for the manipulation of colloidal particles and biomolecules at the interface between an insulating electrode such as silicon oxide and an electrolyte solution. Light-controlled electrokinetic assembly of particles near surfaces relies on the combination of three functional elements: the AC electric field-induced assembly of planar aggregates; the patterning of the electrolyte/silicon oxide/silicon interface to exert spatial control over the assembly process; and the real-time control of the assembly process via external illumination. The present invention provides a set of fundamental operations enabling interactive control over the creation and placement of planar arrays of several types of particles and biomolecules and the manipulation of array shape and size. The present invention enables sample preparation and handling for diagnostic assays and biochemical analysis in an array format, and the functional integration of these operations.

Abstract: The present invention provides novel microfluidic devices and methods that are useful for performing high-throughput screening assays. In particular, the devices and methods of the invention are useful in screening large numbers of different compounds for their effects on a variety of chemical, and preferably, biochemical systems.

Abstract: Disclosed are devices for detecting the presence of a preselected analyte in a fluid sample. The devices comprise a substrate microfabricated to define a sample inlet port, and a mesoscale flow system that includes a sample flow channel extending from the inlet port. The mesoscale flow system further includes an analyte detection region in fluid communication with the flow channel comprised of a binding moiety for specifically binding the analyte. The detection region is constructed with a mesoscale dimension sufficiently small to enhance binding of the binding moiety and the analyte. The binding moiety may be immobilized in the detection region. The mesoscale detection systems of the invention may be used in a wide range of applications, including the detection of cells or macromolecules, or for monitoring reactions or cell culture growth.

Abstract: A particle for a diagnostic agent, which comprises a polymer particle comprising (A) from 20 to 100% by weight of a structural unit derived from at least one of acrylate having an aliphatic hydrocarbon group and methacrylate having an aliphatic hydrocarbon group, (B) from 0 to 10% by weight of a structural unit derived from unsaturated carboxylic acid, and (C) from 0 to 80% by weight of a structural unit derived from a vinyl monomer copolymerizable with the acrylate, methacrylate and unsaturated carboxylic acid, and a turbidmetric immunoassay using the same.

Abstract: The present invention relates to methods of measuring urinary TGF-&bgr; levels to monitor disease progression in patients having chronic fibrotic diseases or kidney diseases, more particularly, methods of preparing urine specimens for measuring urinary TGF-&bgr; levels in patients having chronic fibrotic diseases or kidney diseases.

Abstract: An immunoassay for selectively measuring human C-peptide as well as a kit therefor is disclosed. In the method, human C-peptide contained in a sample, a first anti-human C-peptide antibody, and a second anti-human C-peptide antibody which is immobilized on a solid support are reacted to form an immune complex among these three components. The formed immune complex is separated from the non-reacted antibodies and sample; and then the separated immune complex is quantified. The first antibody recognizes an epitope existing in the region from 1st to 16th amino acid residue from the N-terminal of the human C-peptide, and the second antibody recognizes an epitope existing in the region from 1st to 16th amino acid residue from the N-terminal of human C-peptide; with the proviso that the first and second antibodies do not recognize the same epitope so that they can simultaneously bind to said human C-peptide.

Abstract: An agglutination assay method for quantitatively determination of an analyte in a liquid sample using particles bearing an anti-analyte. A non-fluid substance which retains the particles while suppressing the diffusion of the particles therein is used as a medium which is to be a place where the agglutination of the particles takes place. Upon analysis, a solation agent is added to the non-fluid substance medium to increase the fluidity of the non-fluid substance, thereby the particles bearing the anti-analyte can diffuse in the medium to cause the agglutination with the analyte. Preferably, the solation agent is added to the non-fluid medium together with the sample. The non-fluid substance medium containing the particle-labeled anti-analyte can be stored with a higher stability in the dry state. A dry analysis element for enabling such analysis method is also provided.

Abstract: A method for the multiplexed diagnostic and genetic analysis of enzymes, DNA fragments, antibodies, and other biomolecules comprises the steps of constructing an appropriately labeled beadset, exposing the beadset to a clinical sample, and analyzing the combined sample/beadset by flow cytometry. Flow cytometric measurements are used to classify, in real-time, beads within an exposed beadset and textual explanations, based on the accumulated data obtained during real-time analysis, are generated for the user. The inventive technology enables the simultaneous, and automated, detection and interpretation of multiple biomolecules or DNA sequences in real-time while also reducing the cost of performing diagnostic and genetic assays.

Abstract: A method and apparatus for the manipulation of colloidal particulates and biomolecules at the interface between an insulating electrode such as silicon oxide and an electrolyte solution. Light-controlled electrokinetic assembly of particles near surfaces relies on the combination of three functional elements: the AC electric field-induced assembly of planar aggregates; the patterning of the electrolyte/silicon oxide/silicon interface to exert spatial control over the assembly process; and the real-time control of the assembly process via external illumination. The present invention provides a set of fundamental operations enabling interactive control over the creation and placement of planar arrays of several types of particles and biomolecules and the manipulation of array shape and size. The present invention enables sample preparation and handling for diagnostic assays and biochemical analysis in an array format, and the functional integration of these operations.

Abstract: An engineered microparticle and methods and systems relating thereto. The microparticle includes a conductive core and an insulating layer surrounding the conductive core and having a thickness sufficient to render the microparticle responsive to a dielectrophoretic force.

Abstract: Use of pregnancy-associated plasma protein-A as a marker for inflammatory conditions, and in particular, for acute coronary syndromes is described.

Abstract: The present invention uses the principle that phosphomolybdate binds to hydrophobic surfaces to isolate the phosphomolybdate complex from other phosphate-containing molecules and further uses the SPA concept to bring a radiolabeled phosphomolybdate complex in close contact with a scintillant for measurement by scintillation counting. Generally, the present invention provides an assay for detecting and measuring the amount of orthophosphate (Pi) in an aqueous reaction mixture, wherein the amount of Pi released is separated from the reaction mixture by: adding a solution of molybdate to the reaction mixture to form a phosphomolybdate complex; and contacting the phosphomolybdate complex with a hydrophobic surface, wherein the surface is capable of being separated from the aqueous reaction mixture to allow measurement of the Pi. Particularly, this invention provides an assay for measuring the ATPase activity of enzymes, more particularly, the HPV E1 helicase.

Abstract: The invention concerns a method for the determination of an analyte in which rheumatoid factors or rheumatoid-factor-like substances are added as an interference reducing reagent to reduce of avoid a hook effect. The invention in addition concerns suitable reagent kits for carrying out the method.

Abstract: Reagents and methods for the detection of Staphylococcus aureus are provided. The reagents contain an antibody that binds to a capsular polysaccharide of type 5 of Staphylococcus aureus, and can be used in methods for detection of oxacillin resistant Staphylococcus aureus that escapes detection by agglutination in the presence of fibrinogen and antibodies directed against protein A of Staphylococcus.

Abstract: The present invention provides low molecular weight fluorescent labeling complexes with large wavelength shifts between absorption of one dye in the complex and emission from another dye in the complex. These complexes can be used, for example, for multiparameter fluorescence cell analysis using a single excitation wavelength. The low molecular weight of the complex permits materials labeled with the complex to penetrate cell structures for use as probes. The labeling complexes are synthesized by covalently attaching through linkers at least one cyanine fluorochrome to another low molecular weight fluorochrome to form energy donor-acceptor complexes. Resonance energy transfer from an excited donor to fluorescent acceptor provides wavelength shifts up to 300 nm. The fluorescent labeling complexes preferably contain reactive groups for the labeling of functional groups on target compounds, such as derivatized oxy and deoxy polynucleic acids, antibodies, enzymes, proteins and other materials.

Abstract: This invention relates to novel tracers and their synthesis and use in an immunoassay for the detection of controlled drugs such as amphetamine (APM), methamphetamine (MAPM) and their derivatives, in a biological or aqueous sample. In particular, this invention provides methods for synthesizing novel tracers in which a non-controlled substance is both the starting material in tracer synthesis and the binding site on the resulting novel tracer for the antibody, thereby eliminating the necessity of using controlled substances as starting materials. In addition, the novel tracers of the present invention can be used as an analyte analog in an immunoassay, such as a continuous flow displacement immunoassay. It was unexpectedly discovered that the novel tracers of the present invention substantially improve the performance of the continuous flow displacement immunoassay as compared with conventionally designed tracers.

Abstract: Ligands that interact with a target, such as one present on a virus, can be more easily identified if false positive interactions (either specific or non-specific) are differentiated from the target-specific interaction. An improved method for screening a library of surface-immobilized ligands which bind to a target is presented. The method can be used for multiple screenings of the same surface-immobilized library for a number of different ligands.

Abstract: It has been found that casein and salts of casein are useful as replacements for, or in addition to, BSA as materials for coating solid phases, particularly magnetic particles, used in immunoassays and other binding assays for separation of the desired analyte. By using casein, immunoassays having improved stability and fewer discordant samples have been developed. Casein used at a concentration of 0.05-4.0 grams per gram of paramagnetic particle (optimally approximately 0.78-1.2 grams of casein per gram of magnetic particle) has been found to confer this benefit.

Abstract: The invention provides monoclonal antibodies which are reactive with fibrin(ogen) degradation products (FDPS) generated by matrix metalloproteinases (MMPs), such as MMP-3, MMP-7, and membrane-type 1, MT1-MMP proteolysis of fibrinogen and cross-linked fibrin (and not plasmin or other proteases). Monoclonal antibodies of the invention include, but are not limited to, H5, F2, 90/2, 90/5, B4, 13, C6, A6, G6, E6, 197-1 and 197-2. This invention also provides methods of using monoclonal antibodies for detection of FDPs generated by proteolysis of fibrin(ogen) by MMPs, such as MMP-3, MMP-7, and MT1-MMP. In addition, the present invention provides methods for diagnosing rheumatoid arthritis, osteoarthritis, and synovitides, as well as angiogenesis, atherosclerosis, renal diseases, malignancy and inflammation.

Abstract: The present invention relates to a new hydrophobe biomolecular structure, which is compacted due to the passing of the structure over its point of collapse, a method for the preparation of the structure and use of the new structure for the manufacture of a medicament.

Abstract: A method for utilizing a filtration device for removing interferants from a test sample containing a mixture of a composition of interest and interferants in an automated apparatus is disclosed. The filtration device includes a microporous hollow fiber membrane having a plurality of pores sized to retain the composition of interest while allowing smaller diameter interferants to pass through the membrane.

Abstract: A particle resistant to storage of at least one first and at least one second component, wherein said second component of at least one crosslinkable polymer as a shell at least partially envelops and/or encloses said first component as a core and said first component has at least one ascertainable property, obtainable by reacting said first component with the crosslinkable polymer and subsequently reacting the formed product with a crosslinking agent such that the first component with resistance to storage remains within the second component.

Abstract: Disclosed is a method for determining the concentration of an analyte in a sample of body fluid. The method involves contacting the body fluid sample with a test strip containing mobile, labeled specific binding partner for the analyte, through which strip the test fluid, analyte and any complex formed by interaction of the analyte and labeled specific binding partner therefore can flow by capillarity. The strip contains at least one zone for capture of the labeled specific binding partner and at least one separate zone for retention of the analyte/labeled specific binding partner complex. By determining the magnitude of the signal from the detectable label in the capture zone(s) and retention zone(s) and determining a final response signal by correlating signals using an algorithm and number of zones chosen in a manner that provides a final response signal best suited for the particular assay, the concentration of the analyte can be determined with greater precision.

Abstract: A test method for IgA nephropathy involves determining antibody, which recognizes the core peptide of the hinge region in IgA1, in specimens. The method is a rapid and sample test method for IgA nephropathy having less emotional distress for the patients, low risk for peripheral hemorrhage of the kidney and reduced financial burden for the patients.

Abstract: In a process for the quantitative optical analysis of fluorescently labelled biological cells 5, a cell layer on a transparent support at the bottom 2 of a reaction vessel 1 is in contact with a solution 3 containing the fluorescent dye 4. The sensitivity of analytical detection can be considerably improved if to the fluorescent dye 4 already present in addition a masking dye 9, which absorbs the excitation light 6 for the fluorescent dye 4 and/or its emission light 7, is added to the solution 3 and/or if a separating layer 10 permeable to the solution and absorbing and/or reflecting the excitation light 6 or the emission light 7 is applied to the cell layer at the bottom 2. The separating layer 10 must be composed such that it has a high power of reflection for the luminescent light 11.

Abstract: A method and apparatus for the physico-chemical encoding of a collection of beaded resin (“beads”) to determine the chemical identity of bead-anchored compounds by in-situ interrogation of individual beads. The present invention provides method and apparatus to implement color-coding strategies in applications and including the ultrahigh-throughput screening of bead-based combinatorial compounds libraries as well as multiplexed diagnostic and environmental testing and other biochemical assays.

Abstract: A general stochastic method for synthesizing random oligomers can be used to synthesize compounds to screen for desired properties. The use of identification tags on the oligomers facilitates identification of oligomers with desired properties.

Abstract: A magnetic biological particle separation device comprising a permanent magnet structure substantially surrounding a vessel containing a liquid and a biological sample in colloidal suspension in the liquid is described. The magnetic separation device comprises a window through which to view the liquid. The permanent magnet structure comprises a plurality of permanent magnets arranged in such a manner to provide for superpositioning of the external magnetic field generated by each magnet. The external magnetic field acts on magnetic beads attached to the biological sample, causing the sample to move toward the inner wall of the vessel. The permanent magnets do not completely surround the outside of the vessel to allow the liquid to be poured out of the vessel, substantially leaving the sample.

Abstract: The present invention provides novel microfluidic devices and methods that are useful for performing high-throughput screening assays. In particular, the devices and methods of the invention are useful in screening large numbers of different compounds for their effects on a variety of chemical, and preferably, biochemical systems.

Abstract: Methods, compositions and kits are disclosed. The methods are directed to determining the presence or relative amounts of two or more components in a medium. A combination is provided comprising a medium suspected of containing the components and a label reagent for each of the components. The label reagent comprises a chemiluminescent composition that is activated by electromagnetic radiation. A first specific binding pair (sbp) member may be associated with the reagent depending on the components to be determined. Luminescence emitted by each of the chemiluminescent compositions upon activation is differentially detectable. Where a first sbp member is employed, it is capable of binding to the component or to a second sbp member to form a complex related to the amount of the component. At least one of the chemiluminescent compositions comprises a fluorescent energy acceptor. After the above are combined, the chemiluminescent compositions are activated.

Abstract: A particle resistant to storage of at least one first and at least one second component, wherein

Abstract: An assay device comprises a sample-collecting wick made from non-woven fabric material laminated to plastics sheet. Preferably, the fabric is a 30:70 blend of viscose and polyester, and has a fibrous structure in which more than two thirds of the fibers run substantially parallel to the intended direction of liquid flow in the wick.

Abstract: A solution of a non-reconstituted hormone and a preservative having a useful shelf life of at least six months, and, in some circumstances, at least a year. A series of solution of varying levels of the non-reconstituted hormone may be in a test kit and used in a process to determine the level of the hormone in a patient sample. In an aspect of the invention, the hormone is parathyroid hormone. The preservatives may be polyvinyl alcohol, a dissolved EDTA salt, or dissolved sodium molybdate. The hormone may be in an aqueous or a buffered matrix containing very little protein and substantial amounts of TX100 to reduce non-specific binding. The solution is incubated with a solid phase coated with an anti-hormone antibody and a labeled hormone antibody. The solid phase is read using a suitable device for measuring the labeled hormone antibody. An example of a labeled hormone antibody is an acridinium labeled hormone antibody that is read using a light reading device.

Abstract: The invention relates to a method of evaluating the immunological status of a subject comprising the steps of 1) determining the content of an antibody in a liquid sample from the subject using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the presence of other constituents of the sample to obtain a measurement 1, 2) determining the content of an antibody in the liquid sample using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the absence of other constituents of the sample to obtain a measurement 2, and 3) interrelating measurements 1 and 2 to express the interference and using the interference as a parameter for evaluating the immunological status of the subje

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: An ultrasonic energy source is used to provide a variable force for measuring the binding forces between molecular entities and for sensing the presence of an analyte in a test sample. The device includes a surface that has a first binding member attached thereto and one or more particles that have a second binding member attached thereto. A reaction vessel is provided for exposing the surface to the particles whereby, if the first binding member has a binding affinity for the second binding member, a complex is formed between individual first binding members and individual second binding members and the particles thereby become immobilized with respect to the surface. The ultrasonic energy source is positioned for applying a variable ultrasonic force onto the surface, and the position of the particles is monitored as the intensity of the ultrasonic force is varied.

Abstract: Separation apparatus and method for separating magnetic and/or magnetically-labeled particles from a test medium in a reaction chamber which incorporates baffles, a spinner, a stirrer, or a plunger operable to be displaced along a collection surface to define a narrow flow path through which the particle-laden test medium must flow. The collection surface is a thin-walled non-magnetic material having a plurality of magnetic pole faces positioned therearound. Test medium within a reaction chamber is caused to flow past a collecting surface, and a high-gradient magnetic field is applied to the surface to capture magnetically responsive particles in the test medium. The particles are deflected toward the collection surface in the flow path for the test medium. The narrow flow path assures that substantially all of the particles pass within the high-gradient magnetic field along the collection surface.