Abstract: This invention provides methods, compositions, and kits for detecting the presence of toxigenic strains of C. difficile in a biological sample. One embodiment provides methods for C. difficile detection that involve assaying for both C. difficile glutamate dehydrogenase and C. difficile toxin A or toxin B. In another embodiment, the invention provides a highly sensitive assay for C. difficile toxin A that is useful for determining whether a C. difficile strain is toxigenic. This embodiment involves binding of toxin A to a moiety that reversibly binds to a capture moiety present on a magnetic bead. A magnetic field is applied to the sample to concentrate the toxin A, after which the magnetic beads are dissociated and removed from the solution to obtain a highly concentrated preparation of toxin A, thus making possible a very sensitive assay.

Abstract: A novel immunodeficiency virus is disclosed which has the designation MVP-5180/91 and which has been deposited with the European Collection of Animal Cell Cultures (ECACC) under No. V 920 52 318. The characteristic antigens which can be obtained from it and which can be employed for detecting antibodies against retroviruses which are associated with immunodeficiency diseases are also disclosed, as are the DNA and amino acid sequences of the virus.

Abstract: The subject invention pertains to methods and materials for accurately assessing the presence or absence of analytes of interest in samples, particularly in physiological samples. The subject invention involves utilizing a ligand binding domain (LBD) of a receptor to selectively capture the analyte target specific for that LBD. In one embodiment, the receptor is a protein or polypeptide. The ligand binding domain is allowed to react with a sample and the presence or amount of ligand (i.e., target analyte) bound by the LBD is determined. Suitable analytes include soluble analytes such as hormones, enzymes, lipoproteins, bacterial or viral antigens, immunoglobulines, lymphokines, cytokines, drugs, soluble cancer antigens, and the like. The methods of the present invention can be performed in both liquid-phase and solid-phase.

Abstract: Molecular chemical and/or biological sensors that exhibit a very high density of sensing functionality and which are applicable to a wide variety of different analytes, and enable rapid, convenient and economical detection of analytes are prepared by reacting a dendritic polymer with a diacetylene reagent wherein the diacetylene functional groups are subsequently intramolecularly polymerized to form segments having alternating conjugated double and triple bonds. Sensory groups that can bind with an analyte are bonded to the acetylene monomer units to form molecular sensors that produce observable and measurable color changes when an analyte binds with the sensory groups.

Abstract: The invention concerns a water soluble vinyl membrane-polymer protein amphiphilic complex, characterised in that said vinyl polymer corresponds to formula (I) in which: R1 is a group: COO⊖ M+ M+ being an alkaline cation, COOR7, R7 being a sugar radical; polyoxyalkylene, polyoxyethylene; N-pyrrolidonyl; phenyl sulphonate; CONR8R9, R8 and R9 identical or different being hydrogen atom, a sugar radical, polyoxyalkylene, in particular polyoxyethylene, a zwitterion radical; R4, R5, R6 identical or different are hydrogen atom, or methyl radical; R2 is a COOR12 or CONR13R14 radical, R12 being a linear or branched alkyl or alkylene radical; R13, R14 identical or different have one of the meanings of R12, and moreover one of the two can correspond to hydrogen atom; R3 is a COOR15 or CONR16R17 radical; R15 being a (C1-C5) alkyl radical; R16, R17 having one if the meanings of R15 and moreover one of the two can correspond to hydrogen atom; x, y, z correspond to the respective percentages of units.

Abstract: An immunological latex turbidimetry method for analyzing an antigen or antibody in a sample, comprising steps of:

Abstract: The present invention is to provide calixcrown derivatives of formulae 1 to 3 requisite for the preparation of a self-assembled monolayer as well as a process for the preparation thereof. Further the present invention is to provide a self-assembled monolayer which is produced by immersing a gold substrate or related metal substrate in an organic solution containing said calixcrown derivatives of formulae 1 to 3. Still further the present invention provides a process for fixing a protein monolayer by fixing proteins having molecular weight of not less than 20,000D (20KD) on said self-assembled monolayer.

Abstract: The present invention relates to methods and compositions for the direct detection of analytes using color changes that occur in immobilized biopolymeric material in response to selective binding of analytes to their surface. In particular, the present invention provides methods and compositions related to the encapsulation of biopolymeric material into metal oxide glass using the sol-gel 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 relates to methods for the production of a stable troponin preparation and its use as a calibrator and/or control in immunoassays. The formulation is prepared from mammalian, preferably bovine, heart tissue which provides a calibrator/control composition which remains stable over a long period of time.

Abstract: The invention concerns a method for the immunological determination of an analyte in a sample using magnetic particles coated with the analyte to be determined or analyte-specific bonding partners and directly detectable non-magnetic particles coated with analyte-specific bonding partners or the analyte to be determined or using a non-magnetic substance which is indirectly detectable, and incubation of the reaction mixture. The method is characterized in that the magnetic particles are subsequently separated from the reaction mixture using a magnetic test strip and the analyte concentration is determined directly.

Abstract: Methods, compositions and devices for purifying polypeptides and/or proteins using metal loaded ligand bound membranes by metal ion affinity chromatography are described.

Abstract: The invention provides devices for preparing a reaction substrate for use as an assay device, and methods of using these devices. The devices prepare reaction substrates comprising arrays of biosites bound to reaction substrates. The devices have a plurality of bundled capillary tubes that convey capture probes from a storage area for eventual deposition onto a biosite on a reaction substrate.

Abstract: Disclosed are systems and methods involved in extreme high throughput screening of compounds which have an affinity for a biological target. The system is based on a capillary bundle with two distinguishable ends wherein capillaries on one end are connected to compounds stored in discrete reservoirs and capillaries on the other end are bound and processed to form a two dimensional microarray. A capillary bundle having reaction wells for hybridization and compound reaction in one end of the capillaries is disclosed. The capillaries may be light-conducting. Also disclosed are various methods of identifying a target compound in a liquid using this capillary bundle as well as methods of fabricating the bundle.

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: The present invention relates to methods and compositions for the direct detection of membrane conformational changes through the detection of color changes in biopolymeric materials. In particular, the present invention allows for the direct colorimetric detection of membrane modifying reactions and analytes responsible for such modifications and for the screening of reaction inhibitors.

Abstract: Method for separating and/or screening and/or quantifying one or more infectious compounds (IC) in a biological material, characterised in that a &bgr;2GPLIC complex, chosen from the group comprising a) (&bgr;2GPI)n/IC complexes and b) (&bgr;2GPI)r/nVIC (non viral IC) complexes, is separated and/or screened and/or quantified.

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: Methods for determining whether a feline is infected with feline immunodeficiency virus (“FIV”). The methods involve the use of an antibody-binding composition that includes two enhanced polypeptides, one containing an immunogenic fragment of the FIV gag precursor p55 and the other containing an immunogenic fragment of the FIV env precursor gp130. Also featured are devices for practicing these methods.

Abstract: A method for making an imprint composition capable of capturing a macromolecule of interest, comprising the steps of (a) solidifying a fluidic matrix material capable of retaining shaped cavities when in a solid or semi-solid form in the presence of a template molecule that corresponds to a portion of the macromolecule, thereby yielding a solid or semi-solid matrix material having template molecules entrapped therein; and (b) removing the template molecules from the solid or semi-solid matrix material, yielding an imprint composition capable of capturing the macromolecule.

Abstract: The present invention provides the design, synthesis and characterization of compositions comprising asymmetric bolaamphiphilic lipids that form extended polymeric ribbons and wide sheets. These compositions may be doped, or interspersed, with various compounds to fine-tune the fluidity and rigidity of the bolaamphiphilic lipid composition, and promote other morphologies of the composition, including fluid vesicles and truncated flat sheets. Upon an increase in pH these compositions undergo a calorimetric and morphological transformation.

Abstract: The present invention relates to methods of screening libraries of small molecules such as combinatorial chemical libraries of organic molecules, including peptides and other chemical libraries, for binding to target molecules, using fluoroscence-activated cell sorting (FACS) machines.

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: Provided are a monoclonal antibody making it possible to detect a native fibrin monomer, which is produced at the initial state of blood coagulation, and soluble fibrin; a hybridoma; and an immunoassay for detecting the initial stage of blood coagulation with high sensitivity, quickly, using the monoclonal antibody. Using a fibrinogen analog in blood as an immune source, cell fusion is carried out to prepare a monoclonal antibody which is not reactive with fibrinogen and is specifically and simultaneously reactive with a native fibrin monomer (that is, a fibrin monomer which is present in a body fluid, in particular in blood, and is not solubilized) and soluble fibrin. The fibrin monomer analog is preferably fibrinogen treated with bathroxobin, which is a snake venom.

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: The invention discloses a method for detecting and/or quantifying a hapten in a homogeneous phase, comprising the following steps: adding a known quantity of a hapten inhibitor complex to the solution containing the hapten to be detected and/or quantified; adding to the solution a quantity of antibodies corresponding to the quantity of the hapten/inhibitor complex; adding to the solution a type C &bgr;-lactamase having an active site for two substrates in antigenic competition in the said active site, the first substrate being a reporter substrate capable of being transformed into a detectable and/or quantifiable product, preferably by visible UV radiation measurement, the second substrate being the hapten/inhibitor complex acting on the hydrolysis rate of the reporter substrate; detecting and/or quantifying the concentration of the product resulting from the transformation of the reporter substrate, the Km constant of the reporter substrate being at least a hundred times higher than the Km constant of the ha

Abstract: This invention provides a novel device and method for preparing cytology slides. The device comprises a book-like form including an absorbent material and filter attached to the inside surface of a front cover and a cytology slide removeably attached to an inside surface of a back cover. A sample is removed from the body of a patient, placed in a liquid-based solution, and then on the filter. When the book-like form is closed, the sample is effectively transferred to the slide.

Abstract: This invention provides devices that are useful for applying a magnetic field to a microtiter plate. The devices find use, for example, in the removal of magnetic particles from an aqueous suspension.

Abstract: Devices, processes and compositions are provided for effective separation of cells from a mixture of cells, where depletion or positive selection may be employed to provide a cellular population of interest. Of particular utility is the separation of cells from peripheral blood mononuclear cells, where members of the lymphoid or myeloid lineages may be isolated and used for research, diagnosis or therapy. Also of interest are cellular separation from bone marrow, tumor suspensions or lymphoid tissue suspensions, where cells can be isolated and used for a variety of purposes. The separated cells may be homogeneous, free of exogenous biologicals, viable, capable of replication and exhibit their full complement of biological activities. Multiple phenotypes can be captured simultaneously. Captured cells can be specifically activated with cytokines and antigens to provide cells which are MHC restricted and have antigen-specific effector functions.

Abstract: The invention relates to a novel competitive or non-competitive immunoassay comprising the steps of immobilizing an assay specific component on a solid phase in a reaction well, adding a labelled assay specific component, drying said components, adding the sample containing the marker to be analyzed, allowing the marker to react with the assay specific components, and detecting the signal from the label. Furthermore, the invention relates to a device useful in carrying out the novel assay.

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 method of measuring the amount of cyclosporin in a sample suspected of containing cyclosporin is disclosed. A method of inactivating interfering cross-reactive material in an assay for measuring the amount of cyclosporin in a sample suspected of containing cyclosporin is also disclosed. Compositions wherein cyclosporin is conjugated to an immunogenic carrier or a label, optionally through a linking group, at an alanine nitrogen atom of the cyclic backbone of cyclosporin are also disclosed. Compositions wherein atiocyclosporin is conjugated, optionally through a linking group, to an immunogenic carrier or a label are also disclosed. Where cyclosporin is conjugated to an immunogenic carrier, the conjugates may be used as immunogens for the preparation of antibodies which are capable of recognizing cyclosporin.

Abstract: The present invention relates to devices and methods for detecting cellular products, and in particular for measuring secreted cellular products, including cytokines. Microwells comprising hydrophobic membranes are described having greater capability to detect cytokines from individual cells in a mixture of heterogeneous cells.

Abstract: New surfaces for solid phase chemistry applications are disclosed, specifically plastics surfaces modified by graft polymerization for use in chemical synthesis and/or immobilization of chemical entities and/or compounds. In particular, an activated modular grafted polymeric surface is disclosed which is suitable for use as a reagent for solid phase organic synthesis, or as a reagent for the affinity capture, presentation or preparation of biomolecules such as proteins, oligonucleotides, nucleic acids, peptides, and lectins. The grafted polymeric surfaces are particularly useful as scavenger reagents in combinatorial synthetic protocols, and as affinity reagents in protein purification and proteomics.

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: The blood filter cartridge which can collect a minor component of blood efficiently in a high concentration comprises a blood filtering material and a holder containing the blood filtering material and having a blood inlet and a filtrate outlet, wherein an antibody or an antigen is immobilized on at least a part from the blood inlet to the filtrate outlet or a filtrate receiver.

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

Abstract: A separation medium having a base matrix and matrix-bound groups which exhibit recombinant Protein A containing a cysteine. The groups are of formula: —B—X—rProtein A-cys where B is a bridge which binds to the base matrix and X includes a heteroatom N or S from rProtein A-cys. In a preferred embodiment X is a thioether sulphur and/or a secondary amine (—NH—). An alternative embodiment features a variant of Protein A in which the C-terminal residue is cysteine.

Abstract: A method of making a molecularly imprinted porous structure makes use of a surfactant analog of the molecule to be imprinted that has the imprint molecule portion serving as the surfactant headgroup. The surfactant analog is allowed to self-assemble in a mixture to create at least one supramolecular structure having exposed imprint groups. The imprinted porous structure is formed by adding reactive monomers to the mixture and allowing the monomers to polymerize, with the supramolecular structure serving as a template. The resulting solid structure has a shape that is complementary to the shape of the supramolecular structure and has cavities that are the mirror image of the imprint group. Similarly, molecularly imprinted particles may be made by using the surfactant to create a water-in-oil microemulsion wherein the imprint groups are exposed to the water phase.

Abstract: A lipid bilayer with affinity to an analyte, which directly signals binding by a changes in the light absorption spectra. This novel assay means and method has special applications in the drug development and medical testing fields. Using a spectrometer, the system is easily automated, and a multiple well embodiment allows inexpensive screening and sequential testing. This invention also has applications in industry for feedstock and effluent monitoring.

Abstract: A method for single well addressability in a sample processor with row and column feeds. A sample processor or chip has a matrix of reservoirs or wells arranged in columns and rows. Pressure or electrical pumping is utilized to fill the wells with materials. In a preferred embodiment, single well addressability is achieved by deprotecting a single column (row) and coupling each transverse row (column) independently. After the coupling step, the next column (row) is deprotected and then coupling via rows (columns) is performed. Each well can have a unique coupling event. In other embodiments, the chemical events could include, for example, oxidation, reduction or cell lysis.

Abstract: A method of immobilizing aminated DNA to a substrate surface is provided for use in DNA hybridization assays. The surface can be widely employed in a variety of molded laboratory products including multiwell plates, cell culture dishes, and biological containers. The method comprises the steps of providing a polystyrene substrate having a surface content of between 0.3 and 4.0% atomic percent oxygen, and attaching amine modified oligonucleotide to the surface of the substrate. A resultant product comprising a polystyrene substrate having a surface oxygen content of between 0.3 and 4.0% atomic percent, and a plurality of amine modified oligonucleotides directly attached to the surface of the substrate, is also disclosed.

Abstract: Methods of detecting and quantifying genomic nucliec acid molecule sequences are provided using the simultaneous amplification of a plurality of discrete nanoliter-sized samples. A miniaturized closed assembly is also provided for carrying out amplification of a nucleic acid molecule by polymerase chain reaction in multiple nanoliter-sized samples. Methods of filling miniaturized sample chambers are also provided as are methods for determining the number of template molecules in a sample by conducting replicate nucleic acid sequence amplification reactions on a set of terminally diluted samples and counting the number of positive amplification reactions. The methods can be used to detect a single starting nucleic acid target molecule.

Abstract: Photocurable and photopatternable compositions are disclosed which comprise a) at least one copolymer derived from 1 to 99 parts by weight of at least one azlactone-functional monomer and 0 to 99 parts of at least one co-monomer; and b) at least one photocrosslinker. Articles are disclosed comprising a substrate and a gel layer of the cured composition which may be photopatterned with high resolution and used to bind biomolecules to the substrate.

Abstract: A method and library for determining the sequence of monomers in a polymer which is complementary to a receptor. The method provides for formation of pooled (6) and separate (10, 12) products. Separate products are subjected only to subsequent pooled coupling steps. Each pooled product is subsequently divided for formation of pooled and separate products. The resulting polymer library includes groups of polymer products. A first group of products (42) is used to identify the monomer at a first location in a polymer that is complementary to a receptor. A second group of products (44) is used to identify the monomer at a second location in a polymer that is complementary to a receptor.

Abstract: The present invention provides internally calibrated competitive assays for use on a solid support. Additionally, the invention provides a method of using such assays.

Abstract: Compounds and methods are provided for use in purification of CD34+ cells and specific surface antigens thereof. The present invention discloses methods for releasing CD34+ cells, as well as compounds having a carbohydrate epitope of the CD34 surface antigen, from an affinity matrix, using carbohydrates having the structure: Neu5Ac&agr;2-3Gal&bgr;1-4(X) wherein (X) is GlcNAc, or a monosaccharide or a cyclohexane derivative that is structurally similar to GlcNAc.