Abstract: Chemical entities that are novel compounds, pharmaceutical compositions and methods of treatment of cancer are described.

Abstract: The present invention provides a new method for isolation and/or purification of immunoglobulins from a solution containing one or more immunoglobulins using a solid phase matrix represented by the formula: M-SP-L, wherein M is designates a matrix backbone, SP designates a spacer and L designates a substituted benzimidazole ligand.

Abstract: The present invention provides method and compositions for detecting target molecules present on cells and tissues. In particular, the methods involve adding primary antibodies such as scFv-targeted lactamase that are directed against a target of interest (e.g., cancer markers) to a tissue sample, followed by adding a lactam-containing compound and finally a lactamase reporter system. In some preferred embodiments, the lactamase reporters are fluorescent reporters that bind to the test tissue. In some particularly preferred embodiments, the test tissue contains at least once cancer cell and/or at least one cancer-associated marker.

Abstract: The inventions provides a method for immunologically determining a keratan sulfate level which method includes bringing an anti-keratan sulfate monoclonal antibody into contact with a biological sample, the anti-keratan sulfate monoclonal antibody exhibiting a relative reaction specificity between keratan sulfate-I and keratan sulfate-II represented by IC50KS-I/KS-II of 0.4 to 5, to thereby provide a signal; and detecting keratan sulfate contained in the biological sample from the signal. On the basis of the method, the invention also provides a joint disease detection method and a method for assessing the effect of a remedy for a joint disease and a candidate substance therefor. Through these methods, a very small amount of keratan sulfate contained in a sample, can be determined. Particularly, these methods can determine, at high-sensitivity and high-specificity, the total keratan sulfate including keratan sulfate-I, which have been difficult to determine through a conventional technique.

Abstract: A method and device for detecting analytes in a test sample. Embodiments include methods for quantitatively detecting analytes within a range of concentrations. In an embodiment the method includes a lateral flow test strip with multiple test areas for capturing a labeled receptor to provide a detectable signal.

Abstract: The present inventors screened peptides having a specific sequence specifically binding to amyloid-beta antibody and accordingly confirmed that A?22(pE)-42 peptide showed higher reactivity to amyloid-beta antibody in serum of Alzheimer's disease patients. Therefore, the said A?22(pE)-42 peptide can be used as an active ingredient for the kit for diagnosing dementia and thus it can be said that the peptide can be effectively used for the diagnosis of dementia whose early diagnosis is hardly possible.

Abstract: This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: The present invention relates to methods and devices for detecting biological entities and components associated with hypersensitivity reactions in patients with allergies, cancer or autoimmune disease. Specifically, the assays of the invention are capable of qualitatively and/or quantitatively detecting allergen specific immunocomplexes by assaying for immobilized C3b in a biological sample produced as a result of exposure to food.

Abstract: The present invention discloses a method of purifying bivalent antibodies or antibody fragments that are active at both Fab sites from a source of antibodies or antibody fragments using a non-chromatographic method that includes inducing the formation of cyclic immunoglobulin aggregates by addition of multivalent hapten to a salt solution of soluble antibodies or antibody fragments, wherein the multivalent hapten possesses a linker between the two haptens effective to prevent the binding of both haptens of the ligand to the same antibody or antibody fragment.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: A process for the detection of antibodies in a test sample by preparing a suspension of erythrocytes with a test serum or plasma by mixing a test serum or plasma with erythrocytes; incubating the suspension of erythrocytes at a temperature of from 37° C. to 45° C. to bind any antibodies in the test serum or plasma to the surface of said erythrocytes; combining the suspension of erythrocytes with an amount of a solution of a macromolecule which is effective to agglutinate the erythrocytes; packing the resultant red cell agglutinates by centrifuging the suspension of erythrocytes; and, determining the presence of anti-erythrocyte antibodies by observing if antibody-dependent erythrocyte agglutination has occurred.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: This invention provides a method to detect analyte which comprises preparing fine particles which have a chargeable group in their core and a hydrophilic polymer chain in their shell; obtaining an agglutinated matter by forming a biologically specific bond between a specific residue on the surface of fine particles and analyte, and by simultaneously forming a bond by the electrostatic interaction between impure protein and said particles; and subsequently cleaving only the latter bond by raising ionic intensity. Thus, this invention provides a method to detect analyte with rapidity and high sensitivity with use of agglutination reaction.

Abstract: The present invention provides a method for detecting the presence or amount of an analyte in a sample, said method comprising: a porous surface to which particles having attached thereto a binding substance, analyte and binding substance coated label particles are added. If said analyte is present in the sample an immuno- or chemical reaction occurs in the liquid phase. The separation of bound complex from unbound material is achieved by using said surface where the separation occurs mainly two dimensionally on the surface of the porous surface (e.g. grid). Interestingly, the disclosed surface enables a separation where said complexes are distributed two dimensionally on the porous surface (e.g. grid), whereas unbound materials are distributed three dimensionally. Accordingly, said surface enables both a two and a three dimensional separation.

Abstract: A latex reagent for analyzing adiponectin, comprising a suspension of latex particles carrying a substance which specifically binds to adiponectin, is disclosed. Further, a method for analyzing adiponectin, comprising (1) obtaining a biological liquid possibly containing adiponectin, and (2) bringing the biological liquid, while maintaining the state in which the biological liquid is obtained, into contact with a suspension of latex particles carrying a substance which specifically binds to adiponectin, and optically analyzing a degree of latex-particles-agglutination, is disclosed. According to the latex reagent and the method for analyzing adiponectin, a predilution or pretreatment of the biological liquid to be analyzed is not necessary. Further, the analysis can be performed rapidly and conveniently, and facilities therefor are not limited.

Abstract: An analytical test element for blood analyses is provided having an application site and a microfluidic channel structure in fluid communication with the application site. The channel structure includes at least first and second analytical channels for receiving first and second portions of a blood sample applied to the application site. The first analytical channel includes a first analytical site to determine the total haemoglobin value (Hb) of the blood sample. The second analytical channel includes a second analytical site to determine a glycohaemoglobin value (HbA1c) of the blood sample.

Abstract: Bioelastomers are disclosed for use in methods of binding compounds including immunoassay methods, in biosensors and methods or regenerating biosensors, and in methods for targeting the delivery of a compound to a particular location within an animal subjects. In general, the bioelastomer is conjugated to a binding compound, which is in turn used to bind a compound of interest. For targeted compound delivery, the bioelastomer is conjugated to the compound to be delivered.

Abstract: The invention is directed to a method of detecting gluten-induced diseases such as e.g. celiac disease and dermatitis herpetiformis. Said diseases are indicated by the presence of autoantibodies against tissue transglutaminase tTG in the blood The test is carried out on a whole blood sample using tTG liberated from the red blood cells of the blood sample as an autoantigen. The liberated autoantigens react with the autoantibodies in the sample and form antigen-antibody complexes, which are detected. The presence of such complexes indicates the disease. The invention is also directed to the use of the autoantigen in a test and to a test-kit.

Abstract: We disclose methods of sorting or separating mixtures of living cells (e.g., eukaryotic, prokaryotic, mammalian, pathogenic, bacterial, viral, etc.). We perform our methods by activating cell-selective photophoric labels, which photosensitize and chemically reduce a photosensitive metal compound to form metal grains, particles or crystals. The metal adheres to the cells and forms the basis for sorting or separating different cell types. Photophoric labels may include chemiluminescent agents such as peroxidase enzymes activated with peroxidase substrates capable of luminescence. Photosensitive metal compounds may be present in a light-sensitive matrix or emulsion containing photosensitizable metal compounds, which form metal grains, particles or crystals upon exposure to a developer solution. Developer solutions are formulated to substantially allow living cells to remain viable after exposure to the developing solution.

Abstract: Methods are disclosed which separate and identify lipoproteins in biological samples. An ultracentrifuge density gradient is used to separate lipoprotein fractions. The fractions are visualized, resulting in a lipoprotein profile. The fractions can be further analyzed by a wide array of laboratory and clinical methods. The lipoprotein profile can be used in clinical diagnoses and other medical applications.

Abstract: The immunoassay method of this invention measures the content of a subject substance in a sample. The method includes the steps of: (a) preparing a mixed solution by mixing the sample and an antibody solution including a first monoclonal antibody and a second monoclonal antibody capable of specifically binding to the subject substance; and (b) measuring an optical property of the mixed solution. The first monoclonal antibody is capable of binding to a first epitope of the subject substance, and the second monoclonal antibody is capable of binding to a second epitope of the subject substance different from the first epitope. Each of the first and second epitopes exists singly in the subject substance.

Abstract: A process for isolating and/or identifying at least one active chemical substance from a mixture of active and inactive chemical substances, is characterized by the steps: a) adding a target to said mixture and forming a complex of target and at least one active chemical substance of the mixture, b) separating the complex from the inactive chemical substances of the mixture, and either c) liberating and isolating and/or identifying at least one active chemical substance from the separated complex or d) identifying at least one active chemical substance of the mixture by subtracting from a chromatogram of the mixture of active and inactive chemical substances a chromatogram of the mixture of inactive chemical substances which is obtained after separation of the complex, and possibly liberating and isolating the at least one active substance from the separated complex.

Abstract: The present invention provides an agglutination immunoassay, wherein the agglutination of insoluble carrier particles such as latex are stabilized and uniformized to give good reproducibility, and a reagent therefor. In the agglutination immunoassay which comprises allowing an antigenic substance in a sample to bind to insoluble carrier particles carrying substantially neither antigens nor antibodies thereon, and allowing an antibody or an antibody complex which reacts specifically to the antigenic substance to bind to the antigenic substance to give a selective agglutination of the insoluble carrier particles, a homopolymer prepared by polymerization of a monomer such as 2-methacryloyloxyethyl phosphorylcholine having a phosphorylcholine group and a vinyl group, or a copolymer prepared by polymerization of a monomer having a phosphorylcholine group and a vinyl group, with a monomer having a vinyl group such as n-butyl methacrylate is used.

Abstract: A method of preparing a sample of muscle tissue and of assaying the prepared sample to determine the presence of prions in the sample is disclosed. The muscle tissue is homogenized and mixed with a complexing agent which forms a complex with a higher specific gravity than PrPSc, the complexing agent or other components of the homogenate. Gravity is then used (e.g. ultra centrifugation) to concentrate the complex and the concentrate is assayed to detect prions. The muscle tissue is preferably extracted from a muscle or group of muscles such as hind limb muscle which have a higher or more preferably the highest concentration of prions as compared to other muscle in the mammal.

Abstract: A sample is prepared from blood in a manner which makes it possible to further analyze proteins in the sample, e.g. to detect prions in the sample. Blood is extracted, allowed to clot and subjected to separation processing (e.g. centrifugation) to obtain serum. The serum is treated with a complexing agent which agent binds prions in the sample forming an agent/protein complex which makes it possible to concentrate the complex. Concentration of the complex results in a sample which can be successfully analyzed, e.g. assayed using a range of different types of assay methodologies for detecting prions.

Abstract: This invention relates to methods and kits for measuring ?-amylase activity in grain and plant products such as flour or stock.

Abstract: This invention provides a method for determining the presence of hemolyzed erythrocytes in blood by detecting erythrocyte adenylate kinase in a serum sample from the blood. This invention also provides a method for diagnosing a hemolytic condition in a subject suspected to be suffering from hemolysis, as well as a method for monitoring hemolysis in a subject undergoing treatment for a hemolytic condition.

Abstract: The present invention relates to equine Fc epsilon receptor alpha chain nucleic acid molecules, proteins encoded by such nucleic acid molecules, antibodies raised against such proteins, and inhibitors of such proteins. The present invention also includes methods to detect IgE using such proteins and antibodies. Also included in the present invention are therapeutic compositions comprising such proteins, nucleic acid molecules, antibodies and/or inhibitory compounds as well as the use of such therapeutic compositions to mediate Fc epsilon receptor-mediated biological responses.

Abstract: Reagents and the use of the reagents in a microparticle light scattering agglutination assay are disclosed. The reagents comprise a mixture of particles having relatively stronger light scattering properties and particles having relatively weak light scattering properties with respect to one another. The particles having strong light scattering properties carry a binding partner of high reactivity with the analyte. The particles having weak light scattering properties carry a binding partner of low reactivity with the analyte.

Abstract: Compositions of matter and methods for enhancing bioassay performance are disclosed. More particularly, the composition of matter comprises a molecularly compact polymer-ligand conjugate capable of self-orienting on a surface to improve the orientation of the ligand/receptor binding domains within the bioassay at the nanoscopic level. In a preferred embodiment, the molecularly compact polymer comprises a dendrimer polymer such as a fifth generation polyamidoamine dendrimer having exterior surface hydroxyl and amine functional groups, and the ligand/receptor comprises an antibody or Fab.

Abstract: A colloidal system for detection of a variety of analytes involves techniques which permit reconstitution of a desiccated substance such as for surface enhanced Raman spectroscopic analysis and multiple sensors at once, each having different spectra through the use of markers or the like. Competitive assay techniques and a variety of substances are explained to permit a practical an versatile system which can also be used for immunological assays and can include antibodies tagged to provide spectroscopic indicia.

Abstract: The present disclosure relates to a method for determining cholesterol in low density lipoprotein comprising the steps of (a) measuring total cholesterol level in a sample containing at least high density lipoprotein, low density lipoprotein, very low density lipoprotein and chylomicron, and (b) measuring cholesterol levels in the high density lipoprotein, very low density lipoprotein and chylomicron in the sample, wherein the cholesterol level in the low density lipoprotein is determined by subtracting a value obtained in the step (b) from a value obtained in the step (a). The present invention enables concurrent determination of cholesterol level in low density lipoprotein and total cholesterol level, facilitating acquisition of two types of biological information at a time.

Abstract: Methods are disclosed which separate and identify lipoproteins in biological samples. An ultracentrifuge density gradient is used to separate lipoprotein fractions. The fractions are visualized, resulting in a lipoprotein profile. The fractions can be further analyzed by a wide array of laboratory and clinical methods. The lipoprotein profile can be used in clinical diagnoses and other medical applications.

Abstract: An immunoassay, e.g. ELISA, method and kit for determining (preferably quantitatively) an analyte adsorbed at a surface or present in a liquid sample, comprising binding the analyte to a solid phase, attaching a marker to the analyte, and detecting marker attached to the solid-phase. The invention proposes to use a combination of marker and detection (e.g. an enzyme-substrate combination) which is capable of producing a precipitate on a solid phase which carries the marker and to detect the binding of analyte to the solid phase by in-situ determining the change in surface mass of the solid phase due to the formation of the precipitate. Ellipsometry is an example of a technique suitable for determining the change of surface mass of the solid phase, which could be made of a silicon- or chromium-sputtered glass slide The invention shortens the assay time and/or improves the assay sensitivity, and allows to measure extremely low surface concentrations of analytes of interest.

Abstract: Approaches are described for separating plasma from whole blood samples and include the use of magnetically attractable particles associated with an agglutinating agent. The magnetically attractable particles bind the cellular components in a whole blood sample. Application of a magnetic field gradient to a container with the blood sample and the magnetically attractable particles draws the particles to the surface of the container near the source of the magnetic field gradient. The plasma can be removed and stored or used for monitoring or detecting analytes in the plasma.

Abstract: An immunoassay of a liquid biological specimen for a specific analyte is conducted by forming a test sample by contacting the specimen with: (1) a binding substance of a ligand, antiligand or receptor capable of binding the analyte and (2) a detector substance of a colloidal gold or silver labeled ligand or antiligand to form a test sample. The test sample is applied by flowing onto a defined zone of an insoluble porous support film having a pore size impassable to a complex formed between the analyte, if present, with the binding substance and the detector substance, but passable to the binding substance and detector substance while remaining uncomplexed in the absence of the desired analyte. If the analyte is present in the test specimen, the detector substance binds with the analyte and the binding substance to form a visually inspectable complex on the surface of the porous support film.

Abstract: The present invention is drawn to a novel and newly discovered low molecular weight protein fragments that are degradation products of COMP and have a molecular weight of about 14-33 kilodaltons and polyclonal and monoclonal antibodies to the new COMP fragment and other known COMP fragments of molecular weight 67-80 kDa and 150-250 kDa, and thrombospondin fragments (collectivvly referred to as “ADP”) as well as an assay to measure the level of ADP comprising: (1) incubating a body fluid sample, which has been obtained from an arthritis patient, under reducing or non-reducing conditions; (2) incubating the body fluid sample with an anti-ADP antibody; and (3) measuring the level of bound anti-ADP antibody in the body fluid sample. Also disclosed is an assay to measure the ratio of ADP to KS as a diagnostic measure of arthritic disease.

Abstract: Bioelastomers are disclosed for use in methods of binding compounds including immunoassay methods, in biosensors and methods or regenerating biosensors, and in methods for targeting the delivery of a compound to a particular location within an animal subjects. In general, the bioelastomer is conjugated to a binding compound, which is in turn used to bind a compound of interest. For targeted compound delivery, the bioelastomer is conjugated to the compound to be delivered.

Abstract: Immunoassay methods for measuring the concentration of an analyte in a test specimen are described. The methods use an immunoreagent, where one of the analyte and the immunoreagent is an antigen, and the other of the analyte and the immunoreagent is an antibody which specifically binds to the antigen. An important feature distinguishing these immunoassays over conventional immunoassays is that the standard sample containing a known concentration of analyte is measured in the same reaction vessel as the test specimen containing an unknown amount of analyte.

Abstract: The invention provides isolated nucleic acids molecules, designated Kinase and Phosphatase nucleic acid molecules, which encode novel protein kinase and protein Phosphatase polypeptides. The invention also provides antisense nucleic acid molecules, recombinant expression vectors containing Kinase and Phosphatase nucleic acid molecules, host cells into which the expression vectors have been introduced, and nonhuman transgenic animals in which a Kinase and Phosphatase gene has been introduced or disrupted. The invention still further provides isolated Kinase and Phosphatase proteins, fusion proteins, antigenic peptides and anti-Kinase and Phosphatase antibodies. Diagnostic, screening, and therapeutic methods utilizing compositions of the invention are also provided.

Abstract: An assay device and method are provided which allow the determination of the presence or absence of at least one analyte in a test sample, while providing specific identification of the test subject. The assay device includes a reaction medium having at least one reaction zone and at least one control zone, which is capable of providing a pattern suitable for identifying the test subject. The pattern suitable for identifying the test subject is preferably a fingerprint. In a preferred embodiment of the invention, the reaction zone and the control zone include at least one member of a ligand/receptor pair.

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: The present disclosure relates to a method for determining cholesterol in low density lipoprotein comprising the steps of (a) measuring total cholesterol level in a sample containing at least high density lipoprotein, low density lipoprotein, very low density lipoprotein and chylomicron, and (b) measuring cholesterol levels in the high density lipoprotein, very low density lipoprotein and chylomicron in the sample, wherein the cholesterol level in the low density lipoprotein is determined by subtracting a value obtained in step (b) from a value obtained in step (a). The present invention enables concurrent determination of cholesterol level in low density lipoprotein and total cholesterol level, facilitating acquisition of two types of biological information at a time.

Abstract: Compositions, formulae, devices and methods for the detection of target microorganisms, such as by visual immunoprecipitate assay, enzyme linked immunoassay, chemiluminescence, immunoblotting, or similar detection technology, wherein detection requires the discrimination among closely related genera, species and strains of antigenically related microorganisms based on immunological reactivity of a highly conserved antigen epitopes with a reagent system comprised of an antibody linked to a detecting reagent. The invention permits a detectable event to occur by exposing inaccessible but highly conserved and specific antigen epitopes to the detecting reagent. Exposure of such antigen epitopes without inactivating microbial metabolism allows for specific detection.

Abstract: A generic signaling assay method comprising an affinity matrix for the detection of low molecular weight compositions is provided. A test sample is mixed with a pre-determined amount of a substance conjugated to at least two molecules of the target analyte. When the test sample containing the multiple-analyte conjugated substance is passed over the immunoaffinity column, the antibodies can bind competitively to two species: free analyte and multiple-analyte conjugated substance. The column is then exposed to a second tagged antibody. Upon elution, high label activity is seen in a clean sample. Conversely, only a small amount of the label activity is detected in the eluant of a test sample that is highly contaminated with the free analyte.

Abstract: The present invention relates to an assay apparatus for detecting a product in a sample. The assay apparatus comprises a fluid pathway with an input of the sample and an input for a reagent with a detectable moiety which transports the sample to a detecting means via a barrier arranged to prevent a product-reagent complex passage but allow passage of unbound reagent and sample. The apparatus also includes supply means for supplying a substance adapted to breakdown the complex into a detectable moiety which can flow through the barrier to the detecting means.

Abstract: A apparatus for assaying glycated proteins and other analytes in biological samples such as blood, in which a sample is presented to the apparatus, includes an inlet port between moveable between first and second inlets, such that the inlet can be brought into liquid communication with each inlet in turn. The inlet port accommodates a filter or binder. The apparatus also includes a microprocessor operable via a key pad, at least one light emitter and at least one light detector, a display and driver, and an A to D converter, and is operatively connected to a power source.

Abstract: A microparticle light scattering agglutination assay is disclosed. The assay comprises a mixture of particles having strong light scattering properties with particles having weak light scattering properties. The particles having strong light scattering properties carry a binding partner of high reactivity with the analyte. The particles having weak light scattering properties carry a binding partner of low reactivity with the analyte. Reagents useful in the assay are also disclosed.

Abstract: The invention involves methods for determining analytes, and reagents for use in these methods. The methods and reagents use one or both of a polyvinyl/pyrolidone with a molecular weight of at least 360,000, and a polyethylene glycol with molecular weight of at least 40,000. The assays are carried out nephelometrically, or turbidometrically. The reagents include at least one antibody which binds the analyte. The hook effect is reduced or avoided in the practice of the invention.