Abstract: Compositions and methods are disclosed which enhance the microscopic observation and analysis of biological entities such as cells, bacteria and viruses by eliminating interfering magnetic clusters created by naturally occurring aggregators of colloidal magnetic particles. Additionally means for significantly enhancing the magnetic isolation of low antigen density target cells from biological samples are disclosed.

Abstract: Compositions and methods are disclosed which enhance the microscopic observation and analysis of biological entities such as cells, bacteria and viruses by eliminating interfering magnetic clusters created by naturally occurring aggregators of colloidal magnetic particles. Additionally means for significantly enhancing the magnetic isolation of low antigen density target cells from biological samples are disclosed.

Abstract: This invention relates to a method for establishing and using a decision marker by which positive samples can be discriminated from negative samples. The method employs the analysis of multiple samples from confirmed positive and negative samples. A fluorescence channel is selected so that the desired sensitivity and specificity are achieved. A microparticle having this fluorescence channel then is made and is used in conjunction with a fluorescence marker which is specific for the population of interest.

Abstract: Methods of detecting antibodies to one or more glycosphingolipid(s) of interest in a sample are disclosed which comprise using a solid-phase reactant having carbonyl groups attached thereon, and the glycosphingolipid(s) of interest linked to the solid-phase reactant by an amide bond between an amino group of the glycosphingolipid of interest and a carbonyl group attached to the solid-phase reactant. The methods of detecting antibodies to glycosphingolipid(s) of interest can be used in methods of diagnosing autoimmune diseases in an individual.

Abstract: A method for detecting reducing sugars in samples using a test reagent containing an indicator capable of producing calorimetric changes when contacted with reducing sugars. Under alkaline conditions, reducing sugars present in a sample affect a reduction of the indicator to a colorless or differently colored reduced form. The method may include the additional step of pretreating the sample with a glycosidase to convert non-reducing sugars to reducing sugars.

Abstract: pK-matched buffers, each containing two effective buffering components: one weak base and one weak acid which have similar pKa at 25° C. (within 0.3 pK units On agarose gels, the buffers in various concentrations were tested for separation of double-stranded DNA fragments with various DNA markers, agarose gel concentrations, and field strengths. Mobility was inversely proportional to the logarithm of molecular weight. The buffers provided high resolution without smearing at more dilute concentration than is possible with standard TAE (Tris/Acetate, pH 8.0) or TBE (Tris/Borate, pH 8.3) buffers. The buffers were also tested in 7M urea denaturing LongRanger™ sequencing gels and in non-denaturing polyacrylamide SSCP gels. The pK-matched buffers provide good separation and high resolution, at a broad range of potential pH values.

Abstract: The invention relates to human procalcitonin and the preparation and use thereof. In particular, a process for preparing human procalcitonin is described wherein a gene coding for a polypeptide comprising the amino acid sequence of human procalcitonin is inserted into a vector; a host organism is transformed with this gene-containing vector; and the polypeptide expressed by the host organism is isolated. Furthermore the use of the polypeptides according to the invention, in particular as medicaments and diagnostic agents is described.

Abstract: The present invention relates to male infertility, and in particular to assays for predicting fertility in animals including human and bovines. In some embodiments, semen samples are evaluated by measuring the amount of ubiquitin in the sample, and in particular by measuring the extent of ubiquitination spermatozoa. Increased levels of ubiquitination in a sample are correlated with lower fertility. Ubiquitination may be assayed by several methods, including immunocytochemical measurement, ELISA, and flow cytometry.

Abstract: The invention relates to methods, compositions, kits, and devices for detecting cardiac ischemia, hypoxia, or other causes of heart failure in a mammal by obtaining a test sample from a mammal, measuring a level of a non-polypeptidic cardiac marker in the test sample, and determining if the level of the cardiac marker measured in said test sample correlates with cardiac ischemia or hypoxia or another form of heart failure.

Abstract: The invention relates to methods, compositions, kits, and devices for detecting cardiac ischemia, hypoxia, or other causes of heart failure in a mammal by obtaining a test sample from a mammal, measuring a level of a non-polypeptidic cardiac marker in the test sample, and determining if the level of the cardiac marker measured in said test sample correlates with cardiac ischemia or hypoxia or another form of heart failure.

Abstract: Disclosed is a method of selecting analgesic agents based on their selective ability to block tetrodotoxin-insensitive sodium channels, particularly in comparison to blocking tetrodotoxin-sensitive sodium channels. Also disclosed is a novel class of compounds that is selective for blocking tetrodotoxin-insensitive sodium channels.

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

Abstract: A method having clinically sufficient degree of diagnostic accuracy for detecting the presence of coronary artery disease in a human patient from the general population and for distinguishing between the stages of the disease in that patient is disclosed. The stages are, first, the non-acute stage, which is either asymptomatic coronary artery disease or stable angina, second, the acute stage known as unstable angina, and, third, the acute stage known as acute myocardial infarction. The diseased state (as opposed to the non-diseased state) is indicated by the clinically significant presence of a first marker in a sample from the patient. The presence of one of the two acute stages, unstable angina or acute myocardial infarction, is indicated by the clinically significant presence of a second marker in a sample from the patient. The presence of the more severe acute stage known as acute myocardial infarction is indicated by the clinically significant presence of a third marker in a sample from the patient.

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: Calibration of an assay by converting an analyzer's normal signal response through an arithmetic function prior to performing the curve fit, thereby improving the accuracy of the curve fit in a region of greatest diagnostic interest.

Abstract: The present invention relates to an ELISA diagnostic kit for the assay of A. pleuropneumoniae serotypes 5a and 5b antibodies in the serum of pigs comprising in separate packaging, at least one of the following: a) a plate or solid support having bound thereto a purified lipopolysaccharide A. pleuropneumoniae serotype 5 antigen for a specific binding to anti-A. pleuropneumoniae serotypes 5a or 5b antibodies present in the serum of pigs; b) serum from pigs experimentally inoculated with a strain of A. pleuropneumoniae serotypes 5 to serve as a positive control; c) pig serum from A. pleuropneumoniae free herd to serve as a negative control; and d) a detectably labeled conjugate which bind to pigs antibodies bound to the plate of a).

Abstract: The use of calcium salts, magnesium salts or combination thereof in immunochemical methods for the determination of an analyte in a sample. These salts increase the specificity of such determinations, in particular, the background signal being reduced by addition of these salts in solid phase immunochemical methods.

Abstract: The invention relates in part to the use of independent assay controls (IACs) for the optical communication between an assay device and an instrument in monitoring and performing assays, preferably immunoassays.

Abstract: The present invention relates to stable compositions useful as primary standards and calibrators and controls comprising a cardiac troponin I (cTnI) such as native, recombinant, addition and deletion forms thereof, whether or not complexed with other troponin subunits such as TnC and/or TnT, in an inactivated human serum. The compositions are obtained by incubating troponin complexes with human serum. The compositions are characterized by an immunodetectability ratio of epitopes on the N-terminal segment to epitopes on the C-terminal segment substantially equivalent to that of pooled, fresh serum from acute myocardial infarction patients.

Abstract: This invention provides different compositions extracted from Ginkgo biloba leaves. Said compositions comprise new active components. This invention also provides a method of preparation of the compositions and individual components of said compositions. Finally, this invention provides various uses of this composition.

Abstract: Methods of grading tumors and prognosticating survival rates of cancer patients by determination of p27 expression levels in tissues samples from tumors are provided.

Abstract: The invention provides a Daphnia reproductive bioassay for detecting and confirming the presence of a toxic substance in an aqueous sample, and/or for screening the substance as an endocrine disrupter. According to the assay, a test sample is brought into contact with adult, oviporous Daphnia of a single clone under conditions of crowding and growth conditions to stimulate sexual reproduction and the production of males. The bioassay is based upon the measurement of endpoints that convey quantitative information about the biological activity of the substance: survivorship, numbers of female offspring, numbers of male offspring, number of resting eggs, number of offspring that display developmental deformities or behavioral abnormalities, and nutritional status of the offspring. Also provided are kits for use in conducting the bioassay.

Abstract: The invention disclosed herein relates to a method of monitoring bone metabolism comprising continuously collecting a sweat sample from a subject and assaying the sweat sample to determine the concentration of a marker of bone metabolism in the sample, wherein said marker is not pyridinoline or deoxypyridinoline.

Abstract: The invention relates to the use of a serum rich in factor Va for the preparation of compositions useful as pathological controls or calibrants in methods for analyzing resistance to activated protein C (APC), as well as said compositions, the method for their preparation and a method for the detection of resistance to activated protein C.

Abstract: Methods of detecting antibody to GM1 ganglioside in a sample, comprising covalent linkage of GM1 ganglioside to a solid-phase reactant, are disclosed. The methods of detecting antibody to GM1 ganglioside can be used in methods of diagnosing motor neuropathies, such as multifocal motor neuropathy or immune-mediated motor neuropathy, in an individual. The amount of antibody specific to GM1 ganglioside in a test sample from a individual is measured; a titer of antibody to GM1 ganglioside that is greater than 1,800 is indicative of disease.

Abstract: A process is provided for the detection and identification of human antibody types which are specific for antigens such as platelet glycoproteins and Human Leukocyte Antigen (HLA). The process aids in detecting and identifying antibody types from a patient sample which are specific for a plurality of known glycoprotein types attached to a solid support, each glycoprotein type unique from each other and separated from each other.

Abstract: A method of assay for a ligand in a sample is described in which calibration occurs within the assay. This is achieved utilizing a measurement region and one or more calibration regions. In at least one of the calibration regions a non-zero signal results, either because of the presence of a calibration reagent or as a result of a binding reaction analogous to that which takes place in the measurement region.

Abstract: A reagent composition comprising (a) liposomes encapsulating a marker therein, immobilizing a hapten on liposome membranes and having a size in the range of 100 to 500 nm in terms of mean particle size plus twice the standard derivation, and (b) an antibody to the hapten is effective for measuring human complement activity easily and precisely with excellent storage stability.

Abstract: This invention provides a novel process of using magnetically responsive fluorescent polymer particles comprising polymeric core particles coated evenly with a layer of polymer containing magnetically responsive metal oxide as highly sensitive quantitative reagents for biochemical and immunological studies, wherein the fluorescent magnetic particles can serve as a marker for the number of particles. A wide variety of polymeric particles with sizes ranging from 1 to 100 microns can be used a core particles and transformed into magnetically responsive polymer particles. The surface of these magnetically responsive polymer particles can be coated further with another layer of functionalized polymer.

Abstract: Compositions and methods for avidin or protein having affinity for biotin immobilized on an inert support material, e.g., agarose, are disclosed. The compositions have high activity levels for binding biotin and may include a bulking agent, e.g., maltose, and a protectant to maintain the stability and integrity of the composition during lyophilization and terminal sterilization processes. The compositions have applicability in any instance where avidin agarose and/or the avidin/biotin technology are useful. In particular, the present compositions are useful in an enzyme capture system to prepare fibrin monomers useful for fibrin sealants.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: Assay methods for performing non-competitive ligand-receptor assays, where said assays provide a sensible result when the target ligand identified by the assay is present at a concentration greater than a defined threshold concentration. The threshold concentration can be selected to be the upper limit of a normal range of values for a target ligand in a sample, so that an assay in accordance with the invention provides a sensible result only when the target ligand is present at elevated levels.

Abstract: The invention provides a 6-day Daphnia reproductive bioassay for detecting and confirming the presence of a toxic substance in an aqueous sample, and/or for screening the substance as an endocrine disrupter. According to the assay, a test sample is brought into contact with at least three adult, oviporous Daphnia of a single clone under conditions of crowding and suboptimal growth conditions to cause stress and stimulate sexual reproduction. The preferred clone for use in the assay is Daphnia galeata-mendotae Wingra clone CDF-1. The bioassay is based upon the measurement of five endpoints that convey quantitative information about the biological activity of the substance: survivorship, numbers of female offspring, numbers of male offspring, number of resting eggs, and number of offspring that display developmental deformities. Also provided are kits for use in conducting the bioassay.

Abstract: Methods for screening individuals for Alzheimer's disease are disclosed. Also disclosed are antibodies that immunochemically react with the isoforms of calcium-activated neutral proteinases which are characteristic of Alzheimer's disease. Also disclosed are methods for screening drugs which are useful in treating or preventing Alzheimer's disease.

Abstract: A conjugate consisting of a sequence of the analyte and an antibody against one of the antibodies used in the test can be employed, in aqueous solution and in precisely known quantity, as a stable calibrator in a sandwich immunoassay for detecting the analyte.

Abstract: The invention relates to an artificial positive control reagents based on antibody conjugates that are used in immunochemical detection methods and to processes for the preparation of these reagents.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: A method of inhibiting proteolytic degradation of a thermally-stable intracellular protein is described. The method involves adding 1 or more denaturing agents to a sample which contains the protease and the protein of interest and heating the resulting solution at a temperature and for period of time sufficient to denature the protease. The method optionally includes a step for lysing the cell if the protein of interest is contained in a cell in order to release said protein. Additionally, a method of determining Mx protein induced by interferon in a blood sample is described. The method involves adding to a blood sample a lysing agent, a denaturing agent, and a detergent selected to solubilize Mx protein. The sample containing Mx protein is then heated at a temperature of from about 50.degree. C. to about 60.degree. C. for a period of time of from about 1 minute to about 30 minutes, and the Mx protein in the solution then is determined.

Abstract: A conjugate of at least two binding sites that bind specifically to the analyte-specific binding region of the receptor that is used for detection in a test, wherein the binding sites are linked by at least one soluble carrier substance and the conjugate is a product of a synthetic or recombinant production, dissolved in an aqueous solution in an exactly known amount is particularly suitable as a stable calibrator in a test for the detection of an analyte.

Abstract: Compounds having detergent properties are disclosed. When a modifying reagent is brought into contact with these compounds, the detergent properties are decreased. These compounds are useful, for example, as solubilizing agents for microbial antigens and/or antibodies and for reversibly wetting hydrophobic surfaces. Accordingly, methods are disclosed for increasing the hydrophilic properties of a material, such as a microbial antigen and/or antibody, the methods generally comprising the steps of contacting the material with the compound having detergent properties and a modifiable group, and modifying the compound with a modifying reagent. Kits are also disclosed for use in accordance with this methodology.

Abstract: The present invention relates to a method for quantitatively determining ionized calcium in a sample by using a phospholipase, which comprises carrying out an enzyme reaction with the phospholipase in a buffer comprising a nitrogen heterocycle-binding sulfonic acid having a pK ranging 6.6 to 7.6 or a salt thereof.According to the method of the invention, the amount of ionized calcium in a sample, such as serum, can be accurately determined.

Abstract: A method for calibrating a flow cytometer or fluorescence microscope and for quantitating binding proteins, such as antibodies. Populations of microbeads are provided which are in equilibrium with a saturating amount of fluorescently-labeled protein. The microbeads may have an incorporated fluorescent dye which has a strong signal in a selected channel of a flow cytometer, but no signal in other channels.

Abstract: Ligands that interact with a target can be more easily identified if false positive interactions (either specific or non-specific) from the detecting system are differentiated from the target-specific interaction. An improved method of identifying peptides which bind with a target protein is presented. The steps are: binding a random library of peptides to a support material, allowing detection reagents to contact the peptides and the support material then identifying these interactions, then allowing the target protein to selectively bind to the peptides, allowing detection reagents to contact the bound target protein, and characterizing the peptide bound to the identified support material. Interaction of a ligand or the support material with the detection reagents will cause a distinct color change which distinguishes those ligands which selectively bind to target protein. The characterized peptide can then be used in affinity purification of the target protein.

Abstract: A stabilized liquid standard solution for use in calibrating assays of thyroid function containing albumin and known amounts of at least two analytes selected from a group consisting of total thyroxine, free thyroxine, total triiodothyronine, and free triiodothyronine, and optionally, thyroid stimulating hormone.

Abstract: One sigmoid calibration curve is split into three parts of low concentration region represented by a high degree function, intermediate concentration region represented by an exponential function and high concentration region represented by a high degree function according to the present invention. The boundary condition of the adjacent two functions is set so that the two functions have an equal slope at the boundary point; thereby, regression functions of the calibration curves in respective regions are found. The number of standard samples for finding a calibration curve can be reduced while the calibration curve found is of high accuracy.

Abstract: An immunoassay directed at certain analytes that are polyaromatic hydrocarbons, such that the immunoreactive standard used for assay calibration allows the creation of calibration solutions of superior stability.

Abstract: The invention relates to a composition comprising among others a fibrinopeptide A releasing compound. Furthermore the invention relates to the use of the composition as calibrator in plasma containing fibrinogen. A test kit comprising the said composition and a method to determine soluble fibrin also belong to the invention.

Abstract: The invention is directed to methods and kits for detecting and measuring the presence or absence of perinuclear anti-neutrophil cytoplasmic autoantibody of ulcerative colitis or primary sclerosing cholangitis. The methods and kits of the present invention provide safe and reliable means for diagnosing ulcerative colitis and primary sclerosing cholangitis. The antigens reactive with perinuclear anti-neutrophil cytoplasmic autoantibody of ulcerative colitis and primary sclerosing cholangitis are also provided.

Abstract: .[.There is disclosed an aqueous dispersed solution as a standard solution for determining lipid levels, having a dispersion form and a particle size, which are similar to those of serum lipids. A lipid-dispersed solution is obtained by evaporating an organic solvent from a mixture prepared by adding cholesterol, a phospholipid, a bile acid or bile acid salt, and a neutral lipid and/or a cholesterol ester in the organic solvent, swelling the resultant thin-film like mixture with water or buffer heated at a temperature higher than a phase transition temperature of the lecithin, and then dispersing the solution by a physical shear force. There can be easily obtained a solution having a cholesterol concentration of about less than 1,000 mg/dl, which is extremely stable and can be stored for a long period of time..]. .Iadd.There is disclosed an aqueous dispersed solution as a standard solution for determining lipid levels, having a dispersion form and a particle size, which are similar to those of serum lipids.