Abstract: The purpose of the present invention is to provide a solid-phase carrier on which an IgG-binding peptide is immobilized, the peptide being usable for IgG purification, having resistance to repeated washing with an alkaline solution after IgG purification, and having a high binding affinity for IgG. Specifically, the present invention relates to a solid-phase carrier on which an IgG-binding peptide is immobilized, wherein the two cysteine residues on the outside of the peptide are linked as shown in the following formula: (in the formula, the upper cysteine residue is on the N-terminal side of the peptide, and the lower cysteine residue is on the C-terminal side of the peptide).

Abstract: Processes for quantifying an amount of functional groups immobilized on a solid support are described herein. The processes allow for determining whether sufficient functional groups are provided on a solid support for the attachment of a first binding pair member for the detection of a target analyte.

Abstract: The present invention relates to a method for determining the total amount and/or concentration of an analyte in the presence of a binding molecule as well as kits, compositions and uses relating thereto.

Abstract: The present disclosure relates to an aglycosylated antibody-producing transgenic mouse and the use of an aglycosylated antibody produced therefrom. When the transgenic mouse of the present disclosure is used, it is possible to easily produce aglycosylated antibodies against various target antigens, and to precisely diagnose disease by detecting a glycoprotein biomarker using the produced aglycosylated antibody.

Abstract: The present disclosure relates to protein-polymer conjugates comprising an engineered binding oligomer protein and a polymer for detection of a ligand of interest, methods, compositions and kits thereof.

Abstract: A novel human bladder cancer marker AG-CD71 and a monoclonal antibody ABC71 for preventing AG-CD71 are provided. The human bladder cancer marker AG-CD71 is an abnormal glycosylated transferrin receptor TFRC; the abnormal glycosylated transferrin receptor TFRC refers to the TFRC carrying a saccharide structure Fucal-4(GlcNAcbl-3)[6OSO3]GlcNAc as an epitope. Also provided is an antibody for the human bladder cancer marker AG-CD71; the antibody is the monoclonal antibody ABC71 specific for the human bladder cancer AG-CD71; the monoclonal antibody is secreted from the hybridoma cell strain the preservation number of which is CGMCC No. 14312.

Abstract: Polyacrylamide gels that offer high resolution as electrophoretic media for protein separations and an improved resistance to hydrolysis upon storage are made by including either taurine, asparagine, or both as an ampholyte, in combination with either tris(hydroxymethyl)-aminomethane or bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane as a buffer, plus other conventional components.

Abstract: An object of the present invention is to overcome the problem of nonspecific adsorption of a labeled antibody on the detection site and to provide an immunochromatography method by which the false positive signal can be suppressed, and wherein the detection sensitivity is high and the highly reliable measurement can be performed.

Abstract: We disclose methods for measuring vitamin D metabolite in plasma or serum samples. The methods comprise a step of adding to the plasma or serum samples a non-competitive displacement agent comprising 8-anilino-1-naphthalenesulfonic acid ammonium salt, 3-(acetonylbenzyl)-4-hydroxycoumarin and a water miscible solvent. The non-competitive displacement agent separates vitamin D metabolite from binding proteins in the sample, such that the displaced vitamin D metabolite is available for capture and detection in subsequent binding assays. Thus, our invention finds use in methods of separating and detecting vitamin D metabolites otherwise tightly bound to plasma or serum binding proteins.

Abstract: Improved methods, reagents, and kits for quantitation of HLA-DR and/or CD11b expression on peripheral blood cells are presented. Inclusion of a lysosomotropic amine, such as chloroquine, during staining stabilizes HLA-DR and CD11b expression. Use of a novel anti-CD14 conjugate, anti-CD14-PerCP/CY5.5, permits the ready discrimination of monocytes. The improved methods, reagents, and kits may be used to assess immune competence, and to direct and monitor immunostimulatory therapies in septic patients exhibiting monocyte deactivation.

Abstract: A particle-enhanced assay for determining an analyte in a test sample in which an additive for reducing non-specific particle aggregation is added in an amount to substantially reduce non-specific aggregation. The additive is selected form the group consisting of triethanolamine, trimethanolamine, N-butyldiethanolamine, 3-dimethylamino-2-methylpropyl chloride, N,N-dimethylglycine, N,N-dimethylguanidine, N,N-dimethylglycine ethyl ester, 3-dimethylaminopropionitrile, and N,N-dietylacetamide.

Abstract: This invention relates to preservative solutions for peptides, for example, parathyroid hormone, insulin-like growth factor binding protein 3 (IGFBP3), adrenocorticotropic hormone (ACTH) and mixtures thereof. Preferably, the peptides preserved by the solutions are non-reconstituted. In one embodiment, the preservative solutions comprise a polyvinyl alcohol, EDTA component and molybdic component.

Abstract: A method of treating particles to be used in immunoassays reduces interference in particle agglutination assays. For particles having covalently bound antibodies and residual NHS-ester or sNHS-ester groups on the surface, the reactive esters are treated with an aqueous mixture containing an amine compound of formula (I): H2N—R—X??(I). The moiety —X is —NH2, —OH, or —CO2CH2CH3; and R is an alkyl group or an alkyl ether group. When —X is —NH2 or —CO2CH2CH3, R contains from 1 to 20 carbon atoms; and when —X is —OH, R contains from 4 to 20 carbon atoms.

Abstract: A reagent for use in immunoassays reduces interference in particle agglutination assays. The reagent contains particles having covalently bound antibodies and a tertiary amine compound of formula (I): N(R1—X)(R2—Y)(R3—Z)  (I). The moieties R1, R2, and R3 are independently alkyl or alkyl ether. The moieties X, Y, and Z are independently —OH, —O—R4, —S—R4, —C(═O)—OH, —C(═O)—OR4, or —C(═O)—NHR4 (R4 is alkyl).

Abstract: Aqueous solutions of steroid compounds which have biological activity and have a tendency to oxidative degradation at temperatures between 2 and 8° C. on storage in excess of several months are stabilized by the addition of chelators. Aqueous solutions of particular interest are protein containing solutions which mimic the behavior of human bodily fluids such as serum and are therefore suitable as standards for immunoassays for steroids in such bodily fluids. Chelators of particular interest are transition metal chelators especially those which efficiently sequester iron.

Abstract: Cyanide-free reagents for the determination of hemoglobin and leukocytes present in a blood sample comprise an aqueous solutions of at least one quaternary ammonium salt, preferably selected from the group of alkyltrimethylammonium salts, alkyldimethylbenzylammonium salts or alkylpyridium salts consisting of tetradecyltrimethyl ammonium bromide (TTAB), dodecyltrimethyl ammonium chloride, cetyltrimethyl ammonium bromide, hexadecyltrimethyl ammonium bromide and benzalkonium chlorides, and hydroxylamine salts, especially hydrochloride, sulfate and phosphates and other acid salts. The method involves mixing the reagent with a diluent-diluted blood sample, presenting it to an absorbance spectrophotometer and measuring the resulting optical density as an indicator of hemoglobin concentration. This cyanide-free reagent could be used solely for hemoglobin determinations, or, it can also be used in leukocyte counting and sizing using hematology instrumentation.

Abstract: The present invention relates to a method for the quantitative release of natural or recombinant proteins, polypeptides (thermostable immunoligands) able to bind to the Fc-part of immunoglobulins (antibodies, in particular of the IgG class and primarily becoming bound outside the paratope) from complexes in various sample matrixes in order to make these released natural or recombinant proteins, polypeptides or peptides quantitatively available in immunochemical assays and to keep them quantitatively available. The method is characterized by mixing the sample with reagent compound that is able to bind non-specifically to immunoglobulins, and thereafter subjecting the sample to a heat treatment step followed by a cooling step.

Abstract: An assay element for analyzing a charged analyte employs an immobilized receptor and a material having a net charge which is the same as that of the analyte. In a preferred embodiment, the analyte is an aminoglycoside and the material is a polymer having a net positive charge.

Abstract: A particle-enhanced assay for determining an analyte in a test sample in which an additive for reducing non-specific particle aggregation is added in an amount to substantially reduce non-specific aggregation.

Abstract: Compositions for stabilizing polypeptides or antigens are described. These compositions are useful for stabilizing polypeptides or antigens stored in aqueous formulations. Such formulations can be used for various analytical or other methods.

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: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: Histamine may be quantitatively measured by performing the following steps. First, an oocyte that expresses histamine receptors is held in a recess formed at the bottom of a vessel. Then, first and second electrodes are inserted into the oocyte. Subsequently, the membrane potential of the oocyte is measured by using the first electrode to stabilize this membrane potential at a predetermined level by driving a current through the second electrode using circuitry for clamping the membrane potential of the oocyte. A sample is then infused into a fine reacting tube having an antigen immobilized on its inner surface together with some buffer solution to promote a histamine releasing reaction. The solution containing histamines that is released in the fine reacting tube is transferred to the vessel to make contact with the oocyte in the vessel.

Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample, the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific cellulose blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.

Abstract: A method for stabilizing analyses with antibodies and antibody fragments comprises dissolving the analyte in a liquid to form a solution, adding analyte-specific antibodies, fragments of such antibodies, or both to the solution, heating the solution, and then cooling and filtering the solution. The filtered solution may be diluted in a suitable matrix.

Abstract: Disclosed herein is a method for the detection of a target substance by a colloidal gold immunoassay, which comprises dissolving in an immunoreaction system a metal salt selected from the group consisting of sodium, potassium and lithium fluorides, sodium, potassium, lithium and magnesium iodides, sodium, potassium, lithium and magnesium bromides, lithium and magnesium chlorides, sodium, potassium, lithium and magnesium nitrates, sodium, potassium, lithium and magnesium sulfates, sodium, potassium, lithium and magnesium formates, sodium, potassium, lithium and magnesium acetates, and mixtures of at least two of these metal salts, whereby the metal salt is allowed to exist in a reaction mixture.

Abstract: This invention relates to an improvement in a method for detecting labeled molecules and especially biotinylated molecules and particularly relates to a method for reducing background signal problems in such detection methods.

Abstract: A method for encapsulation of antineoplastic agents in liposomes is provided, having preferably a high drug:lipid ratio. Liposomes may be made by a process that loads the drug by an active mechanism using a transmembrane ion gradient, preferably a transmembrane pH gradient. Using this technique, trapping efficiencies approach 100%, and liposomes may be loaded with drug immediately prior to use, eliminating stability problems related to drug retention in the liposomes. Drug:lipid ratios employed are about 3-80 fold higher than for traditional liposome preparations, and the release rate of the drug from the liposomes is reduced. An assay method to determine free antineoplastic agents in a liposome preparation is also disclosed.

Abstract: Disclosed are methods for measuring non-contractile oxidative metabolism in smooth muscle cells comprising providing a medium suitable for the support of oxidative metabolism, incubating a cell or tissue sample with a specimen from a patient, measuring a marker of oxidative metabolism in the incubate, and detecting an increase in oxidative metabolism which is not attributable to a contractile demand for ATP. Such an increase in oxidative metabolism will be indicative of the existence of an agent or combination of agents able to cause an increase in oxidative metabolism in smooth muscle cells, and thus provides means for diagnosing and monitoring various pathologies associated therewith.

Abstract: Isolated allergens of Dermatophagoides (house dust mites) particularly of the species and Dermatophagoides pteronyssinus, which are protein allergens or peptides which include at least one epitope of the protein allergen. In addition, the or peptides encoded by the isolated DNA, their use as diagnostic and therapeutic reagents and methods of diagnosing and treating sensitivity to house dust mite allergens.

Abstract: This invention is directed to the use of polycarboxylic acid polymers to enhance the performance of immunochemical assays for the quantitation of aminoglycoside antibiotics in biological samples. This invention is also concerned with the improved homogeneous, immunochemical detection assays resulting from the use of said polycarboxylic acid polymers in said assays.

Abstract: A method of detecting malignant tumors and determining their mass includes withdrawing fresh blood and/or serum samples from the patient. The blood or serum sample is then stabilized. The tumor determination is obtained from a shift in the ratio of at least one of the IgG subclasses to the sum of the IgG subclasses, relative to the normal ratio in the samples.

Abstract: A method for encapsulation of antineoplastic agents in liposomes is provided, having preferably a high drug:lipid ratio. Liposomes may be made by a process that loads the drug by an active mechanism using a transmembrane ion gradient, preferably a tranamembrane pH gradient. Using this technique, trapping efficiencies approach 100%, and liposomes may be loaded with drug immediately prior to use, eliminating stability problem related to drug retention in the liposomes. Drug:lipid ratios employed are about 3-80 fold higher than for traditional liposome preparations, and the release rate of the drug from the liposomes is reduced. An assay method to determine free antineoplastic agents in a liposome preparation is also disclosed.

Abstract: A method for quantitatively determining cholesterol in high density lipoproteins, in which, prior to the determination of cholesterol by an enzymatic method, a surfactant and a substance which forms a complex with lipoproteins other than high density lipoproteins are added to a sample containing lipoproteins.The method does not require any pretreatments such as centrifugal separation. With a simple operation, cholesterol in HDLs can be measured effectively. Also, this method can be adopted in a variety of automated analyzers, and thus is very useful in the field of clinical assays.

Abstract: An allergen immunoassay method features the use of a combination of a) closely controlled 1) elevated temperatures for assay reactions, 2) low temperatures for reagents and samples, 3) times for assay steps and especially assay reaction times, 4) reagent concentrations, and 5) reagent amounts; b) the use of a fast and accurate method of sample preparation that removes dust and contaminants; c) the stabilization of samples to avoid auto- and antibody degradation and unwanted effects of sample contaminants; and d) the formation of a colored product to determine the amount of a specific allergen. This combination provides an assay that can be completed in a few hours while retaining the precision, accuracy, sensitivity and response curve of previous methods requiring much longer periods of time.

Abstract: Described are immunoassay of insulin-like growth factors in a biological sample, which comprises prior to the immunoassay, treating the biological sample with an acid solution to liberate the insulin-like growth factors from insulin-like growth factor binding proteins and then neutralizing the so-treated biological sample with a neutralizing buffer containing a recombination inhibitor; and immunoassay kit for insulin-like growth factors.

Abstract: The invention is a rapid, continuous test for glycated hemoglobin using a non-equilibrium affinity binding method. Agarose beads derivatized with 3-aminophenylboronic acid specifically bind glycated hemoglobin. This solid phase is incorporated into a sample processor card, modified to mix and to separate the test solution from the solid phase prior to absorbance readings. Two absorbance readings are made on the test solution, one immediately after mixing the reagent/diluent with the specimen, and one after a significant amount of binding has occurred. A linear correlation between total glycated hemoglobin and hemoglobin A.sub.1c permits standardization and reporting of units equivalent to % hemoglobin A.sub.1c. Stable glycated hemoglobin solutions for use as standards in the assay, and a method for preparing the standards are also disclosed.

Abstract: A chemiluminescent method is provided for the analysis of a target. A peroxidase is first bound as a labelling substance to the target by using a target specific binding reagent. The target so labelled is isolated and then reacted with luminol, hydrogen peroxide and an enhancer in an aqueous solvent. The luminescence of light is detected and measured. The aqueous solvent contains at least one protein selected from the group consisting of skim milk and egg albumin. Preferably, the aqueous solvent also contains a non-ionic surfactant such as a polyoxyethylene ether and/or a sugar alcohol such as mannitol.

Abstract: A method for stabilizing analytes with antibodies and antibody fragments comprises dissolving the analyte in a liquid to form a solution, adding analyte-specific antibodies, fragments of such antibodies, or both to the solution, heating the solution, and then cooling and filtering the solution. The filtered solution may be diluted in a suitable matrix.

Abstract: The invention relates to methods for simultaneously or sequentially detecting multiple nucleic acid analytes in a single medium utilizing oligonucleotide hybridization probes coupled to different chemiluminescent labeling reagents. The methods may be used in a heterogeneous, homogeneous or non-homogeneous assay system. The invention also relates to specific combinations of chemiluminescent labeling reagents suitable, when coupled to an oligonucleotide probe, for use together in methods for the detection of multiple nucleic acid analytes. The invention also concerns kits useful in these methods.

Abstract: This invention provides a method for preserving cells which comprises the steps of (a) suspending cells in a physiologically-acceptable, isotonic medium; and (b) fixing the cells so suspended at a temperature of less than about 10.degree. C. under sufficiently hypertonic conditions so as to disperse the cells in a single, unagglutinated state, thereby preserving cells. This invention also provides a method for detecting cells separated from a sample which have been preserved according to the aforementioned method. This invention also provides a method for visualizing cells. Also provided is a method for detecting a metabolic process in cells present in a sample. This invention also provides a method for detecting the presence of rare cells in a sample which specifically possess on their surfaces a moiety recognized by a known ligand comprising preserving cells separated from the sample according to the aforementioned method for preserving cells.

Abstract: A method is disclosed for preparing lyophilized and frozen cells as cytometry standards.

Abstract: Method for a homogeneous biospecific affinity assay for determining the content of a substance (analyte) in a biological sample. The assay is carried out in an aqueous reaction medium by means of time-resolved fluorescence spectroscopy and with a biospecific affinity reactant labeled with a lanthanide chelate in which a lanthanide ion exhibiting ionic fluorescence is chelated by a ligand bound covalently to the reactant. The characteristic feature is(i) that the lanthanide chelate formed by the lanthanide ion together with the covalently bound ligand forms a fluorescent chelate, and(ii) that a modulator is added which stabilizes the lanthanide chelate so that the lanthanide fluorescence as measured from the medium becomes a practically pure function of the analyte concentration therein.

Abstract: Methods for modulating the rates and dose responses of immunoassays through the incorporation of one or more detergents into the immunoassay reaction are disclosed. The methods are particularly suitable for automated immunoassay formats, especially with formats that use analyte-biotin bidentate reagents. The methods may be used to facilitate the detection of any desired, preselected pharmacological agent.

Abstract: An aqueous composition suitable for use when performing immunological procedures. The composition includes at least one biological buffer, dithiothreitol (alternatively referred to herein as "DTT"), and ethylene glycol. The composition can also include at least one biological detergent, at least one source of positive and negative counterions, e.g., salt, and at least one viscosity modifier, e.g., sugar. The buffer also can include at least one preservative, such as sodium azide. The pH of the composition preferably ranges from about 6.4 to 7.2. A kit containing the composition is also disclosed.

Abstract: The invention is a rapid, continuous test for glycated hemoglobin using a non-equilibrium affinity binding method. Agarose beads derivatized with 3-aminophenylboronic acid specifically bind glycated hemoglobin. This solid phase is incorporated into a sample processor card, modified to mix and to separate the test solution from the solid phase prior to absorbance readings. Two absorbance readings are made on the test solution, one immediately after mixing the reagent/diluent with the specimen, and one after a significant amount of binding has occurred. A linear correlation between total glycated hemoglobin and hemoglobin A.sub.1c permits standardization and reporting of units equivalent to % hemoglobin A.sub.1c. Stable glycated hemoglobin solutions for use as standards in the assay, and a method for preparing the standards are also disclosed.

Abstract: An assay and sample mixture for the enumeration of fluorescently stained target components of a whole blood sample by an imaging instrument. The sample preparation method ensures that the amount of target components per unit of volume of the whole blood sample is preserved by elimination of certain non-quantitative preparation steps while producing an even hematocrit layer within a scan capillary. Typical target components include white blood cells that express certain surface antigens, such as CD-4 and CD-8 proteins. To inhibit aggregation of the red blood cells, a reagent is added to an aliquot of whole blood sample. The aliquot of whole blood is mixed and with a preselected amount of a fluorescent dye and ligand complex which tags the target components.

Abstract: A method and kit for extracting fungus from a plant. An extraction solution is combined with tissue from a plant and the combination is agitated, preferably by shaking, to extract a detectable amount of the fungus from the plant. The extraction solution is a solution containing a dilute acid and a detergent. The extract can then be neutralized without degradation of the fungus and subjected to analysis by immunoassay to detect the presence of pathogenic fungi. The method is particularly useful for the detection of Pyricularia oryzae on rice plants.

Abstract: The present invention features isolated DNA encoding allergens of Dermatophagoides (house dust mites) particularly of the species Dermatophagoides farinae and Dermatophagoides pteronyssinus, which are protein allergens or peptides which include at least one epitope of the protein allergen. In particular, the invention provides DNA encoding the major D, farinae allergens, Der f I and Der f II and DNA encoding the major D. pteronyssinus allergens, Der p I and Der p II. The present invention further relates to proteins and peptides encoded by the isolated D. farinae and D. pteronyssinus DNA, including proteins containing sequence polymorphisms. In addition, the proteins or peptides encoded by the isolated DNA, their use a diagnostic and therapeutic reagents and methods of diagnosing and treating sensitivity to house dust mite allergens, are disclosed.