Abstract: A method for measurement of the hepatitis C virus (HCV) characterized by measuring HCV core antigen and HCV core antibody by their binding with probes in the presence of an anionic surfactant or a non-ionic surfactant, or both.

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

Abstract: The invention concerns a home kit and a method for detection of the presence of a fecal parasite in a stool.

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: A method for performing screening of one or more cell groups of interest obscured by a cell population such as one or more subsets of interest of a WBC population utilizing at least one light sensing parameter. The cell group of interest is enumerated by utilizing microspheres having monoclonal antibodies bound thereto to modify the sensed characteristics of specified cells to differentiate the cell group of interest from the obscuring cell population.

Abstract: Methods and compositions are described for the detection and quantitation of cardiac specific troponin I and troponin T in samples. Cardiac-specific troponin isoforms exist in various forms in the blood, including free and complexed forms. By selecting antibodies that are sensitive and/or insensitive to these various forms, the present invention can provide immunoassays that more accurately reflect the clinical state of an individual. These described methods and compositions can be used for providing indicators of myocardial infarction and other cardiac pathologies.

Abstract: A sample preparation and analysis device which incorporates both immunoassays and PCR assays in one compact, field-portable microchip. The device provides new capabilities in fluid and particle control which allows the building of a fluidic chip with no moving parts, thus decreasing fabrication cost and increasing the robustness of the device. The device can operate in a true continuous (not batch) mode. The device incorporates magnetohydrodynamic (MHD) pumps to move the fluid through the system, acoustic mixing and fractionation, dielectropheretic (DEP) sample concentration and purification, and on-chip optical detection capabilities.

Abstract: Disclosed are a method for quantitatively determining mannose, which comprises reacting mannose in a specimen with an enzyme which is capable of oxidizing the mannose by dehydrogenation, in the presence of an electron acceptor, and quantitatively determining a formed reductant of the electron acceptor; and a reagent for the quantitative determination of mannose.

Abstract: The present invention provides methods of inactivating and removing infectious agents from tissues of use in bioprosthetic devices. The methods include the removal and blockage of binding sites on the tissues for the infectious agents. Also provided are methods for blocking a site on an infectious agent that binds to a site on the tissue.

Abstract: Compositions and methods of use thereof for capture and detection of selected molecules are described. In one embodiment, a first composition includes a ligand component, such as an antibody coupled to a nucleic acid component. An a preferred embodiment, the nucleic acid is labeled with a fluorescent marker to facilitate detection. Another aspect of the invention is the ligand component bound to a solid support via a complementary nucleic acid component and a linker moiety. The method involves binding the target with the first composition in free solution, then binding the target to the solid support by means of both DNA hybridization and antibody-antigen affinity binding. Unbound molecules are washed away, and then the bound targets are detected by fluorescence detection. Vital stains can also be used to detect viable cells.

Abstract: A chromatographic assay device according to the present invention provides a unidirectional immunoassay for an analyte in a whole blood sample with improved sensitivity and freedom from interference.

Abstract: The invention provides a flow cytometric method for measuring dendritic cell function in whole blood, comprising the steps of: (a) contacting a whole blood sample with a dendritic cell activator; (b) adding to the sample a plurality of dendritic cell-distinguishing antibodies and at least one cytokine-specific antibody; and then (c) flow cytometrically assaying the sample for the binding of the cytokine-specific antibody by at least one distinguishable DC subset.

Abstract: The invention concerns a method for the determination of antigen-specific antibodies of the immunoglobulin M class in the presence of immunoglobulins of the G class and/or rheumatoid factors in body fluids by incubation with at least two different receptors R1 and R2 and optionally additional receptors wherein an essential component of R2 is a binding partner in a polymeric form and interference by IgG antibodies of the same antigen specificity is reduced by binding partners in a monomeric form; a reagent for determining an antigen-specific antibody of the immunoglobulin M class, as well as the use of binding partners in a monomeric form to reduce interference by IgG antibodies in the determination of antigen-specific IgM antibodies.

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

Abstract: This invention relates to the discovery of the association of certain nucleic acid sequences and proteins with breast cancer, the use of such sequences as a diagnostic indicator and treatments based on the association.

Abstract: A method for quantitatively and/or qualitatively assaying an analyte in a sample, wherein the analyte is a receptor binding compound, has low detection limits equivalent to those of radioreceptor assays. The method comprises the steps of a) contacting the sample with material comprising a receptor for the analyte in order for receptor-analyte binding to occur and b) further contacting the sample with a detectable ligand for the receptor in order for receptor-ligand binding to occur, followed by c) separating the resulting receptor bound and free fractions, d) subjecting the receptor bound fraction to dissociating conditions releasing the ligand from the receptor and e) assaying for the dissociated ligand in a manner known per se for the detection of the detectable ligand.

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: Disclosed is a method for separating prions from biological materials. The method includes adding a polyalkylene glycol, such as polyethylene glycol, to a solution of the biological material such that a precipitate containing the prion is formed. This precipitate is then separated from the solution of biological material, thereby removing prions. Biological materials include biologically derived fluids, such as cerebrospinal fluid, biological samples, such as brain homogenates, blood plasma fractions, and aqueous solutions of recombinantly produced products. The disclosed method provides an effective process for the removal of these infectious materials from the biological materials, which may be further processed to provide the therapeutic compositions.

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: 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: The present invention is an improvement to the method of determining the concentration of an analyte in body fluid using at least two immunoreactants which specifically bind with separate epitopes of the analyte one of which immunoreactant is immobilized on a solid support and the other is in the form of a polymer or oligomer of the immunoreactant and an enzyme. The improvement involves introducing to the assay system a polymeric conjugate of the enzyme and a water soluble protein other than the enzyme or a non-proteinaceous natural, synthetic or semi-synthetic polymer or oligomer in sufficient amount to reduce bias in the assay due to incorrect recovery of the analyte.

Abstract: The invention provides methods and compositions for the detection and/or quantification of bacterial endotoxins. In particular, provided herein is an inexpensive and reproducible method for producing an improved amebocyte lysate preparation having reduced Factor G activity. Provided also is an endotoxin-specific amebocyte lysate preparation produced by such a method. In addition, the invention provides methods and compositions akin for enhancing the sensitivity to endotoxins of amebocyte lysate preparations having reducing Factor G activity. In particular, the sensitivity of such amebocyte lysate preparations to endotoxins can be enhanced by the addition of exogenous (1→3) &bgr;-D-glucan.

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: A chromatographic strip positive readout binding assay device and method suitable for quick, sensitive and reliable field testing for small molecules such as environmental contaminants, drugs of abuse, therapeutic drugs and hormones. The detectable label is not attached to either the analyte or to the analyte receptor. Low affinity binding pairs can be used in the positive readout binding assay.

Abstract: The present invention provides a reagent for the detection or monitoring of a Toxoplasma gondii infection, which includes as a reactive substance a truncated Toxoplasma gondii P30 protein in which all of the hydrophobic C-terminal region of the native protein starting with the amino acid positioned after the amino acid 299 (SEQ ID NO: 1) has been deleted and all of the region of the native protein having the sequence starting with amino acid 31 and ending with the amino acid 299 (SEQ ID NO: 1) is contained. The present invention further describes methods of screening for anti-Toxoplasma antibodies in a biological sample.

Abstract: The present invention relates to a method and a diagnostic aid for the qualitative or quantitative detection of antibodies and for determining their avidity. This makes it possible to diagnose the early phase of viral, bacterial or parasitic infections. The diagnostic aid according to the invention is particularly suitable for automated processing in large analytical laboratories.

Abstract: ADMA is determined in a physiological sample by first removing interfering components: proteins by precipitation; and amines and citrulline, by means of a cation exchange column, followed by enzymatic hydrolysis of the ADMA to citrulline with DDAH. The citrulline is then determined spectrophotometrically.

Abstract: The present invention includes a method for stimulating increased PSA production by prostate cancer cells, comprising the steps of reducing the amount of iron available to the prostate cancer cells; and causing increased PSA production. In another aspects of the present invention, there are provided prostate cancer diagnostic kits comprising a first container containing an iron chelator; and second container containing a free-PSA-specific antibody, wherein the free-PSA-specific antibody is detectable. Also provided as part of the present invention are methods for diagnosing prostate cancer in a human, comprising reducing the amount of available iron in the human, and subsequently testing PSA levels.

Abstract: A method for the direct analysis of the presence of an analyte which becomes embedded in keratinized structures, e.g., hair, fingernails and toenails, from the bloodstream of a subject which comprises preparing a mixture containing dithiothreitol or dithioerythritol (“DTT”), an enzyme suitable for the digestion of the keratin structure and a sample of the keratin structure; permitting the enzyme to digest the sample of keratin structure to form a digest solution, followed by the addition of a salt of a metal of copper, zinc, manganese, iron, lead, cadmium, mercury, silver and cobalt to deactivate the DTT; and finally subjecting the digest solution to analysis to determine the presence of the analyte in the keratin structure sample. The protease enzymes papain, chymopapain, and proteinase K are preferred for use in the invention.

Abstract: A method and compositions for the detection and/or quantification of an analyte through the use of a plurality of labeled probes, with two or more said probes targeted to different regions of said analyte. In specific embodiments, the labels are separately distinguishable, and/or are present at different specific activities on the labels.

Abstract: The invention relates to a method for measuring the level of a preselected analyte in a sample of blood of a human or animal patient by incubating the test sample with an antibody specific to the analyte to form an immunocomplex, which then interacts with the white blood cell fractions and result in the production of oxidants. Oxidants are detected using chemiluminescent reagents. The assay is performed on the sample and in addition includes a measurement of the oxidant production resulting from a maximal stimulatory dose of immunocomplexes, providing a ratio to indicate the level of analyte in the sample. The white blood cell oxidant response may be enhanced by the inclusion of certain agents such as zymosan.

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 slide having a portion thereof provided with transparent adhesive which adheres to a test sample. The slide and adhesive may be transparent. Specific types of infection and particularly fungal infections can be detected in the test sample using immunotest-methods. In a special embodiment the adhesive slide is fashioned with a peripheral lip or well to contain a test sample and a reagent.

Abstract: The present invention sterol-modified hedgehog polypeptides and functional fragments thereof. Methods of identifying compositions which affect hedgehog activity based on inhibition of cholesterol modification of hedgehog protein are described. In one aspect of the invention, the method provides a means for affecting cholesterol biosynthesis or transport in a cell comprising contacting a cell with an effective amount of a compound that affects hedgehog, thereby affecting cholesterol biosynthesis or transport. The effect may be inhibition or stimulation of cholesterol biosynthesis or transport.

Abstract: A process is provided for converting phytate in a food into inorganic phosphate. The process comprises the steps of: (i) mechanically mixing a slurry comprising: (a) 100 parts by weight of the phytate-containing food, (b) 60-1000 parts by weight of a solvent mixture which comprises water and a water-immiscible organic solvent having a boiling point of 20-100° C., the water-immiscible organic solvent constituting 20-85% by wt. of the solvent mixture, and (c) a phytase; and (ii) drying the food to remove the organic solvent. The process has the advantage of enabling a high conversion rate of phytate into inorganic phosphate in an economical manner.

Abstract: Calibrating an immunoassay by generating two reaction rate measuring curves, from samples having higher and lower relative levels of antigen, extrapolating a combination of the curves to cover sample concentrations known to contain an excess of antigen relative to an amount of capture reagent and combining the low end linear potion of the higher reaction rate measuring curve with the higher end portion of the extrapolated reaction rate measuring curve, thereby eliminating measuring inaccuracies otherwise arising from the hook effect. For antigen concentrations higher than the assay range, a high antigen signal utilizing the two rates avoids reporting false results.

Abstract: The invention provides methods and compositions for the detection and/or quantification of bacterial endotoxins. In particular, provided herein is an inexpensive and reproducible method for producing an improved amebocyte lysate preparation having reduced Factor G activity. Provided also is an endotoxin-specific amebocyte lysate preparation produced by such a method. In addition, the invention provides methods and compositions for enhancing the sensitivity to endotoxins of amebocyte lysate preparations having reducing Factor G activity. In particular, the sensitivity of such amebocyte lysate preparations to endotoxins can be enhanced by the addition of exogenous (1→3) &bgr;-D-glucan.

Abstract: For use in a lipid-dependent diagnostic assay, a stable aqueous suspension of a phospholipid which normally has a hexagonal (HII) organization when dispersed in an aqueous medium without detergent, the suspension containing the phospholipid, a detergent, and an aqueous phase. In the stable suspension, the phospholipid remains in suspension at a temperature of 25° C. for at least one hour. The suspension is suitable for providing the phospholipid to an assay for lupus anticoagulants which includes the step of pre-incubating a test sample with the phospholipid.

Abstract: Disclosed are a color developing method utilizing the reaction of an indolyl derivative with an enzyme in the presence of a specific free radical compound and/or a specific chelate compound, and an enzyme immunoassay using the color developing method.

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 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: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilized on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating mea

Abstract: A specific binding assay process which is useful for quick qualitative or quantitative measurement and which can be used for various purposes, and a specific binding assay device suitable for the practice of the process, in which a substance to be assayed in a liquid test sample is determined qualitatively or quantitatively by developing the substance in a liquid test sample in a matrix, which comprises the steps of, for example: allowing the substance to be assayed to reach with a specific binding substance which has specific affinity for the substance to be assayed; allowing a signal substance generator (a substance which competes with the substance to be assayed for the specific binding substance and which generates a signal) to change its distribution in the matrix in response to the reaction of the above step, and; detecting the resulting distributional changes at a detection means as changes of signals which are rate-limited by the mass transfer of a signal substance generated from the signal substa

Abstract: The present invention relates to a measuring device which comprises electrodes fabricated on porous membrane substrate in which the sample migrates chromatographically; and the method of quantifying material in the sample by using the device. The sample material for measuring can be quantified by the measuring device of this invention, which is consists pretreatment bands in the lower part of porous membrane substrate and electrodes in the upper prt of pretreatment bands, by the procedure as foolows: The sample material for measuring is chromatographically migrated in the porous membrane substrate by applying the sample on the lower part of the porous membrane substrate; and then the changes of electric signal by the material at the electrode are measured to quantify the material.

Abstract: The invention relates to a method for quantitating the level of a preselected analyte in a sample of blood of a human or animal patient by incubating the test sample with an antibody specific to the analyte to form an immunocomplex, which then interacts with the white blood cell fractions and result in the production of oxidants. Oxidants are detected using chemiluminescent reagents. In addition, the white blood cell oxidant response may be enhanced by the inclusion of certain agents such as opsonized zymosan. As part of the assay, separate blood samples are also maximally stimulated with a maximal stimulatory amount of exogenously-added antigen, and corresponding antibody, to form immunocomplexes, to provide a response factor used in the quantitation of analyte.

Abstract: There is described a method for the chemical modification of antibodies and/or antigens in order to minimise sample interference in immunoassays, an immunoassay method in which chemically modified antibodies and/or antigens are employed, the use of chemically modified antibodies and/or antigens in an immunoassay and a kit for assaying biological specimens which comprises the chemically modified antibodies and/or antigens.

Abstract: A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol.

Abstract: The invention concerns a solid-phase determination method and equipment and an adapter for use in these. In the method a sample is allowed to react with a separating reagent bound to the outer surface of a separate solid phase body, whereafter the body is removed from the vessel and is taken to a measurement vessel, if required through one or several intermediate step vessels. At least one vessel contains a medium needed in a determination step to be performed therein when the phase body is brought into this vessel. The invention is especially suitable for use in automatic immunodetermination systems.

Abstract: A diagnostic test strip for determining the presence of a specified analyte in a fluid sample is described. The test strip has a test membrane sandwiched between two layers of a plastic sheath. The upper layer of the sheath has a sample well into which a liquid sample is placed. The test membrane has a sample receiving zone typically containing a buffer and a fatty acid sarcosinate. Adjacent to the sample receiving zone is a reagent zone containing reagent chemicals including gold colloid particles coated with antibodies to the specified analyte. In fluid connection with the reagent zone is a test zone containing immobilized molecules of the specified analyte. Preferably, in fluid connection with the test zone is a control zone containing an indicator that changes color when wetted by the sample and a liquid sink zone to absorb excess liquid in the sample.

Abstract: The present invention is drawn to a method for the quantitative determination of human acute phase serum amyloid A protein (A-SAA) comprising contacting a sample of a biological fluid with antibody specific for A-SAA, the sample being reacted with an organic solvent prior to or simultaneous with antibody contact. The organic solvent is suitably a C1 or C4 alcohol and the antibody can be used on the solid phase and as a component of the detection system of an enzyme linked immunosorbant assay. The method provides a sensitive and reliable measure of A-SAA and inflammatory status which can be used for the diagnosis and clinical management of both acute and chronic inflammatory conditions.