Abstract: A kit for carrying out an immunoenzymological assay for protein, containing a diagnostic reagent consisting of a hybrid protein comprising, in order, a polypeptide P1 which is an N-terminal portion of mature alkaline phosphatase comprising from 6 to 28 of the N-terminal amino acids of said mature alkaline phosphatase, joined to a polypeptide P2, capable of interacting with an antibody or antigen joined to a polypeptide P3 which is selected from the group consisting of a) the C-terminal remaining amino acids of said mature alkaline phosphatase, b) the mature sequence of alkaline phosphatase, and c) enzymatically active fragments of b).

Abstract: Monoclonal or polyclonal antibodies capable of recognizing at least one antigenic determinant located on the FR-900506 compound, are disclosed. FR-900506 isa compound having pharmacological activities such as immunosuppressive activity and antimicrobial activity, and has the following structure: ##STR1## Also disclosed are enzyme immunoassays for FR-900506 based on the antibodies of the invention and test kits for detection of FR-900506. A process for preparing a monoclonal antibody which selectively binds to FR-900506 is also disclosed.

Abstract: New and improved methods for collecting neonatal meconium samples, preparing meconium specimens for testing and for chemically analyzing neonatal meconium samples to determine their chemical composition are provided. A novel extraction method is employed in accordance with the invention to provide a non-aqueous, concentrated "cocktail" meconium extract containing substantially all of many possible target analytes in a single extraction step. Preliminary screening by fluorescence polarization immunoassay methods may be performed on the cocktail extract to qualitatively determine the presence of the target analytes in the meconium sample. If a positive preliminary result is obtained, new and improved quantitative GC/MS confirmatory procedures are provided by this invention to unequivocally identify and quantitate the amount of target analyte present in the sample in terms of nanograms of analyte per gram of meconium tested.

Abstract: The present invention is directed to a method for regulating formation of a complex of a plasminogen activator, its receptor and one of its inhibitors. More specifically, this method involves contacting a target cell having a plasminogen activator receptor with a compound which interacts with a component of the complex such that a change in target cell cytoskeletal stiffness results.

Abstract: A diagnostic kit for detecting the presence of microorganisms, comprising an insoluble substrate; and a carbohydrate receptor immobilized on the insoluble substrate, the carbohydrate receptor being capable of adsorbing microorganisms; and a labelled reagent useful for detecting the presence of microorganisms bound to the carbohydrate receptors and a method for detecting the presence of specified microorganisms in a sample, which comprises contacting a sample to be tested with carbohydrate receptors immobilized on an insoluble substrate; and determining the extent of binding of microorganisms in the sample to the carbohydrate receptors by use of a labelled reagent.

Abstract: A method of assaying a human urine sample, by measuring a concentration of pyridinium crosslinks from which the concentration of total hydrolysed pyridinoline in the sample can be determined, is disclosed. In the method, a urine sample is reacted with an anti-Pyd antibody reagent which preferably has a ratio of reactivity toward native free pyridinoline and urinary pyridinoline peptides larger than 1,000 daltons in molecular weight, of greater than 10:1. By measuring the extent of immunocomplex formed by the reaction, the concentration of total hydrolysed pyridinoline in the sample can be calculated. Also disclosed are an antibody reagent and kit which can be used in the method.

Abstract: A method for assaying for the presence of analyte in a sample based on differential binding affinity involves detecting dissociation of a complex of receptor and ligand in the presence of analyte. The receptor binds the analyte with high affinity and with the ligand with low affinity. The receptor-ligand complex may be formed in situ or may be preformed. In the presence of free analyte, the receptor releases from the receptor-ligand complex and binds free analyte. Release of the receptor-ligand complex is detectable. A kit for performing release assays to detect the presence of analyte is also provided.

Abstract: Assay for detecting the amount or presence of target ligand in a sample. The assay includes a ligand analogue conjugate having a linkage site and a binding site, a ligand receptor, and a sample. The assay includes the steps of providing at least one crosstalk inhibitor. This inhibitor, under assay conditions, competes with the linkage site of the ligand analogue conjugate for binding to the ligand receptor, and does not compete with the binding site of the ligand analogue conjugate for binding to the ligand receptor. In the invention, the assay is performed for the target ligand in the presence of a sufficient amount of the crosstalk inhibitor to reduce the amount of binding of the linkage site of the ligand analogue conjugate to the ligand receptor. The invention also features a method for identifying crosstalk inhibitors, and the crosstalk inhibitors themselves.

Abstract: The diffusion through a membrane assaying apparatus and method facilitates rapid detection of small or larger molecular weight substances such as hazardous wastes, toxic chemicals or the like by using a semipermeable membrane having a predetermined molecular weight cutoff. The semipermeable membrane is provided as part of a container having a removable barrier which facilitates control of diffusion through the membrane. The assaying method includes the use of a reaction mechanism for detection of a predetermined substance. The reaction mechanism includes one or more reagents which are designed to either react or compete for a substance for which assaying is being performed. By selecting the proper reagents and molecular weight cutoff of the semipermeable membrane, the presence or absence of a reaction such as a color change or production of vapor provides indication whether the substance being assayed for is present in the test sample.

Abstract: The present invention relates to proteins associated with human bone marrow cell membranes for adhering hematopoietic cells to human bone marrow cell membranes. These proteins are soluble in lithium dodecyl sulfate but insoluble in 2% nonaethylene glycol octylphenol ether (e.g., 2% Triton.RTM. X-100) solution. These proteins and antibodies raised against them are useful in the treatment and diagnosis of blood disorders. The DNA molecules encoding these proteins have use in gene therapy regimes. Also disclosed is a method for detecting binding between cell adhesion membrane proteins and cells having a potential to be bound to such proteins.

Abstract: A method of determining an analyte in the gaseous or vapour phase and in which a bioreceptor or biomimic is retained at an electrode. The bioreceptor or biomimic is preferably retained at a support at the electrode which comprises a solid or gel matrix of an electrolyte, especially organic salt electrolytes. Electrochemical detection of analytes in this way has several advantages over existing methods which rely on solution monitoring. For example gas sensors can be prepared for monitoring an analyte by the occurrence of a reaction with a bioreceptor or biomimic, in addition to monitoring the presence of toxins due to inhibition of the bioreceptor or biomimic reaction. Furthermore, the invention enables gas or vapour analyte monitoring with increased sensitivity and speed and greater stability of the sensors can be achieved. The invention also relates to novel media for carrying out bioelectrochemical reactions.

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 react 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 chance 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 substance gene

Abstract: Antibodies against highly conserved amino acid sequences of immunogenic substances, a process for the preparation of these antibodies and the use thereof in immunoassays.The invention relates to antibodies which are obtained by immunization with a peptide fragment which represents a highly conserved amino acid sequence of a native protein. The antibodies according to the invention can be used for the preparation of immunoassays, in particular for the preparation of assays for the determination of genetically engineered products such as insulin which arise as sparingly soluble inclusion bodies in microorganisms. The invention particularly relates to a multispecies insulin assay in the form of an RIA.

Abstract: Cell lines which lack human class II histocompatibility antigens are disclosed. The cell lines may be utilized within a method for propagating microorganisms, such as viruses, for determining the presence and/or amount of antibody to a microorganism in a biological fluid, and within a method for producing antibodies to a selected microorganism.

Abstract: Meconium State Pregnancy is diagnosed by analysis of prenatal maternal fluids for the presence of specific meconium antigens, including a specific meconium protein antigen of approximately 14 KD.

Abstract: A monoclonal antibody is disclosed which is reactive to Treponema denticola and produced by the hybridoma deposited under ATCC HB 9966. The invention also discloses diagnostic reagents and methods for detecting Treponema denticola utilizing the hybridoma deposited under ATCC HB 9966.

Abstract: A stabilized peroxidase conjugate is provided herein. Such conjugate includes a stabilizing quantity of polyethylene oxide or polyvinyl alcohol therein.

Abstract: A method for determining head and neck squamous cell carcinomas, bladder tumors and prostate carcinomas is described. The method involves assaying for expression of the gene coding for tumor rejection antigen precursor MAGE-3, or its expression product. Various assays, and kits useful for these assays, are described.

Abstract: In enhanced chemiluminescent (ECL) reactions of a fused aromatic diacyl cyclic hydrazide such as luminol, a peroxidase enzyme catalyst, an oxidant such as hydrogen peroxide and an enhancer, it has been found advantageous to use a combination of an organoboron enhancer such as 4-biphenylboronic acid with a non boron-containing enhancer, especially a phenolic or aromatic amine enhancer, particularly 4-iodophenol. ECL reactions are useful in diagnostic assay.

Abstract: A method for screening for bladder cancer by identifying expression of one or more of MAGE-1, MAGE-2, MAGE-3 and MAGE-4 is the disclosed invention. Expression can be determined by a number of methods, including nucleotide amplification assays.

Abstract: The present invention relates to second generation monoclonal antibodies having binding specificity to a tumor associated glycoprotein having an approximate molecular weight of >10.sup.6 d ("TAG-72") and human carcinomas and methods for employing the same. Hybridomas producing such antibodies have been prepared.

Abstract: Methods for detecting the presence or concentration of an analyte in a matrix by exploiting the specificities of the analyte's antibody and enzyme-substrate are disclosed. The analyte is first extracted from the matrix by binding it to its specific antibody which has been attached to a solid surface. The antibody-bound analyte is then separated from the matrix to remove it from any interfering substances. Next, the antibody-bound analyte is reacted with its specific enzyme-substrate to generate a signal proportionate to the amount of analyte bound to the antibody, which in turn is dependent on the quantity of analyte present in the matrix. Applications of the methods of the present invention to detect the presence and concentration of hemoglobin, a transferase, and a serine protease, are specifically disclosed. Further, kits useful for utilizing the methods of the present invention are also disclosed.

Abstract: A method of immunologically assaying intact human osteocalcin in a human assay sample is provided by using an antibody having an epitope in a region of an amino acid sequence 1 to 20 on the N-terminal side of human osteocalcin and an antibody having an epitope in a region of an amino acid sequence 36 to 49 on the C-terminal side of human osteocalcin. A reagent and a kit therefor are provided. Furthermore, a method of immunologically assaying the total amount of human intact osteocalcin in a human assay sample, and a reagent and a kit therefor are also provided. A monoclonal antibody and a polyclonal antibody are used for the assay. A process for producing these antibodies, and utilization of these antibodies is described.

Abstract: Immunoassays for vitamin B.sub.12 using novel monoclonal antibodies to the intrinsic factor:vitamin B.sub.12 complex and to the vitamin B.sub.12 binding site on intrinsic factor.

Abstract: A disposable diagnostic device and method of its use are provided. The device comprises a housing containing first and second flow paths orthogonal to each other. The first flow path commences at a sample addition port and continues through a transport channel which feeds sample to an incubation area by means of capillary flow. The incubation area comprises a signal producing system and is underneath an optically-clear window. The first flow path terminates in a top waste reservoir which receives sample and wash fluid. The second flow path begins on one side of the incubation area at an inlet port over a side reagent reservoir. Liquid flows along the second flow path from the side reagent reservoir across the incubation area into the side waste reservoir. The incubation area may comprise agitation means for homogenous dispersion of reagent into liquid.

Abstract: Photoresponsive devices including a photoresponsive electrode are provided, and methods for their use to measure changes in environment at a site at or about the surface of the photoresponsive device. By employing a source of light for irradiating a site on the surface and means for biasing the photoresponsive electrode in relation to a counterelectrode, a variation in electrical signal can be related to a change in a medium in photoresponsive modulation relationship to the photoresponsive electrode surface.

Abstract: The peptide N-terminal pro-ANF, which is present in body fluids such as plasma, has been found to be an effective predictor of heart failure and the invention provides prediction and screening methods based upon in vitro assaying of N-terminal pro-ANF in body fluids.

Abstract: A biosensor for the detection and determination of the concentration of toxins by use of enzyme inhibition. Inhibition biosensors are affected by non-specific denaturation and substrate utilization which both result in a limited operational lifetime. These problems are mitigated by providing in an environment an enzyme which is oxidized by hydrogen peroxide the oxidized enzyme being reduced by an electron transfer agent, such as ferrocene, which is itself oxidized in the process. The electron transfer agent is capable of regeneration back to the reduced state and the extend of electron transfer regeneration gives a measure of enzyme inhibition by toxin. Electro-chemical technique allows for the generation of hydrogen peroxide from oxygen in aqueous media and the reduction of oxidized electron transfer agent. Immobilization of the enzyme to an electrode increases efficiency while potentially reducing denaturation. The biosensor can be used for the environmental determination of toxins like cyanide.

Abstract: An immunoassay element comprising at least one layer containing a leuco dye coating composition comprising:______________________________________ Dry Weight Component Ratio (Range) ______________________________________ a) Triarylimidazole leuco dye 55-80 b) Antioxidant 7-40 c) Poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) Alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________

Abstract: An antibody specifically immunoreactive with glycated LDL and methods for using the antibody are provided. The antibody can be used for quantitating amounts of glycated LDL in a sample, for monitoring glycemic control in diabetic patients, for diagnosing disease, for monitoring and diagnosing atherosclerotic cardiovascular disease, and for inhibiting accumulation of LDL cholesterol by cells in tissues subject to atherosclerotic disease.

Abstract: Apparatus for performing determinations of immune reactants (e.g., antigens, antibodies) in bodily fluids includes multiple test units having respective elongated rods with transversely-expanded tips at their distal ends. The tips are each coated with respective immune reactants (e.g., allergens) which react in a known manner with respective allergen-specific or allergen-binding antibodies in human serum. The test units are color-coded to identify the allergen coatings and are supported at their proximal ends and positionally identified on a strip. By correlating the color code to a chart, the specific immune reactant (e.g., allergen) coating can be easily identified. The supporting strip for the test unit has through-holes which frictionally engage the proximal ends of the test unit rods with a spacing that permits all of the supported test units to be simultaneously inserted into an assembly of reaction containers arranged in a linear array.

Abstract: A coupled pair of fiber optic fibers are used an immunoassay device. The fibers are first coupled and then drawn down to a single mode diameter. The coupler senses output ratio change due to chemical, biochemical, bioaffinity, immunogenic-type interactions and other molecular activity occuring within the evanescent field. The fusion joint of the coupler is coated with a first immunoassay component, and then surrounded with a second immunoassay component.

Abstract: An in vitro method and kit for the detection of a cell-mediated immune response to a specific antigen, comprising incubating a whole blood sample with the specific antigen and detecting the presence of gamma interferon released by sensitized lymphocytes in the whole blood sample as an indication of a cell-mediated immune response to the specific antigen.

Abstract: The invention is a non-invasive diagnostic test which is performed on the surface of the skin. This test indicates skin cholesterol levels which can provide information about the extent of aortic atherosclerosis. The invention also relates to reagents in the form of affino-enzymatic test compounds for use in the diagnostic test.

Abstract: Monoclonal antibodies are provided which bind to an antigen associated with prostate cells, including prostate cancers. The monoclonal antibodies and recombinant forms thereof are used individually or conjugated radioisotopes to target the compounds to cancerous prostate cells, and thus are useful in a variety of diagnostic procedures.

Abstract: The method for detecting the sulfidoleukotrienes sLT of the group LTC4, LTD4 and LTE4 by a single immunoenzymatic ELISA assay is based on the interaction between one or several monoclonal anti-sLT antibodies and a sLT conjugated to a revealing enzyme. A biological sample, wherein a content of sLT is assumed, is contacted with a monoclonal anti-sLT antibody bound to a carrier. After the sLTs present in the sample are bound to the said antibody, a conjugate of a sLT with a revealing enzyme is added to the charged carrier. Finally the amount of the conjugate bound to the carrier is evaluated, which amount is in an inverse correlation with the sLT bound to the carrier. The method is useful for in vitro-tests for the diagnosis of inflammatory diseases, as rheumatic diseases, immuno deficiencies, allergies or pseudo-allergies. With a priming of the biological samples with cytokines, e.g. with IL3, IL5 or GM-CSF as priming agents, the sensitivity of the method can be increased.

Abstract: The present invention provides an improved biotin-avidin formulation in which a biotinylated antibody conjugate or an avidin-enzyme conjugate is present in a suitable diluent for immunohistochemical staining. The diluent additionally comprises casein in an amount sufficient to prevent charge interactions of the conjugate with a tissue section and gamma globulin in an amount sufficient to prevent Fc receptor binding and any hydrophobic interaction of the conjugate with a tissue section. In a preferred embodiment, the immunoglobulin is from the same species as the biotinylated antibody conjugate. The formulation effectively reduces overall unwanted binding, irrespective of the source of the binding.

Abstract: A method for detecting the presence of cancer employs monoclonal antibody OXA or OXB, antibodies which bind to the antigen bound by monoclonal antibody OXA or OXB, or fragments of the foregoing which bind to the antigen bound by monoclonal antibody OXA or OXB. The method comprises contacting a sample of a biological fluid from a subject with the antibody under conditions permitting the antibody to form a reaction product, and then detecting the presence or absence of the reaction product. The method is particularly useful for monitoring the progression of treatment in a patient previously diagnosed as having ovarian or colon cancer. The method is also useful for detecting and monitoring endometrial cancer, and for detecting colon cancer.

Abstract: New devices and kits for solid-phase immuno-assays comprising a solid porous support, preferably in the form of a sheet, where antigens or immuno-globulins or both of them are bound by direct application in any suitable geometry, e.g. as an assay of dots or lines. Such porous supports are suitable for effecting an unlimited number of antibody-antigen reactions simultaneously and in one operation.

Abstract: An immunoassay for a protein that is non-enzymatically glycosylated on the alpha amino group of its N-terminal amino acid, the immunoassay comprising: providing a sample containing the glycosylated protein; reacting the glycosylated protein with a reducing agent so that the sugar residue on the N-terminal amino acid is reduced; contacting the reduced glycosylated protein with an antibody directed to Glc-ol-X which is prepared by immunizing an animal with an immunogen of the formula (Glc-ol-X-L).sub.n -carrier; and detecting or quantitating the reduced glycosylated protein bound to the antibody. In the formula (Glc-ol-X-L).sub.

Abstract: An automatic immunoassay apparatus utilizes cartridges each having at least two wells, a first well of said wells containing solid phase material carrying antigen or antibody, a second well of said wells containing antibody or antigen labelled with labelling compound. The wells may be sealed with a suitable sealing film before use and the sealing film is broken when the cartridge is to be used. The cartridges are transported to a predetermined position on a steppingly movable reaction line and conveyed thereby at a predetermined interval. While the reaction line steps, a sample, labelled antigen or antibody contained in the second well and substrate, if necessary, are added to the first well and stirred at predetermined timings and reaction between the sample and a reactive solution is measured under control of a control device having memory means storing operator selectable programs for various measuring methods.

Abstract: A method for detecting the onset of labor in a patient, which comprises analyzing a body fluid of the patient for estriol concentration; correlating the concentration with a standard value; and relating a higher concentration of estriol relative to the standard value as an indication of potential onset of pre-term labor. The standard is usually selected from the group consisting of (1) a predetermined range of estriol concentrations for the body fluid in normal pregnant humans at a preselected time relative to normal, full-term delivery, or (2) a previously measured estriol concentration of the same body fluid of the same pregnant human. Use of this method does not require determination of an estriol/progesterone concentration ratio in the body fluid being test.

Abstract: Methods and test devices for detecting the presence or amount of target ligand in non-competitive sandwich ligand-receptor assay processes. Antibodies which bind to the complex of ligand receptor and target ligand but do not bind significantly to the ligand receptor and which bind the target ligand with substantially less affinity than the complex are taught and their uses described. These assays can be used to eliminate the "hook" effect in non-competitive sandwich assays. Furthermore, the antibodies are selected and assay methods described so that, as a result of the assay process, no detectable response is observed due to the binding of antibody and ligand receptor in the absence of target ligand.

Abstract: A pretreating method for a sample such as plasma for endotoxin measurement which includes diluting the sample with a surfactant-containing aqueous solution, and subjecting the diluted sample to heat treatment can prevent influences of inhibitors, etc. present in the sample and gives high recovery of endotoxins.

Abstract: A method and a device for performing an assay in order to detect or determine the amount of an analyte in a test liquid, wherein bound and unbound reactants can be separated, comprising a capillary canal for liquid transport that is at least partly bordered by a semi-permeable layer, wherein during performance of an assay a movable solid phase material bearing a ligand capable of binding the analyte or binding a reactant for the analyte is within the capillary channel adjacent to the semi-permeable layer, said semi-permeable layer having pores that are sufficiently small to prevent the passage of the movable solid phase material and sufficiently large to permit passage of unbound reactants there through.

Abstract: The invention provides a method of treating cancer in a mammal comprising administering to the mammal an effective amount of modified C-reactive protein ("mCRP"). The invention also provides a method of treating cancer in a mammal comprising administering to the mammal mCRP in combination with another agent such as a chemotherapeutic compound, immunoadjuvant, or cytokine. The mCRP may be administered to the mammal in a pharmaceutically-acceptable carrier or in liposomes. The invention further provides a method of identifying cancer cells in a mammal using mCRP as an imaging agent.

Abstract: The subject invention concerns a selective, sensitive, and highly reliable immunoassay for detecting human IL-1 .beta. in cultured mononuclear cells or human body fluids. It is a competitive immunoassay which is useful in diagnostic work to detect IL-1.beta. selectively, for the first time, from among similar lymphokines and other substances known to interfere with bioassays for IL-1.

Abstract: This invention relates to monoclonal antibody 88BV59 produced by B-cell lines derived from B-cells of cancer patients actively immunized with autologous tumor antigen. These monoclonal antibodies can be used in both diagnostic procedures and therapy for human cancers.

Abstract: A test kit and method for the amplification and detection of specific antigen cells using a probe. The method includes reacting the probe-specific cells with enzyme-conjugated molecules to form separate molecules. The specific antigen cells are mixed with a selected antibiotic which antibiotic is adversely affected by the enzyme in the reporter molecules and incubating the mixture to promote a bacterial chain reaction forming satellite colonies of bacteria microcolonies about the specific cells which amplifies the cells. The method then includes detecting the amplified probe-specific cells by observing the satellite colonies.

Abstract: A saliva enhancement reagent for use in an ELISA wherein a horseradish peroxidase (HRP) enzyme conjugate system is disclosed.