Abstract: The invention relates to a method for detecting ELAM-1 expression in a patient comprising (i) administration of a detectable amount of a labelled ELAM-1 specific antibody (or an anti-ELAM 1 antibody fragment) and a pharmaceutically acceptable carrier, and (ii) detecting the label. ELAM-1 is an endothelial cell surface glycoprotein which participates in endothelialleukocyte adhesion. Induction of ELAM-1 expression has been detected on endothelial cells at sites of inflammation.

Abstract: This invention relates to a substantially purified p100 which is a human neu related protein having a molecular weight in the range from about 97,000 daltons to about 115,000 daltons which corresponds substantially to the extracellular domain of the human neu gene product, said protein being detectable in a biological fluid.In another embodiment this invention relates to assays for detecting this protein.Finally, this invention also concerns monoclonal antibodies which are capable of binding to p100.

Abstract: This invention relates to an improved assay device and assay for detecting or quantitating the presence or absence of a substance in a sample. The device has multiple layers comprising a permeable layer (a) having a capture reagent attached to less than the entire membrane, a selectively permeable layer (b) which does not allow assay reagents to pass through (b) and an absorbent layer (c). Layer (b) is in communication with layers (a) and (c). Layer (b) has at least one hole extending therethrough and the hole or holes are directly below the capture reagent in layer (a). The area of the hole or the combined area of the holes is less than the area covered by the capture reagent. This invention also relates to a method of reducing background color development in an absorbent layer of an assay device.

Abstract: An enzyme immunoassay for an antigen using a solid phase, which employs (a) a biotinylated antibody in which a biotin derivative is bound to a thiol group of an Fab' fragment of an antibody, (b) an enzyme-labelled antibody, and (c) a solid phase immobilized with a substance capable of specifically reacting with the above biotin derivative selected from the group consisting of avidin, streptoavidin and a derivative thereof which is bound to the solid phase directly or via a linkage between another biotin derivative and a high molecular weight substance bound to the solid phase, or alternatively employs (a') a solid phase immobilized with a biotinylated antibody via a substance selected from the group consisting of avidin, streptoavidin and a derivative thereof wherein said substance is bound to the biotin moiety of said biotinylated antibody and is also bound to the solid phase directly or via a linkage between another biotin derivative and a high molecular weight substance bound to the solid phase, and (b') a

Abstract: The present invention provides a method for type determination in body fluids of antibodies of a definite immunoglobulin class which are directed against an antigen A according to the immunoassay principle by incubation of the sample solution with at least two receptors R.sup.1 and R.sup.2, of which R.sup.1 is immobilizable and binds with the antibody to be determined and R.sup.2 is labelled and binds either with the antibody to be determined or with the antigen A, separation of the solid phase from the liquid phase and measurement of the label in one of the two phases, wherein the immunological reaction is carried out in homogeneous phase and the sample solution is incubated simultaneously with receptor R.sup.1 and an excess of human antibodies or fragments thereof which belong to the same immunoglobulin class as the antibody to be determined and are not bindable with the antigen A and subsequently receptor R.sup.2 and possibly further receptors are added thereto.

Abstract: A method for determining chondrocalcin through an immunoassay using an enzyme(s)-labeled mammalian chondrocalcin or enzyme(s)-labeled anti-chondrocalcin antibody which is characterized by that mammalian body fluid is used as a specimen and immunoreaction in a solution is utilized to determine the chondrocalcin of the mammalian, reagents and a kit therefor.This determination can be utilized for diagnosis or the like for cartilage-relating diseases in mammals.

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 cancer. The method is also useful for detecting and monitoring endometrial cancer.

Abstract: The invention relates to a method of detecting an inflammation site in an individual by administering to the individual a diagnostically effective amount of detectably labeled immunoglobulin or fragment thereof, wherein the immunoglobulin substantially accumulates at the site when the site is inflamed.

Abstract: There is described an assay system for the assessment of unoccupied specific ligand binding sites on proteins in biological fluids. The assay is carried out with a multilayer assay element and is based on the principle of equilibrium distribution in which a ligand distributes itself between unoccupied sites on the proteins and the remainder of the element. The ligand can be labeled with a detectable moiety or it may be unlabeled and detected through the use of another detectable species. In one embodiment the assay format is utilized to estimate the number of sites on thyroxine binding globulin (TBG) which are not occupied by thyroxine (T4) or triiodothyronine (T3).

Abstract: The invention is an apparatus useful in carrying out an analytical assay. The apparatus has a positive and negative control, as well as a site for determining the presence, amount, or lack of an analyte in a sample.

Abstract: Immunoassays for the detection of antibodies to HCV are provided which employ "C" domain antigens. Immunoassay kits comprising such antigens are also provided.

Abstract: In order to detect a small cell lung carcinoma, synaptophysin, its oligomers and/or its fragments are determined in body fluids.

Abstract: The precision of identification of analyte composition in a sample, where the possible analytes cross-react with specific binding reagents, is enhanced by applying pattern recognition techniques. Samples to be tested are reacted with a panel of specific binding reagents reactive with the set of analytes to be tested to obtain a pattern of reactivity with respect to each analyte at a given concentration. This results in a databank of "CRIM profiles" for known concentrations of each analyte. This databank is stored in a computationally accessible form, which then can be matched against CRIM patterns obtained by testing unknown samples. In one embodiment, each CRIM pattern obtained is plotted as a single point in n-dimensional space, wherein n represents the number of specific binding reagents in the panel.

Abstract: The present invention provides a human monoclonal antibody (C-OU1) which specifically binds a human adenocarcinoma tumor-associated antigen with an apparent molecular weight of about 43 kD and an isoelectric point of about 5.4-6.2. Screening assays using the antibody are also disclosed.

Abstract: Dopamine releasing protein (DARP) is a protein which stimulates release of dopamine from dopaminergic neurons, and is effective at extremely low concentrations. DARP is useful for stimulating vertebrate nervous systems, and for treatment of Parkinson's disease. Antibodies to DARP are useful for inhibiting dopamine release, and for quantifying the concentration of DARP in samples.

Abstract: Two hybridomas that produce receptors containing antibody combining sites that immunoreact with apolipoprotein B-100 are disclosed as are uses for the receptors, compositions and diagnostic systems that include the receptors.

Abstract: A substance having binding sites for at least two molecules may be detected within a sample. A molecule which can be recognized by the substance is labelled such that when at least two of the labelled molecules are bound the binding sites on the substance, the labels on the molecules electronically interact with each other and vary the wavelength dependance of their spectra. This variation in the spectra of the label can be detected. If the sample is suspected of containing the unlabelled form of a molecule, such as biotin or cocaine, a known amount of the above substance, along with a known amount of the corresponding labelled biotin or cocaine is added to the sample. In this instance, the amount of the suspect molecule in the sample is then determined by the extent to which the variation in the spectra of the label has been reduced. Alternatively, the present invention can be used to determine the binding characteristics of the substance within the sample.

Abstract: An interaction system, including an antibody or, antibody fragment having functional capability, which comprises a surfactant-stabilized microheterogeneous dispersion of aqueous phase in a water-immiscible medium, said aqueous phase containing an amount of said antibody or said fragment in a functional state sufficient to effect the interaction; and methods for making and for using said system.

Abstract: A chemical moiety is disclosed which comprises a chemical, biochemical, or biological substance attached to one or more electrochemiluminescent organometallic compounds. In a preferred embodiment of the invention the substance is attached to one or more ruthenium-containing or osmium-containing luminescent organometallic compounds. Methods are disclosed for detecting low concentrations of the chemical moiety using chemiluminescent, electrochemiluminescent, and photoluminescent means. Compounds are disclosed which are useful for labeling substances of interest with ruthenium-containing and osmium-containing labels or other electrochemiluminescent labels. These labeled substances are useful in methods provided for detecting and quantifying analytes of interest in binding assays and competitive binding assays. The labeled substances are of particular use in homogeneous binding assays.

Abstract: In a process for the quantitative determination of the function and antigenic concentration of a substance contained in a biological liquid, the substance is immobilized, the function is determined by the addition of a specific substrate which is then removed by washing, and in a subsequent step the immunological concentration of the bound substance is determined using an appropriate specific detector system with or without the use of an antibody.

Abstract: Methods are disclosed for separating a component of interest from a mixture containing the component of interest and other components. The method comprises contacting a first liquid medium containing the component of interest and other components with a second liquid medium that is of different density than and/or of different viscosity than the first liquid medium. The contact is carried out in such a way that mixing of the media is minimized or avoided. The component of interest is bound to magnetic particles. The contacted first liquid medium and second liquid medium are subjected to a magnetic field gradient to allow the magnetic particles to migrate into the second liquid medium and separation of the component of interest from other components is realized. Also disclosed are assays employing the present method. Kits for carrying out the present method and assays are also disclosed.

Abstract: In order to determine an analyte by a heterogeneous immunological test using a first partner of a binding pair which is immobilized on a solid phase in which a sample solution containing the analyte is incubated in the presence of the solid phase with either(1) a first conjugate consisting of (a) the second partner of the above-mentioned binding pair and (b) a first substance capable of specific immunological binding to the analyte or(2) a first conjugate consisting of (a) the second partner of the above-mentioned binding pair and (b) a first substance capable of specific immunological binding to the analyte as well as with a second labelled substance capable of specific immunological binding to the analyte,afterwards the phases are separated, in case (1) the liquid phase is replaced by a further solution containing a second labelled substance capable of binding specifically to the analyte and it is again incubated and subsequently separated, and in both cases the label on the solid phase or in the liquid pha

Abstract: Derivatives comprising two hydrophilic haptens and an effector group comprising a radioactive isotope or known to be able to be labelled by a radioactive isotope or comprising an active principle or known to be able to bind an active principle, linked by a connecting bridge application to diagnosis and to therapeutics, diagnostic or therapeutic kits and immunological reagents containing them.

Abstract: The invention concerns a process for the preparation of hybridoma cells which secrete monoclonal antibodies specific for hirudin, the hybridoma cells themselves, the monoclonal antibodies specific for hirudin secreted by these hybridoma cells, derivatives thereof, and a process for the preparation of said antibodies and derivatives. These monoclonal anti-hirudin antibodies and their derivatives are useful for the determination of hirudin and as an antidote to hirudin. The invention also concerns test kits and pharmaceutical compositions comprising said monoclonal antibodies and/or derivatives.

Abstract: A cell surface antigen determination method for determining an immunocyte having an immune antigen-antibody complex composed of an antigen and an antibody combined therewith in a liquid which contains immunocytes having various antigens and also containing many kinds of antibodies, and an apparatus used in this method. In accordance with the inventive method and apparatus, non-specific reactions are restrained so as to reduce the background without using a complement.

Abstract: The present invention relates to the stabilization of enzyme-labeled anti-human interferon-.beta. antibody for use in an enzyme immunoassay of human interferon-.beta. and provides a freeze-dried composition containing an anti-human interferon-.beta. antibody which has been freeze-dried in the presence of trehalose as a nonreducing disaccharide. The freeze-dried composition according to the present invention whose reduction in enzymatic activity remains minimized even when stored for a long period of time is conveniently incorporated into an EIA kit. No conventional non-volatile buffer solution such as a phosphate buffer solution is added to the original freeze-dried liquid of the present invention.

Abstract: A method and compounds useful for this method are described for enzyme-amplified signal detection in analytical assays requiring extremely high detection sensitivity which uses a substrate capable of being transformed by an enzyme from a compound which does not form a luminescent lanthanide chelate into a product which forms a luminescent lanthanide chelate. The method in which a substrate not capable of forming a highly luminescent lanthanide chelate is enzymatically altered to produce a product which forms a highly luminescent lanthanide chelate and hence is particularly useful in time-resolved luminescence analysis as required in many different heterogeneous or homogeneous assay formats is described herein.

Abstract: A method of assay for antigen comprising the following sequential steps (A), (B), (C) and (D):(A): the antigen to be assayed in a subject solution is bound with a functional group or marker to form a modified antigen;(B): the modified antigen is bound to a carrier via an antibody against the antigen, and then the carrier is separated from the subject solution;(C): Either (a) or (b):(a) the modified antigen is dissociated from the carrier; or(b) the modified antigen-antibody complex comprising the modified antigen and the antibody against the antigen is dissociated from the carrier; and(D): the modified antigen or modified antigen-antibody complex of Step (C) is assayed.

Abstract: A method of high sensitivity immunoassay characterized by inclusion of processes (A), (B), (C) and (D) described below.Process (A): A process of binding of a solid carrier and a complex comprising the specific antibody or antigenic substance to be assayed in the test solution and one or more active components.Process (B): A process of dissociating said complex from the solid carrier.Process (C): A process of binding this complex to another solid carrier.Process (D): A process of assay for the complex on the solid carrier mentioned in the description of process (C) above.Permitting rapid, high sensitive immunoassay irrespective of whether the subject of assay is an antibody or an antigen, the method of the present invention is very useful for quick diagnosis of various diseases.

Abstract: The invention relates to an assay for determining an analyte in a fluid sample. Three receptors are used, with formation of a quaternary or four member complex. One of the receptors is bound to a solid phase, and binds to complexes of another receptor and the analyte. A third receptor is labelled, and it, too, binds analyte. The invention also involves the use of a displacement solution to wash fluid sample from solid phase after the first portion of the quaternary complex forms, i.e., prior to binding with the labelled receptor.

Abstract: Heme-containing proteins, such as cytochrome c, are useful in admixture with enzyme-labeled immunoreactants, such as peroxidase-labeled antibodies or fragments thereof. The heme-containing proteins and enzyme-labeled immunoreactants can be supplied in a buffered composition as part of a test kit. The buffered composition comprising the heme-containing protein and peroxidase-labeled immunoreactant excludes 4'-hydroxyacetanilide, which is a phenolic electron transfer agent. The composition can be used in immunoassays for detecting various immunologically reactive species, such as hCG, and chlamydial or gonococcal antigens.

Abstract: Monoclonal antibodies specific for the glycosylated lysine residue at position 525 in glycoalbumin and a method for producing such antibodies. The monoclonal antibodies are useful as reagents in immunoassays for the specific determination of glycoalbumin in human blood samples which is indicative of the severity of the diabetic condition. The monoclonal antibodies are secreted by hybridomas obtained by fusing a myeloma cell with a lymphocyte that has been taken from an animal, usually a mouse, immunized with a peptide immunogen and which produces antibody to the lysine 525 residue in glycoalbumin. The synthetic peptide immunogen comprises a peptide residue which includes an .epsilon.-amino glucosylated lysine and an adjacent amino acid sequence in which at least one of the amino acid units is in a position corresponding to the peptide sequence of human albumin adjacent to lysine 525, the glycosylated peptide residue being linked to an immunogenic carrier.

Abstract: A method for measuring target substance contained in a liquid sample is disclosed. The measurement is carried out by using a device having at least one reaction area comprising a solid phase, and the liquid sample is applied onto the reaction area through a porous member to allow for a reaction of predetermined volume of the liquid sample on the reaction area. A device used for such measurement is also disclosed. A device comprises a body having at least one reaction area comprising a solid phase, and a porous member disposed on or above the reaction area. The porous member allows for the liquid sample to be permeated therethrough.

Abstract: The present invention provides a process for the detection of analytes in body fluids containing free biotin by immunoassay with the use of biotin conjugates for the labelling, immobilization or complexing of immunological reagents, wherein the biotin present in free form is removed from the immunological reaction by incubating the sample solution with polymer particles consisting of a core and a covering which, as core, contain a polymer which has a plurality of binding sites for biotin and, as covering, at least one layer of protein, peptide, carbohydrate or co-polymer of carbohydrate and amino acids, the layer thickness of the covering being so adjusted that the coating is permeable for the free biotin but not for the biotin conjugate.

Abstract: Novel assays employing enzyme fragments which complex to form an active enzyme are provided. The reagents involved are a member of a specific binding pair bound to a solid surface, a first enzyme fragment conjugated to a member of a specific binding pair complementary or cross-reactive in relation to the analyte or antianalyte and a second enzyme fragment which binds to the conjugate to form an active enzyme, where the first enzyme fragment conjugate may be present in up to substantial excess to ensure at least substantially complete binding of all of the analyte. By distributing the conjugate between the solid surface and the medium in relation to the amount of analyte present, the enzyme activity may be determined in relation to the amount of analyte present, without separating the solid surface and the medium.

Abstract: The present invention provides for novel homogeneous immunoassay systems involving complement-mediated lysis of marker-encapsulating lipid vesicles (liposomes) for detection of analyte in a fluid sample. These systems do not require the separation of unbound antigens and/or antibody conjugates yet provide highly sensitive procedures for analyte detection. Liposomes containing a marker, are coupled to antibody fragments in a way which confers the liposomes with immunological specificity yet avoids sensitizing the liposomes to complement mediated lysis in the absence of analyte. Antibody sensitized liposomes (the first reagent) are sequentially incubated with an analyte-containing sample, and optionally "dummy" liposomes, which do not contain encapsulated marker, a second antibody (the second reagent), and finally with a complement source such as plasma. Complement is activated by the liposome-antibody-antigen-second antibody complex causing liposome lysis and a concomitant release of marker.

Abstract: A method of selectively modifying an immunoglobulin having at least one Fab region and at least one Fc region, each region having an isoelectric point wherein said isoelectric point of the Fab fragment of said immunoglobulin is different than the isoelectric point of the Fc fragment of the immunoglobulin, said method comprising modification of the immunoglobulin at a pH between the respective isoelectric points of the Fab and Fc fragments of the immunoglobulin.

Abstract: A nucleic acid hybridization assay employing an immobilized or immobilizable polynucleotide probe selected to form DNA.RNA or RNA.RNA hybrids with the particular polynucleotide sequence to be determined. Resulting hybrids are detected by binding of an antibody reagent, preferably labeled with a detectable chemical group, selective for binding the hybrids in the presence of the single stranded sample and probe nucleic acids. No immobilization or labeling of sample nucleic acids is necessary and hybridization can be performed entirely in solution.

Abstract: A method for carrying out competitive displacement immunoassays which entails the use of an oligovalent labelled antibody having at least 4 binding sites for the analyte to be determined per label.

Abstract: The present invention provides cross-linked protein compositions consisting of two or more units of a target-specific protein joined by binding sulfhydryl groups on the target-specific protein units to a sulfhydryl-selective cross-linking agent and a method of making the compositions. These cross-linked protein compositions combine an increase in binding affinity due to the presence of multiple identical binding sites and stability to reduction conditions.

Abstract: Antibodies that immunoreact with the hepatitis B virus HBxAg antigen and with HBxAg polypeptides, as well as diagnostic system and methods for assaying for the presence of HBxAg and anti-HBxAg antibodies in a body sample are disclosed.

Abstract: A method and kit for typing platelets in whole blood for human leucocyte antigens (HLA). A panel of HLA antigens is made on a microtiter plate. Each well is contacted with serum to be typed and the amount of reaction is followed with anti-human (Fab '2) alkaline phosphatase and disodium p-phenylphosphate.

Abstract: A one vial method for labeling a protein, such as an antibody or antibody fragment, with a radiometal such as Tc-99m or a rhenium isotope, is disclosed. The method comprises contacting in a single vial a mixture comprised of a reducing agent and a protein molecule covalently bound to a sulfhydryl containing bifunctional coupling agent with Tc or Re in an oxidized state. A one vial kit for labeling a protein with Tc or Re is also disclosed.

Abstract: This invention pertains to a method for immobilizing polyethylene oxide (PEO) star molecules in the form of hydrogels. the PEO star molecules are biocompatible and demonstrate non-thrombogenic properties. As such, the PEO star molecules have numerous uses for biomedical applications. The hydrogels contain a high percentage of terminal hydroxyl groups for attachment of affinity ligands and can be used for separating and purifying therapeutic proteins.

Abstract: An antibody-enzyme conjugate is prepared having an enzyme to antibody ratio of approximately 3. The conjugate is produced by adding sulfhydryl groups to an antibody and maleimidyl groups to an enzyme to produce a modified antibody and enzyme, and reacting the modified antibody and enzyme to produce the conjugate. In producing the modified antibody and enzyme, about a 15 molar excess of reagents for introducing sulfhydryl and maleimidyl groups is used. When reacting the modified antibody and enzyme, a four molar excess of the modified enzyme is used, and reacting is stopped after a specified period of time by addition of selective reagents. The selective reagents may be cysteine and iodoacetamide.

Abstract: Means for the detection of free ligand analogue conjugate in fluids from competitive ligand-receptor assay processes. Ligand analogue antibodies that bind the ligand analogue conjugate with substantially greater affinity than their affinity for target ligand are selected and used in competitive ligand-receptor assay processes to bind the free fraction of the ligand analogue conjugate. This means permits the detection of the free fraction of ligand analogue conjugate even in the presence of substantially higher concentrations of free target ligand. For the purposes of the present invention, ligand analogue antibodies are antibodies that exhibit at least 100.times.greater affinity for the ligand analogue conjugate compared to their affinity for the target ligand.

Abstract: A method for the determination of the presence of free light chains (Bence Jones protein) in a unconcentrated and undiluted urine sample is provided in which the sample is reacted with an anti-free light chain antiserum reagent, where the presence of the free light chains is revealed by increase in turbidity of the reacted sample. By comparison with the turbidity of calibrators having predetermined concentrations reacted with anti-free light chain antiserum, a quantitative analysis of the amount of free light chains in the urine sample can be determined. A kit for performance of the analysis, including anti-free light chain antiserum reagent, calibrator, and reagent without antiserum, is also provided.

Abstract: The present invention provides a process for the determination of a specifically bindable substance by incubation of a sample solution with at least three receptors R.sub.1, R.sub.2 and R.sub.3, of which R.sub.1 is specifically bindable with R.sub.2 and R.sub.3, as well as with the substance to be determined, R.sub.2 brings about the binding to a solid phase and R.sub.3 carries a labelling, separation of bound labelling from unbound labelling and measurement of the labelling in one of the two phases, wherein, as receptor R.sub.1, a receptor is used which has at least two binding positions which bind specifically with an epitope of the substance to be determined, as R.sub.2 a conjugate of a partner P.sub.1 of a specifically binding pair and of a substance S which corresponds to the substance to be determined or is a derivative thereof and has at least one epitope of the substance to be determined, the partner P.sub.1 thereby either being bound to a solid phase or being immobilized, and as R.sub.

Abstract: There is disclosed, in an immunoassay employing an immunoassay reagent comprising liposomes comprised of at least any one of phospholipids and glycolipids, a marker material enclosed in said liposomes, and an antibody or part of the antibody, or an antigen, immobilized on said liposomes by a cross-linking method, the improvement wherein a material for preventing nonspecific lysis of the liposomes is made present together in a reaction mixture.

Abstract: The present invention provides a process for the determination of an antibody by incubation with three different reagents R.sub.1, R.sub.2 and R.sub.3, of which R.sub. and R.sub.3 are present in liquid phase and are bindable with the antibody, R.sub.2 is present bound to a solid phase and is bindable with R.sub.1 and R.sub.3 carries a label, separation of the solid phase from the liquid phase and measurement of the label in the solid phase, wherein as R.sub.1 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a reaction component of a specific binding system, as R.sub.3 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a label and as R.sub.2 there used the other binding component of the specific binding system. The present invention also provides a composition for the determination of an antibody, wherein it contains two different soluble reagents R.sub.1 and R.sub.