Abstract: A tumor-mimetic cell surface antigen (TMCSA) is produced by chemical treatment of normal human cells with a nucleophilic reagent which causes a hydrophobic-hydrophilic interconversion at the cell surface, such as a halobenzene derivative or a benzene sulfonate derivative. This TMCSA cross-reacts with tumor antigens from every type of tumor examined of any histopathologic type. Cancer is detected by detecting the presence of lymphocytes sensitized to tumor antigens based on their reactivity with TMCSA in a binding assay or lymphocyte stimulation or migration inhibition assay.

Abstract: The present invention is drawn to an immunoassay capable of the rapid detection of a variety of test substances that may be present in a test sample. One feature of the invention is that extraction or isolation of the test substance occurs simultaneously with the formation of the primary antigen-test substance complex. The primary antigen-test substance complex is then captured in a solid phase format having a plurality of interstitial spaces which facilitate rapid and efficient detection. The immunoassay of the present invention works over a wide range of environmental conditions and is simple enough to be used in the absence of laboratory facilities.

Abstract: The present invention provides novel methods of screening for ulcerative colitis and Crohn's disease which include the detection of two disparate autoantibodies: pANCA and VH3-15 autoantibody. The present invention also provides kits for screening ulcerative colitis and Crohn's disease.

Abstract: A new method for the preparation of a whole cell bacterial vaccine for improved protection against bacterial pathogens, particularly against those pathogens which have multiple antigenic serotypes is described. The method particularly involves selective sonication of the whole cells of virulent strains of the bacteria. The preferred vaccine prevented infection of swine with Actinobacillus pleuropneumoniae (APP), which causes porcine contagious pleuropneumonia. The vaccine has good safety and few side effects even at a higher dose than commonly used for bacterins and improved protection against the homologous serotype of the pathogen; and improved cross-protection against heterologous serotypes. The whole cell vaccine, is most useful for veterinary (lower mammal) vaccines.

Abstract: The present invention provides a method for determining the amount of HIV-1 p24 antigen or anti-HIV-1 p24 antibody present in a suitable bodily fluid sample from an HIV-1-infected subject. This invention also provides a kit for determining the amount of HIV-1 p24 antigen or anti-HIV-1 p24 antibody present in an HIV-1-infected subject.

Abstract: A novel method of detecting antibodies to thrombomodulin in plasma or serum as an indication of an individual's propensity to thrombosis or inflammation is disclosed. A method for identifiying patients at risks of thrombosis or glomerular nephritis by monitoring autoantibodies to truncated soluble thrombomodulin is revealed. A preferred method is an ELISA assay to detect antibodies to thrombomodulin.

Abstract: A tumor-mimetic cell surface antigen (TMCSA) is produced by chemical treatment of normal human cells with fluordinitrobenzene. This TMCSA cross-reacts with tumor antigens from every type of tumor examined of any histopathologic type. Cancer is detected by detecting the presence of lymphocytes sensitized to tumor antigens based on their reactivity with TMCSA in a binding assay or lymphocyte stimulation assay.

Abstract: A unitary collection and displacement immunoassay device for determining a toxic substance adhered to aerosols in the air is provided. The device comprises an elongated body having proximal and distal ends and encloses a space defining a collection chamber, a reaction chamber and a measurement chamber, each chamber separated by a liquid flow barrier which delays liquid transport between chambers until a vacuum source is applied to the distal end of the test device to pull liquid into the next chamber. The collection chamber contains a solution for solubilizing the toxic substance from the aerosols and a semi-permeable means for separating the solubilized toxic substance from the aerosols. The reaction chamber contains a labelled immunoreactant bound to a solid phase carrier material. The labelled reagent can be displaced by the solubilized toxic substance.

Abstract: A method for the measurement of serum bile acids by ELISA comprising: preparing a bile acid active ester, reacting the ester with a bovine serum albumin solution, dialyzing, and immunizing a mammal other than human being with the dialyzate thus obtained as an antigen to thereby give an anti-bile acid antibody; reacting said active ester with an enzyme to thereby prepare an enzyme-labeled bile acid as an enzyme-labeled antigen; to a secondary antibody-coated plate, adding a dilution of the serum to be assayed, an anti-bile acid antibody solution and an enzyme-labeled antigen solution and reacting these substances followed by the addition of a substrate and the reaction therewith; measuring the absorbance of the reaction mixture and determining the concentration of each bile acid on the basis of the standard curve measured simultaneously; and referring the sum of the concentrations of these bile acids to the total bile acid concentration; and a method for the diagnosis of a liver disease comprising: calculating

Abstract: The present invention is directed to novel opiate derivatives which are synthesized for the covalent attachment to antigens (proteins or polypeptides) for the preparation of antibodies or receptors to the opiates and opiate metabolites. The resulting novel antigens may be used for the production of antibodies or receptors using standard methods. Once generated, the antibodies or receptors and the novel derivatives which are covalently attached to proteins, polypeptides or labels may be used in the immunoassay process.

Abstract: The present invention relates to the rapid detection of Group A streptococci in clinical specimens, through the enzymatic digestion by a semi-purified Group C streptococcal phage associated lysin enzyme and the identification of the released antigens, through the reaction of a labelled ligand and its respective antigen or receptor. The labelled ligand can be included during the digestion of the bacteria, enabling the total assay time to be less than five minutes. The lysin enzyme is stabilized and can be lyophilized for in situ reconstitution.

Abstract: In a method for measuring a specified component in a specimen by reacting the specimen with a first reagent formed by binding a substance active to the specified component, with carrier particles and a second reagent formed by labelling a substance active to the specified component with a first label, and measuring the substances in the complexes obtained in the reaction, there is disclosed a method featured by labelling the carrier particles with a second label different from the first label, and detecting the second label and then the first label utilizing the detection of the second label as a trigger.This method enables a highly precise measurement without the influence of noise components in the detection of specified trace components in the specimen, utilizing an antigen-antibody reaction or a nucleic acid hybridization.

Abstract: This invention relates to a monoclonal antibody which specifically recognises an antigen of a protozoon parasitizing a mollusk.Application: immunodiagnosis of parasitoses due to a protozoon in mollusks.

Abstract: The invention provides a novel means of diagnosing, or confirming a diagnosis of, affective disorders, such as depression, based on the blood levels of arginine vasopressin and thymopoietin, either alone or in combination.

Abstract: A process for preparing a purified syphilis antigen which comprises adsorbing an extract originated from Treponemda pallidum on a hydroxyapatite gel, followed by elution, while an aqueous medium is used.

Abstract: A method of monitoring markers of bone metabolism by continuously collecting a body fluid sample containing bone loss markers therein and analyzing the components of the body fluids for the markers of bone metabolism.

Abstract: Inter alia, a process for the selective removal of salivary .alpha.-amylase from a sample comprising salivary .alpha.-amylase and pancreatic .alpha.-amylase characterized in that there is used a monoclonal antibody against salivary .alpha.-amylase, which is immobilized or is coupled to a physically separable or seperate support and which exhibits a binding affinity towards salivary .alpha.-amylase of at elast 1.times.10.sup.7 l/m and a cross-reactivity with pancreatic .alpha.-amylase of less than 1% is disclosed. The remaining pancreatic .alpha.-amylase may be assayed.

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

Abstract: A method of identifying compounds that effect integrin activation in intact cells is provided.

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 invention is a simple and rapid method for immune complex dissociation and destruction of rheumatoid factors. It permits the quantitative measurement of the total, i.e., free and immune complex-bound, antigen contained in a test sample. The method involves heating the test sample to a point sufficiently above 65.degree. C. at which the antigen-binding function of antibodies is destroyed. As a consequence, interference by rheumatoid factors is eliminated and the antigen is released from immune complexes, after which it can be measured in an antigen assay that recognizes the heat-denatured antigen.

Abstract: A flow cytometric method for determining procoagulant platelet-derived microparticles in whole blood is described.

Abstract: A non-invasive method to measure total body tissue iron stores comprising recovering iron released from total ferritin contained in a body fluid sample derived from a host, measuring the ferritin-iron in the total ferritin and thereby determining total body tissue iron stores. Such an assay is utilized for diagnosing negative iron balance as well as positive iron balance, wherein the latter promotes cancer, coronary artery disease, atherosclerosis, and hepatic failure among other diseases, as well as the susceptibility to such diseases.

Abstract: The invention discloses monoclonal antibodies which bind specifically to Type II collagen, but not to its peptides, or vice versa. Also disclosed are the methods of preparing hybridomas for production of these antibodies; the assays which utilize these antibodies to detect or quantify Type II collagen and/or its peptides in a solution (e.g., body fluid, culture medium, and tissue extract); and assay kits containing these antibodies.

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: Method for extracting an antigen from a micro-organism organism of the genus streptococcus contained in a sample including the steps of contacting the sample with reagents which generate hyponitrous acid, further contacting the sample with a base, or contacting the sample with hypochlorite, and neutralizing the sample.

Abstract: Peptides which present an epitope substantially similar to the activation site region epitope of apolipoprotein(a) are provided. Antibodies raised against such peptides bind to apolipoprotein(a). Such antibodies and peptides, as well as peptide constructs for immunization are provided. Also provided are monoclonal antibodies and hybridomas, polyclonal serum, assays, diagnostic systems in kit form, chromatographic methods and materials, and synthetic secondary standards. Therapeutic compositions and methods are also provided.

Abstract: Alloantigen is extracted from a cellular source, preferably blood cells, with a mild detergent, and partially purified by precipitation of potentially interfering components. The alloantigen preparation is then used in an assay to determine the presence and specificity of receptors specific for alloantigens. The detection of bound receptor is determined by ELISA or other suitable immunoassays.

Abstract: The present invention relates to the determination of thrombocytopenia induced by an inductor drug such as heparin. According to the invention, a sample is mixed with a complex of an antigenic substance such as platelet factor 4 (pF4) and heparin to determine if the sample contains antibodies which react with the complex. The presence of these antibodies is indicative of heparin-induced thrombocytopenia.

Abstract: A method for the direct analysis of analyte indicative of marijuana exposure found in keratinized structures, e.g., hair, fingernails and toenails, which comprises preparing a mixture containing dithiothreitol or dithioerythritol, a protease suitable for the digestion of the keratin structure and a sample of the keratin structure; permitting the enzyme to at least substantially digest the sample of keratin structure to form a digest solution, followed by mixing the digest solution with a suspension of an ion exchange resin to remove an interfering, cross reacting substance naturally found in hair and finally subjecting the digest solution to analysis to determine the identity and amount of marijuana analyte in the keratin structure sample. To accelerate the method, cupric sulfate may be added to the mixture after degradation of the keratin sample in order to deactivate the activator. The enzyme may be a protease with papain, chymopapain, and proteinase K being preferred for use in the invention.

Abstract: Antigenic compositions are disclosed for use in diagnostic kits and the like for detecting the presence of antibodies specific for Campylobacter pylori, bacteria often associated with the occurrence of Type B gastritis and peptic ulcer disease. Samples of bodily fluids, for instance, may be contacted with immobilized antigen which is then washed and tested for the occurrence of significant levels of antigen/antibody complex. Levels exceeding a predetermined positive threshold are indicative of antibodies to Campylobacter pylori in the sample tested. Kits employing the antigenic compositions of the invention preferably include means for detecting the antigen/antibody complex such as materials and reagents for conducting an enzyme-linked immunosorbent assay, Western blot technique, liposome-based assay or other known detection tests.

Abstract: The present invention includes novel assays employing a capture reagent, involving a first specific binding member conjugated to a polymeric anion such as carboxymethylamylose, and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to/ the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. The use of carboxymethylamylose to prepare a suitably charged capture reagent provides a superior capture reagent that is capable of binding and retaining the analyte on the solid phase even in the presence of polyanionic non-specific binding blockers.

Abstract: The invention relates methods of determining Entamoeba histolytica antigenic reference patterns of proteins recognized by sera from patients having amebic liver abscesses, patients having intestinal amebiasis and patients negative for any amebic disease and methods using these antigenic reference patterns for aiding in the differential diagnosis of a patient with amebic liver abscesses or intestinal ambiasis by detecting the presence of antibodies in a sample of human serum which bind to Entamoeba histolytica proteins identified in the antigenic reference patterns.

Abstract: This study describes method for extraction and quantification of calprotectin (L1 protein) in feces by enzyme immunoassay. This protein is a prominent antimicrobial component of neutrophils, monocytes, macrophages and squamous epithelia. Calprotectin was stable in feces during storage for seven days at room temperature. Fecal calprotectin quantitated in a five gram sample taken from a 24 hours feces collection gave a reliable estimate of calprotectin found in the pooled collection. The assay had a within assay precision (=CV) of 1,9% and a between assay precision of 14,8%. The following mean fecal calprotectin levels were found: Healthy subjects (n=33) 3095 .mu.g/l, hospital controls (n=40): 14697 .mu.g/l, patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis), (n=28) 40850 .mu.g/l. The differences between the means are highly significant.

Abstract: A method is described for the use of monoclonal antibodies in a sensitive immunoassay for halogenated dioxins and dibenzofurans in industrial samples which contain impurities. Appropriate sample preparation and selective enzyme amplification of the immunoassay sensitivity permits detection of dioxin contaminants in industrial or environmental samples at concentrations in the range of a few parts per trillion.

Abstract: The present invention provides devices, methods, and kits for treatment and detection of analytes requiring pretreatment in samples. One-step treatment and detection is possible utilizing the devices and methods of the present invention.

Abstract: A simple immunoassay method is provided which distinguishes pathogenic from nonpathogenic forms Entamoeba histolytica in biological samples. This assay utilizes monoclonal antibody preparations which are specific for designated epitopes of the 170 kd subunit of the Gal/GalNAc lectin. When pathogenic forms, specifically, are to be detected, at least one antibody which is immunospecific for an epitope unique to the forms of the 170 kd lectin found in pathogenic strains is used in the assay. The invention further includes monoclonal antibodies which are immunospecific for epitopes 1-3 of the 170 kd subunit of the Gal/GalNAc lectin of either pathogenic or nonpathogenic forms and to monoclonal antibodies specifically immunoreactive with epitopes unique to nonpathogenic derived 170 kd subunit, as well as purified forms of the Gal/GalNAc lectin from both pathogenic and nonpathogenic forms.

Abstract: A method has been developed for determining microorganisms associated with periodontal diseases which is highly sensitive and shows very low background and cross-reactivity among various closely related antigens. Antigen is extracted at relatively high pH, and either before or immediately after extraction, the antigen-containing specimen is mixed with a blocking composition having at least about 0.2 weight percent of a non-immunoreactive blocking protein. The pH of the resulting mixture is kept high when contacted with the antibodies specific to the antigen of interest. The compositions and components needed for the assay can be supplied in a diagnostic test kit.

Abstract: An assay is provided in which a target ligand is detected in a biological specimen. The method involves treating the target ligand with detergent and then binding the treated ligand to a particle by means of a capturing substance on the particle, thereby forming a complex. The complex is then applied to a porous membrane having a charge similar to that of a glass fiber filter in order to immobilize the complex in the porous membrane. The pore size of the membrane is substantially larger than the size of the complex such that the immobilization of the complex is substantially accomplished by means of the attraction of the complex to the charge of the porous membrane, and not as a function of the pore size of the membrane. Thereafter, the presence of the complex in the porous membrane is detected.

Abstract: A method for determining total analyte concentration in a sample having both free and bound analyte is described. This method involves (a) disassociating immune complexes, (b) assaying for the concentration of free analyte, (c) assaying at least once for the concentration of free analyte in the sample wherein said sample contains a known quantity of analyte which has been added to the sample, and (d) determining total analyte concentration from the assayed concentrations obtained in steps (b) and (c).

Abstract: A rapid, simple, sensitive and reliable method for detecting fecal carcinoembryonic antigens in stool, indicative of the presence of the colorectal cancer is described. The invention is based on the discovery that previous methods of removing coarse and gelatinous materials from a stool and liquid mixture resulted in removing a significant amount of total CEA and CEA-like substances. By not removing or destroying or altering molecules smaller than 500,000 MW, in the process of preparing the stool sample to be examined, a significant portion of CEA and CEA-like substances will remain in the filtered liquid for detection.

Abstract: Methods and compositions for improved liquification of mucoid secretion specimens by treatment with a disulfide bond reducing agent and a DNA digestion agent, and for improved concentration of selected bacterial species from such specimens, are disclosed. The disclosure has applicability to bacterial assay techniques including nucleic acid hybridization, culture and stain techniques.

Abstract: The present invention provides methods, reagents and kits for determining the presence of aromatic ring-containing compounds by immunoassay techniques, including enzyme, fluorescent, chemiluminescent and biosensor immunoassay, as well as radioimmunoassay. Monoclonal and polyclonal antibodies may be used in the practice of the present invention.

Abstract: This invention provides a molecule comprising cyclosporine A or a congener of cyclosporine A which is photochemically attached to a ligand containing a reactive group. This invention also provides a composition of matter which comprises a conjugate of a compound and the aforementioned molecule wherein the compound is bound to the molecule through the reactive group. This invention further provides an antibody directed to the aforementioned composition of matter specific for cyclosporine A or congener of cyclosporine A. This invention also provides methods for detecting the presence of cyclosporine A or congener thereof, methods for detecting the concentration of cyclosporine A or congener thereof, as well as a method of monitoring levels of cyclosporine A or congener of cyclosporine A in a subject.

Abstract: An extraction composition is described which is buffered to a pH from about 8 to about 11 and which contains from about 1 to about 10 weight percent of a water-soluble cationic surfactant which is a quaternary ammonium salt or a mixture thereof and from about 1 to about 10 weight percent of an anionic surfactant which has a sulfate anion having from 6 to 14 carbon atoms and an alkali metal or ammonium cation. The extraction composition is used to extract antigens from Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis or Prevotella intermedia. Extracted antigens are determined using immunological methods. The extraction composition can be supplied as part of a diagnostic test kit.

Abstract: A method for the direct analysis of analyte in keratinized structures, e.g., hair, fingernails and toenails, which comprises preparing a mixture containing a low redox potential compound such as dithiothreitol or dithioerythritol, an enzyme suitable for the degradation of the keratin structure and a sample of the keratin structure; permitting the enzyme to at least substantially degrade the sample of keratin structure, and subjecting the mixture to analysis to determine the identity and amount of analyte in the keratin substance sample. To accelerate the method, cupric sulfate or sodium arsenite may be added to the mixture after degradation of the keratin sample. The enzyme may be a peptidase, endopeptidase or proteinase, with papain, chymopapain, and proteinase K being preferred for use in the invention.

Abstract: The present invention provides an improved method for staining slides using immunochemical reagents. The method comprises the following steps. The assay region of a slide (the region containing the tissue section) is washed with an improved rinsing solution comprising water and a detergent. An evaporation inhibitor liquid is applied to the slide to cover the assay region. For antigens requiring unmasking, the tissue section is combined with an improved, stabilized proteolytic enzyme solution. The slide is rinsed, and the evaporation inhibitor liquid is reapplied to the slide. A primary antibody in an improved diluent containing globulins from the same species as a second antibody is combined with the tissue section for a time sufficient for substantially complete antibody binding. The slide is rinsed, and the evaporation inhibitor liquid is reapplied. A labeled second antibody in the improved diluent is combined with the tissue section for a time sufficient for substantially complete antibody binding.

Abstract: This invention relates to methods that have been found useful in reducing non-specific binding in immunochemical assays, via methods that can be implemented much faster than those used by Ishikawa. The techniques include the use of a lipophilic bridge, such as a liposome, or the elution of the antigen-antibody complex from the solid phase by the use of an anti-idiotypic antibody or an antibody, or the use of a heterologous reversible bridge.

Abstract: Disclosed is a novel immunoassay methodology, bridge immunoassay, which employs a primary free solution analyte/receptor binding reaction, for example, in a sandwich-type format (two or more analyte receptors), in a competitive format (single analyte receptor) or in a related immunoassay format, and a universal solid phase and capture system. The universal capture system comprises a first receptor bound to a solid phase and a bridge receptor (a second receptor) which functions both as a ligand for said bound first receptor and as a receptor for a ligand conjugated to a sample analyte receptor (a third receptor). The bridge receptor is used to immobilize the immunocomplexes formed free in solution by linking them to the bound first receptor. The universal capture system can be used for assays for any analyte as the bridge receptor binds to a ligand, for example, a hapten or binding protein, conjugated to the sample analyte receptor. Methods, compositions and test kits for such bridge immunoassays are provided.

Abstract: A detecting reagent for an antiplatelet antibody, comprises a carrier particle, and a platelet antigen component immobilized on a surface of the carrier particle. The reagent particles do not agglutinate with each other, contrary to the platelets subjected to natural agglutination, probably because the platelet membrane antigen component immobilized on the carrier particle is solubilized in advance.