Abstract: Isolated complexes (which include basement membrane components), antibodies to such complexes or polypeptide constituents thereof, and methods for detecting such complexes or constituents are disclosed. Detection of such complexes in a biological sample by immunological and non-immunological methods allows the diagnosis of a variety of diseases, including cancers, collagen degenerative diseases, and hepatitis. Suitable biological samples include urine, cervical secretions, bronchial aspirates, sputum, saliva, feces, serum, synovial fluid, and cerebrospinal fluid.

Abstract: One or more specific binding ligands can be detected with a competitive immunoassay which utilizes a water-soluble conjugate of ligand and reporter enzyme for each target ligand. Target ligand is allowed to compete for a first receptor with the conjugate. Uncomplexed conjugate is then contacted with an immobilized second receptor to form a reaction product which can be used to generate a detectable signal. This assay provides a direct correlation of the generated signal to the one or more target ligands.

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: A novel method for detecting chitin, and for diagnosing fungal infections (including yeast infections), with a chitinase or other chitin-specific binding protein. This method should allow the convenient, broad spectrum diagnosis of fungal infections in tissue samples or in body fluids. Fungal infections are a particular problem in immunocompromised hosts such as AIDS patients, where they can cause opportunistic infections. This invention overcomes difficulties experienced by prior methods of diagnosing fungal infections.

Abstract: A method to determine reactivity of a candidate compound with a target receptor which method does not require the physical presence of the receptor is disclosed. By providing a formula for treating data obtained from a reference set of receptors which is predictive of reactivity with the target receptor, the compound to be tested can be physically assessed with respect to the reference receptors, the formula applied, and reactivity with the actual target receptor may be predicted.

Abstract: A method is provided for measuring the activity of cholesteryl ester transfer protein or MTP. The method comprises the steps of: adding a prepared emulsion particle to a buffer to form a buffered solution simulating physiological conditions, adding an emulsion of lipid to the buffered solution of prepared sonicated particle, adding a source of CETP or MTP to the buffered solution, adding a compound to the buffered solution for the purpose of testing the compound's effect on the neutral lipid transfer protein (CETP or MTP) activity, incubating the buffered mixture, reading the fluorescence of the solution, and calculating the effect of the compound on the emission spectra of the transfer label so transfer activity can than be accurately determined. A device that determines the activity of CETP or MTP by the use of a newly synthesized donor particle without regard to the presence of colored or otherwise interfering factors.

Abstract: Disclosed are novel compositions and methods, based on ubiquitin subdomain fusion proteins, which are useful for studying the interactions of two members of a specific binding pair, both of which are predetermined. A preferred embodiment relates to the determination of a predetermined ligand in a sample.

Abstract: Drug-dependent antibodies that bind to granulocytes, erythrocytes, platelets or membrane proteins derived from these cells, in the presence of a drug, but not in its absence, can be detected using a sensitive assay. Detection of the drug-dependent antibodies permits diagnosis of cytopenia mediated by the drug.

Abstract: A medium and method for blotting macromolecules is disclosed. The method begins with the separation of macromolecules on a slab gel. Next, a sheet of cellulosic paper is dipped into an alcohol bath. The dipped paper is placed against the slab gel. The paper and the gel are exposed to a means for transferring the macromolecules from the gel onto the paper. In a particularly advantageous embodiment of the method, the paper is dipped into a methanol bath, the transferring means includes an electric field, and the paper is either xerographic paper or cotton bond paper. The present invention is also a medium for blotting macromolecules comprising a piece of cellulosic paper that has been dipped in alcohol.

Abstract: The present invention provides novel monoclonal antibodies HE-22A, HE-35A, HE-39E, and HE-69B against human IgE, a mixture thereof, hybridomas producing the antibodies, and immunoassays of human IgE employing the antibodies, which are useful for clinical diagnosis of allergic diseases or parasitic infections.

Abstract: A process for identifying plasma samples containing effective antibody titers for the treatment and/or prophylaxis of infections caused by a respiratory virus. The process comprises contacting a plasma sample containing antibodies against a respiratory virus with the respiratory virus. The mixture of plasma sample and virus is then contacted with a plurality of cells. The remaining non-neutralized virus in the sample is then determined through an immunoassay following replication of the virus in the cells. Plasma samples which, at a preselected minimum antibody titer value, prevent viral replication in the cells, are then selected. Plasma from which the selected samples were derived are then pooled to provide an immunoglobulin preparation having increased effectiveness in the prophylaxis and/or treatment of infections caused by the respiratory virus.

Abstract: The present invention concerns a method to catalyze reporter deposition to improve detection or quantitation of an analyte in a sample by amplifying the detector signal which comprises reacting an analyte dependent enzyme activation system with a conjugate consisting of a detectably labeled substrate specific for the enzyme system, said conjugate reacts with the analyte dependent enzyme activation system to form an activated conjugate which deposits substantially wherever receptor for the activated conjugate is immobilized, said receptor not being reactive with the analyte dependent enzyme activation system.In another embodiment the invention concerns an assay for detecting or quantitating the presence or absence of an analyte in a sample using catalyzed reporter deposition to amplify the reporter signal.

Abstract: A recombinant antibody capable of binding to two different antigenic sites, contains Fab fragments from the same or, preferably, different antibodies, which are brought into association by complementary interactive domains which have been inserted into a region of the antibody heavy chain constant region.

Abstract: A sensitive chemiluminescence immunoassay method for field detection of the presence or the amount of low chlorinated biphenyl compounds in a solution is disclosed. The assay has a five minute analysis time and a working range of detection as low as about 1 part per billion chlorinated biphenyl. Kits for the detection of chlorinated biphenyls are disclosed.

Abstract: The present invention provides a process for the determination of the thyroxine-binding capacity in serum, wherein, for the calibration, there are used at least two different standard solutions which contain substantially the same amount of thyroxine-binding globulin but a differing content of thyroxine.The present invention also provides a standard solution for the determination of the thyroxine-binding capacity containing thyroxine-binding globulin dissolved in a buffer system.

Abstract: The invention relates to a process for reducing RNA concentration in a mixture of biological material, comprising the steps of: (a) providing a mixture of biological material having a first concentration of RNA; (b) filtering the mixture through a diatomaceous earth material to produce a filtrate having a second concentration of RNA, wherein the second concentration is less than the first concentration; and (c) collecting the filtrate having a reduced RNA concentration.

Abstract: An IgM class monoclonal antibody which specifically reacts with mucus glycoproteins produced by human gastric gland-type mucous cells is provided. By performing immunohistochemical staining using a labeled derivative of the monoclonal antibody, human gastric gland-type mucous cells as well as mucus secreted by these cells can be specifically stained. The monoclonal antibody can also be used for the analysis of gastric gland-type mucous cell-derived mucus glycoproteins in human body fluids as well as for the examination or diagnosis of cancer.

Abstract: This invention relates to antibodies and is particularly, though not exclusively, concerned with diagnostic and therapeutic methods using monoclonal bi- or tri-specific antibodies. The invention also provides a method in which binding of a first antigen to a first antibody binding site causes release of a second antigen from an adjacent second antibody antigen binding site.

Abstract: A method for reducing or eliminating tyramine interference from amphetamine and methamphetamine immunoassays, comprising treating the sample with aqueous tyramine oxidase for a time and at a temperature and pH sufficient to deaminate any tyramine present in the sample, is provided.

Abstract: An assay for detecting an analyte which comprises applying a sample containing analyte to a surface of an absorbent material having at least one binder for the analyte supported on at least a portion of the surface. The absorbent material has a porosity which is capable of retaining non-charged particles having a size of at least 0.1 micron and no greater than 10 microns on the surface thereof. The sample flows past the binder and into the absorbent material. Porous plastics or ceramics are preferred absorbent materials.

Abstract: A method for reducing interferent bias such as hemoglobin bias in immunoassays using dried slide test elements featuring peroxidase and leuco dye as the labeling mechanism.

Abstract: An immunoassay element for quantitatively analyzing a ligand by determining the change in enzymatic activity caused by a reaction between the ligand, a linked product of the ligand and a high molecular weight compound and an enzyme-labelled antibody. The immunoassay element comprises a substrate layer containing a non-diffusible substrate which forms a diffusible material in the presence of the enzyme, and a reagent layer containing a fragmenting enzyme for further fragmenting the non-difussible material. Also provided is a process for quantitatively analyzing a ligand contained in a sample by the use of the immunoassay element.

Abstract: Methods for determining the presence of a ligand in a sample suspected to contain the ligand are provided, along with apparatus suitable for performing the methods. The methods depend upon a color visualization indicating the ligand's presence or absence in the sample. Preferred methods comprise contacting the sample with colored particles which bear on their surface a receptor specific for the ligand, passing the sample/particle mixture through a filter, and then analyzing the color of the filtrate. The presence of ligand in the sample is established where the color of the filtrate is substantially different from the color of the receptor-bearing particles.

Abstract: This invention pertains to methods to detect antibodies in a sample. The methods use an amount of antigen that is up to 1000, preferably 10-100 times the minimum amount antigen that can be reliably detected and that is less than the maximum expected amount of antibodies in the sample. An antigen:antibody complex is formed and becomes bound to a binding agent that does not bind free antigen. The free antigen is then detected as a measure of antibodies present in the sample.

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

Abstract: Apparatus for carrying out automatically in several successive steps an immunoassay of at least one biological substance in a plurality of biological samples, and the method and the reagents for the use of the said apparatus.

Abstract: A highly sensitive chemiluminescent indicator system is disclosed for determining the presence or amount of an analyte in a liquid sample. The new acid optimum chemiluminescent indicator system comprises haloperoxidase (halide:hydrogen peroxide oxidoreductase), halide, oxidant and chemiluminigenic substrate. The indicator system acts as a synthesizer of highly reactive singlet molecular oxygen (.sup.1 O.sub.2), which reacts with the chemiluminigenic substrate to yield an excited state, oxidized reaction product. The excited state reaction product then relaxes to a lower energy (e.g., ground) state with the emission of measurable light in an amount related to the amount of each of the reaction participants present in a reaction solution. Known, non-rate limiting amounts of three of the reaction participants are provided in an assay solution to determine the presence or amount of the fourth participant in a test sample.

Abstract: An assay and method for screening newborns to determine risk of Sudden Infant Syndrome is described. The assay and method is based on the detection of elevated IgM-anti-IgG (MAG) levels in newborns' serum within the first year of birth. In particular, it has been discovered that elevated MAG levels indicate an increased risk of Sudden Infant Death Syndrome (SIDS).In a preferred embodiment of the invention, an ELISA is utilized in which a first binding agent having specific affinity for IgM is used to capture and separate IgM antibodies from the newborn's blood sample. A second binding agent having specific affinity for IgG which has been separated from the sample eluant by complexing with MAG, is then used in conjunction with an enzyme conjugate to indirectly determine the amount of MAG in the newborn's blood. The MAG level is then compared to a cut-off which is selected to separate out approximately 4% of the newborns which have the highest MAG levels.

Abstract: Disclosed is a method of isolating a ligand from a sample, the method including: providing a hybrid molecule including the receptor for the ligand covalently bonded to the first member of a specific binding pair; contacting sample with the hybrid molecule to form an affinity complex between the ligand and the hybrid molecule; and isolating the affinity complex using the second member of the specific binding pair. Also disclosed is a c-kit ligand, nucleic acid encoding such a ligand, and recombinant cells containing such nucleic acid. The c-kit ligand may be used to stimulate hematopoietic cell growth.

Abstract: A rapid diagnostic method for detecting the rupture of fetal membranes is disclosed. The presence of insulin-like growth factor binding protein 1 (IGFBP-1) in a vaginal secretion sample, resulting from the rupture of fetal membranes, is detected with the aid of at least one specific binding substance for IGFBP-1 .

Abstract: The invention provides a new method for screening for colorectal cancer by measurement of the level of lactoferrin or myeloperoxidase in feces. Particularly, a screening test method for colorectal cancer by measurement of the level of lactoferrin or myeloperoxidase in feces by immunoassay and by measurement of the level of whole-sized lactoferrin by immunoassay utilizing monoclonal antibody.

Abstract: A moist unitary non-laminar chromogen agar color reactive test sheet for use in a simplified enzyme-linked immunosorbent assay (ELISA) for the diagnosis of viral, fungal, bacterial and parasitic diseases. The diagnostic test is designed for use in non-laboratory settings where the usual equipment and supplies, including running water, may not be available. The test sheet comprises chromogen agar paper (CAP) impregnated with an enzyme substrate, and electron acceptor, if needed, in agar. It is applied over a conjugate in the form of a species specific enzyme-linked anti-immunoglobulin bound to an antibody-antigen coating of a previously prepared test plate. After incubation to cause a color reaction, the results are read and interpreted in comparison with known standards.

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: A simplified measuring apparatus for use in the qualitative or quantitative measurement of substances to be assayed in test samples, such as proteins, antibodies and the like, in a small amount of test samples by a simple and easy operation without requiring a B/F separation step comprises: (a) a liquid permeable porous reaction membrane whose surface having at least one reaction area to which an affinity substance capable of directly or indirectly capturing a substance to be assayed or a soluble agent is immobilized; (b) a porous body arranged on the upper part of the porous reaction membrane, to which a soluble agent capable of being solubilized by the addition of a test sample is adhered in a releasable manner; (c) an absorption member arranged on the lower part of the porous reaction membrane, which contacts with a periphery, excluding the reaction area, of the porous reaction membrane via a liquid non-permeable sheet; (d) a liquid non-permeable transparent cover arranged on the lower part of the absorpti

Abstract: An assay method, compositions and test kits using a hydroxyaryl cyclic diacylhydrazide is described. A hydrogen peroxide and peroxidase enzyme. The preferred compositions incorporate enhancer compounds and a chelating agent which suppresses light production prior to addition of a peroxidase enzyme. The assay method can test for a peroxidase enzyme, a peroxide or can be used in immunoassays and probe assays.

Abstract: A method for making a test strip is described. The test strip is generally a substrate, a layer disposed on the substrate and located near the distal end of the substrate. The layer typically contains a chemical reagent detection system capable of detecting the presence of a predetermined analyte in a sample of biological fluid, wherein the reagent detection system produces a detectable change in the layer in the presence of the analyte.

Abstract: An immunoassay element for quantitatively analyzing a ligand by determining the change in enzymatic activity. When the ligand is a low molecular weight antigen, competitive reactions between the ligand, enzyme-labelled antibody and conjugate of the antigen and high molecular weight compound are utilized. When the ligand is a macromolecular antigen, a reaction between the ligand and an enzyme-labelled antibody is utilized directly. The immunoassay element comprises a substrate layer containing a non-diffusible substrate which forms a diffusible material in the presence of the enzyme, and a reagent layer for detecting the thus formed diffusible material. The non-diffusible substrate is composed of a pulverized insoluble polysaccharide. The reagent layer may further contain a fragmenting enzyme for further fragmenting the non-diffusible material.

Abstract: A glycoprotein antigen which is generally characteristic of human carcinomas, regardless of the tissue associated with the carcinoma--human carcinoma antigen (HCA)--and which is generally not present on normal human cells. Immunodeterminant-containing fragments of HCA substantially separated from elements of HCA's naturally occurring environment are also disclosed. HCA is generally characterized by: a) a molecular weight in excess of 750,000; b) carbohydrate moieties characteristic of mucin-type glycoproteins and comprising a relatively high proportion of sialic acid, galactose, and N-acetylgalactosamine residues (e.g., at least 50% of the carbohydrate residues are sialic acid, galactose, or N-acetylgalactosamine residues); c) an isoelectric point below pH 3.

Abstract: A hierarchy of at least two assay techniques is utilized in testing for disease-associated mutations. The first assay in the hierarchy is selected to provide a highly specific test for the existence of the disease-associated mutation, although the accuracy of the test need not be high. The final assay in the hierarchy is selected to provide a highly accurate and highly specific test for the existence of the disease associated mutation. Intermediate tests of progressively greater accuracy may also be included in the hierarchy. Once the hierarchy has been selected for a given mutation-associated disease, a patient sample is analyzed the patient sample using the first, lowest accuracy assay in the hierarchy. If the result of the first assay is negative for the presence of a disease-associated mutation, then the next assay in the hierarchy is performed.

Abstract: The amount of an analyte in a sample derived from a living sample is measured by reacting the analyte with an excess of a substance having affinity for the analyte, followed by separation of complex by high pressure liquid chromatography and measurement using a linear calibration curve representing the peak area values associated with known concentrations of analyte.

Abstract: Complexes (which include basement membrane components) and their polypeptide components are found to be related to the invasiveness of a bladder tumor. Detection of such complexes or constituents in a urine sample by immunological or non-immunological methods permits determining the invasiveness of a bladder tumor.

Abstract: An assay for determining the presence of a threshold concentration of an analyte in a sample comprises first reacting the sample with an amount of anti-analyte selected to reduce the free analyte to a marginally detectable concentration. The sample is then contacted with anti-analyte immobilized on a test region or indicator zone on a solid phase, whereby the residual free analyte may be bound. The binding of free analyte to immobilized anti-analyte is detected by a variety of techniques to indicate the presence of the threshold concentration. By employing limited amounts of anti-analyte on the solid phase, the change between maximum binding of label and no binding of label will be responsive to very small changes in the analyte concentration originally present in the sample.

Abstract: Immunoassay devices and methods that employ non-antibody control substances are disclosed. A non-antibody substance, such as Protein A, that specifically binds to the Fc portion of IgG is used to determine whether patient sample is properly added to the device during the assay procedure.

Abstract: Methods to identify and characterize a candidate drug by detecting and recording its reactivity with each member of an antibody panel are described. A characteristic profile thus obtained can be compared with the profile obtained in an analogous manner for a ligand known to bind a target so as to identify compounds which also bind the target. A similarity in the analogously obtained characteristic profile of the candidate compound and the known ligand indicated that the candidate will bind a target as well.

Abstract: An antibody raised to type I collagen carboxyterminal cross-linked telopeptide isolated from decalcified human or animal bone, may be used in an assay to determine the concentration of liberated carboxyterminal telopeptide region of the type I collagen molecule in a sample. When the sample is a body fluid such as serum or urine the degradation product measured is resistant to further degradation, since it contains a multivalent intermolecular cross-link, and can thus be found in the body fluid. The assay may be used to assess the degradation of type I collagen, the major organic constituent of bone matrix.

Abstract: A method for determining qualitatively or quantitatively the presence of polychlorinated biphenyl in a test sample. The method includes the steps of: providing a known quantity of antibodies to polychlorinated biphenyl; providing a competitor that will bind to said antibodies in competition with polychlorinated biphenyl and having a lower affinity to said antibodies than said antibodies have to polychlorinated biphenyl; incubating said antibodies and said competitor in the presence of a test sample; and detecting the presence of polychlorinated biphenyl in the test sample. The competitor used in this method has one of the following structures: ##STR1## wherein A is selected from the group consisting of --NH--, --S--, --O--, --CH.sub.2 --, --NH--C(O)--, --C(O)--NH--, --NH--C(O)--NH--, --NH--C(S)--NH--, --N(CH.sub.3)--, --N(CH.sub.3).sub.2 --, and --O--C(S)--NH--; B is preferably a single bond or an organic or inorganic group; C is selected from the group consisting of --CO.sub.2 H, --NH.sub.

Abstract: The invention provides methods for detecting calpain activation by measuring levels of calpain-generated spectrin BDPs using antibodies that specifically bind to these spectrin BDPs, but not intact spectrin, or spectrin BDPs generated by other proteases. Also included in the invention are kits for diagnosing diseases associated with increased levels of calpain activation, and methods for screening for effective therapeutics for these diseases.

Abstract: The present invention is directed to the measurement of cell-associated interleukin-2 receptor .alpha. (IL-2R.alpha.) expression in solid non-lymphoid tumors, and the use of such measurement In prognosing the metastatic potential of the tumor, diagnosing the metastatic localization of non-lymphoid tumor, and aiding the monitoring of efficacy of anticancer therapy against metastatic cells of non-lymphoid tumor. The present invention also relates to the use of T-cell receptor (tumor specific TCR.beta. idiotype) in monitoring the efficacy of anticancer therapy against non-lymphoid tumors.

Abstract: Methods and compositions are provided for the determination of cross-reactive alleles, where there is no antibody which will specifically distinguish between the two alleles. Particularly, the method employs an antibody which binds to the two alleles bound to a surface, an antibody specific for one of the alleles, a labeled conjugate which binds to a consensus sequence present in both alleles and positive and negative controls. By having an enhanced value where the interfering allele is present as compared to a value for the target allele, one can distinguish between the various alternatives involving the presence or absence of one or both alleles.

Abstract: Disclosed is a method for detecting analytes in samples of whole blood using solid-phase, permeable support assay devices. The whole blood assays require no steps or reagents other than those necessary to carry out the same analysis on plasma or serum using the devices. The color visualization of the analytical field on which the interpretation of the assay depends is not affected by the presence of intact erythrocytes or any degree of hemolysis in the blood sample.