Abstract: Tumor cells, particularly carcinoma cells, are separated from peripheral blood by magnetic sorting. The tumor cells are magnetically labeled with antibodies directed to tissue specific antigens, preferably cytoplasmic proteins. Labeling for cytoplasmic antigens is accomplished first permeabilizing, then fixing the cells. The cells are separated on a magnetic matrix. The number of tumor cells in the enriched fraction is used to calculate the number of tumor cells present in a patient hematopoietic sample.

Abstract: A method of measuring the amount of cyclosporin in a sample suspected of containing cyclosporin is disclosed. A method of inactivating interfering cross-reactive material in an assay for measuring the amount of cyclosporin in a sample suspected of containing cyclosporin is also disclosed. Compositions wherein cyclosporin is conjugated to an immunogenic carrier or a label, optionally through a linking group, at an alanine nitrogen atom of the cyclic backbone of cyclosporin are also disclosed. Compositions wherein atiocyclosporin is conjugated, optionally through a linking group, to an immunogenic carrier or a label are also disclosed. Where cyclosporin is conjugated to an immunogenic carrier, the conjugates may be used as immunogens for the preparation of antibodies which are capable of recognizing cyclosporin.

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

Abstract: Disclosed is a diagnostic device for the colorimetric detection of an analyte in a test fluid. The device is a dry reagent layer which is overcoated with a transparent, fluid permeable membrane. The membrane is made up of a combination of a water dispersible and a water soluble polymer. The membrane may contain a surfactant and a thickener.

Abstract: In order to extend the measuring range and to reduce the Hook effect in an immunological method of determination of an antigen based on the principle of a sandwich assay it is preferable to use a method which is characterized in that the labelled detection molecule is an oligomer of a binding molecule selected from antibody or/and antibody fragment.

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

Abstract: The present invention provides a relatively accurate, rapid and economical method of screening a patient for the presence of inflammatory diseases such as an intraamniotic infection, bacterial meningitis and the sexually transmitted diseases; gonorrhea, chlamydia and trichomoniasis. The method of the present invention involves measuring the concentration of neutrophil defensins HNP1-3 and the concentration of lactoferrin, found in a bodily fluid, tissue or a combination thereof, adding these two concentrations together to yield a summed total, and correlating the measured summed total to known summed totals to give an indication of whether the patient is at risk of suffering from inflammatory diseases such as an intraamniotic infection, bacterial meningitis or the sexually transmitted diseases; gonorrhea, chlamydia and trichomoniasis.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex.

Abstract: One aspect of the present invention relates to a method for releasing a ligand from a complex thereof. The method comprises contacting a medium suspected of containing such complex with an effective amount of a compound effective in releasing the ligand. Another aspect of the present invention is an improvement in a method for the determination of an analyte that is a member of a specific binding pair in a sample suspected of containing such analyte. The method comprises the steps of (a) providing in an assay medium the sample and a binding partner for the analyte and (b) detecting the binding of the binding partner to the analyte. The improvement comprises including in the assay medium a compound of the invention in an amount sufficient to enhance the accuracy of the determination. The invention has particular application to a method for releasing mycophenolic acid from a complex thereof.

Abstract: There is provided a method and kit for measuring the amount of an objective constituent contained in a specific lipoprotein in a biological sample such as serum and plasma, specifically for measuring the amount of cholesterol contained in high density lipoprotein, which can be applicable to clinical tests.

Abstract: Enhanced extraction and assay of solubilized lipopolysaccharide antigens from bacteria such as Chlamydia by the use of a buffer containing an anionic polysaccharide, especially heparin, and surface active agent, especially CHAPS or CHAPSO.

Abstract: The invention relates to a method for staging sepsis in a patient by concurrently measuring in a sample of the patient's blood four parameters which are indicative of the stage of sepsis: 1) the level of microbial product level in the blood; 2) the level of tumor necrosis factor (TNF) response reserve; 3) the maximum oxidant production by neutrophils, and 4) the responsiveness of the patient's neutrophils to immunocomplexes. Based on determining the stage of sepsis, appropriate treatment for the patient may be identified.

Abstract: A (1.fwdarw.3)-.beta.-D-glucan binding protein obtainable by affinity chromatography or gel filtration of an extract of horseshoe crab amoebocytes and having a molecular weight of about 580 kDa, as determined by gel filtration under non-reducing conditions, and about 170 kDa, as determined by SDS-PAGE under reducing conditions, is provided.An antibody which selectively recognizes the protein is also provided. Methods for detecting or removing (1.fwdarw.3)-.beta.-D-glucan in or from a sample using the protein and antibody are disclosed.

Abstract: The invention relates in part to methods and compositions for identifying the presence, measuring the amount, stabilizing, and facilitating recovery of troponin complexes or individual troponin isoforms in a sample.

Abstract: The invention concerns the use of peptides which are comprised essentially of D-amino acids to eliminate interference in diagnostic methods, a method for eliminating interference in diagnostic methods by peptides which are comprised essentially of D-amino acids as well as a reagent that eliminates interference containing at least one peptide which is comprised essentially of D-amino acids.

Abstract: A method for extracting prion protein from a biological material, e.g., an animal tissue or product. In a specific example, abnormal prion protein is extracted from homogenized sheep brain with hexafluoro-2-propanol. The hexafluoro-2-propanol is separated from the aqueous brain preparation by increasing the ionic strength of the aqueous solution. Prion protein in the organic extract can be further purified, or the extract can be tested, e.g., by immunoassay, for the presence of prion protein, and more particularly abnormal prion protein. The extraction process permits testing for the presence of abnormal prior protein, e.g., for diagnosis of transmissible spongiform encephalopathies (TSE).

Abstract: A method for measuring the concentration or the activity of UTI quickly and easily at high sensitivity. A urine sample, a buffer solution, a trypsin solution and a substrate solution are mixed and the trypsin activity is then measured. Thus, the UTI concentration in the urine sample is determined. In this case, a substrate solution having only L-BAPNA is used as the substrate, and the surfactant is mixed in at least one selected from the buffer solution and the enzyme solution. The mixing ratio of the surfactant is about 1 wt. % in the entire enzyme reaction solution. Examples of the surfactant include polyoxyethylene (40) octylphenylether, polyoxyethylene (10) octylphenylether, 3-[(3-cholamido propyl)dimethylammonio]-propanesulfonic acid, 3-[(3-cholamido propyl)dimethylammonio]-2-hydroxypropanesulfonic acid, and polyoxyethylene sorbitan monolaurate. As shown in FIG. 1, the sensitivity improves when using L-BAPNA.

Abstract: The field of the present invention is that of identification and analysis of chemical and/or biological species of the enzyme/substrate, enzyme/inhibitor or antigen/antibody etc. type. The problem on which the invention is based is to provide a system for qualitative and/or quantitative analysis of biological substances by amplified chemiluminescence which allows an actual significant improvement in the emission of light resulting from passage of a chemiluminescent reagent to the excited state. This problem has been solved by means of a system according to the invention, which involves a ligand a) which can be coupled with the substances to be analysed, a chemiluminescent reagent b) of the luminol type, an enzyme c), a substrate d) which oxidizes the enzyme c), and at least one amplifier e), this system being characterized in that the amplifier e) is chosen from the family of halogenophenol (iodophenol) esters.

Abstract: A process for determining glycosaminoglycans in antithrombin III (ATIII)-containing solutions by increasing the ionic strength of the AT III-containing solution until the interaction between AT III and glycosaminoglycans is prevented, removing the AT III which has been released from the glycosaminoglycans from the solution, and desalting and determining the glycosaminoglycan which has remained in the solution.

Abstract: The invention provides a method of assessment of carbohydrate-deficient transferrin in a transferrin containing body fluid, said method comprising the steps of:i) obtaining a transferrin containing liquid sample of or derived from a said fluid;ii) contacting said sample with a source of iron ions;iii) subsequently contacting said sample with an anionic ion exchange resin at a pH such as to cause carbohydrate-deficient transferrin to be retained by said resin;iv) subsequently contacting said resin with an eluant serving to release carbohydrate-deficient transferrin into the eluate from said resin;v) collecting a volume of said eluate substantially free from tetra- and penta-sialo transferrin; andvi) assessing the transferrin variant content in said volume of eluate.By including at least a proportion of the trisialotransferrin in the eluate, it is possible to use relatively simple assessment techniques such as turbidimetry in the assay.

Abstract: Disclosed herein is a method for the detection of a target substance by a colloidal gold immunoassay, which comprises dissolving in an immunoreaction system a metal salt selected from the group consisting of sodium, potassium and lithium fluorides, sodium, potassium, lithium and magnesium iodides, sodium, potassium, lithium and magnesium bromides, lithium and magnesium chlorides, sodium, potassium, lithium and magnesium nitrates, sodium, potassium, lithium and magnesium sulfates, sodium, potassium, lithium and magnesium formates, sodium, potassium, lithium and magnesium acetates, and mixtures of at least two of these metal salts, whereby the metal salt is allowed to exist in a reaction mixture.

Abstract: This invention relates to an improvement in a method for detecting labeled molecules and especially biotinylated molecules and particularly relates to a method for reducing background signal problems in such detection methods.

Abstract: A multilayer dry immunoassay element comprising 1) a spreading layer having a sample application area and a signal read area and 2) a separate receptor layer residing on 3) a radiation-transmissive support characterized in that the spreading layer contains a light absorbing material.

Abstract: An assay device for detection or determination of an analyte in a sample uses opposable components and is suitable for assay of human chorionic gonadotropin and other protein or glycoprotein hormones.

Abstract: A therapeutic method comprising counteracting or preventing pathologies mediated by IL-5, including those characterized by eosinophil infiltration, degranulation and inflammation, by administering to a mammal in need of such therapy, one or more compounds that bind to the eosinophil sulfonylurea receptor, optionally in combination with one or more topical anesthetics and/or glucocorticoids.

Abstract: A process and a reagent for the determination of ions in fluids, wherein the influence of these ions on the activity of an enzyme is measured. The ions for example are sodium, potassium, calcium, magnesium, manganese, lithium, lead, zinc, copper, iron or other heavy metals or non-metallic ions comprising chloride, bicarbonate, protons, ammonium and substances that give rise to ammonium. The enzymes which are used may be a transferase, a hydrolase, an oxidoreductase or a lyase. An essential feature is a method to exclude interferences by ions by masking the interfering ions with a binding agent.

Abstract: The present invention relates to methods for substantially reducing adsorption of at least one positively charged molecule to a negatively charged surface upon contact therebetween, the method comprising combining the positively charged molecule with at least one blocking agent in an amount sufficient to substantially reduce the adsorption of the positively charged molecule to the negatively charged surface.

Abstract: A method is disclosed for determining the presence or amount of analyte in a fecal sample. The method comprises the steps of (A) contacting the fecal sample with an extraction reagent comprised of at least one detergent and at least one buffer to form a mixture, (B) applying the mixture to an absorbent filter that is in proximity to or in contact with an immunoassay such that analyte present in the sample is transferred to the immunoassay, and (C) detecting the presence of analyte by said immunoassay. In a preferred embodiment, the immunoassay comprises a porous strip containing immunoreagents for detecting analyte.

Abstract: A process is provided for the detection and identification of human antibody types which are specific for antigens such as platelet glycoproteins and Human Leukocyte Antigen (HLA). The process aids in detecting and identifying antibody types from a patient sample which are specific for a plurality of known glycoprotein types attached to a solid support, each glycoprotein type unique from each other and separated from each other.

Abstract: The invention provides sets of liquid reagents that afford calibration stability in an enzyme based spectrophotometric assay for the measurement of lactate in patient samples. The reagent sets include a lactate oxidase, a peroxidase, a hydrogen donor, an agent that substantially prevents ascorbic acid interference, and agent that substantially prevents bilirubin interference, a coupling agent, a buffer and, optionally, a preservative. The invention further provides methods for using the liquid reagent sets.

Abstract: The present invention relates to a process for the determination of an analyte, in which a sample optionally containing the analyte to be determined is brought into contact with a first receptor R1, which has a binding affinity for the analyte, immobilized on a solid phase, and a receptor R2, which likewise has a binding affinity for the analyte, is added and in which furthermore the resulting immune complexes are brought into contact with a binding factor which has a binding affinity for the analyte and for a receptor R3 immobilized on the same or a second solid phase and in which the amount of the analyte bound to the first solid phase or, if present, to the second solid phase is detected in a suitable manner.

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

Abstract: The invention provides a new method for antiglobulin testing from serum of a potential blood transfusion recipient in which warm autoantibodies are removed from serum so as to allow identification of alloantibodies present. The method involves contacting serum from a patient with one or more ligands that bind warm autoantibodies but do not bind alloantibodies, separating the non-bound serum components from the bound warm autoantibodies, and using the warm autoantibody-depleted serum in antiglobulin testing. Suitable ligands include phospholipids, the polar head groups of phosphoglycerides, and naturally occurring and synthetic analogues of these molecules.

Abstract: A method for identifying a toxicant in an environmental water or soil sample comprising (a) adding to the sample an antibody known to form a complex with a toxicant suspected to be present in the sample; (b) incubating the antibody with the sample for a time and under conditions sufficient to allow complexes to form between the antibody and the toxicant; and (c) comparing the toxicity of the sample treated as in the step (b) with the toxicity of the sample prior to the step (a), whereby a reduced amount of toxicity of the treated sample compared with the untreated sample indicates the presence of the toxicant in said sample. The method described herein provides unexpected and important advantages by providing more accurate correlations between predicted and observed toxicity of a sample than previous methods.

Abstract: A method is provided, in one embodiment, for the determination of an analyte in a biological fluid sample in the presence of a substance interfering with an assay for the analyte. This embodiment is implemented by using antibodies to cause the selective immunoreaction of at least one of the analyte or the interfering substance and then conducting an assay for the analyte in at least one of the immunoreactants or the non-reactants. Another embodiment provides a disposable reaction device to implement the method. The invention is applicable to the detection of a wide variety of analytes, including cholesterol in a targeted lipoprotein class in the presence of cholesterol in another class; to targeted isozymes of enzymes such as creatine kinase, lactate dehydrogenase, amylase, and alkaline or acid phosphatases in the presence of other isozymes; as well as to targeted immunoglobulins in the presence of non-targeted immunoglobulins.

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

Abstract: This invention provides a method for preserving cells which comprises the steps of (a) suspending cells in a physiologically-acceptable, isotonic medium; and (b) fixing the cells so suspended at a temperature of less than about 10.degree. C. under sufficiently hypertonic conditions so as to disperse the cells in a single, unagglutinated state, thereby preserving cells. This invention also provides a method for detecting cells separated from a sample which have been preserved according to the aforementioned method. This invention also provides a method for visualizing cells. Also provided is a method for detecting a metabolic process in cells present in a sample. This invention also provides a method for detecting the presence of rare cells in a sample which specifically possess on their surfaces a moiety recognized by a known ligand comprising preserving cells separated from the sample according to the aforementioned method for preserving cells.

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

Abstract: The present invention relates to novel methods and devices for detecting non-complexed prostate specific antigen (free PSA), which is used in conjunction with total PSA tests to identify patients having either benign prostatic diseases (BPD), such as benign prostatic hyperplasia, prostatitis, or glandular atrophy or prostatic adenocarcinoma (CAP). In a biological sample, one can find not only free PSA, but also prsotate specific antigen (PSA) which has formed a complex with .alpha.1-antichymotrypsin (ACT). The present invention removes complexed PSA (PSA-ACT) from a fluid sample, thereby removing any possible interference due to binding of complexed PSA to an allegedly free PSA specific antibody in an immunoassay for free PSA.

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

Abstract: The present invention relates to a process for the immunochemical determination of one or more analytes in a sample using an immobilized specific receptor R1, which exhibits interactive bioaffinity with the analyte, and a specific receptor R2, which likewise exhibits interactive bioaffinity with the analyte and which as a rule is labeled. In the novel process, a receptor R3, which possesses one or more than one specific binding site for the analyte, is added and the resulting immune complexes are entirely or partially dissociated, after which they are reassociated and subsequently detected. According to a further embodiment, a receptor R4 is employed in addition to the receptor R3, which receptor R4 possesses an affinity towards R3 and is immobilized on the solid phase, with the resulting immune complexes being entirely or partially dissociated, after which they are reassociated and subsequently detected.

Abstract: A method for assaying a substance is provided in which an optical image is obtained from spots of light emitted from a chemiluminescent material capable of undergoing a luminescent reaction. The method comprises: (a) a step of distributing solid particles on the surface of a support, the solid particles having a diameter of not more than 100 .mu.

Abstract: A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow "one-point" in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.

Abstract: The invention concerns a composition composed of several different antibodies or/and antibody fragments which is suitable as a reagent to reduce interferences in an immunological method for the class-specific detection of antibodies from one or several of the immunoglobulin classes G, M, A, D and E.

Abstract: An assay device comprising a centrifugation tube and, as a sliding fit therein, a less deep inner tube whose base has one or more apertures sufficiently large to allow the passage of particles. This device can be used in an assay for microorganisms in a liquid sample containing fatty material, which comprises centrifuging the sample and a clearing agent in the device, removing the inner tube containing the fatty material, removing at least substantially all of the liquid supernatant in the centrifugation tube, and determining the presence of ATP in the sedimented pellet.

Abstract: A method of performing immunoassay to detect the level of target proteins common to various malignancies including metallopanstimulin or metallopanstimulin-like materials as well as complement components, in a biologic sample is provided wherein the protein molecules in the patient sample compete with radiolabeled peptide for sites on the Anti-peptide-specific antibody. The amount of radioactivity measured is inversely proportional to the concentration of protein molecules present in the patient sample, which is determined from a standard curve. Another method includes determining the presence of a protein elevated in the serum of patients with neoplasms by the detection of the interference of binding or precipitation of a first antibody by a second antibody by the target protein.

Abstract: Chlorine and calcium ions are measured in a biological sample using a maltose derivative having a chromogenic group at the reducing end. These ions are accurately measured in biological samples such as blood and urine without influence of amylase that may be present in such samples.

Abstract: An elcctrobiochemical system for the determination of the presence and optionally concentration of an analyte in a liquid medium, the system comprising an electrode having immobilized thereon a member of a recognition pair, the other member of said pair being said analyte, the presence of said analyte in the medium resulting in formation of a pair complex, being a complex between said immobilized member and said analyte; the system further comprising redox molecules capable of changing their redox state by accepting electrons from or donating electrons to the electrode; the formation of the pair complex on the electrode bringing a change in the electrical response of the system, whereby the presence and optionally the concentration of said analyte in the medium can be determined.

Abstract: A method and device for detecting the presence, absence or amount of an analyte in a whole blood sample is disclosed. The device comprises four zones, a sample receiving zone, a labeling zone, a capture zone and an absorbent zone. The sample receiving zone contains an irreversibly immobilized reagent that allows for removal of substantially all red blood cells from the whole blood sample. Flow through the device is via capillary migration and all of the dissolved or dispersed components in the sample flow at substantially equal rates and with relatively unimpaired flow through the device. The method involves the use of the device for detection of analyte in a whole blood sample.

Abstract: For the qualitative or/and quantitative detection of a substance to be determined in a test sample with the aid of an immunoassay or nucleic acid hybridization assay the following components are used:a) a capture reagent which enables a specific detection of the substance to be determined by means of two different binding sites 1) if desired together with further test components and 2) is bound or is capable of binding to an active solid phase via a specific binding pair one partner of which is linked to the capture reagent and the second partner of which is coupled to an active solid phaseb) an active solid phase andc) an inactive solid phase which substantially corresponds to the active solid phase but to which the capture reagent cannot bind,wherein the test sample is either firstly brought into contact with the inactive solid phase alone and only later with the active solid phase, or is simultaneously brought into contact with the active and inactive solid phase during which the capture reagent and if des