Abstract: This invention relates to a spin filter assembly and its usage to facilitate the isolation and analyses of molecules and compounds such as proteins present in various biological and non-biological solutions. The spin filter assembly of this invention comprise of a tube having an open top end, a bottom end opposite the open top end, a body of a first length, an inner diameter and a first outer diameter, a filter means at the bottom end, the tube insertable to an upper portion of a centrifuge holder having a closed lower end, an open upper end, a length longer than the first length of the tube, and a second inner diameter greater than the first outer diameter of the tube; and, a container closure means that fits on top of the open end of the tube. The spin filter assembly can be a component of a sample preparation or assay kit, for example, a kit for analyzing proteins by immunoprecipitation. A process for analyzing proteins by immunoprecipitation using the spin filter assembly is described.

Abstract: A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member comprising a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.

Abstract: The invention relates to multiplex ligase chain reaction (LCR). Two or more putative target sequences are selected. For each one, a set of four probes is used simultaneously to amplify the putative sequence if it is present in the sample. Preferably, all the amplicons are labeled with a common label/hapten and, for each different target, with a unique label/hapten. The invention also relates to an immunochromatographic strip device and method employing a diagonal array of capture spots.

Abstract: This invention relates to a lateral flow immunochromatographic assay device with an increased range of sensitivity without an increase in the clearance time or the occurrence of false positive results. The indicator reagent for the analyte is located in both a separate labeling reagent region and a discrete zone of the analyte detection region.

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: Disclosed is a method for determining the concentration of an analyte in a fluid test medium by use of an immunochromatographic test strip through which the test fluid can flow by capillarity. The test strip has at least two capture bands and optionally one or more collection bands which capture labeled anti-analyte antibody to provide a detectable signal. The signals from the label is quantitatively detected in each of the bands to provide a pattern of signals which is unique to the concentration of analyte in the test fluid. The pattern of signals are mathematically combined to create a monotonous dose-response curve to thereby factor out the high analyte hook effect which can be present in this type of assay.

Abstract: Disclosed is a device and method for carrying out an assay for an analyte in a fluid test sample by immunochromatography. The device involves a strip having a non-porous receiving member of a hydrophobic material in direct fluid communication with a reagent region of an absorbent material through which the fluid test sample can flow by capillarity. By applying the fluid test sample to the non-porous hydrophobic receiving member rather than directly to the absorbent material the reliability of the assay is enhanced.

Abstract: A method of determining the concentration of a sample antigen in the presence of an interferant by (1) running two immunoassays on the sample: one assay where the interferant influences the binding of both the sample antigen and a labeled antigen and a second assay where the interferant influences the binding of the sample antigen but not the labeled antigen; (2) obtaining a plot of the possible sample antigen concentrations versus the possible interferant concentrations corresponding to the readout for the sample for each of the two immunoassays; and (3) determining the sample antigen concentration and the interferant concentration which correspond to the point that appears on both of the immunoassay plots.

Abstract: The invention provides a method for measuring the amount of analyte in a sample of biological fluid using a simple low sample volume reagent test strip with a built in metering system. The test strip may include a microtitration zone to prevent oversampling and an integrated capillary to prevent problems associated with short sampling and act as means of absorbing the fluid sample. The test strip comprises a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip. The test strip is used in single use applications such as the determination of the concentration of glucose in blood.

Abstract: A test device for detecting or quantifying determining an analyte in a test solution includes an absorbent material having contact, liposome lysing and electrochemical measurement portions. The contact portion is positioned for contact with and uptake of the test solution. The liposome lysing portion is segregated from the contact portion and has a liposome lysing agent bound thereto. The liposome lysing portion is further either positioned between the contact portion and the electrochemical measurement portion, or partially or completely coincides with the electrochemical measurement portion. The electrochemical measurement portion comprises a first conductor comprising a plurality of fingers disposed on the absorbent material, and a second conductor similarly comprising a plurality of fingers disposed on the absorbent material, where the fingers of the first and second conductors are interdigitated to form an array.

Abstract: A method for increasing the percentage of mammalian offspring of either sex which comprises contacting a semen sample with an antibody specific for the spermatozoa determinative of one sex and separating said spermatozoa from spermatozoa determinative of the other sex, said antibody being bound to a non-porous magnetic bead support having a diameter of 0.1 to 2 microns.

Abstract: The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include, flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.

Abstract: The present invention provides an analytical test device for conducting assays of biological fluids. Methods for carrying out the assays with the disclosed analytical test device are also provided.

Abstract: The slope lines of the peak lines are determined for a reference specimen and a test specimen and then compared with one another to analyze peak lines independently of the background. Preferably a minimum amplitude of a slope line is established with a threshold specimen so that fluctuations with a smaller amplitude can be disregarded. This method is suitable especially for automatic analysis of blot strips.

Abstract: The present invention relates to the field of site directed therapy. More specifically it relates to site directed radio therapy. It provides a method for production of radioimmuno conjugates and an apparatus for radioimmuno therapy. The method, conjugates and apparatus can be practicalized without the need for radioactive shielding and/or airtight facilities. Without these restrictions the invention provides a simple and efficient means of therapy at the bed-side of the patient.

Abstract: A method of determining the concentration of a sample antigen in the presence of an interferant by(1) running two immunoassays on the sample: one assay where the interferant influences the binding of both the sample antigen and a labeled antigen and a second assay where the interferant influences the binding of the sample antigen but not the labeled antigen;(2) obtaining a plot of the possible sample antigen concentrations versus the possible interferant concentrations corresponding to the readout for the sample for each of the two immunoassays; and(3) determining the sample antigen concentration and the interferant concentration which correspond to the point that appears in both the immunoassays plots.

Abstract: The invention provides methods for separating bound label from unbound label within an assay mixture, for predispensing assay reactants in self-contained assay vessels, as well as for detecting the presence and/or amount of an analyte within a fluid sample. In addition, a reusable detection vessel for use therein and with specific binding assays in general is disclosed. In the methods, generally an analyte within a sample is detected or measured by forming an assay mixture containing sample, analyte binding components and label, placing the assay mixture in contact with an immisable primary layer, subjecting the assay mixture to conditions that separate the analyte bound with binding components and label from unbound binding components and label, and subsequently detecting bound label.

Abstract: A suspension of inert particles is prepared in an aqueous solution, to which an antibody or an antigen and a carrier-bound antigen or antibody, respectively, are added in any desired order. After centrifuging, the positive, weakly positive, or negative reaction can easily be recognized on the basis of a simple pattern.

Abstract: The invention relates to multiplex ligase chain reaction (LCR). Two or more putative target sequences are selected. For each one, a set of four probes is used simultaneously to amplify the putative sequence if it is present in the sample. Preferably, all the amplicons are labeled with a common label/hapten and, for each different target, with a unique label/hapten. The invention also relates to an immunochromatographic strip device and method employing a diagonal array of capture spots.

Abstract: The test kit includes a substrate and, welded or bonded thereto, a plastic sheet having blisters. One of the blisters is shaped as a siphon. The other blisters act as reaction vessels and also serve to receive and store a reagent. The test kit may contain a test strip in one of the blisters. The test kit is particularly suited for carrying out immunological tests, whereby the siphon markedly facilitates the procedure during the washing step.

Abstract: A non-competitive method for the determination of analytes. Initially the analyte is bound to a specific binding partner, after which the unoccupied binding sites of the binding partner are inactivated. The bound analyte is then dissociated from the binding partner and replaced by a labeled marker, after which the bound labeled marker is determined. The signal from the bound labeled marker is directly proportional to the initial amount of analyte in the sample, which makes the present method more favorable than the competitive assays.

Abstract: A displacement-type flow immunoassay is performed using a microcapillary sage. The inner wall of the microcapillary passage has immobilized thereon antibodies to the antigen of interest. Labeled antigen is immunologically bound to the immobilized antibodies. Sample antigen passing through the column displaces the labeled antigen. Downstream, the displaced labeled antigen is detected. The microcapillary format of the present invention enhances the sensitivity of the immunoassay over the sensitivity of displacement-type flow immunoassays performed in a column at similar flow rates.

Abstract: Subject matter of the invention is a method of binding a biological material to a solid phase by providing a sample liquid containing the biological material in a sample vessel (A) having an inner contour (A17); then a hollow body (C) which has a contour (C12) that matches the inner contour (A17) is introduced into the sample vessel (A) while being closed with respect to the sample vessel by means of a porous matrix (C11); the sample liquid can enter the structural form (C) through the porous matrix (C11). This method is easy to automate and reduces the generation of aerosols.

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: 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: An antibody specific for a target analyte is purified by affinity chromatography on a substrate bearing a low-affinity analogue of the target analyte. The antibody is displaced from the substrate by contact with a second analogue of intermediate affinity, which remains complexed with the antibody. This complex can be used in a conventional assay for the target analyte, which displaces the intermediate-affinity analogue. The complexed antibody is rendered more storage-stable because the second analogue protects the antibody binding reagion.

Abstract: The invention provides a method for separating target cells from a plurality of cells which is based on a reversible high affinity interaction between two molecules. The method comprises: forming a target cell/cell binding reagent/first molecule/second molecule/solid support complex, wherein the cell binding reagent is specific for target cells present within a plurality of cells and wherein the first molecule reversibly binds to the second molecule; removing non-target cells of the plurality of cells not attached to the solid support; and reversing the first molecule binding to the second molecule, thereby releasing the target cells as separate cells from the plurality of cells.

Abstract: A test device for detecting or determining an analyte in a test solution includes an absorbent material having contact, liposome lysing and electrochemical measurement portions. The contact portion is positioned for contact with and uptake of the test solution. The liposome lysing portion is segregated from the contact portion and has a liposome lysing agent bound thereto. The liposome lysing portion is further either positioned between the contact portion and the electrochemical measurement portion, or partially or completely coincides with the electrochemical measurement portion. The electrochemical measurement portion comprises a first conductor comprising a plurality of fingers disposed on the absorbent material, and a second conductor similarly comprising a plurality of fingers disposed on the absorbent material, where the fingers of the first and second conductors are interdigitated to form an array.

Abstract: A method for assaying bone resorption rates which consists of quantitating the concentration of free lysyl pyridinoline derived from bone collagen, found in a body fluid is disclosed. The method includes immunometric assay, fluorometric assay and electrochemical titration. The structure of specific 3-hydroxypyridinium cross-links found in urine of Paget's disease patients and procedures for making monoclonal antibodies is described.

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

Abstract: Compositions useful in quantitating collagen peptides to determine the rate of bone resorption are prepared by treating bone with a protease, such as collagenase, and purifying the compositions so as to enrich them with peptides that contain 3-hydroxypyridinium cross-links.

Abstract: The present invention is a method useful for the detection of bloodgroup antigens and antibodies. The method of the present invention is envisioned for two types of assays: a direct assay and an indirect assay. The direct assay comprises adding a sample of erythrocytes to a reaction tube charged with two layers of immunoreactive particles, a first layer, preferably Sepharose, having Protein G coupled to the surface of those particles and a second layer, preferably Sephacryl S-200, having Protein A coupled to those particles in a buffer solution. Antibodies specific for the bloodgroup antigens tested for are coupled to the Protein G. The reaction tube is then centrifuged for a time sufficient to force to the bottom of the reaction tube erythrocytes that do not attach to the antibodies.

Abstract: This invention relates to a novel analytical device for collecting, analyzing and storing of biological samples and, more specifically, to an analytical device used in the analysis of biological fluids such as urine.

Abstract: The present invention is an apparatus and a method of detecting a chemical released by perspiration, typically through sweat and broadcasting the detection to a receiver. The chemical may be a drug of abuse. The device which is attached to the skin of a subject contains labeled antibodies or label containing microspheres attached to antibodies. The labeled antibodies are bound to solid phase drug via antigen-antibody interaction. These labeled antibodies are displaced from the solid phase support to which they are bound by free drug molecules in the perspiration. These labeled antibodies then migrate through a spacer layer and are trapped by a layer containing a suitable selective binding material. The label is illuminated or excited by a light source and detected by a photodetector. The signal can be recorded, or transmitted to a remote radio monitor.

Abstract: Disclosed are methods of purifying shiga-like toxins (SLTs) from Polymyxin B sulfate extracts of Verotoxin-producing Escherichia coli. The methods are facile, efficient and reproducible. In another aspect, the toxin is inactivated for use in a vaccine against SLT mediated disease conditions.

Abstract: An immunoassay plate for an immune complex transfer immunoassay, comprising a well type solid phase and a dip stick type solid phase which can be inserted into said well type solid phase, wherein the dip stick type solid phase is coated with either substance (A) or (B) to be mentioned below and the well type solid phase is coated with the other, remaining substance, and these solid phases are used as the two solid phases to be used for an immune complex transfer immunoassay:(A): a substance having a reactive group which specifically binds to a functional group previously introduced onto a substance, which specifically forms an immune complex with a test substance(B): a substance having a reactive group capable of specifically binding to the test substance in the immune complex, a substance which specifically forms an immune complex with the test substance, or a functional group conjugated in advance with said substance, provided that the moiety which binds to the reactive group of (A) does not bind to the rea

Abstract: A chromatographic strip positive readout binding assay device and method suitable for quick, sensitive and reliable field testing for small molecules such as environmental contaminants, drugs of abuse, therapeutic drugs and hormones. The detectable label is not attached to either the analyte or to the analyte receptor. Low affinity binding pairs can be used in the positive readout binding assay.

Abstract: A chromatographic assay device for use with immunoassays allows rapid and convenient assays of analytes of biological interest, and permits extractions to be carried out in situ, avoiding the use of separate extraction vessels. The device has a wide dynamic range and avoids interference from particulates or colored components. In one form, the device comprises: (1) a first opposable component comprising a sample preparation zone adapted to receive a sample to be assayed; (2) a second opposable component comprising a chromatographic medium; and (3) a conductive barrier attached to the second opposable component. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label. Other variations of the device vary the arrangement of components to provide optimal chromatography for a variety of analytes.

Abstract: A suspension of inert particles is prepared in an aqueous solution, to which an antibody or an antigen and a carrier-bound antigen or antibody, respectively, are needed in any desired order. After centrifuging, the positive, weakly positive, or negative reaction can easily be recognized on the basis of a simple pattern.

Abstract: The present invention provides a method of performing an immunological assay separately and in parallel for each of at least a first sample containing or prospectively containing a first binding moiety, which can be an antigen or an antibody, and a second sample containing or prospectively containing the first binding moiety, the method comprising: placing the first sample and the second sample into an array comprising a solid substrate, a plurality of wells and channels, wherein at least one channel is a crossover channel formed in the upper surface of the substrate and is situated above another channel formed in the lower surface of the substrate, thereby forming crossovers comprising crossing but non-intersecting channels; moving said first sample into a first well containing a second binding moiety, which can be an antigen or an antibody, that binds to the first binding moiety, wherein the second binding moiety is bound to the walls of the first well; moving said second sample into a second well containin

Abstract: A method for detecting an analyte of interest present in a mixture at an ultralow concentration includes selecting a radioactive derivatizing agent comprising a multiphoton-emitting radioisotope moiety and a moiety reactive with the analyte of interest, the radioisotope moeity being bound to the derivatizing agent by a bond that is stable under the conditions employed in the other steps of the method, derivatizing the analyte of interest with the derivatizing agent, separating the analyte of interest from other components of the mixture by chromatography, and detecting the analyte of interest using multiphoton detection. The derivatizing step may be performed before or after fractionation. A radiophore for multiphoton emission enhanced chromatography has a first moeity bound to a multiphoton-emitting radioisotope, and a second moiety that is reactive with a functional group of an analyte of interest.

Abstract: A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member comprising a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.

Abstract: The invention relates to novel purified human immunoglobulin E binding factors (IgE-BFs), its individual optionally glycosylated proteins, and fragments thereof, processes for the purification of IgE-BFs, novel monoclonal antibodies to lymphocyte cellular receptors for IgE (Fc.sub..epsilon. R) crossreacting with IgE-BFs, derivatives thereof, processes for the preparation of these antibodies and their derivatives, hybridoma cell lines that produce these antibodies, processes for the preparation of said hybridoma cell lines, the use of the monoclonal antibodies and their derivatives for the qualitative and quantitative determination of IgE-BFs, test kits containing the monoclonal antibodies and/or their derivatives, the use of the monoclonal antibodies for the purification of IgE-BFs, the use of purified IgE-BFs, its individual optionally glycosylated proteins and/or fragments thereof for the prevention and/or treatment of allergy, and to pharmaceutical preparations containing them.

Abstract: A novel technique is disclosed for the prevention of false positive reactions in immunological testing which are caused by interference of C.sub.1 and C.sub.1q. The method is based on heating a sample of a body fluid at a temperature of 59.degree.-64.degree. C. in the presence of a particular neutral salt. A method for screening for rheumatoid factor is also disclosed.

Abstract: A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample.

Abstract: The present invention provides devices and methods for the detection of creatinine in biological fluids using lateral flow methodologies. The invention is particularly useful in providing one step creatinine assays for correcting urinary steroid hormone assays.

Abstract: A method and device is described for direct removal of heparin from whole blood during extracorporeal therapy. In clinical situations where the blood is heparinized to prevent clotting in the extracorporeal circuit containing e.g., a hemodialysis cartridge or a heart-lung machine, it would be desirable to eliminate the systemic heparinization of the patients. The extracorporeal circuit contains a device having antithrombin III immobilized and inserted between the outlet port of the primary extracorporeal device, such as the hemodialysis cartridge or heart-lung machine and the patient. When the heparinized blood comes in contact with the immobilized antithrombin III, heparin is removed and the reperfused blood is substantially free of heparin. The advantage of the system lies in the fact that heparin is removed from the blood rather than neutralized. This helps overcome the adverse reactions and side effects associated with the use of heparin anticoagulation.

Abstract: A test device for detecting or determining an analyte in a test solution includes an absorbent material having separate contact, competitive binding, and measurement portions. The contact portion is positioned for contact with and uptake of the test solution. The competitive binding portion has a binding material for the analyte non-diffusively bound thereto. The measurement portion has a receptor for the analyte and marker-encapsulating liposomes non-diffusively bound thereto. In a method for using the test device, a solution containing the analyte and the analyte-liposome conjugate is allowed to traverse the absorbent material from the contact portion through the competitive binding portion and on through the measurement portion of the absorbent material. The amount of marker in the measurement portion of the absorbent material, following traversal by the test solution, is then determined as a measure of the analyte in the sample.

Abstract: The assay reagent and kit of the present invention suppress non-specific binding of a labeled substance onto a solid phase, and can assay one or more species of antibodies or one or more species of antigens by means of a single reagent in a simple manner. The assay method involves reacting immunological ligands in a test sample with the assay reagent which contains a combination of components (A) and (B), thereby forming complexes, which complexes are captured onto the independently and separately present Solid phases (C), to assay the label contained in the complexes.

Abstract: The novel analytical devices and methods of the present invention involve a semiquantitative specific binding assay method for the detection of the presence of at least a predetermined minimum concentration of an analyte in the test sample. A calibration reagent is present at a concentration sufficient to inhibit the formation of a detectable analyte complex unless a predetermined minimum concentration of analyte is present in the test sample.