Abstract: The present invention relates to a filtration-detection device for detecting or quantifying an analyte in a test sample including a filtration device having a first binding material immobilized thereto, wherein the first binding material is capable of binding to a portion of the analyte, and a detection assembly positioned relative to the filtration device to detect or quantify analyte bound to the first binding material. The present invention also relates to methods of using the filtration-detection device.

Abstract: A chromatographic assay or test device for detection and/or determination of an analyte in a test sample, comprises a base member, and a chromatographic medium located in or on said base member, the base member being provided with a receptacle to receive an applicator having the sample applied thereto, and the applicator being movable when located in said receptacle between a first position in which the applicator is out of fluid contact with the chromatographic medium, and a second position in which the applicator is in fluid contact with the chromatographic medium so as to apply a sample on the applicator to the chromatographic medium. In an alternative aspect, the test device comprises a base member, and a second member, at least one of the base member and the second member including a chromatographic medium, and the second member being slidably movable with respect to the base member from a first position to a second position.

Abstract: This invention relates methods for conditioning affinity chromatography resins to decrease leaching of the ligand during purification. The methods involve incubating the resin in a buffered solution of a hydroxyalkylamine compound (e.g., ethanolamine) prior to use of the resin for an affinity purification. The treatment removes unstably bound ligand from the resin.

Abstract: An improvement in the immunofixation electrophoresis procedure for detecting proteins in serum, urine or cerebral spinal fluids. Multiple samples from a single patient are placed on a gel and subjected to electrophoresis for resolving or separating proteins. A container has multiple receptacles which store, separately, various antisera. The separate antisera are withdrawn from the receptacles and simultaneously applied to the sample areas for subsequent incubation. The receptacles are preferably arranged in multiple series in the container, each series offset from, and partially overlapping, the receptacles of the next series.

Abstract: A disposable, dry chemistry analytical system is disclosed which is broadly useful for the detection of a variety of analytes present in biological fluids such as whole blood, serum, plasma, urine and cerebral spinal fluid. The invention discloses the use of the reaction interface that forms between two liquids converging from opposite directions within a bibulous material. The discovery comprises a significant improvement over prior art disposable, analytical reagent systems in that the detectable reactant zone is visually distinct and separate from the unreacted reagents allowing for the use of reaction indicators exhibiting only minor changes as well as extremely high concentrations of reactants. In addition, staged, multiple reagents can be incorporated. Whole blood can be used as a sample without the need for separate cell separating materials.

Abstract: The invention relates to methods, compositions, kits, and devices for detecting cardiac ischemia, hypoxia, or other causes of heart failure in a mammal by obtaining a test sample from a mammal, measuring a level of a non-polypeptidic cardiac marker in the test sample, and determining if the level of the cardiac marker measured in said test sample correlates with cardiac ischemia or hypoxia or another form of heart failure.

Abstract: The invention relates to methods, compositions, kits, and devices for detecting cardiac ischemia, hypoxia, or other causes of heart failure in a mammal by obtaining a test sample from a mammal, measuring a level of a non-polypeptidic cardiac marker in the test sample, and determining if the level of the cardiac marker measured in said test sample correlates with cardiac ischemia or hypoxia or another form of heart failure.

Abstract: A rapid, simple, and inexpensive sandwich enzyme-linked receptor based immunodot assay detects pathogens or pathogenic products in test samples using receptors for a characteristic component of the pathogen. This assay is widely applicable because it is highly specific, it does not require special equipment, and the results can be obtained within a few hours with the naked eye. Since the lipid-based receptors have a long-shelf life, they can be easily stored and used for a long time.

Abstract: A disposable, dry chemistry analytical system is disclosed which is broadly useful for the detection of a variety of analytes present in biological fluids such as whole blood, serum, plasma, urine and cerebral spinal fluid. The invention discloses the use of the reaction interface that forms between two liquids converging from opposite directions within a bibulous material. The discovery comprises a significant improvement over prior art disposable, analytical reagent systems in that the detectable reactant zone is visually distinct and separate from the unreacted reagents allowing for the use of reaction indicators exhibiting only minor changes as well as extremely high concentrations of reactants. In addition, staged, multiple reagents can be incorporated. Whole blood can be used as a sample without the need for separate cell separating materials.

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: A system and method for removing contaminants from a surface. The system is designed to use particles having means thereon which are capable of selectively binding to a contaminant or contaminants of interest. The particles are applied to the surface whereupon the contaminants bind to the particle. When the particle is removed, the desired contaminants are also removed. Preferably, the present invention utilizes magnetic particles having iron therein. The particles may then be readily removed using magnets. The means for binding the contaminant to the particle preferably comprise a ligand or a charge specifically designed to remove the contaminant of interest. The particles may be included in a carrier to facilitate their application to the surface. The invention is especially useful for the removal of contaminants from skin.

Abstract: System, method, and test strip for solid phase, electrochemical, quantitative analysis of analytes contained in biological fluid samples. Preliminary to analysis, a test sample solution can be applied to a sample collection pad associated with the solid phase test environment of the test strip. The test sample solution and a test kit reagent are thereby initially contacted, under assay conditions, within this solid phase test environment, and caused to migrate along a fluid pathway therein. Irrespective of the assay format (competitive assay, sandwich assay, etc.), a test kit reagent (e.g. labeled substance) and the analyte of interest (e.g.

Abstract: A competitive binding assay kit and process for the immunological detection of a blood antigen of specified phenotype (for example phenotypes of human platelet antigen HPA) in a sample of whole blood. The kit contains a substrate having purified blood antigen of specified phenotype immobilized thereon, antibody specific to said blood antigen and means for enabling detection of antibody bound to said blood antigen. The process comprises mixing a sample of whole blood with a predetermined amount of antibody, so as to bind the antibody to any antigen present in the sample of whole blood and bringing the mixture into contact with the immobilized antigen so as to bind any remaining unbound antibody to the immobilized antigen, and determining the amount of immobilized complex and consequently the specified blood antigen phenotype.

Abstract: Methods for detecting parasites, such as Cryptosporidium parvum, in turbid and non-turbid samples by solubilizing molecular markers or antigens of the parasite. The molecular markers are solubilized by incubating a sample containing the parasite with a solubilization buffer and detecting the solubilized antigens by electrochemiluminescence. The solubilization buffer contains one or more detergents alone or in combination with one or more denaturing agents in a buffered solution. The methods are an improvement over existing immunofluorescence assays for C. parvum because the methods described herein are quantitative, reproducible, have high sensitivity, are not labor-intensive, require only minimal sample processing, and avoid being adversely affected by sample turbidity. In addition, by using a electrochemiluminescence assay, microscopy is not required.

Abstract: Device for assaying an analyte, comprising a labelling zone, where a label can bind to the analyte, in communication with a capture zone, wherein the pore size of the capture zone is such that label which is not bound to the analyte can migrate therethrough, whereas label which is bound to the analyte cannot. During migration from the labelling zone (large pore size) to the capture zone (small pore size), unbound label can pass into and through the capture zone, whereas bound label will be captured at the junction of the labelling zone a the capture zone. The device relies upon the label being smaller than the analyte, such that free label is not retarded by the capture zone. It is particularly suitable for assying analytes such as spermatozoa, which are large in comparison with a label such as a labelled antibody.

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 comprise 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: Staphylococcus aureus virulence genes are identified, thereby allowing the identification of novel anti-bacterial agents that target these virulence genes and their products, and the provision of novel S. aureus mutants useful in vaccines.

Abstract: Invention performs an assay to determine presence or quantity of specific analyte in fluid sample. Representative device has two separate flow paths established sequentially in device with a single user activation step. First flow path delivers sample, and conjugate soluble binding reagents to solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. Sample volume delivered by first path determined by absorbent capacity of solid phase, and not by amount of sample added to device. User need not measure sample volume. Sample/conjugate mixture is prevented from entering second flow path because capillary and surface energy of second flow path prevent it from being wetted by this mixture. Second flow path allows wash reagent to remove unbound conjugate and sample from solid phase to the absorbant, and optionally deliver detection reagents.

Abstract: The invention concerns the stabilization and amplification of electrochemiluminescence signals in detection methods.

Abstract: A method for specifically immunoprecipitating albumin from a serum sample, using a “collapsible affinity matrix.” Also provided is a method for the co-removal of immunoglobulin using a “collapsible affinity matrix.” Removal of the highly abundant serum proteins, albumin and immunoglobulin, thereby improves the fractionation of the remaining serum proteins. Due to the collapsible nature of the matrix, less protein is trapped in the void space. Through specific removal of the abundant serum proteins by the collapsible affinity matrix and application of a two dimensional gel electrophoresis method, HiCap 2-D PAGE, the concentrations of a large number of low abundant serum proteins are estimated simultaneously, allowing the identification of several disease-related proteins in a relatively short period of time.

Abstract: The present invention relates to the field of site directed therapy. More specifically the invention relates to site directed radio therapy, and provides a method for production of radioconjugates and an apparatus for radioimmunotherapy. 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 kit for testing male fertility comprises a vessel, a base unit, a liquid supply containing liquid and two filters. The first filter is a sample separation filter which forms a hindrance to transmission of spermatozoa. The second filter of the kit is a spermatozoa detection filter comprising a reagent for identifying spermatozoa. Activation of the kit is prevented until a transport medium, such as the liquid, fills a gap allowing spermatozoa to transmit to a detection zone. The kit may be of one-piece construction and utilizes a thin piece of filter material to separate motile from non-motile spermatozoa.

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: The present invention provides a monoclonal antibody useful for immunoassay of human serum amyoloid A (SAA), which can be used as a marker for inflammations based on the agglutination reaction, as well as a reagent for immunoassay comprising the monoclonal antibody, and a method for immunoassay utilizing the monoclonal antibody. In a preferred embodiment, the monoclonal antibody recognizes at least one epitope of human amyloid A and it agglutinates with human serum amyloid A. The present invention improves the specificity of immunoassay by utilizing the agglutination reaction of SAA and monoclonal antibody in the presence or absence of other monoclonal antibodies recognizing SAA.

Abstract: A method for detecting mutated alleles in an excess of wild type alleles in a sample by isolating sample DNA; amplifying a target DNA sequence; and separating mutated DNA sequences from wild type DNA sequences by virtue of the preferential binding of the wild type sequences to carrier-bound complementary oligonucleotides. The amplification and separation steps may be iterated through one or more additional cycles to enhance sensitivity.

Abstract: A immunochromatographical test device including a cap, an absorbent pad, a membrane, a test strip, a holder, and a housing is disclosed. The housing contains the membrane and the test strip which contains immunoreagents. Secured to the holder is the absorbent pad which contains the sample to be tested. The cap fits over the holder and the holder fits within the housing. When the absorbent pad contacts the membrane, the membrane indicates that a proper amount of the sample has been collected. When the absorbent pad contacts the test strip, a reaction, if any, can be observed via a window formed within the housing.

Abstract: A device for collecting oral liquids includes a lateral flow chromatography strip having a collection pad for insertion into the mouth. The collection pad is separated from the remainder of the chromatography strip by a liquid impermeable removable barrier which prevents liquid in the collection pad from entering the chromatography strip. Once adequate oral liquid has been collected (as indicated by a sample sufficiency indicator), the device is withdrawn from the mouth and the barrier is removed to allow oral liquids to flow through the strip. The liquids interact with binding partners in the strip to provide test results, such as an indication that an analyte of interest is present in the liquid. The strip may be contained in a housing with an access opening through which the removable barrier may be manipulated, and windows through which test results may be viewed. This device avoids reflux of reagents from the strip into the mouth of a test subject during use.

Abstract: The invention concerns a novel method for purifying and quantifying viral particles. More particularly, the invention concerns a method for purifying and quantifying adenovirus by ion-exchange chromatography. The invention also concerns a method for identifying different adenovirus serotypes.

Abstract: An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg.

Abstract: An assay device and method are provided which allow the determination of the presence or absence of at least one analyte in a test sample, while providing specific identification of the test subject. The assay device includes a reaction medium having at least one reaction zone and at least one control zone, which is capable of providing a pattern suitable for identifying the test subject. The pattern suitable for identifying the test subject is preferably a fingerprint. In a preferred embodiment of the invention, the reaction zone and the control zone include at least one member of a ligand/receptor pair.

Abstract: A micro sample tube is disclosed which is of a standard size on the exterior, but which has a reduced internal volume. A slope of an inner wall of the sample tube is a second order or higher curve, and is preferably a circle. Dead volume is reduced, and standard barcode labels can be used, due to the restricted internal dimensions and standard external dimensions. The curved inner wall of the sample tube, and an internal length of the sample tube which is the same as a conventional tube, reduces the likelihood of a sample probe of an automated analyzer impacting on an inner surface of the sample tube and potentially gouging the tube and/or damaging the automated probe. In a preferred embodiment, fins extend around said tube for reduced weight and improved heat transfer of the micro sample tube.

Abstract: The present invention relates to an assay apparatus for detecting a product in a sample. The assay apparatus comprises a fluid pathway with an input of the sample and an input for a reagent with a detectable moiety which transports the sample to a detecting means via a barrier arranged to prevent a product-reagent complex passage but allow passage of unbound reagent and sample. The apparatus also includes supply means for supplying a substance adapted to breakdown the complex into a detectable moiety which can flow through the barrier to the detecting means.

Abstract: The present invention relates to a method for at least one of detecting, quantifying or isolating at least one analyte from a liquid medium in which the analyte is distributed and comprises providing a reagent comprised of particles having a receptor for an analyte fixed to the particles distributed in the medium and a capturing means having an exposed surface defining an active zone. An intermediate reagent is formed by the complex of the reagent with the analyte. A second receptor is fixed in the active zone to capture either the analyte bound by the reagent or the receptor (capture partners). The active zone serves as a site of isolation and concentration of the capture partners.

Abstract: An immunity testing device formed of a thin sheet of material folded to three portions, and the two end portions; named “front cover”0 and “back cover”; fold back to different sides of the center part; named base seat; to provide protection on both sides of the base seat. Two absorbent sheets bridged with a test paper are fixed on the side of base seat that's facing the front cover. A hole is present at the position of the first absorbent sheet on base seat for specimen application. The front cover is disposed with observation cover plates at the position corresponding to the test paper and/or water-absorbing sheets for observation of test result as well as for preventing pollution before, and after use. The test paper is pre-embedded with antibodies/antigens to capture the corresponding antigens/antibodies in the test specimen as in Immunity method. The used testing device can be burned down to ensure environmental protection.

Abstract: An analytical element can be used to sensitively and rapidly detect a wide variety of specific binding ligands in either a competitive or sandwich assay format. The assays are carried out using a vanadium bromoperoxidase-labeled immunoreactant and a chemiluminescent signal-providing wash composition which comprises a 2,3-dihydro-1,4-phthalazinedione derivative; a halogen, pseudohalogen, halogen-providing source or pseudohalogen-providing source; and a peroxide or a peroxide-generating reagent composition.

Abstract: A displacement-type flow immunoassay is performed using a microcapillary passage. 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: The invention provides an improved test cell for detecting the presence of an analyte in a liquid sample. The device has an elongate casing defining a liquid sample inlet, a reservoir volume, a test volume, and a window through the casing at the test volume. Disposed within the cell is a sample absorbent, a novel biphasic substrate and a reservoir, together capable of transporting an aqueous solution within the casing along a flow path extending from the sample inlet through the test volume and into the reservoir volume. The invention further comprises a method for detecting the presence of an analyte in a liquid sample using the device and a biphasic chromatographic material for carrying out the method.

Abstract: Microporous solid phase materials that are suitable for lateral flow and other assays for detecting the presence of analytes in test samples, that are stable under variations in humidity and, even after storage for extended periods of time, can form stable covalent bonds with molecules containing a free primary or secondary amine group or sulfhydryl group are described. The invention further concerns chemically derivatized solid phase materials, and conjugates comprising such materials. Examples of lateral flow devices for the quantitative or semi-quantitative determination of an analyte in a biological sample are described.

Abstract: A living body component in a sample derived from a living body can be rapidly and accurately measured by reacting the sample with a reagent comprising a combined product of an affinity substance and a polypeptide having at least three acid residues derived from a strong acid, separating the resulting complex by a method applying negative change such as using an anion-exchanger, and determining the amount of the analyte to be measured, on the basis of the amount of the complex or free combined product.

Abstract: The present invention concerns a method for separating at least one species of biological entities from a sample solution, by contacting the sample with a matrix of magnetic particles formed on a substrate such as a sheet a gel, etc. The particles in the matrix are coupled to entities capable of specifically binding to the species of biological entities to be separated. The separation is carried out either for detection purposes for obtaining separately each species of biological entities or for synthesis purposes. The invention further concerns matrices of magnetic particles formed on various substrates and kits for use in the method.

Abstract: The present invention relates to an assay for the detection of modified nucleoside levels in a patient. Detection of the modified nucleoside levels in a patient having a disease such as cancer allows for the progression of the disease to be followed and therapeutic regimens to be altered. Such an assay is particularly useful in following the response of cancer patients to chemotherapeutic treatment.

Abstract: The present invention provides a viscometric method of detecting the presence or absence of an analyte in a solution. The method utilizes a dispersion of a conjugate and a receptor. The conjugate functions as an analog of the analyte, and the receptor can interact with both the analyte and the conjugate to change the viscosity of the dispersion. The test solution is introduced into an aliquot of the dispersion. Equivalent spots of the dispersion and the aliquot containing the analyte within the dispersion are then placed on a substrate such that the spots can spread upon the substrate. The presence of analyte in the test solution is detected by noting a change in the viscosity of the dispersion through a comparison of the spots. To facilitate the method, the invention provides a test kit comprising a conjugate comprising an analog of the analyte, a receptor binding the analog and the analyte, and a substrate upon which spots of liquid can spread.

Abstract: The present invention is directed to an Assay for high capacity screening of substances interfering with the attachment of human IgE to its high affinity receptor and/or of substances capable of detaching already bound IgE from this receptor and for the differential analysis between autoimmune disorders and classical allergies.

Abstract: A device that provides for both the collection of saliva and detection of at least one analyte therein, e.g., a drug, is provided. This device provides for rapid analysis of saliva samples, while also providing a convenient assay method that does not require the addition of extraneous reagents, or other materials. Thereby, this device can be used by non-laboratory personnel without risk of user introduced errors.

Abstract: Formed constituents of a quiescent anticoagulated whole blood sample are optically or visually analyzed in a sample chamber which has a varying through plane thickness due to convergent opposing sample chamber walls. At least one of the convergent walls of the chamber is transparent so that the blood sample constituents can be observed. The chamber's varying thickness produces a first lesser thickness region in the chamber wherein a quiescent monolayer of red blood cells in the sample will reside after the sample is introduced into and fills the chamber. Larger formed constituents such as white blood cells in the sample are unable to enter the aforesaid lesser thickness region of the chamber. The red cells which reside in the greater thickness regions will agglomerate to form rouleaux and lacunea. The exact thickness of the chamber at any particular location in the chamber can be predetermined, or can be determined in situ as the sample is being analyzed.

Abstract: The present invention provides a method and a device that utilizes capillarity-mediated, chromatographic transport, for the qualitative or semi-quantitative analysis of selected analytes in liquid samples. The device utilizes an applicator/collection device for collecting and administering the sample to the flow path such that reagent(s) flow through the applicator/collection device, washing the sample into the reaction pathway. The device farther utilizes an air gap between the initial location of the reagent and the reaction pathway to funnel the reagent efficiently through the sample so as to collect all or substantially all of the sample and make it available for the reaction(s).

Abstract: This is invention is directed to methods of identifying analytes that are differentially present between two samples. The methods involve determining retention data by desorption spectrometry for analytes in different samples using the same selectivity conditions, comparing the data, and identifying analytes that are differentially retained.

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 separation method, a method for detection, a sensor, and a test-kit find application in immunological detection. The separation method provides for separation of a primary species which separation method is suitable for use in an immunoassay method for the detection of an analyte species and includes the use of a first auxiliary species capable of being formed into a second auxiliary species which second auxiliary species is capable of interacting with a third species to facilitate separation.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.