Abstract: A method and apparatus for the manipulation of colloidal particles and biomolecules at the interface between an insulating electrode such as silicon oxide and an electrolyte solution. Light-controlled electrokinetic assembly of particles near surfaces relies on the combination of three functional elements: the AC electric field-induced assembly of planar aggregates; the patterning of the electrolyte/silicon oxide/silicon interface to exert spatial control over the assembly process; and the real-time control of the assembly process via external illumination. The present invention provides a set of fundamental operations enabling interactive control over the creation and placement of planar arrays of several types of particles and biomolecules and the manipulation of array shape and size. The present invention enables sample preparation and handling for diagnostic assays and biochemical analysis in an array format, and the functional integration of these operations.

Abstract: Disclosed is a device, for detecting an analyte in a sample, comprising a sample pad for collecting the sample, a test strip coupled to the sample pad, and a housing enclosing and allowing visualization of the test strip. The sample pad can include one or more markings for determining the amount of sample collected. The device can also include a run fluid container that fits over the sample pad and forms an air-tight seal around the housing. Further, the device can include a second sample pad/test strip combination for detection of a second analyte. Also disclosed are methods for detecting an analyte in a sample using the device.

Abstract: This invention relates to a device for the simultaneous qualitative or quantitative determination of several analytes in a liquid sample. The device comprises a membrane with a charging zone, for the application of the liquid sample, at least two indicator zones which can interact with the analyte(s) and at least one absorption region, which accepts the fluid after passing through the indicator zones, whereby the indicator zones lie between the charging zone and an absorption region, characterized in that the flow directions (flow tracks) are essentially parallel from the application zone through each indicator zone to an absorption region and at least two different flow tracks are present.

Abstract: A method to facilitate recovery troponin I and/or troponin T from a sample comprising addition of troponin C to the sample or to a surface from which the troponin I and/or troponin T are recovered.

Abstract: The invention provides a dipstick and a kit comprising the dipstick, for testing for the presence of a plurality of different targets in a sample solution which comprises: a dipstick having a plurality of different capture zones and, immobilised to each capture zone, a different capture moiety, each capture moiety capable of capturing a different target; and, separately, a plurality of different detection probes, each detection probe capable of binding to a different target and each detection probe being labelled with or enabling the formation of a detection signal so that the presence of each target is indicated by the formation of a signal at the capture zone for that target; wherein the target for at least two of the capture moieties is a disease causing micro-organism or a marker indicating the existence of a disease, disorder, or condition of the host from which the sample solution was derived, and wherein at least two of the capture moieties are capable of binding to different components or markers of t

Abstract: A device for automation of biological and medical tests wherein test subjects or specimens that are placed in test vessels are subsequently treated by different liquid reagents, including: at least two test vessels of dimensions providing accommodation of specimens, a hydraulic gravity feeding system to deliver the liquid reagents into the two test vessels, a hydraulic gravity discharging system to remove waste liquid or spent reagents from the test vessels and directing them into an apparatus for accommodation of the such waste liquid or spent reagents, and a control system operating the device. A mechanical system is provided for agitating the test vessels.

Abstract: A test strip configured for the detection of an analyte in a fluid sample and methods for manufacturing and for using the same. The test strip comprises a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween. The first flow matrix comprises a detection composition movably bound thereto, wherein the detection composition when exposed to the analyte produces at least one detectable product and wherein the first and second solid matrices are selected so as to accumulate the at least one detectable product at the interface between the two matrices, when the fluid sample travels from the first flow matrix to the second flow matrix.

Abstract: A sampling device is described for analysis of a substance, wherein the substance is selected from the group consisting of isocyanates, aminoisocyanates, isothiocyanates, anhydrides, amines and carboxylic acids and can be present in both gas and particle phases in an air flow passed, for sampling, through the sampling device, said device comprising: a) an adsorption device comprising a coating, wherein said coating comprises a reagent mixture in the form of one or more primary or secondary amines and an acidic compound having the ability to form a salt (or ionic bond) with the amine(s) for adsorption of and reaction with the substance in the gas phase of the air flow; and b) a filter device comprising said mixture of amine(s) and acidic compound for adsorption of and reaction with the substance in the particle phase of the air flow.

Abstract: A system for treating a blood sample (700) having an analyte of interest comprises a strip (200) having a membrane (218), respective portions (216, 220 and 222, or 300) which are provided for receiving the sample, for lysing cells of the sample to liberate hemoglobin, and for capturing glycated hemoglobin. The latter two portions (220 and 222, or 300) of the membrane are treated with lysing and capture agents, respectively. A portion of the strip (214 or 230 or 240) is provided for holding an eluting agent and for releasing the agent upon a release condition. A system for detecting analyte comprises an optical subsystem (550) that is aligned with the strip to provide a signal corresponding to an amount of analyte, and an electronic subsystem (650) for processing the signal (560) to provide a result, such as an amount or percentage of glycated hemoglobin.

Abstract: A rapid immunochromatographic assay system is provided for measuring the amount of glycated albumin in a blood sample relative to the total level of albumin in the sample. The assay system is comprised of a disposable cassette that contains the test strips and testing reagents, and a measurement device that automatically reads, calculates and displays the test results over a period of time. The test cassette contains two test strips that are used to measure glycated albumin and total albumin respectively. The strips are contiguous beneath the single sample application well so that the same sample is tested simultaneously by both test strips. Part of the sample will migrate thru the glycated albumin test strip where it will react with the glycated albumin test reagents to yield a glycated albumin result, while part of the sample will migrate thru the total albumin test strip where it will react with the total albumin test reagents to yield a total albumin result.

Abstract: The invention is related to different embodiments of a kit for the simultaneous qualitative and/or quantitative determination of a multitude of analytes comprising a sensor platform comprising an optical thin-film waveguide with a layer (a) transparent at least at an excitation wavelength on a layer (b) with lower refractive index than layer (a), also transparent at least at said excitation wavelength, and at least one grating structure (c) modulated in said layer (a), for the incoupling of said excitation light into layer (a), at least one array of biological or biochemical or synthetic recognition elements immobilized in discrete measurement areas (d) directly or by means of an adhesion-promoting layer on layer (a), for specific recognition and/or binding of said analytes and/or for specific interaction with said analytes, means for laterally resolved referencing of the excitation light intensity available in the measurement areas, and optionally means for the calibration of one or more luminescences gen

Abstract: The present invention relates to a dry reagent assay device having at least one test zone and at least one reference zone, which provides an internal mechanism for assuring correct and reliable assay procedures and reagent qualities. In one embodiment, the present invention relates to an assay device having at least one test zone for detecting at least one analyte in a sample by reacting the sample with a labeled indicator reagent, and a reference zone for receiving unreacted labeled indicator reagent.

Abstract: An apparatus for preparing a macromolecule sample from a complex liquid mixture includes a hydraulic system adapted for control by an automated controller, comprising a pump and one or more valves. The hydraulic system can be controlled by an automated controller to apply the liquid mixture to one or more filters with a pressure differential across each filter. The filters include a rough filter selected to separate, from a macromolecule in a liquid mixture, at least a portion of one or more rough components in the mixture that are larger than the macromolecule. Further included is a fine filter selected to separate from the macromolecule at least a portion of one or more fine components in the mixture that are smaller than the macromolecule. A method for preparing a macromolecule sample includes automatically acquiring a liquid mixture, the mixture including a macromolecule.

Abstract: A novel method for detecting the concentration of a metabolite in a fluid sample is provided. Devices for the detection of the analyte are also provided. In particular, a device for determining the concentration of 11-dehydro thromboxane in a urine sample and comparing it to a set of standardized quartile concentrations is provided. A concentration of urinary 11-dehydro thromboxane that falls within the fourth quartile is indicative of a greatly increased risk of a recurrent cardiovascular event.

Abstract: The present invention provides methods for detecting and quantifying metabolites in a biological sample by measuring the concentration of a test metabolite in the sample and comparing that concentration against the concentration of the reference metabolite; enabling accurate metabolite concentration measurements to determine aberrant drug usage patterns. Also disclosed is an analytical testing device and related computer-assisted products for detecting and quantifying metabolites in a biological sample efficiently and accurately.

Abstract: A compact biosensor cartridge allows biosensors to be tested one by one and protects the biosensors from moisture until they are set. A biosensor dispensing device is also disclosed. A biosensor cartridge may be installed in the dispensing device and pushing and rotating elements are both used to eject the biosensors through a sensor ejecting port in the case. The biosensors are discharged to outside the case when ejection means inside the cartridge are driven by a driving means outside the biosensor cartridge. This configuration allows the biosensor cartridge to be made smaller and thinner.

Abstract: The present invention is to provide a simple membrane assay method for detecting or quantitating an analyte in a specimen sample using an assay device equipped with a membrane bound with a capture-substance to capture the analyte, comprising the steps of filtering a specimen sample using a filter, dropping the filtrate onto said membrane and detecting the presence of the analyte in said specimen sample, as well as a simple membrane assay kit for detecting the presence of an analyte in a specimen sample, comprising (1) a filter tube, and (2) an assay device equipped with a membrane bound with a capture-substance to capture the analyte. The method or the kit can decrease the occurrence of false positivity and can provide a highly accurate detection of the analyte such as pathogen and antibody in a specimen collected in a medical scene or by an individual.

Abstract: A diagnostic assay device that directs an applied sample to the analytical membrane of a directed flow device. The device has a sample receiving port defined by layers of built-up material on one end of the test strip. The port contains the sample and specifically directs it to the membrane in a controlled fashion. Additional features include configuration of the housing in a general C-shape with the test strip spanning the opening of the C-shape to allow access by a reader device. A preferred method employs superparamagnetic particles to label the target analytes for detection and measurement by means of an electromagnetic reader device.

Abstract: The invention is directed to an oligonucleotide comprising a molecular rod, wherein preferentially the molecular rod covalently connects the 3? end of a first nucleotide residue with the 5? end of a second nucleotide residue. Such oligonucleotides are highly advantageous for real time PCR melting curve analysis.

Abstract: A process for the depletion or removal of endotoxins from preparations containing active ingredients designated for therapeutical use which are obtained from natural sources by genetic engineering and/or biotechnology by treatment with chromatographic material wherein said natural sources are lysed, the fractions obtained are optionally centrifuged, filtrated or treated with affinity chromatographic methods; said fractions are preincubated with an aqueous salt solution and detergents, treated with anion exchange material and then washed with another salt solution, and the active ingredients are eluted from the anion exchanger, followed by further purification in a per se known manner.

Abstract: Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.

Abstract: A device for conducting an assay to determine the presence or amount of an analyte in a fluid sample. The device includes a flow path that facilitates fluidic flow by capillary action. The flow path has a first fluid permeable region, a second fluid permeable region, a barrier that inhibits fluidic flow between the first and second regions, and a fluidic bridge. The bridge includes a fluid permeable material overlapping at least a portion of each of the first region, the barrier and the second region.

Abstract: A test kit for immunochromatography comprising a test strip and a test tube is described. The test strip comprises a detection zone for detecting an analyte in a sample. The test tube accommodates the test strip. The test tube comprises an indicator at a position corresponding to the detection zone of the test strip which is inserted into the test tube.

Abstract: A gunpowder particle test kit for determining gunpowder residue includes a transparent sleeve having a closed end and an open folded end sealed with a clip forming a sealed cavity carrying a test strip and a crushable ampoule carrying a diphenylamine solution. The test strip has an adhesive area on a front surface. An opaque label is provided on a rear surface on the sleeve opposite the adhesive area. In use, the clip is removed to open the cavity, the test strip removed and applied to possible residue areas on a subject. The strip is returned to the cavity; the clip reapplied to seal the cavity. Thereafter, the ampoule is crushed to release the solution, which develops a distinctive coloration observable against the label to indicate the presence of possible gunpowder residue.

Abstract: The invention is related to different embodiments of a kit for the simultaneous qualitative and/or quantitative determination of a multitude of analytes comprising a sensor platform comprising an optical thin-film waveguide with a layer (a) transparent at least at an excitation wavelength on a layer (b) with lower refractive index than layer (a), also transparent at least at said excitation wavelength, and at least one grating structure (c) modulated in said layer (a), for the incoupling of said excitation light into layer (a), at least one array of biological or biochemical or synthetic recognition elements immobilized in discrete measurement areas (d) directly or by means of an adhesion-promoting layer on layer (a), for specific recognition and/or binding of said analytes and/or for specific interaction with said analytes, means for laterally resolved referencing of the excitation light intensity available in the measurement areas, and optionally means for the calibration of one or more luminescences gen

Abstract: The invention provides methods and materials for conversion of cytosine to uracil. In some embodiments, a nucleic acid, such as gDNA, is reacted with at least one bisulfite salt having the formula X+HSO3? or Y+2(HSO331)2; wherein X+ is ammonium ion, a tetraalkyl ammonium ion, or a group 1A ion other than sodium; and Y+2 is a group 2A ion or a group 7B ion; under conditions effective to convert at least one cytosine nucleobase to a uracil nucleobase. In some embodiments, X+ comprises at least one of lithium ion, potassium ion, ammonium ion, tetraalkylammonium ion, magnesium ion, manganese ion and calcium ion. In some embodiments, the reacting is performed optionally in the presence of a polyamine catalyst and/or a quaternary amine catalyst. Also provided are kits that can be used to carry out methods of the invention.

Abstract: An apparatus comprising one or more piezoelectric mass sensors for use in diagnostic and analytic processes, in particular for immunochemical detection of diagnostically relevant analytes in real time, is described. Each piezoelectric mass sensor comprises a piezoelectric crystal with a receptor surface which has immobilized thereon a lawn of recombinant antibodies comprising single VH chain or single-chain Fv (scFv) polypeptides specific for a particular antigen. Binding of antigen to the recombinant antibodies results in a change in mass on the receptor surface which is detected as a change in resonant frequency. In a preferred embodiment, the receptor layer is a precious metal such as gold which facilitates self-assembly of the recombinant antibodies into a lawn on the receptor surface via a cysteine residue at the carboxy terminus of the attachment polypeptide.

Abstract: It has been found that a urine test for ovarian reserve can be provided which is equivalent in sensitivity to current laboratory methods which determine ovarian reserve based on FSH levels in serum. A lateral flow device for indicating ovarian reserve is disclosed. The device has an application zone for receiving a urine sample, a labelling zone containing label which binds to FSH in the sample, and a detection zone where FSH-bound label is retained. The detection zone has a threshold value which corresponds to a serum FSII level of between 5-20 mIU/ml (e.g. 10 mIU/ml). A test result above the threshold value indicates diminished ovarian reserve.

Abstract: A test strip and method for detecting an analyte present in a sample.

Abstract: The present invention relates to a biosensor for point-of-care testing (POCT) whose detection sensitivity was remarkably improved by introducing to membrane strip chromatographic assay system a successive cross-flow procedure for immune reaction and enzymatic reaction.

Abstract: The present invention provides an assay device for detection of an analyte which is a member of a specific binding partner in a sample, the assay device comprising a sample application zone, a preabsorbing zone and a specific binding zone. The device can provide a HSV-2 specific assay by preabsorbing HSV-1 antibodies in the preabsorbing zone.

Abstract: A device is provided for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature. The device comprises a cartridge having a plurality of cavities. The device may include a plurality of penetrating members each at least partially contained in the cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from openings on the cartridge to penetrate tissue. The device may also include a plurality of analyte detecting members and a plurality of chambers. Each chamber may be associated with one of the cavities, the chambers positioned along an outer periphery of the cartridge, wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of chambers. In one embodiment, the device may also include a fluid spreader positioned over at least a portion of said analyte detecting member to urge fluid toward one of the detecting members.

Abstract: The invention relates to a device for collecting samples of fluids, in particular of body fluids such as saliva, said device comprising an absorbent pad and two housing parts which are connected to the latter in a movable manner and can enclose the absorbent pad. The device permits easy and safe handling when taking a sample and when transferring the sample for testing for an analyte in the sample. The device can also be handled hygienically and safely by persons not trained in taking samples.

Abstract: The present invention is an analytical device which comprises a porous piece assembly consisting of a liquid reagent-receiving porous piece (1), a labeled substance-retaining piece (2), a test piece (3) comprising a detection site (4) and a reference site (5), and a sample-absorbing porous material piece (6); and a sample-receiving porous material piece (7) disposed independently therefrom and partially communicated therewith through a connection. The analytical device of the present invention exhibits extremely high sensitivity and can accurately perform various types of analysis.

Abstract: A specimen cup (100) has slide-in cassette (102) hermetically sealed in a chamber (104), with a outer partition being transparent. The cassette comprised chemical test strips (106) used to provide testing of drugs of abuse or other chemical or biological substances. The cassette is designed to draw urine up from the front bottom of the cup, thereby reduces the amount of urine required to perform the test. Further the cassette is designed to form isolated test channels through the use of strategically placed vertical and horizontal bars which are hermetically sealed. The cup further comprises a spill prevention flap or float (108) and an optionally enlarged sample collection portion (110) for its operation. The windows of the test cassette are covered with transparent fluid-resistant plate to prevent urine from accidentally spill onto the strips.

Abstract: The invention concerns a method for the detection of an analyte in a sample using analyte-specific conjugates which have at least one heterologous group for an analyte-independent binding to a control zone. The present invention additionally provides new conjugates and reagent kits.

Abstract: A method of determining allergen activity in dust comprises: providing a dust sample; extracting from the dust sample at least one breakdown component or proteins or peptides; reacting the extracted at least one breakdown component with a colorimetric amine detection reagent such as TNBSA; and quantitatively measuring the intensity of any resulting coloration. The allergen activity may be gauged by the intensity of coloration.

Abstract: The present invention provides a method for the detection of early renal disease in animals. The method includes the steps of (a) obtaining a sample from an animal to be tested and (b) determining the amount of albumin in the sample. An amount of albumin in the range of from 10 ?g/ml to about 300 ?g/ml indicates the presence of early renal disease. The present invention also provides antibodies to canine, feline and equine albumin which can be used to detect the presence of early renal disease.

Abstract: Devices for dispensing test strips and methods of using the same are provided. The subject devices are characterized by having a base and a cover, where the cover includes a test strip selecting element. The subject devices may also be characterized by having a test strip holding means, which may include a cover with resiliently deformable walls and/or a gravity controlled test strip holding mechanism. In the subject methods, a test strip container with at least one test strip is provided and placed into a position that causes at least one test strip contained in the base to move into the cover so that a single test strip is selected for use. The subject methods may also include positioning the device in a particular orientation that causes a selected test strip to be held in a fixed position. The subject invention also includes kits which include the subject devices.

Abstract: The invention relates to method for the ESR-spectroscopic detection of changes in the transport properties of albumin in an albumin-containing sample. Said method can be used in the medical, biological, biotechnological and veterinary praxis for diagnostic purposes and/or for monitoring physiological or pathological changes in the human or animal body or for the quality control of albumin-containing preparations, especially blood products. The invention further relates to an ESR spectrometer for carrying out the inventive method, which—being an automated ESR analyzer—allows for a simple and reliable handling required in modern clinical laboratories. The inventive ESR spectrometer integrates automatic device controls, signal registration and signal evaluation in combination with a computer program for the diagnostic analysis of the measured data.

Abstract: The invention relates to an assay method for assessing a transferrin variant or combination of transferrin variants for the diagnosis and monitoring of alcoholism, and to kits for performing the assay. In particular, the invention provides a method of producing an algorithm for determining the content of a transferrin variant or combination of transferrin variants, preferably a CDT variant or combination of CDT variants, in a sample of body fluid, said method comprising: (a) obtaining at least two solutions each having known contents of asialo- (A1, A2, A3, etc.) and disialo-transferrins (D1, D2, D3, etc.); (b) determining the content in each of said solutions of a transferrin variant or combination of transferrin variants fractions substantially free from tri- and higher sialylated transferring; (c) determining the total transferrin variant content (T1, T2, T2, etc.

Abstract: This invention provides methods of retentate chromatography for resolving analytes in a sample. The methods involve adsorbing the analytes to a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.

Abstract: Purified genes encoding a cytokine or composite cytokine from a mammal, reagents related thereto including purified proteins, specific antibodies, and nucleic acids encoding these molecules are provided. Methods of using said reagents and diagnostic kits are also provided.

Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Abstract: This invention provides a novel fluorescent particle including a core or carrier particle having on its surface a plurality of smaller polymeric particles or nanoparticles, which are stained with different fluorescent dyes. When excited by a light source they are capable of giving off multiple fluorescent emissions simultaneously, which is useful for multiplexed analysis of a plurality of analytes in a sample. The coupled complex particles carrying on their surface fluorescent nanoparticles, methods of preparing such polymer particles, and various applications and methods of using such particles are claimed.

Abstract: The present invention relates mainly to reaction vessels, to sets of such vessels for automatic immunological assay apparatuses, to automatic immunological assay apparatuses making use of such sets of vessels, and to a method implementing sets of such vessels. According to the present invention, photometric detection is implemented of the luminescence of a reaction mixture found in a reaction vessel, the apparatus and/or the vessel guaranteeing light-tightness so as to prevent entry of external light falsifying the measurement. Advantageously, sets of vessels in accordance with the present invention are made out of a material that is opaque. The present invention is particularly applicable to detecting the presence of a chemical or a biological substance in a sample. The present invention applies mainly to medical analysis and research.

Abstract: Carriers hold remote-acting bodies which can be manipulated by a remote force, and also hold a micro-substance which is a target substance of an assay. The remote-acting bodies are manipulated in order to control the positions of the micro-substances, so as to execute assays for various target substances efficiently, at low cost, easily, and reliably. Various aspects of interest include the carriers which hold the micro-substances, a system suspending the carriers, an apparatus for manipulating the carriers, and a method of controlling the position of the carriers.

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 novel monoclonal antibody which specifically binds to apo-B-48 is disclosed. The monoclonal antibody specifically binds to apo-B-48 but does not bind to apo-B-100.

Abstract: A diagnostic tool is disclosed for accurately and rapidly diagnosing the condition of an ailing organ. Although applicable to numerous organ and organ systems, this application particularly illustrates the concept of conjunctive marker utilization as it relates to diagnosing and distinguishing congestive heart failure. The invention particularly relates to the conjunctive utilization of cardiac Troponin I (cTn-I) and natriuretic peptide, e.g. ANP, pro-ANP, BNP, pro-BNP and CNP as a retrospective tool for diagnosing the underlying mechanism of heart failure and as a prospective analytical device for monitoring disease progression and efficacy of therapeutic agents.