Abstract: The invention concerns a process for producing an analytical tape for liquid samples in which a rollable transport tape is provided with test fields that are spaced apart in the direction of the tape for analyzing the liquid samples. A multilayered test label tape is prefabricated from at least a detection film and an adhesive tape and subsequently the test fields are transferred as self-adhesive test labels from the test label tape onto the transport tape.

Abstract: A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to “target” with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.

Abstract: Novel solid-phase biosensors that utilize ink jet printing of biocompatible sol-gel based inks to create sensor strips are reported herein. Biomolecules and other reagents useful in bioassays to detect, for example, pathogenic microorganisms or toxic substances, are immobilized on a substrate, which can be paper based, by layering these substances between two layers of biomolecule compatible sol gel. The sol gel precursor solutions and solutions of the assay reagents are printed from separate nozzles in a layered approach which avoids clogging of the nozzles by the pre-mature gelling of the sol gel precursor solution. In certain embodiments of the application, a capture agent is used to concentrate a compound to be detected in specific areas on the substrate to facilitate detection.

Abstract: Devices and methods for the detection of antigens are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

Abstract: A process for the quantitative optical analysis of fluorescently labeled biological cells involves contacting a cell layer on a transparent support at the bottom of a reaction vessel with a solution containing the fluorescent dye. This process can also be used for improving the sensitivity in the quantitative optical analysis of a luminescent biological cell layer. Analogously, these process principles can also be used in receptor studies for the masking of the interfering background radiation in the quantitative optical analysis of fluorescently or luminescently labelled reaction components. In this case, a receptor layer at the bottom of a reaction vessel is in contact with a solution in which a fluorescent or luminescent ligand is dissolved.

Abstract: The invention provides devices, test kits and methods for removing target agents from a sample. The device contains one or more porous matrices having pore sizes larger than 10 ?m, and a plurality of particles impregnated therein. The target agents attach the device and are removed from the sample.

Abstract: A disposable cartridge adapted to be used with a sensor-dispensing instrument comprises a housing, test sensors, a mechanical mechanism and moveable seals. The housing forms at least one opening therethrough. The test sensors are stacked in the housing. The test sensors are adapted to assist in testing at least one analyte. The mechanical mechanism is adapted to urge the test sensors in a first direction. One of the test sensors is positioned for ejection from the cartridge. The moveable seals is adapted to be in a closed position that seals the at least one opening so as to provide a substantially moisture-proof and a substantially air-tight cartridge, and one of the moveable seals is adapted to be in an open position that allows one of the test sensors to be moved therethrough.

Abstract: A method is provided for producing an analytical element comprising at least one test field for analyzing a liquid sample, wherein provision is made for a carrier on which a polymer fabric is arranged. At least one portion of the polymer fabric is irradiated with UV laser light and thereby hydrophobized.

Abstract: Articles for testing a coagulation process in whole blood.

Abstract: Methods of manufacturing test strips are disclosed. Embodiments include laminating a two piece covering layer over a substrate with a series of cavities, wherein the two pieces are separated by a gap, the gap forming a vent opening for the cavities. Other embodiments include covering the sample receiving chamber with a cover thinner than the cover covering the body of the test strip, the thicker body cover absorbing more force than the chamber cover to reduce the possibility of adhesives squeezing out from under the chamber cover. The present invention also provides an advantageous method of mass-producing the inventive test strips without having to align the slot or vent opening laterally with respect to the test strips and without having to punch a vent opening. The method is also well suited to mass production by roll processing techniques.

Abstract: The invention provides devices, test kits and methods for removing target agents from a sample. The device contains one or more porous matrices having pore sizes larger than 10 ?m, and a plurality of particles impregnated therein. The target agents attach the device and are removed from the sample.

Abstract: The invention concerns test elements, in particular diagnostic test elements, for determining the presence or concentration of biological, medical or biologically or medically effective substances including nucleic acids, proteins, viruses, microorganisms and cells, characterized in that these test elements contain nanofibers.

Abstract: A method and device for investigation of a surface layer of a material. The material without surface layer is exposed for a gas and the penetration of the gas into the material is measured. Then the surface layer is applied to the material. Finally, the material including the surface layer is exposed for the gas and the penetration of the gas into the material through the surface layer is measured. The measurement of the passage of the gas into the material is performed by a method comprising measurement of light absorption by the gas by absorption spectroscopy.

Abstract: A method for rapid collection and assay of oral fluids is disclosed. The method comprising the steps of: (a) placing an assay device into an oral cavity, (b) removing said assay device from said oral cavity; and (c) determining the presence or absence of at least one analyte.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: Devices and methods for the detection of antigens are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

Abstract: The invention concerns test elements, in particular diagnostic test elements, for determining the presence or concentration of biological, medical or biologically or medically effective substances including nucleic acids, proteins, viruses, microorganisms and cells, characterized in that these test elements contain nanofibers.

Abstract: The invention relates to embodiments of an analysis system and to a method for analyzing a sample on an analytical test element, with the analysis system comprising a test element receptacle for receiving and positioning a test element in an analysis position. In an exemplary embodiment, the test element receptacle contains a guide part and a lock part, the guide part having means for guiding a test element into and out of the analysis position, the lock part comprising a frame and a bolt element, which frame and bolt element are connected to one another by a hinge. The bolt element can be pivoted about the hinge between a first position and a second position with respect to the frame. The bolt element comprises a latching lug for engaging in a recess in test element when the bolt element is in the first position and when the test element is positioned in the analysis position.

Abstract: A discrimination medium cannot be easily falsified. Since the visibility of the discrimination medium is unique, the discrimination medium is superior in determination of the authenticity. The discrimination medium is structured such that a cholesteric liquid crystal layer 106 and a multilayer film 103 having plural light transparent films which are laminated and are different from each other in refraction index are laminated. The reflection light reflected by the discrimination medium includes circular polarization lights which are different in polarization direction, and the discrimination medium has unique optical characteristics. A discrimination method using the above unique optical characteristics, an article to be discriminated by the discrimination medium, and a discrimination apparatus using the above unique optical characteristics are provided.

Abstract: An object of the present invention is to overcome the problem of nonspecific adsorption of a labeled antibody on the detection site and to provide an immunochromatography method by which the false positive signal can be suppressed, and wherein the detection sensitivity is high and the highly reliable measurement can be performed.

Abstract: Methods and immunoassays for diagnosing a bite or sting of a venomous organism in a patient having symptoms consistent with such a bite or sting are provided. A sample of venom is collected from the area of the suspected bite or sting using a swab and then contacted with an antibody that specifically binds to an antigenic site on venom present in the sample. Binding is then detected. The invention is illustrated by examples showing diagnosis of brown recluse spider bite, distinguishing it from other diagnoses with which it is often confused. This extremely sensitive test can detect venom antigens down to about 20 picograms even after the sample has been shipped and stored for periods of up to three weeks during the summer.

Abstract: A sensor has a sensor substance, an electromagnetic energy source, and a detector. The sensor substance may be able to emit electromagnetic energy different than that provided by the energy source when an analyte of interest is in contact with the sensor substance and electromagnetic energy is received by the sensor substance. The energy source and the detector may be provided on the same side of the sensor substance. In a method according to the invention, a determination may be made as to whether an analyte is present in a sample. Such a method may provide a sensor, such as that described above. Electromagnetic energy may be provided to the sensor substance using the energy source, and the sensor substance may be contacted with a sample. Electromagnetic energy may be emitted from the sensor substance and received at the detector. The detector may provide a signal indicating the type of electromagnetic energy emitted from the sensor substance.

Abstract: A test strip having a small sample-receiving chamber on the order of less than 1 microliter. The inventive test strip includes a reagent layer that extends across the width of the test strip and also extends to the sample-receiving end, such that the edges of the reagent layer are aligned with the side and dose receiving edges of the test strip. The hydrophilic reagent extending to the dosing edge of the strip promotes wicking of the sample into the test strip. The end and side edges of the reagent layer are preferably formed as part of a cutting process that forms individual test strips from a larger web, which results in a smooth and thin reagent layer with a uniform thickness, substantially covering the entire floor of the sample-receiving chamber. The inventive mass production process helps improve the reproducibility of the quantity, location, thickness and other properties of the reagent layer, which in turn improves the accuracy of the test result.

Abstract: The present invention concerns a reagent coating mass which can be used in slot-die-coating of flat support materials in the manufacturing processes of test strips. Advantageously, the reagent mass of the invention exhibits certain superior rheological properties such as viscosity, surface tension and thixotropy. The reagent mass is preferably used to coat thin, narrow and homogeneous stripes of reagent material onto flat web material.

Abstract: A lateral flow test strip for the analysis of a sample featuring numerous capture zones arranged in an array such that each capture zone is substantially equidistant from the sample containing area. The sample does not pass through another capture zone to reach any one of the other capture zones. The capture zones are preferably arranged in a linear array perpendicular to the flow of the sample through the lateral flow test strip. The lateral flow test strip allows for an increased number of simultaneous analyses of numerous analytes from one sample to occur on one lateral flow test strip.

Abstract: An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample are described. The assay design prevents interference by reagents used for such removal with the HDL quantification reaction or with other assays carried out on the same sample. If desired, removal of non-HDL lipoproteins and assay of HDL cholesterol can be carried out without interruption of the assay.

Abstract: A specimen testing device having a folding top having a top inside and a top outside; a back portion having a back inside and a back outside, the back portion in folding communication with the folding top; a front portion in folding communication with the back portion and the folding top covers at least a portion of the front portion when the front portion is in a folded closed position; a reagent test sheet in communication with at least a portion of the back portion; at least one enclosed bubble containing developer attached to at least one of the back portion and the front portion, wherein a fecal sample is placed on the reagent test sheet and the at least one enclosed bubble is pierced to release the developer to the fecal sample to indicate the presence of fecal occult blood.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample and indicating to the user the presence or absence of the analyte through the formation of a recognizable symbol during the assay. In one embodiment, the present invention provides test strips having a matrix including a sample application zone, a reagent zone, and a detection zone. Within the detection zone are located positive and negative control areas, and an analyte binding area. The positive control area contains one or more components that exhibit a first color when dry and a second color when wetted. When the assay is conducted, the positive control area is wetted by the assay fluids and turns to a second color, thereby functioning as a positive procedural control. When analyte is present in the sample, it binds at the analyte binding area, which interacts with the positive control area to form a second recognizable symbol at the detection zone.

Abstract: A measuring apparatus for determining an analyte in a liquid sample includes the following apparatus components: a test element with a test field for applying the liquid sample, the test element experiencing a detectable modification due to the analyte to be determined, a detector which detects the modification and generates an electrical detector signal as a function of it, an evaluation circuit arranged downstream of the detector, which evaluates the detector signal to form a measurement result, a display device connected to the evaluation circuit for displaying the measurement result, and an electrical power supply for supplying electrical power to the electrical apparatus components. At least some of the electrical apparatus components are formed on the basis of polymer electronics so that the analyte can be determined straightforwardly, conveniently and inexpensively.

Abstract: The invention relates to devices for performing single step assays for the determination of the presence or absence of an analyte in a liquid sample, and methods of determining the presence or absence of such analytes using such devices. Devices disclosed comprise a labeled analyte-binding reagent reversibly-immobilized on a non-porous solid material, which solid material is in physical contact with a dry porous carrier bearing an immobilized analyte-binding reagent. Also provided are quantitative assay devices.

Abstract: In a process for the quantitative optical analysis of fluorescently labelled biological cells 5, a cell layer on a transparent support at the bottom 2 of a reaction vessel 1 is in contact with a solution 3 containing the fluorescent dye 4. The sensitivity of analytical detection can be considerably improved if to the fluorescent dye 4 already present in addition a masking dye 9, which absorbs the excitation light 6 for the fluorescent dye 4 and/or its emission light 7, is added to the solution 3 and/or if a separating layer 10 permeable to the solution and absorbing and/or reflecting the excitation light 6 or the emission light 7 is applied to the cell layer at the bottom 2. This process can also be used for improving the sensitivity in the quantitative optical analysis of a luminescent biological cell layer. The separating layer 10 must in this case be composed such that it has a high power of reflection for the luminescent light 11.

Abstract: A kit for determining the gender of an unborn fetus. The kit comprises a container holding a solid composition therein, the solid composition including a basic salt and a transition metal. An atmosphere in the container is substantially free of water.

Abstract: An assay device and method for measuring the concentration of HDL-associated cholesterol in a blood-fluid sample are described. The assay design is such that removal of non-HDL lipoproteins from a sample and assay of HDL cholesterol in the sample occur without interruption of the assay. The device also prevents interference by reagents used for the HDL assay with other assays carried out on the same sample.

Abstract: An indicator device for determining the efficacy of an antimicrobial treatment process. The indicator device includes an active agent encapsulated in an encapsulation component. The encapsulation components preferably takes the form of an electrospun nanofiber including a polymer.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

Abstract: A specimen testing device having a folding top having a top inside and a top outside; a back portion having at least one flap opening, the back portion in folding communication with the folding top; a front portion having at least one opening with the folding top covering the front portion when in a folded closed position and the front portion in folding communication with the back portion; a reagent test sheet in communication with at least a portion of the back portion and interposed between the front portion and the back portion; at least one enclosed bubble containing developer attached to the inside of the flap opening of the back portion, wherein a fecal sample is placed on the reagent test sheet, the folding top is in a folded closed position and the enclosed bubble releases the developer to indicate the presence of fecal occult blood.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: A system and method for determining the concentration of an analyte in a fluid sample includes a test strip having a first and second portion separated by a bend line formed in the base. The bend line traverses the longitudinal axis of the base and the base is adapted to bend about the bend line. The test strip further includes a test element disposed on one of the portions. The test strip includes a reagent adapted to react with the analyte in the fluid sample.

Abstract: A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids.

Abstract: In one aspect, an assay test strip includes a test label that specifically binds a target analyte and a control label that is free of any specific binding affinity for the target analyte and has a different optical characteristic than the test label. In another aspect, an assay test strip includes a test label that specifically binds a target analyte and at least one non-specific-binding label that is free of any specific binding affinity for the target analyte. Systems and methods of reading assay test strips also are described.

Abstract: An interactive system is provided with at least one active surface of plastic from monomers containing at least one structural element derived from a carbon dioxide (A), and at least one substance associated to a linker with at least one structural element (B) capable of establishing a hydrogen bond, and involving an interaction between the structural elements (A) and (B). The interactive system is suitable for presenting and eliminating substances in liquids.

Abstract: A device for testing for the presence of an analyte, the device comprising at least one reagent adapted to provide a calorimetric indication in the presence of the analyte, a catalyst to catalyse the reaction providing the calorimetric indication, and where there is provided one reagent, means for substantially inhibiting reaction between reagent and catalyst or where there is provided more than one reagent, means for substantially inhibiting reaction between said reagents and between said reagents and catalyst, prior to introduction of the analyte, wherein the at least one reagent and the catalyst are solids.

Abstract: A method for determining contamination in marine diesel lubricating oils. The method has been found to have particular utility in estimating asphaltenes contamination in marine diesel lubricating oils.

Abstract: A multilayer food sterilization dosage indicator having (a) an indicator layer including an ion-sensitive ink, an ionic photoinitiator, a proton source; (b) a substrate, and an overlayer including a UV-absorber. The ink undergoes a color change upon exposure to a known amount of sterilizing radiation. A method for indicating the amount of exposure to sterilizing radiation using the dosage indicator.

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: 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: A method for determining contamination in marine diesel lubricating oils. The method has been found to have particular utility in estimating residual fuel and insolubles contamination in marine diesel lubricating oils.

Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: An assay pad for measuring the concentration of HDL-associated cholesterol in a sample, a method for using the pad, and a diagnostic assay device for carrying out the method are described. The assay pad includes a polymer adhesive or heat laminate bond. The assay design prevents interference by reagents used for such removal with the HDL quantification reaction or with other assays carried out on the same sample. If desired, removal of non-HDL lipoproteins and assay of HDL cholesterol can be carried out without interruption of the assay.

Abstract: The present invention relates to improved specific binding assay devices comprising a chromatographic medium including a reaction site at which a specific binding reagent is immobilized, a sample application well located adjacent to the chromatographic medium and offset upstream from the reaction site, and liquid absorption blotter offset downstream from the reaction site.