Abstract: A method and a blood oxygen tester for determining whether a blood sample is arterial or venous blood are disclosed. A blood oxygen tester for determining whether a blood sample is arterial or venous blood includes a housing and a blood sample receptacle defined by the housing. A blood oxygen sensor is in communication with the blood sample receptacle and a test result indicator is in communication with the blood oxygen sensor. The indicator is responsive to the blood oxygen sensor for indicating whether a tested blood sample is arterial blood or venous blood.

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 apparatus for use in a flow through assay process is disclosed. The method is characterised by a “pre-incubation step” in which the sample which is to be analyzed (typically for the presence of a particular protein), and a detection analyte (typically one or more antibodies bound to colloidal gold or a fluorescent tag) which is known to bind to the particular protein may bind together for a desired period of time. This pre-incubation step occurs before the mixture of sample and detection analyte come into contact with a capture analyte bound to a membrane. The provision of the pre-incubation step has the effect of both improving the sensitivity of the assay and reducing the volume of sample required for an assay. An apparatus for carrying out the method is disclosed defining a pre-incubation chamber for receiving the sample and detection analyte having a base defined by a membrane and a second membrane to which a capture analyte is bound.

Abstract: A mammalian disease detecting system used to provide a visual indication of a possible disease state includes particles made of a material that is substantially clear or transparent to permit the easy visual detection of blood in urine of a mammal. The system also includes additives to permit visually detection of possible disease states or infections in mammals, such additives being of the type that are not reactive with the particular material.

Abstract: Biological reagent compositions with improved sensitivity to the concentration of blood glucose in patient samples for use in measuring systems and methods. The reagent compositions comprise a glucose oxidoreductase enzyme, a flavin nucleoside coenzyme and a mediator formulation. The mediator formulation comprises at least one electroactive organic molecule and at least one coordination complex.

Abstract: A device for separating and drying a fluid sample in one embodiment includes an upper layer including a sample window and a viewing window extending therethrough, the viewing window spaced apart from the sample window, an absorbent layer, having a width and a length, positioned beneath the upper layer and extending beneath the sample window and the viewing window, and a non-absorbent layer positioned beneath the absorbent layer, the non-absorbent layer having a width and a length greater than the width and the length of the absorbent layer.

Abstract: The present invention provides devices, methods, and kits for the collection of a solid or semi-solid sample and analysis for the presence, absence, or quantity of an analyte. The invention provides a collection slide having a first card and a second card. The first card has a sample collection area. The first and second cards have orifices allowing the passage of fluid through the sample collection area, and the cards are hingeably connected to each other. The invention also provides an assay device having a housing with a test element, a results window, and a docking area for receiving and engaging the collection slide. In one embodiment the collection slide and device can be used to detect the presence of fecal occult blood (human hemoglobin) in a stool sample. Many other embodiments are described herein.

Abstract: The present invention provides a test strip for measuring a concentration of an analyte of interest in a biological fluid, wherein the test strip may be encoded with information that can be read by a test meter into which the test strip is inserted.

Abstract: A system for detecting biomaterials that are suspected to be present in a medium that contains multiple materials. A hydrated substrate has water molecules entrapped within molecular spaces between polymeric chains of the substrate. The hydrated substrate also has detection material, which has a specific affinity for a target material. The entrapped water molecules provide a source of water for the detection material such that a change in charge occurs when the target material and detection material coalesce. A display unit detects the change in charge and provides an indication that the target material is present when the change in charge is detected.

Abstract: An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Abstract: A method for patterning a one or more biomolecules on a substrate that includes coating the substrate with a coating of the one or more biomolecules, applying a laser to the coating, and ablating a portion of the one or more biomolecules with the laser in a predetermined pattern.

Abstract: Disclosed are chemically active surfaces for the detection of nitroaromatic, nitramine, and nitrate ester compounds, the primary constituents of explosive devices. Transparent conductive composites (TCCs) combine with gold nanoparticles in a conducting polymer matrix to create a conductive, flexible, and electrochromic material. Hybrid, nanostructured surfaces constructed from TCCs are decorated with conjugated conductive oligomer wires. Selective binding of the target to the oligomer alters the electron charge mobility in the TCC, affecting the redox state. The binding event is identified by measuring the conductivity of the TCC and/or through color changes of the TCC. Conjugated oligomers that are functionalized with thiol groups at one end and nitro-derivative receptors at the other provide the bases for selectivity and sensing. The thiol group anchors the oligomer to the metal sites on the TCC surface and the receptor starts the charge transfer mechanism when targeted with the appropriate molecule.

Abstract: This invention discloses a substrate of an analytical strip. The substrate has a channel provided concavely on an upper surface of the substrate. The channel comprises a first area for receiving a fluid sample, a second area for delivering the fluid sample, and a third area where the fluid sample reacts. These areas are connected sequentially. Nitrocellulose layers are formed at bottoms of both the second area and the third area. The conformation of the nitrocellulose layers is a hollow matrix. In addition, the nitrocellulose layer of the second area has an average thickness that is not greater than that of the nitrocellulose layer of the third area.

Abstract: An object of the present invention is to provide a sensing device capable of easily grasping whether or not a concentration of a sensing target is equal to or less than a standard value.

Abstract: An oral fluid collection and transfer device comprises a collection device (10) and a test cartridge (100). The collection device includes a frame or chassis (14), and an absorbing pad (12) for absorbing oral fluid and which is secured around part of the frame with part of the frame protruding from the pad. A collapsible cover (16) covers the absorbing means and has apertures (68) for the ingress of oral fluid into contact with the absorbing pad. A cap (18) covers the part of the frame protruding from the absorbing pad. The cap and the cover latch together to surround the frame and the absorbing pad. The device also includes a fluid adequacy indicator (20) in the form of an electrical circuit with an LED (66) which is completed when the absorbing means has absorbed a predetermined volume of oral fluid.

Abstract: A specimen sample collection device and test system includes a handle with a sufficiency indicator and locking teeth, an absorbent pad partially contained within the handle; a pad compression tube with outlet ports and locking holes insertable over the pad and handle; one or more collection tubes attachable to the pad compression tube outlet ports. The apparatus may include a light pipe sufficiency indicator with a spring compressor to force the absorbent pad into contact with the light pipe. The apparatus may include a collector dam. The apparatus may include a secondary seal. The apparatus may include a cylindrically shaped absorbent pad and a wrap-around light pipe sufficiency indicator with vent grooves. The apparatus may include a pad seat with buffer material disposed within the pad compression tube. The apparatus may include an absorbent pad split and divided into two lengths connected at a base. The apparatus may include a bar code identification.

Abstract: A method and kit for determining a concentration of iron in brake fluid when contacting a calorimetric reagent such that a color results. The level of iron can be used to determine the amount of active corrosion within a brake system and determine if special service procedures are required.

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

Abstract: The present invention relates to a test strip for determining and/or quantifying a property of a sample, such as the concentration of an analyte, the pH, the viscosity, or the specific gravity of a fluid specimen. More particularly, the present invention relates to an improved test strip and scale for determining and/or quantifying a property of a sample, such as the concentration of an analyte, the pH, the viscosity, or the specific gravity of a fluid specimen.

Abstract: The present invention relates to a lateral flow assay and system, including a test strip, for detection and quantification of analytes in samples, such as samples containing cells and fluid. In general, according to the present invention, a test strip for a lateral flow assay for detection of at least one analyte in a sample comprises: (1) a chromatographic strip, a sample filter, a fluid-impermeable barrier, and means for providing a mobilizable detectable agent that is capable of binding to the at least one analyte or to the capture agent after capturing the analyte to the chromatographic strip such that the mobilizable detectable agent migrates through the chromatographic strip and contacts sample that has passed through the sample filter and also has migrated through the chromatographic strip. The test strip allows detection with or without quantitation of an analyte in a sample containing whole cells.

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 present invention is a testing apparatus and method for detecting the presence of a date rape drug such as flunitrazepam or gamma hydroxyl butyrate in a liquid, such as an alcoholic beverage. The testing apparatus includes a base member and a flap member removably attached to the base member. The testing apparatus also includes at least one testing stick enclosed within the base member. The testing sticks include an elongated member and a chemical reagent disposed on the distal end or anywhere along the elongated member. The chemical reagents utilized to detect the presence of flunitrazepam are Zimmerman's Test reagent methanolic 2,4-dinitrobenzene and potassium hydroxide and the chemical reagent for GHB is 5,5 Dibromo-o-cresolsulfonphthalein. The chemical agent reacts with the date rape drug to produce a change in color of the chemical reagent indicating the presence of the date rape drug in the liquid.

Abstract: A test strip for immunochromatography comprising a sample receiving member, a label holding member, and a chromatography membrane is described. The chromatography membrane has a first detection zone and a second detection zone. The second detection zone is formed by utilizing a blocking material and the second substance. A method for producing above the test strip is also described.

Abstract: Hydrophilic threads as platforms for inexpensive, low volume, portable diagnostic systems, and methods of making the same are described. A diagnostic system includes a hydrophilic loading thread having an inlet zone at a proximal end; a testing zone at a distal end; and an intermediate zone located between the inlet zone and the testing zone, wherein the testing zone does not directly contact the inlet zone. In another aspect, a diagnostic system includes (i) a hydrophilic loading thread that includes an inlet zone at a proximal end and an intermediate zone at a distal end; and (ii) one or more additional hydrophilic threads that contact the intermediate zone of the loading thread.

Abstract: Disclosed are Surface Enhanced Resonance Raman Spectroscopy (SERRS) probes and their use in detection methods for bioassays. Further disclosed is signal optimization of surface enhanced resonance Raman probes achieved by chemical modification of the probes. Also disclosed are methods for increasing the Raman cross-section by varying the chemical composition of a linker group linking a signal molecule to a nanoparticle surface. The signal molecules, such as dyes, may be modified with a linker group designed to both enhance the SERRS signal and to couple the signal molecule to the nanoparticle surface.

Abstract: The present invention concerns embodiments of a system for determining the concentration of an analyte in a body fluid which comprises an analytical test element and an instrument separate therefrom, wherein at least a part of the electrical components of the system are comprised of polymer electronics. Embodiments of the analytical test element comprise an area with reagent chemistry for the detection of an analyte and a transponder configured for wireless transmission of lot-specific data and/or measured values. The instrument has a reading module configured for wireless transmission of data, or data and energy, to the test element and an evaluation unit for evaluating the data or measured values received by the transponder.

Abstract: There is provided a simple, inexpensive reaction analysis kit and system capable of performing highly sensitive, quantitative measurement. A chemical luminescence reaction is employed and a sensor element is used to detect the reaction in a highly sensitive manner. That is, a reaction detection plate is used to transmit a signal detected in the sensor element via a reader coil and a reader and then analyze the reaction. The reaction detection plate has a) a membrane, b) a first antibody impregnated section that is disposed such that it faces the membrane and holds a first labeled antibody that specifically binds to a substance to be analyzed, c) a second antibody immobilized section that is provided in part of the membrane and has an immobilized second antibody, the second antibody specifically binding to the substance to be analyzed, and d) a sensor element that is disposed such that it faces the second antibody immobilized section and includes a light detector and a signal transceiver.

Abstract: A biological specimen collection card comprises a specimen retaining panel, a rear panel, and a cover panel. There is an opening in the specimen retaining panel for retaining an absorbent insert which is to be impregnated with a biological specimen. The absorbent insert is exposed on both sides of the specimen retaining panel when the absorbent insert is retained in the opening. The rear panel is angularly spaced apart from the specimen retaining panel when the collection card is in an open configuration to facilitate drying of the biological specimen. The cover panel is movable between a first position and a second position. The collection card is in the open configuration when the cover panel is in the first position, and the collection card is in a closed configuration when the cover panel is in the second position. The cover panel covers the absorbent insert when the absorbent insert is retained in the opening and the collection card is in the closed position.

Abstract: A meter is provided that includes an improved user interface that enables the user to take a specific action, leading them directly to data input options. Such a user interface could be used to input first selected information, such as whether a test was premeal or postmeal, immediately after receiving a result. Optionally, the user interface may include the ability to add an additional comment after inputting the first selected information. Provision of such a user interface would facilitate simpler capture of the first selected information each time the user performs a test, leading to an enhanced understanding of a patient's level of glycemic control. Designing a user interface to enable first selected information to be entered by a user directly after receiving a result is more likely to engage a patient by making it easy and simple to enter important information. This may enable capture of the information thought to be most pertinent e.g.

Abstract: A method for detecting the onset of ovulation in a female mammal is provided. The method includes contacting mouth air of the female mammal with an arylmethane test chromogen in an amount effective to undergo a rapid and detectable color change in the presence of one or more volatile sulfur compounds. The color of the test chromogen is compared to a control color that corresponds to a pre-ovulatory sulfur content. The difference in color between the test chromogen and the control color is correlated to the onset of ovulation.

Abstract: Dipstick tests for detecting analyte are described. In a preferred embodiment, a multiple biotinylated antibody capable of binding analyte is bound to an anti-biotin antibody labeled with colloidal gold and wicked up the dipstick with test solution thought to contain analyte. Complex formed between analyte, biotinylated anti-analyte antibody, and colloidal gold labeled anti-biotin antibody is captured at a capture zone of the dipstick. Presence of colloidal gold label at the capture zone indicates the presence of analyte in the test solution. The sensitivity of analyte detection using such methods is an order of magnitude higher than for comparable methods in which biotinylated anti-analyte antibody bound to analyte is wicked up the dipstick in a first step, and a colloidal gold labeled anti-biotin antibody is wicked up the dipstick in a separate step. Kits for performing the tests of the invention are also described.

Abstract: This invention provides an immunochromatography detection apparatus exhibiting excellent convenience, sensitivity, and specificity, a detection method therefore, a kit using the same, and a method for producing such apparatus and kit, by constructing a solid-phase support, on which the conditions for the reaction wherein an analyte specifically binds to a labeled reagent containing a ligand that specifically binds to the analyte and those for the reaction wherein a capture reagent specifically binds to a complex of the analyte and the labeled reagent in the immunochromatography detection method are continuously optimized, and the pretreated specimens are optimized for such reactions.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: Provided is sampling and testing device for the detection of specific molds, allergens, viruses, bacteria, fungi, and other protein containing substances. Embodiments of the device include a sampling member slideably engaged with a base that contains a lateral flow strip adapted to detect specific analytes of interest. The sampling member defines a solvent reservoir that stores an elution solvent in a fluid-tight manner before the device is used to sample and test environmental surfaces. During slideable withdrawal of the sampling member from the base, the elution solvent stored in the reservoir is automatically released to a wick assembly of the sampling member. The wick assembly includes a wick adapted to receive, distribute, and retain the elution solvent. After a user samples an environmental surface for an analyte of interest with the elution solvent wetted wick, the sampling member is returned to the base where the wick contacts the lateral flow strip contained in the base.

Abstract: The systems of the invention include test cells with a first sorbent material defining a first flow path for a solution, a second sorbent material defining a second flow path distinct from the first flow path for a sample, and a test site with immobilized antigens or antibodies or other ligand binding molecules such as aptamers, nucleic acids, etc. located at the junction of the first and second sorbent materials for identifying one or more ligands. The first and second sorbent strips touch each other at the test site location. The test cell may be used to test for pregnancy, HIV (including different HIV antigens or peptides), tuberculosis, prion, urin-analysis/drug, cardiac markers, cancer markers, Chagas, Chlamydia, dental bacteria (SM/LC), influenza A, influenza B, adenovirus, rotavirus, strep A, other bacteria or viruses, etc., and veterinary applications such as CPV, FIV, FeLV, heartworm, etc., although it is not limited to those applications.

Abstract: The present invention pertains generally to colorimetric indicia provided by a primary device, and more particularly, to at least one indicator moiety influenced by changing environments wherein the indicator moiety exhibits a rapid initial response and a protracted transient time for visualization by an operator. As compared to heretofore colorimetric indicator technologies, the present invention allows for improved accuracy of data interpretation by direct visual capture of changing environments with shorter duration transients.

Abstract: Devices and methods are provided for immobilizing a diagnostic target (e.g., indicative of a disease) from a solution (e.g., a biological fluid). The diagnostic target is first bound to a capture conjugate that includes a reversibly-associative polymer moieties attached to a first binding moiety that binds to the diagnostic target. Once the diagnostic target is bound to the capture conjugate, the solution is subjected to a change in heat and/or pH to cause the reversibly-associative polymer moieties to aggregate. The aggregates are then immobilized (e.g., via filtration).

Abstract: A tester for testing for explosives associated with a test location comprising a first explosives detecting reagent; a first reagent holder, the first reagent holder containing the first explosives detecting reagent; a second explosives detecting reagent; a second reagent holder, the second reagent holder containing the second explosives detecting reagent; a sample collection unit for exposure to the test location, exposure to the first explosives detecting reagent, and exposure to the second explosives detecting reagent; and a body unit containing a heater for heating the sample collection unit for testing the test location for the explosives.

Abstract: A porous solid phase for binding assay that enables a test sample such as whole blood to be analyzed promptly, conveniently, accurately, and inexpensively without requiring a pretreatment, and a binding assay method using said porous solid phase are disclosed. At least one surfactant is incorporated into the porous solid phase for binding assay prior to addition of a test sample, the at least one surfactant being selected from the group consisting of (A) a sugar-containing surfactant that comprises a compound shown by a general formula (I), (B) a sugar-containing surfactant that comprises a sucrose fatty acid ester wherein the constituent fatty acid has 5 to 14 carbon atoms, and (C) a steroid surfactant.

Abstract: A specimen cup system for sample testing includes a cup defining sealable first and second regions. A receptacle is formed at a bottom of the first region and extends vertically therein. The receptacle has a first opening defined at the bottom of the first region, a second opening in a radial wall of the receptacle for fluid communication with the first region, and a third opening in the radial wall of the receptacle for fluid communication with the second region. A base having a hollow post is inserted in the first opening of the receptacle. The hollow post has a radial opening formed therein that, when aligned with the second opening, defines a pre-test condition. The hollow post forms a fluid tight seal with the receptacle about the radial opening. The base is coupled to the bottom of the cup in a rotatable fashion such that the hollow post can be rotated to align the radial opening thereof with the third opening in the receptacle to define a test condition.

Abstract: The invention concerns a reagent system for the so-called on-board control of analytical elements, in particular test strips, containing an organic N-oxide or a nitroso compound. The invention also concerns analytical elements containing a reagent system for a detection reaction and a reagent system for an on-board control. Furthermore, the invention concerns a method for checking analytical elements in which a reagent system for an on-board control is examined optically or electrochemically with the aid of a measuring instrument for changes which could indicate a stress of the analytical element.

Abstract: The present invention provides a dry testing tool with which a metal in the various types of samples such as biological samples, food, and the like can be measured very easily, rapidly, high sensitively, and specifically by a simple colorimetric method and a method for measuring the metal. The dry testing tool of the present invention is a dry testing tool for measuring a metal in a sample, including a porous support and a chelate dye, wherein the chelate dye is bound to the porous support by a hydrophobic bond. The measuring method of the present invention is a method for measuring a metal in a sample, including the steps of: forming a composite of the chelate dye and the metal in the sample by supplying the sample to the porous support to which a chelate dye is bound by a hydrophobic bond; and detecting the metal in the sample using a developed color of the composite.

Abstract: The present invention is a biaxially oriented polyester film support in which the surface has been subjected to an energetic treatment to produce amine groups on the polyester surface. The treated surface is then coated with a dilute amine reactive hardener solution. After drying the hardener solution a photographic emulsion is coated to the surface. The resulting film element has better adhesion of the photographic emulsion after photoprocessing than previous known methods.