Abstract: A calibration device and method of using the device to calibrate an analytical instrument capable of reading a photoluminescent oxygen probe. The device includes at least (a) a first mass of an oxygen sensitive photoluminescent dye retained within a hermetically sealed space so as to isolate the dye from environmental oxygen, and in fluid communication with an activated metal-air battery whereby any oxygen permeating into the hermetically sealed space is quickly consumed by the battery, and (b) a second mass of an oxygen sensitive photoluminescent dye in fluid communication with an environmental concentration of oxygen.

Abstract: A multilayered optical sensing patch, for the measurement of conditions, such as pH, oxygen level, etc, within containers, is provided. The multilayered optical sensing patch of the present invention is comprised of a heat sealable polymer substrate layer, and a polymeric sensing membrane later attached thereto. The polymer sensing membrane layer is formed of a porous polymer support membrane, and an optical sensing composition (comprising a reactive indicator) covalently bonded thereto. The heat sealable polymer substrate layer is capable of being securely bonded to the inner layer of bioreactor bags, as well as the porous polymer support substrate layer. Further, the porous polymer support membrane layer provides a firm supporting structure for the polymeric sensing layer, thereby protecting the optical sensing composition disposed therein from degradation/damage.

Abstract: The invention relates to a sterilization testing device comprised of a housing with a test chamber, an indicator placed therein, and with a supply for supplying the sterilization medium. According to the invention, the sterilization testing device consists of at least two housing parts that are matched to one another. A supply channel is made inside the housing part and serves to supply the sterilization medium. The supply channel is configured in such a manner that it forms the base body of the test chamber. The test chamber accommodates the indicator that indicates the completion of the sterilization process. Alternatively to this solution, the invention provides a variant, which is very effective with regard to manufacturing and which permits a quantitative statement regarding the sterilization. Webs are formed inside the housing in the at least partially meandering and/or spiral configuration of the supply channel.

Abstract: A delivery apparatus for selectively delivering one or more liquid reagents into a reaction or test chamber (2), especially of an assay apparatus, the apparatus comprising: one or more respective storage chambers (5,6) for containing the one or more liquid reagents and arranged generally above the reaction or test chamber (2); and a plunger element (4) arranged and operable for insertion into the mouth of a selected storage chamber so as to displace a selected reagent from therewithin into the reaction or test chamber (2) generally therebelow by gravitational liquid overflow from the mouth of the chamber. The apparatus may conveniently be provided as a discrete delivery unit, with the storage chambers (5,6) prefilled with the selected reagents.

Abstract: An analysis system for detecting at least one analyte in a sample is proposed, in particular for detecting glucose in a bodily fluid. The analysis system is designed to detect the analyte using at least one test element. The test element has at least one analysis zone for detecting the analyte. The test element includes at least one coding with at least one test element specific item of information and/or at least one position specific item of information. The analysis system includes a detector and furthermore at least one transfer device which is designed to afford the detector the possibility of acquiring the analysis zone in at least a first position and to afford the detector the possibility of acquiring the coding in at least a second position which differs from the first position.

Abstract: A scanning sensor system, methods of use and kits for detecting a biologically active analyte are provided. The scanning sensor system includes a light source, a detector, a substrate comprising a plurality of waveguides and a plurality of optical sensing sites in optical communication with one or more waveguide of the substrate, and at least one adapter configured to couple with the substrate and provide optical communication between the light source, the waveguides of the substrate, and the detector.

Abstract: A rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a dried indicator reagent delivery unit for receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The delivery unit comprises a label zone permeated with a dried indicator reagent which can be placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

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: An optical measurement apparatus is provided for conducting a test by efficiently reading color development of a reagent after reaction by optical measurement. To the above end, an optical measurement apparatus is provided which is to be used with at least one test instrument mounted to the apparatus. The test instrument includes a carrier provided with at least one reagent retaining portion which retains a reagent, and a sample is applied to the carrier. The optical measurement apparatus includes a reader for reading color development of the reagent retaining portion, and a controller for performing driving control of the reader and determination. The controller performs the determination by utilizing data obtained by a reading operation P to read the color development of the reagent performed after the lapse of a reaction completion period Tr1-Tr6 from the mounting of the test instrument, and the reaction completion period depends on the reagent.

Abstract: The present invention relates to devices and methods for performing assays, especially for determining the presence and/or amount of one or more analytes. In particular, the invention relates to a device for the detection of analytes, comprising a reversibly compressible matrix located between a first surface and a second surface, wherein the second surface is located opposite to the first surface, and wherein the distance between the first surface and the second surface is variable. The invention also relates to a corresponding method using such a device for the detection of one or more species of analytes.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: The present invention relates to a color-changing material and to a multiple-component material that includes a color-changing composition. The color-changing materials and color-changing compositions are capable of changing color in order to indicate a change in condition, such as a change in pH. The color-changing materials and color-changing compositions include a hydrogel-forming composition, a charged colorant and a pH adjuster. The hydrogel-forming composition includes at least one charged species.

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: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: The present invention relates to using a marker in a functional fluid, which survives the use of the functional fluid in an application, with a reagent solution to identify the functional fluid rapidly either before, during or after the functional fluid's use and which is a suitable method for identifying a functional fluid in the field, and which may employ the use of test wipe, or medium, that contains the reagent solution.

Abstract: The invention relates to an analytical test element for analysis of a liquid sample. The analytical test element may contain a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening. At least one test field may be arranged in the channel, spaced apart from the inlet opening. The test element comprises a sample application site which is closed with a seal and which is designed in such a way that, when the seal is opened, the sample application site and the inlet opening of the channel are simultaneously open to the outside environment of the test element. The test element can then receive the liquid sample inside the channel via the sample application site and inlet opening, for analysis in the test field. The invention also relates to a test element magazine and to a system for analysis of liquid samples with at least one test element.

Abstract: The system and method for explosives detection may be used for detecting the presence of explosive elements. A testing device may have a case with a cover. A sample holder may be disposed in the case for receipt of a sample element and may have a sample retainer. The sample element may have a swipe pad attached to a backing element a heater may be disposed in the sample holder wherein the heater may be below the swipe pad adjacent the backing element when the sample element may be positioned in the sample holder. The heater may be in communication with an electric power source. The case may have a plurality of cavities formed therein for receipt of a plurality of fluid containers. The plurality of fluid containers may have at least a first reagent fluid and a second reagent fluid.

Abstract: A control device is suitable for one-time dipping a urine reagent strip therein, comprises an elongated package having front and rear walls, a top portion and a bottom portion, and an elongated chamber partially filled with test urine. At least a portion of the front wall is substantially transparent or translucent. User information is on the rear wall.

Abstract: An ophthalmic device which comprises a holographic element comprising a medium comprising a phenylboronic acid group and, disposed therein, a hologram, wherein an optical characteristic of the element changes as a result of a variation of a physical property of the medium, and wherein the variation arises as a result of interaction between the medium and an analyte present in an ocular fluid.

Abstract: A binding assay product (1) for detecting the presence of an analyte in a sample comprising a labelling module (5), a label, a capture module (9) and a visualization module (10). The labelling module (5) comprises a first binding component capable of binding the analyte. The label is connectable to the first binding component. The capture module (9) comprises a second binding component capable of binding the analyte. The visualization module (10) is for detecting the first binding component connected to the label and bound to the second binding component via the analyte. The labelling module and the capture module comprise a fluid conducting medium in which the binding components are embedded. The labelling module (5), the capture module (9) and the visualization module (10) together define a flow path along which the sample is capable of flowing.

Abstract: A calibration card and method of using the card to calibrate an analytical instrument capable of reading a photoluminescent oxygen probe. The card includes at least (a) a first mass of an oxygen sensitive photoluminescent dye retained within a hermetically sealed space so as to isolate the dye from environmental oxygen, and in fluid communication with an activated metal-air battery whereby any oxygen permeating into the hermetically sealed space is quickly consumed by the battery, and (b) a second mass of an oxygen sensitive photoluminescent dye in fluid communication with the environment whereby the second mass of photoluminescent dye is exposed to an environmental concentration of oxygen.

Abstract: A liquid delivery apparatus is provided for depositing liquid materials onto prescribed areas. The apparatus includes a sensing and delivery pin and a photo sensor. The apparatus is sized to deliver a droplet of liquid material to the surface of a target area without coming into contact with the target surface. The apparatus is also capable of drawing geometric features, such as lines and grids of liquid material. The photo sensor measures the intensity of light during a processing cycle. Measured reflected-light intensity can be compared in real-time to a reference curve which is based on test process cycles representing the light intensity expected when the process proceeds in the preferred fashion to produce a normal spot having an expected droplet size. The light intensity measurements can also be fitted with a mathematical function such as an asymmetric double sigmoidal curve.

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: A wearable article comprising a dehydration indicator adapted to measure a urine ionic strength correlated to a specific gravity of the wearer's urine and provide a visible signal when the urine ionic strength reaches a value corresponding to a predetermined threshold of the specific gravity. The wearable article may be a disposable absorbent article. The dehydration indicator may also be comprised in an insert for use with a wearable article. The dehydration indicator may provide qualitative or quantitative information about the ionic strength of the wearer's urine.

Abstract: A method and kit for determining a concentration of iron in brake fluid when contacting a colorimetric 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: 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: Diagnostic in-vitro devices for use in the assaying of biological fluids are provided which include cover plates or backing strips which exhibit hydrophilic properties to assist in transport of the biological fluid or retention of same within the device. Exemplary diagnostic devices include lateral flow devices, microfluidic devices and microtiter plates. The devices may also be comprised of low fluorescent material in order to facilitate any diagnostic determination by use of fluorescent emissions. Hydrophilic properties may be imparted to the cover plates or backing strips by physical or chemical treatment thereof. The cover plates or backing strips may exhibit heat sealable or pressure sensitive properties.

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: A continuous indicator strip having a multiplicity of separate individual sequential test sections along the surface thereof, wherein a plurality of test sections are impregnated with the same indicator enabling the utilization of the strip for sequential repetitive testing of samples, the strip being provided with at least 20 such test sections.

Abstract: An optical measurement method for determining a pH of a medium includes adding a fluorescent pH indicator to the medium. The pH indicator is based on naturally-obtained or synthesized ageladine A. The pH indicator is irradiated with light of at least one wavelength so as to provide fluorescence excitation of the pH indicator. An emitted fluorescence intensity of the pH indicator is detected as a measure for the pH of the medium.

Abstract: With respect to a lead detection method that uses rhodizonic acid, it is made possible to clearly identify pink or red coloration caused by a reaction between lead and rhodizonic acid even in cases where Sn is present in a specimen. To this end, an acidic aqueous solution or a buffer solution thereof (e.g., tartaric acid) in which hydrogen peroxide coexists is used as a reagent. Hydrogen peroxide oxidizes Sn2+ into Sn4+. Since Sn4+ does not react with rhodizonic acid, the presence of Sn does not interfere with the visual identification of any pink or red coloration caused by the reaction between lead and rhodizonic acid.

Abstract: A method and an arrangement of measuring acidity or other chemical or physical property of a gas. The invention comprises a membrane having optical indicator molecules bound to a microporous matrix arranged to be placed into contact with the gas to be measured, the optical indicator molecules changing their colour in response to the acidity or other chemical or physical property of the gas, a light source, and a detector. The light source is arranged to emit and direct light to the membrane, the light being transmitted through the membrane, whereby a part of the light is absorbed into the optical indicator molecules, and the rest of the light emitted is guided to the detector, where it is measured.

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: A container with a rotatable lid for reading and handling diagnostic reagents in tape form comprising a body portion, a lid portion, a continuous tape, a reagent-sensing device, and a storage device. The body portion includes an inner and outer surface. The lid portion is attached to the body portion and is adapted to rotate from a closed position to an open position. The continuous tape includes a diagnostic reagent. The reagent-sensing device is attached to either the body portion or the lid portion and adapted to read the diagnostic reagent. The storage device is attached to the body portion that is adapted to hold and dispense an unused portion of the continuous tape. During the rotation of the lid portion, the continuous tape is advanced from the first storage device and is extended over the reagent-sensing device.

Abstract: A diagnostic and testing apparatus and related methods for the use of the same are disclosed which derive and use antibodies to equine albumin and equine hemoglobin in testing apparatus, kits, and methods for detecting and localizing gastric and colonic ulcers or bleeding in horses. Fecal droppings from a horse to be tested are placed in a container together with a buffered liquid solution and mixed thoroughly, following which several drops of liquid from the container are placed into a test kit. Visual markers in the test kits signify the detection of the indicators equine hemoglobin and equine albumin, which are respectively indicative of the presence of gastric and/or colonic ulcers or bleeding.

Abstract: Platinum (II) terdentate or bidentate complexes with non-linear optical properties are provided. The complexes have a broadband spectral and temporal response, and strong reverse saturable absorption and two-photon absorption in the visible and the near-IR region. As such, the complexes are useful for organic light-emitting diodes and optical-switching or sensing devices.

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 coated test elements and in particular test elements comprising a capillary gap which have a hydrophobic structured coating at least in the area surrounding the capillary gap.

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: The invention relates to a device for estimating total antioxidant capacity (TAC) of a range of fluids and extracts. More particularly the invention relates to a device where the TAC is measured using lateral flow technology on a solid support. For example, the device may be a test strip.

Abstract: A control device suitable for a urine reagent strip comprises an elongated package having front and rear walls, a top portion and a bottom portion, and an elongated chamber partially filled with test urine. An elongated chamber extends from the top portion to the bottom portion. At least a portion of one of the walls at the chamber is substantially transparent or translucent. The device includes a flap of at least one quarter inch wide on one side of the chamber and a closed access section in the top portion. User information is on at least one of the walls.

Abstract: A flow-through assay for detecting the quantity of an analyte residing in a test sample is provided. The flow-through assay contains a porous membrane that is in fluid communication with probe conjugates that contain a specific binding member and a detectable probe. The porous membrane also defines a detection zone and a calibration zone. The calibration zone contains a polyelectrolyte substantially non-diffusively immobilized on the porous membrane. The polyelectrolyte is capable of generating a detectable calibration signal that can be readily compared (visually, quantitatively, and the like) to a detection signal to determine the amount of analyte in the test sample.

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: A method for controlling fluid flow in an assay device that employs a membrane is provided. Specifically, one or more recessed regions are formed in the membrane by applying a solvent treatment thereto. The solvent treatment is selected based on its particular dissolving capacity for the material used to form the membrane. For example, an alcohol-based solvent, such as methanol, may be used as a solvent for nitrocellulose membranes. Upon contact with the solvent treatment, a recessed region is formed that may serve a variety of different functions relating to flow control. In one particular embodiment, the recessed region may function as a metering channel that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay.

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: A disposable test cassette for qualitative and/or quantitative analysis of analytes, having a structured body having introduced cavities connected to one another by channels, at least one inlet for introducing a sample fluid containing the analyte, at least one reagent chamber in which one or more reagents are stored and at least one detection chamber in which a signal for detection or quantitative analysis of the analyte is detected, wherein a floor or ceiling of the detection chamber is a signal transducer or a window for detection of a signal, fluid cannot be drawn by capillary forces into the reagent chamber or to the opening, and at least the reagents in the reagent chamber are stored in dry form. Also disclosed is an apparatus for bioassaying analytes including the test cassette, and also a method for operating this apparatus.

Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

Abstract: The invention relates to a method and an immunological test kit for predicting the risk of transplant rejection by detecting anti-AT1 receptor auto-antibodies in biological materials of a patient to be examined, e.g. by an immune reaction with the AT1 receptor or functionally analogous peptides or proteins thereof. The invention is also directed to the use of the AT1 receptor or functionally analogous peptides or proteins in order to predict (diagnose) the risk of transplant rejection. Said risk exists if anti-AT1 receptor auto-antibodies can be detected in such biological materials, e.g. in body fluids or tissues.