Abstract: The present invention provides an immunochromatographic device, which contains the following (a) and (b): (a) a first device part holding a first insoluble carrier used for developing a complex formed with an analyte and a labeling substance comprising a metal labeled with a first binding substance that can bind to the analyte and capturing the analyte and the labeling substance at a reaction portion containing a second binding substance that can bind to the analyte, and (b) a second device part holding a second insoluble carrier used for developing a liquid and a third insoluble carrier used for absorbing a liquid, in such a way that the first insoluble carrier does not come into contact with the second insoluble carrier and the third insoluble carrier.

Abstract: Disclosed are a test strip and a method for measuring medical data. The test strip comprises an upper cover having one or more application holes; a lower support having one or more detected parts at positions corresponding to detecting units of the measuring apparatus; an erythrocyte and LDL cholesterol-filtering layer designed to filter off both of erythrocytes and LDL cholesterol from an applied blood sample by agglutinating erythrocytes and precipitating LDL cholesterol; and a reaction layer in which the blood sample free of erythrocytes and LDL cholesterol is reacted with an reagent, the filtering layer and the reaction layer being stacked between the lower support and the upper cover. Structured to filter off erythrocytes and low-density lipoprotein (LDL) cholesterol from a blood sample in a single layer, the test strip of the present invention can be made to be slim and allows a low volume of blood to be analyzed.

Abstract: This invention discloses an analyzing method for detecting a specific analyte in a fluid sample. The method comprises the following steps. First, a substrate is provided. The substrate has a channel provided concavely on an upper surface thereof. The channel comprises a first area, a second area and a third area, and these three areas are connected sequentially. Each of the second and the third areas comprises a nitrocellulose layers containing a reaction material and formed at the bottom thereof. The nitrocellulose layer of the third area can absorb a fixed volume of the fluid sample. Second, the fluid sample is applied to the first area and delivered by the second area and then to the third area. Finally, the reaction material reacts with the specific analyte in the fluid sample to produce a signal for detection.

Abstract: Methods, materials, apparatus and systems are described for performing capillary flow assay. In one aspect, a system includes a sample collection unit to collect a sample liquid and a sample testing and storing unit to interface with the sample collection unit to test and store the collected sample liquid. The sample testing and storing unit includes a sample inlet shaped to receive the collected sample from the sample collection unit, and a sample well positioned below the sample inlet to retain at least a portion of the sample liquid. The sample testing and storing unit includes a sample housing unit to store a remainder of the sample liquid not retained in the sample well, and an analyte testing unit housing shaped to receive an analyte detecting unit to test a presence of a target analyte in the sample liquid.

Abstract: A microorganism culture device comprising a porous matrix layer having a basis weight of 40 to 100 g/m2 and an air permeability of 7 to 24 cm/sec, and at least one layer of a water-soluble polymer layer laminated with the matrix layer.

Abstract: An embodiment of the present invention provides a-method for performing a lateral flow assay. The method includes depositing a sample on a test strip at an application region, detecting a first detection signal arising from the test strip in the first detection zone, and generating a baseline for the first measurement zone by interpolating between values of the detection signal outside of the first measurement zone and inside of the first detection zone. The method may include locating a beginning boundary and an ending boundary for the first measurement zone on the test strip. Additional detection zones having measurement zones may also be incorporated with the embodiment.

Abstract: The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples.

Abstract: A guided structured testing kit which may include a test strip container, a test strip meter, a testing protocol advisor, and at least one of diagnostic test strip is presented. The diagnostic test strip includes a support element, a glucose reagent provided on the support element, and a glycemic context code provided on the support element. The glycemic context code can be machine-readable. The glycemic context code signals a glycemic context to a test strip meter, either upon insertion of the diagnostic test strip or by a user manually inputting the glycemic context into the test strip meter. A method for performing a guided structured test is also provided.

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 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: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.

Abstract: The present invention relates to the field of chemical detection. Specifically, the invention provides devices that respond quickly to various target chemical analytes present in the environment. Responses are based on a change in an electrical property (such as impedance or resistance) caused by adsorption or absorption of the target analyte(s) to or in a substrate-free chemical sensing element. The chemical sensing element is composed of a thin, electrically conductive polymer material (due to doping of structural polymer material(s) with electrically conductive particles and/or the use of electrically conductive polymer material(s)), which can allow vapors to pass through with little pressure drop. The chemical sensing material is either suspended in the environment, or emplaced adjacent to one or between two porous membranes, resulting in a sensing patch capable of high gas or vapor flux through the chemical sensing element.

Abstract: A biochip substrate capable of realizing the high detection accuracy by restricting a nonspecific adsorption or bonding of a substance to be detected, when used for a detection or analysis of protein, nucleic acids and the like. The biochip substrate is for fixing a biologically active substance on a surface of a solid substrate, and characterized in that it has a layer comprising a polymer compound obtained by copolymerizing an ethylenically unsaturated polymerizable monomer having an alkylene glycol residue, an ethylenically unsaturated polymerizable monomer having a functional group for fixing a biologically active substance and an ethylenically unsaturated polymerizable monomer having a cross-linkable functional group, on the surface of the substrate.

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: It is an object of the present invention to provide: a dry analytical element for analyzing pancreatic lipase wherein the triglyceride is not transcribed on the support to contaminate a transportation slip or other analytical elements and wherein an additive solution of the triglyceride neither reaggregates nor precipitate, so that the dry analytical element is stable and is compatible with production. The present invention provides a dry analytical element for measuring pancreatic lipase contained in body fluid, which comprises triglyceride of long chain alkyl fatty acid having 12 to 22 carbon atoms, monoglyceride lipase, and a glycerin measurement reagent, and which comprises a water-impermeable support and at least one spreading or reagent layer, wherein a hydrophilic polymer at a weight ratio of 1.8:1 or greater with respect to the triglyceride is contained.

Abstract: A membrane strip biosensor device using a fluid mobile conductive composition of ferromagnetic particles bound to a conductive polymer bound to a capture reagent is described. The biosensor device is designed to detect analytes at low concentrations in near real-time with an electronic data collection system and can be small. The device can be used to detect pathogens, proteins, and other biological materials of interest in food, water, and environmental samples.

Abstract: Provided is an assay device and kit for detecting the presence or amount of an analyte of interest.

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: A clinical testing assay device that can differentiate bacterial from viral infections is described. The assay device has a sample contact zone with an absorbent pad on which a test sample is deposited and a detection zone with a colorant indicator that is sensitive to bacteria cells. The colorant indicator changes color when exposed to a bacteria sample. The color change signal can manifest relatively quickly, usually within a few minutes, and with an intensity correlative to the concentration of bacteria in a test sample. A method of use is also provided.

Abstract: The disclosed invention relates to monoclonal antibodies (MAbs) which recognize human fatty acid synthase (hFAS) and are distinct from previously known anti-hFAS antibodies. Compositions, devices and kits comprising the MAbs are provided along with methods of using the MAbs in a variety of applications.

Abstract: Methods and devices for isolating nucleic acids from a mixture containing such nucleic acids and extraneous matter are provided. In one embodiment, the method of the invention comprises passing the mixture through a glass frit under conditions effective to separate the nucleic acids from the extraneous matter. In a more specific embodiment, the glass frit is a sintered glass frit.

Abstract: Methods and devices for isolating nucleic acids from a mixture containing such nucleic acids and extraneous matter are provided. In one embodiment, the method of the invention comprises passing the mixture through a glass frit under conditions effective to separate the nucleic acids from the extraneous matter. In a more specific embodiment, the glass frit is a sintered glass fit.

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: The present invention is directed to immunoassays for detecting one or more target analytes in a fluid sample wherein the detection reaction occurs on a solid support and involves an amplification system. In particular, the invention is directed to making and using a test device having at least one site for detecting the presence of at least one target analyte, wherein a conjugate comprising dextran-polystreptavidin is immobilized at the test site(s) as a capture reagent for a complex containing the target analyze.

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 a dry stick test device for the determination of an analyte in a sample by means of a chemical assay. The device comprises: (i) optionally a solid support, (ii) at least one reagent pad comprising a reagent capable of reacting with the analyte, a derivative of said analyte or an indicator compound for said analyte to provide a detectable signal when in moistened state, and (iii) a development pad which is located in contact with the at least one reagent pad, optionally between the solid support and the at least one reagent pad, said development pad comprises at least one controlling compound capable of providing a condition required for the reagent to react with the analyte to provide a detectable signal, wherein the at least one reagent pad and the development pad are arranged to avoid precipitation of sample component(s) on the top-face of the device.

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

Abstract: It is intended to provide a target substance detection element wherein a target substance capturing body for capturing target substances is immobilized with good orientation in a desired region on the surface of the target substance detection element, a method for producing the target substance detection element, and a detection method using the target substance detection element.

Abstract: In one aspect, the invention is directed to a method for determining the concentration of anionic polymers or oligomers in industrial water comprising combining a buffer solution and a cationic dye solution, measuring absorbance of the buffer-dye admixture at selected wavelength(s) and determining the polymer or oligomer concentration from the previously determined absorbance values. In alternate embodiments of the invention, the buffer solution may be a multifunctional buffer solution and may be comprised of multiple buffers, masking agents. and/or stabilizing agents and combinations thereof. Other embodiments provide that multiple dyes may be employed.

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: The present invention provides a method for producing a dry analytical element for measurement of pancreatic lipase contained in a body fluid which contains triglyceride of long chain alkyl fatty acid having 12 to 22 carbon atoms, monoglyceride lipase, and a glycerine measurement reagent, and comprises a water-impermeable support and at least one spreading or reagent layer, said method comprising the step of coating an emulsion/dispersion solution of triglyceride with an average particle size of 1 ?m or less.

Abstract: In some aspects, a modular analyte measurement system having a replaceable strip port module is provided to permit contaminated modules to be replaced. Some aspects of the present disclosure related to barriers for strip ports or the sealing of strip ports and/or analyte measurement devices to maintain a clean strip port and/or enable the strip port to be cleaned for reuse. Cleaning tools are also provided. Also provided are strip port interfaces that guide fluid away from the strip port opening, as well as absorptive elements that prevent fluid from entering a strip port. Analyte measurement devices with gravity sensors or accelerometers are also provided, along with methods related thereto. Also provided are docking station that serve as an information server and provides storage and recharging capabilities.

Abstract: A test material for providing an indication of a substance in a sample applied to the test material, the test material comprising: an elongate, flexible, substrate; and a plurality of test sites arranged along the substrate, wherein each test site comprises one or more test reagents, and wherein the one or more test reagents are operable to produce said indication, a cassette for housing such a test material and a test meter.

Abstract: A chromatographic specific binding assay strip device, comprising: a non-permeable platform strip; a permeable membrane testing strip positioned on top of said non-permeable platform strip, with the testing strip comprising at least one capture reagent site containing a capture reagent for at least one specific analyte, a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip, with the sample receiving pad having contact with a proximal end of said permeable membrane testing strip, a reservoir pad positioned on top of and at a distal end of said non-permeable membrane testing strip, with the reservoir pad having contact with a proximal end of said permeable membrane test strip; a supporting strip attached to and extending from the proximal end of said non-permeable platform strip; and a conjugate pad positioned on said supporting strip, said conjugate pad comprising a semi-permeable membrane containing a colorant conjugate.

Abstract: According to one embodiment of the present invention, an optical-based test sensor for use in the determination of an analyte in a liquid sample is disclosed. The test sensor includes a base, a polymer carrier, and a test membrane. The base has a capillary channel formed in a surface of the base that is adapted to move a liquid sample from an inlet to a reaction area formed in the base. The polymer carrier has a lower surface adhered to the surface of the base and is disposed over at least a portion of the capillary channel. The test membrane, which contains a reagent, is adhered to the lower surface of the polymer carrier and extends from the polymer carrier into the reaction area.

Abstract: The present invention describes a system and method for accurately measuring the concentration of a substance within a filter housing. A concentration sensor and a communications device are coupled so as to be able to measure and transmit the concentration of a particular substance within the filter housing while in use. This system can comprise a single component, integrating both the communication device and the concentration sensor. Alternatively, the system can comprise separate sensor and transmitter components, in communication with one another. In yet another embodiment, a storage element can be added to the system, thereby allowing the device to store a set of concentration values. The use of this device is beneficial to many applications. For example, the ability to read concentration values in situ allows integrity tests to be performed without additional equipment.

Abstract: The present invention relates to a forensic test strip and method for the detection of semen. This strip is comprised of a paper element coated with reagents which react to the presence of acid phosphatase (AP), an enzyme found in semen, and is sandwiched between a clear plastic cover and an opaque plastic backing. This assembly is peeled apart, the paper element exposed to a source of semen, and the clear cover replaced. A positive test is characterized by a bright purple color, which easily can be seen through the clear cover. An adhesive backing is provided, which allows an investigator conveniently to affix the test strip directly to a notebook.

Abstract: An analytical strip and a detecting method using the analytical strip are provided. The analytical strip includes a substrate having a channel thereon. The channel has a first region, a second region and a third region, which are arranged successively. A first antibody is localized in the first region. A saccharide and a peroxidase are localized in the first or second region. A second antibody for recognizing a different epitope of an identical antigen with the first antibody is immobilized in the second region. A substrate reagent including a saccharide oxidase is localized in the third region.

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: A dried blood-spotting device includes a carrier card having a window therethrough along with a punchable glass fiber paper disposed in the window for a uniform absorption of a blood droplet sample into a homogeneous circular sport. The glass fiber paper is configured for enabling improved analysis for small molecules by a liquid chemotography/mass spectroscopy of punched specimens of the sample absorbed glass fiber paper.

Abstract: Providing an absorption pad which shows remarkable water absorptivity and can shorten a detection time when employed for an immunoassay apparatus. A water absorption pad for the immunoassay apparatus, containing 50% by weight or more of silicon-containing particles wherein a moisture absorptivity is 30% or less at a humidity of 60% or less and a moisture absorptivity is 40% or more at a humidity of 90% or more, a strip for an immunoassay using said absorption pad as a suction part, and an immunoassay apparatus including said strip for the immunoassay.

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: A reconfigurable sample preparation device includes a rotary plunger device having a hollow body and a coupling device, provided above one end of the rotary plunger, and accommodating a sample. The device also includes at least one sealed reagent module. When the rotary plunger is rotated on the coupling device, a film of the reagent module is pierced, mixing the sample with a substance from the reagent module.

Abstract: [PROBLEMS] To reduce the amount of, for example, a capturing antibody to be employed without lowering detection sensitivity. At the same time, to enable the achievement of intense color development or light emission in a determination area even in the case where only a small amount of a labeled antibody is accumulated. To lower the detection limit in the sandwich method. To enlarge the dynamic range in the competition method. [MEANS FOR SOLVING PROBLEMS] A method of analyzing a test substance by an immunological analysis method by using the test substance, a support having a determination area, on which one member selected from a capturing antibody capable of binding specifically to the test substance and a capturing antigen capable of binding specifically to the test substance has been immobilized, and a labeled antibody capable of binding specifically to the test substance, wherein a label having a sensitizing effect has been immobilized on the determination area of the support.

Abstract: The present invention refers to articles for collecting samples from a surface, articles for microbiological analyses of said samples, and methods of use of said articles. The articles include sample collectors, sample housings with optional barrier layers, and sample-ready reagent strips comprising hydrophilic agents to grow and detect microorganisms. The disclosure includes methods to collect, detect, and quantify microorganisms in a surface sample.

Abstract: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.

Abstract: The present disclosure provides a device for simultaneously detecting hemoglobin and glycohemoglobin in blood. The device includes a lateral flow assay strip, a laser-induced epifluorescence detection device, and an LED detection device. The present disclosure further provides a method for simultaneously quantifying hemoglobin and glycohemoglobin in blood by an immunological method using the same.

Abstract: The present invention provides a non-toxic diagnostic composition for intravaginal monitoring of vaginal infections. The present invention further provides a diagnostic article for intravaginal monitoring of vaginal infections with the article including an absorbent material for absorbing vaginal secretions and a composition suitable for identification of the pH or the buffer capacities associated with vaginal secretions. The diagnostic composition provides a visible indication of vaginal infections, such as bacterial vaginosis.