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.

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: The present invention describes a system for accurately measuring the concentration of a substance within a filter housing. A concentration sensor and a communications device are coupled so as to measure and transmit the concentration of a particular substance within the filter housing while in use. This system allows the operator to certify the integrity of the filters within the filter housing at the customer site without additional equipment. In one embodiment, a tracer gas, such as helium or hydrogen, is added to a carrier and injected into the system. The concentration of tracer gas at a specific operating transmembrane pressure is indicative of bubble pointing specific pores in the filter. This test will give a more sensitive indication of the bubble point and the presence of defects than a standard diffusion test. In a second embodiment, two gasses, in a known ratio, are introduced into the filter housing.

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 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 strip or electrochemical sensor for measuring the amount of an analyte in a biological fluid, e.g. the glucose content of whole blood, includes a size self-limiting reagent formulation employing an enzyme system for reaction with the analyte, the reactive system mixed into a water-soluble swellable polymer matrix containing small water-insoluble particles having a nominal size of about 0.05 to 20 ?m, preferably about 1 to 10 ?m. The weight ratio of the water-insoluble particles to the water-soluble swellable polymer matrix is about 1/2 to 2/1. The reagent formulation is deposited onto a non-porous substrate to form a thin layer about 6-16 ?m thick, providing a rapid and stable response to application of a sample, while being insensitive to the amount of the sample.

Abstract: The invention relates to a device for simultaneously, qualitatively or quantitatively identifying a number of analytes in a liquid sample. The device comprises a membrane with: a charging zone for applying the liquid sample; at least two indicator zones, which can interact with the analytes, and at least one absorption area, which absorbs the liquid after passing the indicator zones, whereby the indicator zones are located between the charging zone and an absorption area. The invention is characterized in that the flowing directions from the charging zone through the respective indicator zones to an absorption area (flow paths) are essentially parallel, and at least two different flow paths exist. The invention also relates to a method for identifying a number of analytes or the derivatives thereof in a liquid sample.

Abstract: The present invention relates to a technique for efficient isolation of long nucleic acids and short nucleic acids from a sample containing long nucleic acids and short nucleic acids via safe and convenient operations. Specifically, long nucleic acids and short nucleic acids are isolated from a sample containing nucleic acids by mixing a chaotropic agent with the sample containing nucleic acids, allowing the mixed solution to pass at least twice through a first solid phase containing silica that has passage pores having predetermined pore sizes, allowing the mixed solution to pass at least twice through a second solid phase containing silica that has passage pores having pore sizes smaller than those of the first solid phase containing silica, and separately recovering nucleic acids that have bound to the first solid phase containing silica and those that have bound to the second solid phases containing silica.

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: An immunochromatoassay method that allows high detection sensitivity measurement. The method including the steps of: permeating an analyte solution that includes a visibly labeled second binding substance that specifically binds to a detection target substance into a test area of a chromatography medium provided with a first binding substance that specifically binds to the detection target substance, simultaneously with or after the permeation of the analyte solution into the test area, permeating a visual recognition aid solution into the chromatograph medium, the solution having a refractive index whose refractive index difference ?n from that of the chromatograph medium is ?0.1??n?0.1, and visually observing the test area while the visual recognition aid solution is permeated in the test area.

Abstract: Hollow particles for use in various types of assay devices are provided. Due to their hollow or voided structure, the particles may exhibit a variety of beneficial properties. For instance, hollow particles are generally lightweight, and thus, relatively inexpensive in comparison to other types of particles. Hollow particles may also form a stable system without requiring refrigeration or rotation. In addition, hollow particles may possess enhanced light diffraction capabilities, which may be particularly beneficial in certain types of assay devices, e.g., diffraction-based assay devices.

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

Abstract: This invention relates to a method and apparatus for process cell cultures. The apparatus comprises a micro-chamber comprising no more than one absorption layer and at least one gel layer, in this order, laminated on a transparent base plate having no conspicuous absorbency in visible and infrared regions, and at least one light source. The absorption layer has absorbency in visible and infrared regions, and the gel-like material is a substance which has a gel dissolution temperature of 100 degree C. or less, solates when heated and is in a gel state at room temperature and has absorbency for a specific wave length of visible and infrared regions. The light source is monochromatic light in the specific wave length. The light source is disposed such that it irradiates on the absorption layer and/or gel layer, with the exception that when no absorption layer is provided, at least two layers each composed of a gel-like material are laminated on the transparent base plate.

Abstract: The present disclosure relates to detection of the presence or absence of cerebrospinal fluid (CSF) in a sample, in particular to the analysis of the CSF protein lipocalin-type prostaglandin D2 synthase (L-PGDS). The present disclosure provides assays for the analysis of L-PGDS indicating the presence or absence of CSF in a sample.

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 invention concerns a diagnostic kit for simultaneous assay of antibiotics of different classes. The kit contains a single reaction mixture containing at least one first labelled receptor, specific of recognition of ?-lactams, a second labelled receptor, specifically and competitively identifying a tetracycline and a biotinylated nucleic acid fragment, an antisulfamide antibody and a labelled sulfamide analogue; and a recovery system in the form of a solid support comprising a nitrocellulose membrane whereon are fixed in three separate testing zones, respectively an antibiotic with ?-lactam nucleus, an avidin and an antibody capable of specifically identifying the antisulfamide antibody, so that the labelling intensity detected on the recovery system at the three testing zones results independently from a competitive recognition of each antibiotic by its labelled receptor.

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: A container is provided for holding a chemical compound or mixture. Areas are provided on the surface of the container which allow for gaseous by-products from the chemical contained within the container to permeate from a chamber through the surface of the container. A septum is over-molded into the surface of the container. The septum is formed in such a manner that it provides a sealing effect to close an opening in the container.

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: 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: 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 connected sequentially. 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. An optical substrate and a substrate reagent including a saccharide oxidase are localized in the third region.

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

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 flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes multiple detection zones, one of which is premised on “competitive” binding of the analyte and the other is premised on “sandwich” binding of the analyte. The present inventors believe that the combination of these zones may enable the detection of an analyte over extended concentration ranges.

Abstract: The present invention provides an immunological detection method that can detect milk allergens, allergens of albumen, flour, buckwheat and peanut with high sensitivity in foods containing these allergens regardless they are denatured/native, and a detection kit to be used therefor. It is a method for detecting allergens by using 2 or more monoclonal antibodies recognizing native and denatured milk allergens, native and denatured albumen allergens, native and denatured flour allergens, native and denatured buckwheat allergens, and native and denatured peanut allergens, using asl casein which is the main protein of milk casein, ?-lactoglobulin which is the main protein of whey, ovalubumin and ovomucoid which are main proteins of albumen, gliadin which is the main protein of flour, protein with a molecular weight of 24 kDa and 76 kDa which are main proteins of buckwheat, and Ara h1 which is the main protein of peanut as an index.

Abstract: Methods and compositions detect and quantify viable Legionella. Dip-slides that include an absorbent medium, growth promoting, and growth selective substances are useful in rapid detection and quantification of microcolonies of Legionella. Most probable number method of detection and quantification of Legionella are disclosed.

Abstract: Methods and compositions detect and quantify viable Legionella. Dip-slides that include an absorbent medium, growth promoting, and growth selective substances are useful in rapid detection and quantification of microcolonies of Legionella. Most probable number method of detection and quantification of Legionella are disclosed.

Abstract: The present invention is directed to methods and apparatus for detection of one or more analytes. Analytes include agents or components of infectious agents such as pathogenic virus, as well as enzymes, proteins and biomarkers.

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 specimen sample collection device includes a handle having a sufficiency indicator and an absorbent pad partially contained within said handle. A specimen sample collection device and test system includes a handle having a sufficiency indicator, an absorbent pad partially contained within said handle, a pad compression tube insertable over said absorbent pad within said handle and around an end of said handle, and a collection tube having one or more sample chambers, attachable to said pad compression tube, and wherein said compression tube defines one or more chambers, and wherein when said collection tube is attached to said pad compression tube, the chambers are in fluid communication with said pad compression tube. A specimen sample collection device including a sufficiency indicator made up of a light pipe indicator window. A specimen sample collection device including an absorbent pad split and divided into two lengths connected at a base.

Abstract: A sample collection system includes a vial and a collection stick. The collection stick includes an elongated handle portion and an absorbent head portion detachably connected to the handle portion. The absorbent head portion is configured to absorb and retain the fluid sample therein prior to insertion of the collection stick within the vial. During the sample collection process, the collection stick is inserted into the vial to express the fluid sample from the absorbent head portion into the vial. The absorbent head portion is retained within the vial in a generally compressed state with the handle portion being detached and removed from the vial.

Abstract: An inexpensive biosensor is provided that can realize an electrochemical analysis and perform measurement with high accuracy or convenience. The biosensor is an immunological sensor that enables measurement anywhere at anytime by anyone while keeping convenience. The biosensor includes: an electrode sensor unit 4 in which an electric conductive layer 2 is provided on an electrode-unit forming substrate 1 having an insulating property and an electrode portion 3 for detecting an electrochemical signal is formed on the electrode-unit forming substrate 1; and a chromatographic sensor unit 10 in which an extended layer 7 including a porous film for extending a specimen solution is provided on an extended-portion forming substrate 6, wherein the electrode sensor unit 4 and the chromatographic sensor unit 10 are stacked with the extended-portion forming substrate 6 interposed between the electrode sensor unit 4 and the chromatographic sensor unit 10.

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: A diagnostic test kit for detecting the presence or quantity of an enzyme or enzyme inhibitor is provided. The diagnostic kit utilizes reactive complexes to facilitate the detection of the enzyme or enzyme inhibitor. The reactive complexes include a substrate joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter and specific binding member. In one embodiment, for example, a peptide, protein, or glycoprotein substrate is joined to a reporter (e.g., dyed latex particle) and specific binding member (e.g., biotinylated compound). In this embodiment, the substrate provides a cleavage target for a proteolytic enzyme. Specifically, upon contacting the reactive complexes, the proteolytic enzyme cleaves the substrate and releases the reporter and/or specific binding member. The signal exhibited by the released reporters may then be used to indicate the presence or quantity of an enzyme or enzyme inhibitor within the test sample.

Abstract: Methods and compositions detect and quantify viable Legionella and other heterotrophic aerobic bacteria. Dip-slides that include an absorbent medium, growth promoting, and growth selective substances are useful in rapid detection and quantification of microcolonies of Legionella. Most probable number method of detection and quantification of Legionella are disclosed.

Abstract: A lateral flow assay device for detecting the presence or quantity of an enzyme or enzyme inhibitor is provided. The lateral flow assay device utilizes a molecular substrate to facilitate the detection of an enzyme or enzyme inhibitor via detection of the substrate and/or a product formed in an enzyme-catalyzed reaction of the substrate. In one embodiment, for example, upon contacting a molecular substrate, an enzyme catalyzes a reaction with the molecular substrate and forms a product. The lateral flow assay device also includes a detectable substance that may generate a detectable signal for determining the presence or amount of enzyme in a test sample. For example, the detectable substance may be directly or indirectly attached to a specific binding member that has affinity for the product. Following the enzyme catalyzed reaction, the product may bind the detectable substance which may, in turn, generate the detectable signal.

Abstract: It is an object of the present invention to provide a method for simply mixing two or more types of liquids in a porous carrier.

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. The devices are especially useful for identifying analytes in small volumes of whole blood samples utilizing one membrane principally for separating particles such as red blood cells from plasma and a second membrane as the site for reactions to identify the analytes.

Abstract: Disclosed is an assay device for determining the presence and/or extent of one or more analytes in liquid sample containing a) first and second assays each comprising a flow-path having a detection zone for immobilising a labelled binding reagent, wherein detection of a labelled binding reagent at one or both detection zones is indicative of the presence and/or extent of one or more analytes; b) a shared reference zone; c) one or more light sources to illuminate the detection zones and the reference zone; d) one or more photodetectors to detect light from the detection zones and the reference zone, which photodetector/s generate a signal, the magnitude of which signal is related to the amount of light detected; and e) signal processing means for processing signals from the photodetector/s.

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 provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.

Abstract: Methods for measuring the relative amount of two or more analytes of interest in a fluid sample, as well as kits useful in the methods, are disclosed. The methods involve assays that utilize a solid phase apparatus with a membrane having an application point and at least two sample capture zones having sample capture reagents; analyte binding particles or analyte coated particles; and assessment of a ratio of such particles arrested in capture zones, wherein the ratio is equal to, or inversely equal to, the relative amounts of the analytes of interest in the fluid sample.

Abstract: Lateral flow assay devices and methods for detecting an analyte in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations.

Abstract: A new class of biosensors and methods for making and using same are disclosed. The biosensors are multi-layered membrane composites, where at least one layer is prepared by the layer-by-layer process and at least one layer is responsive to changes is a property of a biological system such as changes in the concentration of an atom, ion, molecule or molecular assembly. Because the biosensors are multi-layered, a single biosensor is capable monitor a number of different properties of a biological system simultaneously. The biosensors are monitored by systems that impinge an excitation waveform on the biosensors and analyze a reflected and/or a transmitted resultant waveform. Additionally, the biosensors can be associated with field activated electronic components so that implantable, self-contained analytical devices can be constructed and monitored by field generators, where data is transmitted to an analyzer after field activation.

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: A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes conjugated probes that contain a specific binding member for the analyte of interest. The specific binding member preferentially complexes with the analyte within a test sample when contacted therewith. Excess analyte that remains uncomplexed with the specific binding member undergoes non-specific binding, such as to a hydrophobic domain. As a result, the ability of the uncomplexed analyte to compete with the complexed analyte at the detection zone of the device is restricted. Thus, the incidence of “false negatives” is limited in a simple, efficient, and relatively inexpensive manner.

Abstract: Disclosed is a test strip for measuring medical data, in which a hydrophilic material is introduced to improve the spreadability of blood. Having the structure comprising a blood-filtering layer designed to filter off either or both of erythrocytes and low-density lipoprotein (LDL) cholesterol from an applied blood sample; a reaction layer in which the blood sample free of erythrocytes and/or low-density lipoprotein (LDL) cholesterol is reacted with an reagent, and a hydrophilic material, intercalated between the blood-filtering layer and the reaction layer, for uniformly spreading the blood sample filtered through the filtering layer, the blood-filtering layer and the reaction layer being stacked between the lower support and the upper cover, the test strip prevents the infiltration of erythrocytes into the reaction layer and improves the spreadability of blood to reduce measurement errors, thus bringing about higher reproducibility.

Abstract: Device for immunochromatography comprise a test strip comprising a sample application member, a label holding member and a chromatography membrane, a first case member and a second case member. Detection kits and methods for testing an analyte substance are also described.