Abstract: The present invention relates to an assay device for determining the presence and/or amount of an analyte of interest in a sample, the assay device comprising: a) a housing that includes a liquid receiving unit that is adapted to accommodate one or more types of liquid; b) a mixing chamber adapted for containing a solution that is a product of one more types of liquid, and for receiving a sample to interact with said solution; c) an actuating lid which is capable of being actuated to enable the transfer of the liquid into the mixing chamber; and d) an assay means that is in fluid communication with said mixing chamber for determining the presence and/or amount of an analyte of interest in the sample after the interaction of said sample with said solution in the mixing chamber.

Abstract: A testing system for conducting electrochemistry analysis of a specimen sample is provided. The testing system includes a testing receptacle device and a diagnostic device. The testing receptacle device includes a receptacle having an interior space defined therein and a lid configured to be secured on an upper end of the receptacle. The lid includes an opening extending into the receptacle and a cartridge slot for receiving a test sensor cartridge having a functionalized electrode strip with an electrode well contact point provided thereon. The diagnostic device is configured as a potentiostat or similar device and includes a docking port for receiving a lower end of the testing receptacle device. The testing system is configured for receiving a specimen sample through the opening in the receptacle lid and placing the specimen sample in contact with the electrode well contact point of the functionalized electrode strip.

Abstract: An assay device is provided for use in determining the presence of a target analyte in a sample. The assay device comprises a solid platform comprising a fibrous mat, the solid platform impregnated with a first FRET chromophore. An antibody-FRET chromophore conjugate is immobilized on a surface of the solid platform, wherein the antibody-FRET chromophore conjugate comprises an antibody affixed to a second FRET chromophore. The first FRET chromophore and the second FRET chromophore are selected to provide an energy transfer from one to another when located within a Förster distance with respect to each other, thereby forming a FRET donor-acceptor chromophore pair. In a further aspect, a method of detecting a target analyte in a sample is provided. In yet a further aspect, packaging sheet materials and packaging articles employing the assay device under certain conditions are provided.

Abstract: Devices and associated methods for analyzing patient samples are disclosed herein. In some embodiments, a device includes a housing base configured to retain a test strip, and a housing cover configured to couple to the housing base to at least partially enclose the test strip. The housing cover can include a fluid reservoir configured to hold a solution for hydrating a sample swab. The housing can further include an aperture configured to permit transfer of a sample from the sample swab onto the test strip.

Abstract: An apparatus for testing for streptococcal pharyngitis includes a tube having an open first end and a second end, and an opening on a side thereof, a dipstick inserted into the tube through the side opening, and an insert with a hole that can receive the dipstick and sized to nest the dipstick into the side opening of the tube. A swab at the end of the dipstick inside the tube receives microbes in a breath exhaled by a patient holding the first end of the tube to the patient's mouth. After being exhaled upon by the patient, the dipstick is removed for testing for the presence of microbes that cause streptococcal pharyngitis.

Abstract: A specimen collection and delivery apparatus for collecting clinical specimens and delivery of samples thereof to, e.g., microfluidic testing devices for diagnostic analysis is disclosed. The specimen collection and delivery apparatus includes a closure housing for coupling with a sample tube at one end, an open luer for coupling with a complementary luer on a microfluidic device at the other end, and a filter matrix disposed in the interior. The filter matrix is air permeable and liquid impermeable at atmospheric pressure and prevents sample from flowing through the open luer end when coupled to a sample tube containing a specimen. Under vacuum, the liquid sample fraction of the specimen can be drawn through the filter matrix and into the microfluidic testing device through the luer connection for diagnostic analysis.

Abstract: The glove having chromogenic material is a medical glove that further comprises a chemical indicator. The chemical indicator is selected to indicate the presence of a specific chemical or chemical condition within a biological material that is being handled by the medical glove. The chemical indicator reacts to the specific chemical or chemical condition in a visible manner such that medical personnel handling the biological material is notified of the specific chemical or chemical condition. In the first potential embodiment of the disclosure, the chemical indicator that forms the coating indicates the pH of the biological material. In a second and third potential embodiment of the disclosure, the chemical indicator that forms the coating detects the presence of a biologically active chemical that is diagnostically relevant when found in the urine of a mammal.

Abstract: A receptacle for detecting a targeted substance is provided and may include at least one chamber configured to accommodate a reagent and a test swab. A first opening may be provided at a first end of the receptacle and a testing area may be provided at a second end of the receptacle. The receptacle may further include an image, readable by an image sensor, that is positioned a predetermined distance from the testing area and configured to facilitate alignment of the image sensor with the testing area for a colorimetric analysis of the targeted substance.

Abstract: A sample liquid preparing apparatus includes a first cylinder portion, a cap portion, and a liquid preparation vessel. The first cylinder portion has a first to-be-fixed portion and a second to-be-fixed portion. The first cylinder portion accommodates a first plug and a second plug. A liquid is sealed between these plugs. The cap portion includes a plunger portion to push the second plug and a first fixing portion to limit the plunger portion from pushing the second plug by fixing the first to-be-fixed portion. The liquid preparation vessel includes a second cylinder portion whose internal space is pressed by the first cylinder portion and a second fixing portion to limit the first cylinder portion from pushing by fixing the second to-be-fixed portion.

Abstract: Disclosed is a biopsy specimen carrier adapted for tissue biopsy samples where the specimen need not be removed or handled once housed within and including a backer board, a media removable secured to the backer board, a media carrier removable secured to the media and receptive to hold a tissue biopsy sample, a first strip of adhesive material on the media adjacent to the media carrier, and a release strip covering the first strip of adhesive material. The media is foldable to cover the media carrier carrying a tissue biopsy sample and is secured to the first strip of adhesive material with the release strip removed.

Abstract: Methods for the detection or diagnosis of a bacterial infection or colonization utilizing mass spectrometric analysis are provided. The methods involve short-term enrichment of samples followed by mass spectrometric analysis of biomarker profiles. Also provided are methods for preparing short-term enrichment cultures.

Abstract: There is provided an automatic analysis system that dispenses samples and reagents into a plurality of reaction vessels to cause reaction and to measure the liquid resulting from the reaction. The system implements a method of handling capped sample containers such as vacuum blood collection tubes along transfer routes. A sample container opening/closing mechanism is provided which removes the caps of the sample containers prior to sample dispensing and which closes the sample containers following sample dispensing using the same corresponding caps as before the dispensing. Also provided is an opening/closing mechanism that retains and manages the caps removed from the sample containers, as well as a transport unit capable of selecting one of the transport routes which fits the identified sample containers so as to close them with the fit caps.

Abstract: A cytological cell sample collection, storage, and transport device is disclosed. The device comprises a sheath, a collection assembly, a base, and a containment vial. The collection assembly is slideably coupled to the base to expose a swab head comprising the collection assembly. The containment vial may be configured to enclose the sheath and collection assembly within the internal volume defined by the containment vial and the base.

Abstract: Methods, devices, systems, and kits useful for the collection and analysis of samples obtained by swabs are disclosed. Swab containers configured for receiving a swab containing a sample; cartridges for holding one or more of: a swab container, a swab, assay units, pipette tips, vessels, transport units, and implements; systems (which may include a sample processing device); kits; and methods for their use are disclosed. A swab container may include an entry port; an assay chamber having an assay port; a conduit comprising an interior channel connecting the entry port; and an interior channel providing fluidic communication between the entry port and assay chamber. An interior channel may be configured to squeeze a portion of a swab placed in or through the conduit. A cartridge may include a cartridge frame configured to receive one or more of swab containers, assay units, transport units, pipette tips, vessels or implements.

Abstract: A container for storing a biological sample for molecular diagnostic testing and/or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A breakable membrane, such as a piercable foil, extends within the container and separates the two chambers. When the breakable membrane is broken, fluid can pass between the first and second chambers. The membrane may be broken through an activator on the closure, such as a depressible member or a rotatable carrier, causing the sample holder to break through the membrane.

Abstract: The present invention relates to a sealing device for closing an introduction aperture, the sealing device comprising a fixed support and a shutter mounted movably in translation relative to the support between an extended position and a final retracted position, wherein the sealing device is in a final retracted configuration and wherein the shutter closes introduction aperture. The device includes locking means for preventing any movement of the shutter when it is in the final retracted position. The sealing device further comprises an intermediate retracted configuration, wherein the shutter is at least partly retracted. The sealing device also comprises motion guiding means for guiding the movement of the shutter and designed so that the extension of the shutter is required to move the shutter from the intermediate retracted position to the final retracted position.

Abstract: Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics and kits are provided.

Abstract: A cytological cell sample collection, storage, and transport device is disclosed. The device comprises a sheath, a collection assembly, a base, and a containment vial. The collection assembly is slidably coupled to the base to expose a swab head comprising the collection assembly. The containment vial is configured to enclose the sheath and collection assembly within the internal volume defined by the containment vial and the base.

Abstract: The present invention relates to devices and systems for detecting the existence of oral conditions.

Abstract: An object of the present invention is to provide an element for SPR measurement without the need of a mechanical solution-sending mechanism.

Abstract: A detection kit comprises a plurality of swabs, each of the plurality of swabs having the form of a stick, being bundled together in a single test kit for detection of a plurality of chemical compounds. A user opens a detection kit, swabs a surface or surfaces with the bundled sticks, collecting chemical constituents to be tested on detection surfaces of each of the plurality of sticks. Liquids, mists, vapors and powders may be tested in one method, utilizing one or more dry reagents on the detection surfaces. The sticks may comprise a volume of fluid, releasably contained within the sticks, such that when activated, a fluid, such as a reagent or solvent, is wicked by a wicking tip to the detection surface of the stick. For example, a mechanism is provided that is capable of breaking a vial or ampoule containing the fluid, when activated by a twisting motion or compression. Adhesive may be present on one or more of the detection surfaces.

Abstract: A device, system and method for sampling sample material for an analyte including a receiving swab, wherein at least a portion of the receiving swab is compressible; a sensor for sensing the analyte; and a casing, wherein the casing at least partially encloses the receiving swab and the sensor and allows for a transfer of sample material received by the receiving swab to the sensor along a transfer path inside of the casing. The compressible portion of the receiving swab is located inside the casing, wherein by compressing the compressible portion, the transfer path is closable towards the outside of the device.

Abstract: A screening device for testing bodily fluids for the presence of certain constituents. The device can include a planar front face through which all of the test strips are viewed. The device also includes an inclined surface that directs the fluid under test to test strips with more efficiency, and partitions the fluid that is directed to a given test strip to better assure that the test strip receives an adequate amount of bodily fluid for a valid analysis. In one embodiment, the device includes a three-dimensional gasket that creates a pressurized environment upon insertion of the sampling stem for improved diffusion of the bodily fluid into the test strips.

Abstract: The present invention relates to the use of TFF3 in the diagnosis and detection of Barrett's esophagus using non-invasive, non-endoscopic methods.

Abstract: A collection device for use in connection with off-device testing of collected samples. The device includes a first panel having one or more apertures for receiving samples, a second panel opposite the first panel, and a removable tab having a first portion and a second portion. The first portion is aligned with at least one of apertures on the first panel and constructed such that depositing the sample through the at least one aperture causes the sample to be directly deposited on the first portion of the tab, and the second portion includes a sample-free grasping area accessible from an exterior of the device for removing the tab. A method of obtaining a sample is also disclosed.

Abstract: An immunochemical filter device which has filter material attached to a support member (such as a cap) which is, in turn, attachable to a sample collection vessel. The filter material includes a labeled binding reagent that is released from the filter material into solution by migration of a liquid sample solution through the filter material. The mixture of the sample solution and the labeled specific binding reagent is transferred to an analyzer device for performance of a method for determining the presence or absence of an analyte in a sample solution.

Abstract: A device for receiving a sample carrier is provided. The device includes an opening for receiving part of the sample carrier and a cutter for removing a part of the sample carrier. The cutter is coupled to a lid, which is movable to allow the cutter to make an incision in the sample carrier and, at the same time, to close at least part of the opening left open after receipt of the sample carrier. The disclosure further relates to a system comprising such a device and a method for operating such a device.

Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

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: Apparatus and methods are provided for evidence specimen collection having integral reagent holders to hold reagent vials and having drying agent or desiccant holding areas that permit the renewal of the desiccant and permit the introduction of variously size desiccant qualities to allow modulation of the specimen drying time to achieve early stabilization of specimens while holding the specimen in an isolated drying area during storage and shipment and for simultaneous collection of multiple evidence samples with simultaneous storage, drying, marking, evidence security and shipping provided and with the provision for simultaneous storage, drying, marking, evidence security and shipping provided for a control specimen.

Abstract: Apparatus and methods are provided for evidence specimen collection having integral reagent holders to hold reagent vials and having drying agent or desiccant holding areas that permit the renewal of the desiccant and permit the introduction of variously size desiccant qualities to allow modulation of the specimen drying time to achieve early stabilization of specimens while holding the specimen in an isolated drying area during storage and shipment and for simultaneous collection of multiple evidence samples with simultaneous storage, drying, marking, evidence security and shipping provided and with the provision for simultaneous storage, drying, marking, evidence security and shipping provided for a control specimen.

Abstract: A suspension storage container 10 has a flat portion across a specific region including the tail end. The flat portion has an outer peripheral wall 13 forming a flat outer peripheral surface and partition walls 14 that extend in the flat cross section of the outer peripheral wall 13 in a direction substantially orthogonal to the major axis direction of the flat cross section to partition a chamber inside the outer peripheral wall 13 into plural chambers S1 through S3 aligned side by side in the major axis direction. A suspension K is stored only in part of all the chambers S1 through S3, that is, the chamber S2, and a sealing film 21 having the outline almost identical with the outline of the outer peripheral wall is laminated to the tail end surfaces of the outer peripheral wall 13 and the partition walls 14.

Abstract: A sample collection device suitable for low-volume extraction includes a substantially tubular collection vessel having a closed end, an open end, and one or more sidewalls defining a vessel chamber having a vessel volume. The device further includes a swab for sample collection. The swab formed with a substantially closed-celled polymer foam head and the swab is configured for insertion into the collection vessel.

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 specimen collection apparatus and method is provided that allows for obtaining a specimen of evidence from a crime scene or evidence of any event and the sequential use and transfer and analysis of such evidence in a manner which maintains a demonstrable chain of custody.

Abstract: The present invention relates to a diagnostic kit and more specifically to a self contained diagnostic kit providing analysis of a sample by a sample collectin element and an immunochromatography test strip.

Abstract: Disclosed herein is test device and method for detection of sample analytes in which after sampling has occurred a closure is provided. Such a test device and method can be usefully employed to detect a variety of analytes including microorganisms.

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