Abstract: The field of the present invention pertains to a controlled transfer biological collection device using a dry solid storage and transfer medium and a method for the collection of biological material of interest (genetic or proteinaceous material) in a form suitable for storage and/or subsequent analysis. Specifically, the present invention provides for a sampling device that controls the transfer of the biological sample to the storage medium by holding the storage medium and a moveable sample collection member having an analyte collection surface. The invention further provides for a method not only for storing a biological analyte on this collection device but also for analyzing the stored biological analyte using methods that are suited for automated analyzing systems.

Abstract: The methods and apparatus of the present invention allow the evaluation of inflammation of the esophagus. Measurements may be utilized, for example, to diagnose a disease of the esophagus, to monitor inflammation of the esophagus, or to access the treatment of a disease of the esophagus. In one embodiment, the invention comprises a method for measuring esophageal inflammation comprising deploying a device into the esophagus of a subject, removing the device after a predetermined period of time, analyzing the device for a diagnostic indicator of esophageal inflammation and evaluating the diagnostic indicator to diagnose esophageal inflammation.

Abstract: The present invention relates generally to a system and method for measuring the structural characteristics of an object. The object is subjected to an energy application processes and provides an objective, quantitative measurement of structural characteristics of an object. The system may include a device, for example, a percussion instrument, capable of being reproducibly placed against the object undergoing such measurement for reproducible positioning. The structural characteristics as defined herein may include vibration damping capacities, acoustic damping capacities, structural integrity or structural stability.

Abstract: The present disclosure relates to a surgical instrument for sampling molecules in an organ which can be accessed directly or via a surgical portal, including: a device for capturing the molecules, a stylet supporting the capture device, capable of entering the organ, a guide for inserting the stylet into the body as far as the organ, wherein the distal end of the guide is provided with a damping block intended to come to bear upon the organ.

Abstract: The present invention provides methods to concentrate cells onto microparticles, to concentrate the microparticles, and to detect the cells. The present invention also includes unitary sample preparation and detection devices to be used in accordance with the methods.

Abstract: Swabs, and materials of the present disclosure, and methods of making same, include randomly arranged sea-island bicomponent fibers which have randomly splayed terminal ends.

Abstract: The devices and methods taught in this disclosure are directed to facilitate the observation, collection, transportation, storage, and preservation of specimens possibly containing DNA, said specimens potentially constituting evidence of sexual assault. The devices and methods described further allow for a means of minimizing the possibility of specimen contamination, dilution, or degradation during the collection and storage processes. The disclosed devices may contain electrical components that provide for the generation and recordation of information (specifically, times, dates, and locations) related to circumstances surrounding the collection of such specimens. This information may serve as evidence corroborating the circumstance of specimen collection, it may help to maintain a known and identifiable Chain of Custody (CoC), and it may additionally be used for unique device identification (UDI), inventory control, and current procedural terminology (CPT) coding purposes.

Abstract: Implants are described herein which contain an activated adhesive on at least a portion of the surface of the implant. A release sheet may be positioned over at least a portion of the adhesive. Packages which contain the implants and methods of preparing the implants are also described.

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: Devices and methods for profiling microbiota of skin are described which include a microbe profiling device including a device head and a hand-held housing, the device head including an epidermis-engaging component and an access window and configured to dislodge microbes from a skin surface, and the hand-held housing defining an opening aligned with the access window, the hand-held housing including a motor operably coupled to a motivatable component, a substrate disposed in relation to the motivatable component and including signal-generating complexes, a location-capture component to detect a location of one or more regions of the skin surface as the epidermis-engaging component contacts said one or more regions, at least one sensor component to detect one or more signals emitted from the signal-generating complexes, and a computing component including circuitry to associate the location of said one or more regions of the skin surface and the detected one or more signals.

Abstract: Devices and systems for sampling and profiling microbiota of skin are described which include a replaceable microbe sampling unit including a substrate and a location information storage component, the substrate including a microbe-capture region configured to capture at least one type of microbe from one or more regions of a skin surface of an individual, and the location information storage component configured to store information associated with the location of said one or more regions of the skin surface of the individual.

Abstract: Systems and devices for sampling and profiling microbiota of skin are described which include a replaceable microbe sampling unit including at least one rotatable component, an elongated flexible strip, and a location information storage component, the elongated flexible strip including a microbe-capture region configured to capture at least one type of microbe from one or more regions of a skin surface of an individual, and the location information storage component configured to store information associated with the location of said one or more regions of the skin surface of the individual.

Abstract: Devices and methods for profiling microbiota of skin are described which include a microbe profiling device including a device head and a hand-held housing, the device head including an epidermis-engaging component and an access window and configured to dislodge microbes from a skin surface, and the hand-held housing defining an opening aligned with the access window, the hand-held housing including a motor operably coupled to a motivatable component, a substrate disposed in relation to the motivatable component and including a microbe-capture region, a location-capture component to detect a location of one or more regions of the skin surface as the epidermis-engaging component contacts said one or more regions, at least one sensor component to detect one or more signals emitted or reflected from the microbe-capture region, and a computing component including circuitry to associate the location of said one or more regions of the skin surface and the detected one or more signals.

Abstract: Devices and methods for profiling microbiota of skin are described which include a hand-held microbe profiling device including a housing defining an opening, the housing including at least one rotatable component at least partially disposed in the opening defined by the housing, an elongated flexible strip disposed on an outer surface of the at least one rotatable component, the outer surface of the elongated flexible strip positioned to contact one or more regions of a skin surface of an individual through the opening defined by the housing, a location-capture component to detect a location of one or more regions of the skin surface as the elongated flexible strip contacts said one or more regions, at least one sensor component to detect one or more signals emitted or reflected from the elongated flexible strip, and a computing component to associate the location of said one or more regions of the skin surface and the detected one or more signals.

Abstract: The present invention relates to a sampling instrument adapted for taking a sample in situ and in vivo or taking a sample ex vivo of a target tissue or body structure, in a maximum quantity of less than 10?6 g, the instrument comprising an elongated active member (10) with a distal operative end (11) having at least one retaining surface (12) arranged for contacting directly the target tissue or body structure, capturing and retaining molecules of the target tissue or body structure thereto.

Abstract: Biological samples, such as saliva, are commonly collected on a swab and subsequently transferred to an absorbent storage medium. Embodiments of the present invention provide a biological sample collection device comprising a collection portion and a body portion, the body portion including a holding portion for holding a biological sample storage medium, and a sample transfer means, such as a cover. The collection portion can be arranged in a first position separated from the body portion for collecting a sample, and in a second position at least partly between the sample transfer means and the holding portion, with the sample transfer means being operable to push the collection portion towards a position at which the holding means is arranged to hold the biological sample storage medium, enabling a sample held in the collection portion to be transferred to the latter. This provides an improved means of collecting a biological sample.

Abstract: A device for collection of exfoliated cells from the rectal mucosa comprises a hollow, cylindrical body having an inflatable and invertible flexible membrane attached to one end thereof. Applying positive pressure to inflate the membrane after the device is inserted, preferably through a rectal access tube, into the rectum causes exfoliated cells to be collected on the surface of the membrane. Before removal of the device, negative pressure is applied and the membrane, along with the collected sample of exfoliated cells, is deflated, inverted and withdrawn into the body of the device, thereby avoiding contact of the collected sample with body surfaces or the rectal access tube as the device is removed from the rectum.

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: The invention provides devices and methods for self-administered noninvasive retrieval of biological materials of the uterus and/or cervix. The cervical device comprises a receptacle with a variable volume receptacle cavity, a controller configured to change the volume of the receptacle cavity, a surface for collection of biological materials, and a flexible pouch for generation of suction to facilitate efficient retrieval of biological materials. The biological materials retrieved include various biomarkers of diseases and disorders of reproduction, are directly isolated from a site of pathology, and are not metabolized or diluted. Information generated by analyzing these biological materials permits early diagnosis and prognosis assessments of disease and disorders of the female reproductive organs, irregularities of pregnancy, anomalies of the fetus in utero, and microbial infections.

Abstract: Disclosed are devices, compositions, and methods for diagnosing eosinophilic esophagitis in a subject. Also disclosed are methods for monitoring the course of eosinophilic esophagitis in a subject before, during, and after treatment.

Abstract: Kits, devices, methods, and systems for assessing microbiota of a body surface and selecting treatment agents to apply to the body surface to modulate one or more types of microbes are described which include a kit including a plurality of treatment agents, a microbe sampling unit including a microbe-capture region, and an analyzer including a user interface, at least one sensor component, and a computing component with a processor and circuitry.

Abstract: An arrangement for collecting a tissue or stool sample has a sample vial and a source of preservative fluid. A fluid valve controls a flow of the preservative fluid from the source of preservative fluid to the sample vial. An air equalization vent tube is coupled to the source of preservative fluid and an air valve controls a flow of air through the air equalization vent tube, the air valve and the fluid valve being actuated simultaneously. A scoop for collecting the sample is coupled to the sample vial coupler and extends into the sample vial. The preservative fluid flows from the source of preservative fluid to the sample vial by force of gravity upon actuation of the fluid valve. The air equalization vent tube transfers air from the sample vial to the source of preservative fluid upon actuation of the air valve.

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 provides a liquid sampling, storage, transfer and delivery device comprising housing containing a porous nib. The porous nib in the device contacts the sample, collects the sample, stores the sample, transports the sample inside its porous matrix and releases the sample from the porous matrix upon demand.

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 provides a liquid sampling, storage, transfer and delivery device comprising housing containing a porous nib. The porous nib in the device contacts the sample, collects the sample, stores the sample, transports the sample inside its porous matrix and releases the sample from the porous matrix upon demand.

Abstract: The invention relates to a swab system, comprising a sample tube, which is closed at the front end and open at the rear end, and a swab. The swab has an elongated, tubular swab rod, wherein the swab rod is provided with a sample-gathering means at the front end of the swab rod and a gripping piece at the rear end of the swab rod. The gripping piece closes the rear, open end of the sample tube in an accurately fitting manner and is equipped with a closing cap for covering the gripping piece in a sealed manner. The gripping piece has the internal taper of a Luer connection, wherein the internal taper of the Luer connection has a fluid connection to the tubular swab rod.

Abstract: A sampling device adapted for transcervical sampling of biological materials from a pregnant patient comprising: an elongate insertion tube (4) having a first end (5) adapted for insertion through the external orifice (external os) of said patient's cervix and a second end (6) including a handle means (7) for manipulating said tube; a measuring means for determining the position of said first end of said tube within said cervix, wherein said first end (5) includes a sampling head (9, 14) adapted to collect biological material including cells, mucus and biological fluids, and wherein said measuring means is adapted to determine the extent of insertion and transcervical position of said first end to optimise the transcervical sampling site.

Abstract: Disclosed herein is a sample recovery and collection device comprising a tube, a cap, an insert, and an opening. The cap includes an O-ring and is removably secured to the tube for sealing the tube. The insert includes a first end having a ring that is adhered to the tube and second end opposite the first end. The insert also includes a first leg, a second leg, and a third leg, each coupled to and extending from the ring to the second end. The opening extends from the ring to the second end and the insert defines a diameter. Also disclosed herein is a kit comprising the sample recovery and collection device. Further disclosed herein is a method of collecting a sample from a subject.

Abstract: A swab assembly for collecting a specimen from a patient includes an elongated shaft having a proximal end, a distal end, and a notch between its proximal and distal ends; a sheath having a proximal end, a distal end, and a lumen extending between its proximal and distal ends, wherein a portion of the elongated shaft is disposed within the sheath lumen, and the sheath is slidable relative to the elongated shaft; and a collection tip coupled to the distal end of the elongated shaft and configured for obtaining the specimen. The sheath is slidable between a first position in which the shaft notch is disposed within the sheath lumen and wherein the sheath protects the elongated shaft from breaking at the notch, and a second position in which the shaft notch is exposed out of the sheath lumen.

Abstract: A low pressure sample collection apparatus includes a double-ended cap member having similarly sized plug members extending from opposite sides, a vacuum connection nipple on one side and a shaft connection portion one the opposite, a passage extending through the cap from the nipple to the shaft connection portion, a tubular shaft connected to the shaft connection portion and having a sample collection swab member secured to an outer end thereof, and a container member having one end closed and an opposite end open. The cap member is reversibly plugged into the container either to use the container as a handle or to position the swab within the container for protection. A vacuum source may be connected to the assembly to draw air through the swab. The shaft may have a barrel telescoped thereon for separation of the swab from the shaft without contacting the swab.

Abstract: Embodiments relate generally to a sampling device adapted for sampling of biological materials from a subject and methods of use or manufacture of such devices, as well as diagnostic methods employing such devices and kits including such devices. The sampling device may comprise: an outer tube; an elongate insertion member having a first end and a second end, wherein the first end is distal of the second end, the insertion member being received in and sized to be movable through the outer tube; a coupling portion disposed at the first end of the insertion member; and a sampling portion coupled to the coupling portion and configured to collect the biological materials. The coupling portion is separable from the insertion member.

Abstract: The invention relates to trans-epithelial frictionally abrasive tissue sampling devices for performing biopsies and methods of inducing an immune response against a pathogen, wherein epithelial cells containing the pathogen are disrupted with the frictionally abrasive tissue sampling device to introduce the pathogen into the bloodstream of a patient.

Abstract: A unitized apparatus for collection and/or drying and/or transport and/or analysis of a specimen is provided having a desiccant chamber that permits variable quantities of desiccant to be loaded into the device and to allow the desiccant to be recharged within the device without contacting or causing damages to the specimen collected thereon.

Abstract: Skin cholesterol is measured by applying an adhesive tape onto a selected area of the skin to adhere the tape to the selected skin area and stripping the tape off the selected skin area to obtain a sample representative of the outer stratum corneum layer of the skin, the sample adhering to the tape so as to have exposed skin constituents. The sample is assayed using a detector reagent that specifically binds to cholesterol and in addition has an indicator component that allows quantitation of the amount of cholesterol present in the exposed skin constituents.

Abstract: A bio-nano-chip (BNC) technology that works in connection with non-invasive samples, such as saliva, cheek swab or urine samples that can be easily performed by non-specialists, such as security personnel and police officers is disclosed. The microfluidic system for drug testing includes an analyzer or reader having a housing containing a slot for receiving a cartridge, a drug testing cartridge, a processor having a user interface, an optical or energy sensing means, and a means for moving fluid.

Abstract: A sampling device adapted for transcervical sampling of biological materials from a pregnant patient comprising: an elongate insertion tube (4) having a first end (5) adapted for insertion through the external orifice (external os) of said patient's cervix and a second end (6) including a handle means (7) for manipulating said tube; a measuring means for determining the position of said first end of said tube within said cervix, wherein said first end (5) includes a sampling head (9, 14) adapted to collect biological material including cells, mucus and biological fluids, and wherein said measuring means is adapted to determine the extent of insertion and transcervical position of said first end to optimise the transcervical sampling site.

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: A sampling system comprises a mailing package; a cell sampling device comprising a flexible shaft having a handle at one end, wherein the shaft is configured to allow an individual to self collect a cell sample from mucous tissue, and a sample collecting element removably connectable with the other end of the shaft and operable to collect a cell sample from mucous tissue of an individual; and a sealable unit, wherein the unit is configured to store the sample collecting element having a cell sample thereon configured to receive the remaining components of the system for delivery to a user.

Abstract: The invention relates to trans-epithelial frictionally abrasive tissue sampling devices for performing biopsies and methods of inducing an immune response against a pathogen, wherein epithelial cells containing the pathogen are disrupted with the frictionally abrasive tissue sampling device to introduce the pathogen into the bloodstream of a patient.

Abstract: A biological sample collection system is described comprising a biological sample collecting wand and a buffer container with a buffer solution. The biological sample collecting wand includes a handle and a sample collector detachably coupled to the handle. The sample collector include one or more sample protrusions, one or more sample apertures, or a combination thereof, at least the sample collector to removably insert into the buffer container.

Abstract: A biopsy device comprises a probe assembly, a holster assembly, a tissue sample holder, and a manually operated rotation mechanism configured to rotate the tissue sample holder. The probe assembly comprises a cutter configured to sever a tissue sample. The tissue sample holder includes a plurality of tissue chambers configured to receive discrete severed tissue samples. The holster assembly comprises the non-motorized, manually operated rotation mechanism configured to allow a user to align consecutive chambers to successively collect discrete severed tissue samples. The tissue sample holder rotation mechanism may comprise a first button, a first lever, a first pawl, a first ratchet, an indexing shaft, and a first gear, which are all configured to, ultimately, rotate a tissue sample holder. The tissue sample holder rotation mechanism may alternately include thumbwheels, a worm gear, or a ratcheting lever, among other things.

Abstract: The present invention relates to a swab for collecting biological specimens of the type consisting of a rod terminating in a tip covered with fibre with hydrophilic properties to allow absorption of said specimens, wherein said fibre covers said tip in the form of a layer deposited by flocking.

Abstract: The invention relates to a flocking swab for biological sampling quantitatively and a method for making the same. One or two ends of the swab shaft form a loop by injection molding process. Flocking fiber is flocked into a layer on the surface of the loop by conventional electrostatic flocking process. By controlling the diameter of the loop frame, the diameter of the cylinder of the loop, and parameters of flocking fibers, a quantitative swab for biological sampling can be made. The swab disclosed in this invention can be used in quantitative sampling, has large sampling volume and securely attached swab tip. Moreover, it is safe and easy to use.

Abstract: Provided is a biological tissue collecting tool capable of reducing a variation in the amount of collected biological tissue at the time of collecting the biological tissue from a biological aperture. A biological tissue collecting tool 10 according to the present invention includes: an exterior body 3 having first space formed therein and having a first collection opening 2 formed in a wall thereof, the exterior body 3 having such a shape as to be insertable in a biological aperture; a collecting portion 15 disposed in the first space such that the collecting portion 15 is movable in the first space, the collecting portion 15 being configured to collect a part of biological tissue that protrudes into the first space through the first collection opening 2; and an operating portion 7 connected to the collecting portion 15, the operating portion 7 allowing the collecting portion 15 to be operated from outside of the exterior body 3.

Abstract: A kit is provided for gathering biological specimens. The kit generally comprises a self-contained specimen gathering device including a protective housing and a preservation solution. Also provided is a method of gathering specimens and a holistic method of deterring crime using the kit.

Abstract: A sample collection implement S1 includes a container 1 having an accommodation portion 10 in which a liquid 5 for suspending or diluting a sample is accommodated, a sample collection stick 2 being able to be disposed in the accommodation portion 10, a filter 3 provided inside the container 1, and a movable member 4 that can be moved in a predetermined direction inside the container 1 and has a function of pushing the liquid 5 and causing the liquid to pass through the filter 3, when moved in the predetermined direction. With such a configuration, when the liquid 5 is filtered, it is not necessary to move the filter 3 by directly pushing it and a filter with a low mechanical strength can be used as the filter 3. In addition, it is not necessary to use a centrifugal apparatus.

Abstract: A kit and method for collecting, storing and transporting genetic samples from an animal to a storage facility. The kit comprises at least a collection swab, a protective tube, a follicle sample collection card, and an extraction device. The collection swab is housed within a sterile protective package. The collection swab has a shaft connected at one end by a collection head. The collection swab includes a cap and plug, wherein the cap is encircled around the shaft of the collection swab. The protective tube is adapted to receive the collection head of the collection swab. The follicle sample collection card has a protective backing covering an adhesive strip disposed on the follicle sample collection card. The extraction device is provided to pull at least one hair with follicle from the animal.

Abstract: A combination exo-endocervical sampling device includes a shaft that includes a first end opposite a second end, and a combination exo-endocervical sampler configured to simultaneously collect endocervical cells and exocervical cells. The combination exo-endocervical sampler is coupled to the second end and includes a pair of opposing wings disposed transverse to the shaft and a brush extending from the wings along a central axis of the shaft. Each of the opposing wings includes a plurality of flexible loops configured to collect exocervical cells.

Abstract: A sample collection tool comprises a collection end configured for collecting a sample. Optionally, the sample is collected from within a body cavity of an animal without causing significant discomfort or injury to the animal. A first handle portion has a first end connected to the collection end and a second end. A second handle portion is connected to the second end of the first handle portion by a breakable connection. The second end of the first handle portion has at least one winglet. The at least one winglet is compliant in a preferential direction. The breakable connection is ruptured at least in part when the at least one winglet is forced in the preferential direction.