Abstract: A system for mixing a sample with a combined buffer includes a sampler body, the sampler body including a first reservoir and a second reservoir. The system further includes a first separator forming a first enclosure with the sampler body for the first reservoir. The system further includes a second separator forming a second enclosure with the sampler body for the first reservoir. The system further includes a third separator, in conjunction with the second separator, forming a third enclosure and a fourth enclosure, respectively, both in conjunction with the sampler body, for the second reservoir.

Abstract: The inventive applicator has a pliable plastic tube for holding a hermetically sealed crushable glass ampoule containing fluid to be dispensed from the applicator and applied by the applicator to a surface, and a pliable dispensing member mounted onto the plastic tube. The dispensing member has a dauber from which the fluid is dispensed and a protective device which surrounds a portion of the tube and is squeezed inwardly between the user's forefinger and thumb to cause the portion of the tube positioned thereunder to deform inwardly and crush the crushable glass ampoule positioned within the tube to release the fluid contained within the ampoule. The protective device guards against and minimizes the chances of users being cut by glass shards of the crushed glass ampoule when the protective device is subsequently squeezed inwardly to cause the fluid to move through the applicator to the dauber.

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

Abstract: The present invention provides exchangeable, reagent pre-loaded carriers (10), preferably in the form of plastic sheets, which can be temporarily applied to an electrode array (16) on a digital microfluidic (DMF) device (14). The carrier (10) facilitates virtually un-limited re-use of the DMF devices (14) avoiding cross-contamination on the electrode array (16) itself, as well as enabling rapid exchange of pre-loaded reagents (12) while bridging the world-to-chip interface of DMF devices (14). The present invention allows for the transformation of DMF into a versatile platform for lab-on-a-chip applications.

Abstract: A biological sterilization indicator (BI) and a method of using same for assaying the lethality of a sterilization process. The BI can include a housing, which can include a first portion, and a second portion, which can be movable with respect to the first portion between a first and second position. The BI can further include a frangible container comprising a liquid. The BI can further include a spore reservoir and a projection positioned in the housing. The projection can be configured to fracture the container when the second portion of the housing is moved from the first position to the second position. The method can include maintaining a minimal cross-sectional area of space around the container when the second portion of the housing is in the first position, and fracturing the container in response to moving the second portion between the first and second positions.

Abstract: Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

Abstract: A microfluidic chip orients and isolates components in a sample fluid mixture by two-step focusing, where sheath fluids compress the sample fluid mixture in a sample input channel in one direction, such that the sample fluid mixture becomes a narrower stream bounded by the sheath fluids, and by having the sheath fluids compress the sample fluid mixture in a second direction further downstream, such that the components are compressed and oriented in a selected direction to pass through an interrogation chamber in single file formation for identification and separation by various methods. The isolation mechanism utilizes external, stacked piezoelectric actuator assemblies disposed on a microfluidic chip holder, or piezoelectric actuator assemblies on-chip, so that the actuator assemblies are triggered by an electronic signal to actuate jet chambers on either side of the sample input channel, to jet selected components in the sample input channel into one of the output channels.

Abstract: A detection instrument determines whether a specimen container (e.g., blood culture bottle) is positive for presence of microbial agent growth therein. When the container is deemed positive it is made available (e.g, transferred or exposed to) to an automated instrument performing identification and/or characterization of the microbial agent. The identification and/or characterization instrument removes a portion of the sample from the specimen container and places it into a disposable separation and concentration device. The microbial agent is concentrated via optional selective lysis of non-microbial agent cellular material which may be present and centrifugation. A reading module reads the concentrated microbial agent using spectroscopic methods, e.g., measurements of intrinsic fluorescence. Such interrogation may occur while the microbial agent remains concentrated in the disposable device.

Abstract: The invention is directed to multi-fluidic cartridges for sample analysis and to methods of using said cartridges. In one embodiment, the cartridge comprises: (a) a first conduit beginning at a sample entry port for receiving a fluid sample and in fluid communication with one or more sensors; (b) a plurality of rupturable fluidic pouches, each containing a different fluid and in fluid communication with a respective delivery conduit configured for delivering a respective fluid to said first conduit; and (c) at least one pneumatic pump configured to move said fluid sample to said one or more sensors and for transporting at least one of said different fluids to said first conduit.

Abstract: An automated instrument for identification and/or characterization of a microbial agent present in a sample. The instrument includes (a) a sample removal apparatus operative to remove a test sample from a specimen container and add the test sample to a disposable separation device; (b) a separation and concentration apparatus operative on the separation device to separate the microbial agent from other components which may be present in the test sample and concentrate the microbial agent within the separation device; and (c) a identification and/or characterization module interrogating the concentrated microbial agent to identify and/or characterize the microbial agent.

Abstract: An analysis cartridge and an analysis system thereof are disclosed. The analysis cartridge comprises a cartridge body, a liquid storage box and a sealing film. The cartridge body has an accommodation portion. The liquid storage box is disposed within the accommodation portion and has a liquid storage tank and a pillar receiving hole. The sealing film covers the pillar receiving hole and seals an opening of the liquid storage tank.

Abstract: The present invention generally relates to systems and methods for counting biomolecules or cells. In certain embodiments, the invention provides a cell counting or biomolecule counting system including: a covered chamber having a known height and configured to hold a suspension of biomolecules or cells in a sample; at least one fluorescent light source connected to at least one fluorescent light beam narrowing device; a bright-field light source connected to a bright-field light beam narrowing device; a microscope objective; a detection device; a fluorescent filter assembly to allow only excitation light to illuminate the sample and allow only emission light from the sample to be imaged by the detection device; and a movable light shutter to block bright-field light during fluorescent detection.

Abstract: Apparatus for performing an assay to detect the presence of an analyte in a test sample. A housing defines a slot for receiving a sample collector, and a capsule contains a buffer liquid, the capsule being sealed by an openable lid, and being connected to the housing such that insertion of a sample collector into the slot causes the lid to open releasing the buffer liquid into the slot. The housing further defines an incubation chamber containing or configured to receive a reagent, and an aperture permitting liquid communication between said slot and the incubation chamber. The apparatus comprises one or more test elements, a substantially liquid tight sealing member separating the incubation chamber and the test element(s), and an activation mechanism operable to open said liquid tight sealing member thereby bringing at least a portion of the or each test element into liquid communication with said incubation chamber.

Abstract: A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

Abstract: A detection instrument determines whether a specimen container (e.g., blood culture bottle) is positive for presence of microbial agent growth therein. When the container is deemed positive it is made available (e.g, transferred or exposed to) to an automated instrument performing identification and/or characterization of the microbial agent. The identification and/or characterization instrument removes a portion of the sample from the specimen container and places it into a disposable separation and concentration device. The microbial agent is concentrated via optional selective lysis of non-microbial agent cellular material which may be present and centrifugation. A reading module reads the concentrated microbial agent using spectroscopic methods, e.g., measurements of intrinsic fluorescence. Such interrogation may occur while the microbial agent remains concentrated in the disposable device.

Abstract: A sample collection container and a cartridge system employ reagent bodies having reagents confined by a restraining agent. The sample collection container comprises one or more reagent bodies, each having one or more reagents confined by a restraining agent. The restraining agent is capable of being broken down to release the reagents which are dispersed through the restraining agent. The cartridge system comprises a reagent component for storing reagents and a processing component for processing the reagents in an assay. At least one of the components includes one or more reagent bodies, each having one or more reagents confined by a restraining agent capable of being broken down. The reagent component and the processing component are configured to be coupled together to form a cartridge, the reagent component and/or the processing component having at least one compartment to accept waste from the assay.

Abstract: A device for assay can evenly develop solution, and performs highly accurate and sensitive measurement. A first device part (10) maintains a second insoluble carrier (12) and a third insoluble carrier (13) in such a manner that they overlap with each other at a detection portion (14) of a first insoluble carrier (11). These three carriers (11), (12) and (13) are housed not in contact with each other. A pressing unit (18) having a pressing surface (18a) that is parallel to the detection portion (14) is provided on an inner surface of the second device part (20) facing the detection portion (14). The pressing surface (18a) is displaced by being pressed toward the detection portion (14), and presses, from the upper side of the first insoluble carrier (11), the second insoluble carrier (12) and the third insoluble carrier (13) onto the first insoluble carrier (11). The first device part (10) and the second device part (20) are joined together.

Abstract: A device for biochemical processing and analysis of a measured sample volume of a sample is described. The device is characterized in that it consists of a sealed vessel (1) and that it comprises at least one thin pierceable membrane (2) through which a capillary tube (3) containing said measured sample volume of a sample can pass into said sealed vessel (1). Said sealed vessel (1) further contains at least one biochemically reactive substance (4) and a liquid (6). A method, wherein the device according to the invention is used for analysis, is also described.

Abstract: A device for assay can evenly develop solution, and performs highly accurate and sensitive measurement. A first device part (10) maintains a second insoluble carrier (12) and a third insoluble carrier (13) in such a manner that they overlap with each other at a detection portion (14) of a first insoluble carrier (11). These three carriers (11), (12) and (13) are housed not in contact with each other. A pressing unit (18) having a pressing surface (18a) that is parallel to the detection portion (14) is provided on an inner surface of the second device part (20) facing the detection portion (14). The pressing surface (18a) is displaced by being pressed toward the detection portion (14), and presses, from the upper side of the first insoluble carrier (11), the second insoluble carrier (12) and the third insoluble carrier (13) onto the first insoluble carrier (11). The first device part (10) and the second device part (20) are joined together.

Abstract: Automated sample processing systems may include onboard efficient high-speed mixing of at least two components with an automatic vertical force fluidic turbulent component mixer of which a mixed component may be aspirated and high-speed dispensed in a mixing vial. Other aspects may include single sweep applying a multi-treatment cleaning cycle to at least one slide. A multi-treatment cleaning cycle may include a washing treatment and a drying treatment. In yet other aspects the present invention may include an automated recovery sample processing system with the capability of detecting at least one immediate condition of a fortuitously terminated automatic sample processing run and perhaps even an automatic terminated sample processing run reconstruction calculator.

Abstract: A reader for mechanical actuation of fluids within a test cartridge. The instrument interface including multiple independently-controlled plungers aligned to respective fluidic pouches on a test cartridge that is inserted into a testing apparatus embodying the instrument interface. The plungers include tips for applying mechanical force to the respective fluidic pouches.

Abstract: A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

Abstract: A microbial detection assembly is disclosed which includes a tubular body, a pierceable septum, and a plunger. The tubular body defines a longitudinal axis and has a first end and a second end. The pierceable septum is configured to seal the first end of the tubular body. The plunger head is configured to substantially close the second end of the tubular body. Together, the plunger head, the pierceable septum, and the tubular body define a reservoir dimensioned to receive a medium and a sample substance. Additionally, the plunger head is positioned and is movable within the tubular body in response to changes in pressure within the reservoir.

Abstract: Test cells have a first sorbent strip with a sample receiving location and defining a first migration path, a distinct second sorbent strip which receives buffer solution and at least partially defines a second migration path distinct from and elongated relative to the first migration path, conjugate supported by the second strip, a test site located at a junction of the first and second strips and having an immobilized ligand-binding mechanism, and a divider which directs a first amount of the buffer to the first strip to move the sample to the test site and a second amount to the second strip to move the conjugate to the test site. The first and second migration paths have first and second lengths chosen so that ligand in the sample reaches the test site and binds to the immobilized ligand-binding mechanism prior to the conjugate reaching the test site.

Abstract: A field colorimetric test device includes a housing having at least one interior compartment. A sampling device is configured to be associated with a distal end of the housing. A selection device is attached to a proximal end of the housing.

Abstract: The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

Abstract: A disposable cassette for blood analysis includes a housing having an upper panel and a sampling section having a filling inlet; at least one pair of chambers in a form of depression of the upper panel of the housing and sealed by a diaphragm; portions of the diaphragm over the chambers being flexible; and one or more channels adapted to interconnect the pair of chambers; one of the chambers containing a predetermined amount of a reagent for blood analysis; and a sample outlet disposed next to and connected to the chamber containing the reagent, the sample outlet including an outlet cavity recessed from the upper panel, a divider disposed therein, and a cover covering the outlet cavity; the sample outlet sealing the reagent to the chamber containing the reagent. Further disclosed is the method of using the disposable cassette for measurements of hematology parameters on a blood analyzer.

Abstract: An aspect of the disclosure is a method and device for the detection of antibiotics in a sample. Embodiments include a microbial culture with growth indicators and sensitivity adjustment reagents. Adjustment reagents include a variety of antibiotic binders that can be added to microbial culture to reduce sensitivity to certain antibiotics. Some embodiments include multiple buffers with a variety of pKa ranges. Some embodiments also include a complete self-contained apparatus for sampling and testing.

Abstract: Provided is a sample packing device for packing a sample with respect to a microchip for performing reaction of a micro component contained in the sample, the microchip at least including: a sample reservoir; a reaction reservoir; and a channel connected between the sample reservoir and the reaction reservoir, in which a package including a sample chamber packed in advance with the sample is mounted on the microchip so as to pack the sample in the sample chamber into the sample reservoir.

Abstract: A devise for fecal occult blood test comprises a first and a second casings, a sampling portion extending from the first casing, a specimen processing portion, at least a testing portion and a packing cylindrical member. The packing cylindrical member is coupled between the first and second casings when unused and dismantled therefrom when used. After sampling via a specimen collecting portion of the sampling portion, the specimen collecting portion is drawn into the first casing to reduce the device size. The first and second casings are fixedly coupled together in a specimen processing position thereof to mix specimens with a liquid of the specimen processing portion into a testing liquid, and then in a specimen testing position thereof to disperse onto the testing portions for testing and directly display test results. The present invention advantages high accuracy, rather hygiene, significant size reduction, real-time testing-result display and convenient use.

Abstract: An analysis device includes: a separation cavity 18 for separating a test liquid into a solution component and a solid component by using a centrifugal force; a higher specific gravity component quantitative cavity 23 for holding a portion of the separated solid component which has been transferred; a sample solution overflow cavity 22 arranged between the higher specific gravity component quantitative cavity 23 and the separation cavity 18 and connected to a connecting channel 21 for transporting the sample liquid from the separation cavity 18; and a capillary cavity 19 formed in the separation cavity 18 for temporarily holding a separated solution component (blood plasma) in the separation cavity 18. A blood plasma component 57a remaining in the separation cavity 18 is trapped by the capillary cavity 19.

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

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

Abstract: A disposable cassette for blood analysis includes a housing having an upper panel and a sampling section having a filling inlet; at least one pair of chambers in a form of depression of the upper panel of the housing and sealed by a diaphragm; portions of the diaphragm over the chambers being flexible; and one or more channels adapted to interconnect the pair of chambers; one of the chambers containing a predetermined amount of a reagent for blood analysis; and a sample outlet disposed next to and connected to the chamber containing the reagent, the sample outlet including an outlet cavity recessed from the upper panel, a divider disposed therein, and a cover covering the outlet cavity; the sample outlet sealing the reagent to the chamber containing the reagent. Further disclosed is the method of using the disposable cassette for measurements of hematology parameters on a blood analyzer.

Abstract: The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

Abstract: Articles are provided for the detection of cells in a sample. The articles include a release element. The release element comprises an encapsulating agent and a cell extractant. The release element controls the release of the cell extractant into a liquid mixture containing the sample. Methods of use are also disclosed.

Abstract: The present invention relates to a technique for moving a mobile component such as a sample and a reagent, in an analyzing article. A method of analyzing a sample according to the present invention includes a first movement step of moving a mobile component from a fluid entrance port (61) to a first goal (511) in a passage (51), and a second movement step of moving the mobile component from the first goal (511) to a second goal (512) in the passage (51), in an analyzing article (Y1). The analyzing article (Y1) further includes a branch passage which branches from the first goal (511), and a first opening for releasing gas from within the branch passage. The first movement step is carried out by establishing communication between inside and outside of the branch passage via the first opening.

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: 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 test device for liquids of the human or animal body, comprises a tube-shaped housing, in which are disposed: an in-feed area for feeding in a prescribed quantity of a bodily fluid, a reaction area connected downstream of the in-feed area and separated from the same by at least one closed separating wall, and in which the bodily fluid is brought to a chemical reaction with at least one reagent, and an indication area connected downstream of the reaction area and separated from the same by a separating element having a defined through-hole, and in which an indication element is disposed, the bodily fluid being passed through the through-hole after reacting with the reagent. A cutting device is thereby provided by means of which the separating wall can be opened or destroyed.

Abstract: Sample processing devices with variable valve structures and methods of using the same are disclosed. The valve structures allow for removal of selected portions of the sample material located within the process chamber. Removal of the selected portions is achieved by forming an opening in a valve septum at a desired location. The valve septums may be large enough to allow for adjustment of the location of the opening based on the characteristics of the sample material in the process chamber. If the sample processing device is rotated after the opening is formed, the selected portion of the material located closer to the axis of rotation exits the process chamber through the opening. The remainder of the sample material cannot exit through the opening because it is located farther from the axis of rotation than the opening.

Abstract: A device and method for enhancing rapid confirmatory immunological testing (“RCIT”) in chromatography strip-type rapid IVD devices useful in, for example, clinical, point-of-care, laboratory or over-the-counter settings. The device drives a flow fluid, primarily under the force of gravity alone, through a first chamber having a porous dam structure to enhance and substantially complete the first affinity binding reaction between a source of mobilizable labeled binding members and an analyte in the fluid. Flow through the dam causes a delay, mixing and trapping of the typically chemically disuniform initial fluid front so that fluid exiting the dam exhibits a more uniformly high degree of first affinity binding and decreased non-affinity binding.

Abstract: The present invention relates to a collection device for a substance, and methods related to collecting thereof.

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: 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: An optical sensor according to the present invention significantly enhances the sensitivity of an optical sensor for molecular measurement using light such as Surface Enhanced Raman Scattering and Plasmon Resonance Spectroscopy utilizing the local plasmon's excitation of a noble metal. By using a transparent substance deposition step for forming a large number of anisotropic nano-columns having a predetermined aspect ratio, with their longitudinal direction and transverse direction aligned, by depositing a transparent substance onto a substrate from an oblique position while periodically inverting the position and a noble metal deposition step for depositing a noble metal onto surfaces of the formed anisotropic nano-columns, it is possible to manufacture an optical sensor with very high sensitivity at very low cost.

Abstract: Provided is a sample collection container comprising one or more reagent bodies, wherein each body comprises one or more reagents confined by a restraining agent, wherein the restraining agent is capable of being broken down to release the one or more reagents, and wherein the one or more reagents are dispersed through the restraining agent.

Abstract: The present invention, provides a flow cytometry apparatus for the detection of particles from a plurality of samples comprising: means for moving a plurality of samples comprising particles from a plurality of respective source wells into a fluid flow stream; means for introducing a separation gas between each of the plurality of samples in the fluid flow stream; and means for selectively analyzing each of the plurality of samples for the particles. The present invention also provides a flow cytometry method employing such an apparatus.

Abstract: A bio sample processing apparatus and method using vacuum chambers in which a bio sample is injected into a first vacuum chamber connected with one end of a bio processor and, after processing, is ejected into a second vacuum chamber connected with the other end of the bio processor. The vacuum chambers and bio processor are connected with each other to form an environment with a pressure lower than atmospheric pressure, and the bio sample moves toward the second vacuum chamber due to the pressure difference created by the injection of the bio sample into the first vacuum chamber.