Abstract: A specimen tube comprises a tubular body having a first end that is open, a second end that is closed and at least one side extending axially between the first end and the second end. The side and the closed end define an interior of the tube. In sonic implementations, the specimen tube comprises a plurality of foot members protruding from the second end of the tube, wherein at least a first foot member and a second foot member have different shapes from each other. In some implementations, at least one internal wall positioned within the interior of the tube defines a sample carrier holding space between at least one surface of the internal wall and an adjacent surface of the side of the tube, the sample carrier holding space being sized to store a swab inserted from the open end of the tube.

Abstract: The concepts herein relate to a device for collecting, transferring and storing samples of biological and/or chemical material. The device includes a support body extending along a main longitudinal direction between a first and a second end opposite each other and a collecting portion engaged with one of said ends of the support body and suitable for collecting an amount of a sample of biological and/or chemical material. The support body is defined by at least a first sub-body and a second sub-body extending longitudinally and configured to be selectively engaged and separated with and from each other. The support body is configured to operate between an assembled condition, wherein the first and the second sub-body are engaged with each other, and a separated condition, wherein the first and the second sub-body are separated and bear, respectively, a first and a second sub-collecting portion of the collecting portion.

Abstract: According to the present disclosure, a method for detecting an analyte using surface enhanced Raman spectroscopy (SERS) is provided. The method comprises (a) contacting one or more analyte-binding molecules with the analyte under conditions that allow binding of the analyte to the one or more analyte-binding molecules to form a first mixture, wherein the analyte is preferably haptogloblin and the analyte-binding molecule may comprise haemoglobin or is a haptogloblin antibody, (b) contacting a liquid reagent comprising a peroxidase substrate and a peroxide source with the first mixture to form a second mixture, while maintaining pH of the second mixture at 10 or less, (c) quenching the second mixture to form a third mixture, (d) optionally contacting the third mixture with a SERS-active substrate, and (e) detecting a surface enhanced Raman signal from the third mixture and/or a surface of the SERS-active substrate.

Abstract: A method includes capturing a signal of a detection substrate exposed to a sample containing a target substance; determining that the detection substrate is in a testable state; and generating an assessment of the presence of the target substance in the sample.

Abstract: Computerized devices provide microscopy and electrochemistry tests, performed in dual channels. The devices can be brought to the field, for on-site testing with instant results. The dual channels include an imaging (optical or microscopic) channel and a signal channel. Microfluidic chips are disclosed for use with the microscopy channel optics.

Abstract: The present invention provides a dermal patch for selectively retaining one or more analyte(s) from a body of a subject comprising: a membrane layer (101) for retaining one or more analyte(s) from a body of a subject, with a first and a second side, wherein the first side is adapted to be in fluid communication with the skin of the subject; optionally holding means for securing the membrane layer in place; an adhesive layer (104); and a backing layer; wherein between the backing layer and the membrane layer (101) there is an expandable layer (103) for applying pressure to the membrane layer.

Abstract: The technology described in this document can be embodied in a test strip for use in measuring a level of an ST2 cardiac biomarker in a whole blood sample. The test strip includes a base, and a plurality of conjugates, wherein each conjugate includes a reporter group bound to a first antibody that binds to ST2. A conjugate pad holds the plurality of conjugates that bind with ST2 to produce conjugate-ST2 complexes. The test strip also includes a plurality of second antibodies that bind to ST2, and a plurality of third antibodies that bind to the conjugate-ST2 complexes. The plurality of second antibodies are bound to a membrane in a test location, and the plurality of third antibodies are bound to the membrane in a control location. A plasma separation pad passes blood plasma from a whole blood sample to the conjugate pad while inhibiting other components.

Abstract: Described herein is a fluid collection unit comprising: a receptacle for passively collecting a fluid sample; and a fluid flow path in fluid communication with the receptacle, the fluid flow path passing through the unit for directing the fluid sample from the receptacle to an opposing end of the unit.

Abstract: Determining the relative binding capacity of albumin (A), and amount of functional albumin, involves at least two measurement solutions of a test and reference sample. The measurement solutions contain an albumin-binding marker M. The marker in the measurement solution of the test and reference samples exceeds the presumed available albumin binding capacity. The test sample contains a defined amount of albumin of unknown binding capacity. The reference sample contains the same defined amount of albumin having a reference binding capacity. The measurement solutions are incubated under conditions that allow M:A complexes to form. The M:A complexes are removed. The presence or amount of unbound marker M in the solutions is detected after M:A complex removal by a test strip that allows determination of the unbound marker. The relative binding capacity of albumin in the test sample based on the presence or detected amounts of unbound marker is determined.

Abstract: The present invention discloses a detection apparatus, comprising a base layer, wherein the base layer comprises a groove for containing a testing element and a sample chamber for collecting a fluid sample. The detection apparatus can achieve fast, efficient and accurate detection of analytes in liquid samples, make operators to perform testing conveniently and freely, without causing incorrect results. In some preferred modes, the sample chamber comprises a liquid channel.

Abstract: A sensor assembly includes a first sensor substrate with upper surface, lower surface opposite upper surface, and a first set of sensors on the first sensor substrate. The sensor assembly includes a second sensor substrate with upper surface, lower surface in opposite upper surface, and a second set of sensors on the second sensor substrate. The sensor assembly includes a base with upper surface, lower surface opposite upper surface of the base along a vertical direction, a front end, a rear end opposite the front end along a longitudinal direction perpendicular to the vertical direction, a first recess at least partially holds the first sensor substrate, a second recess at least partially holds the second sensor substrate, a first fluid passage for receiving a fluid, and a second fluid passage in series with and open to the first fluid passage. Both sensors are exposed to its corresponding fluid passage.

Abstract: A device for testing a biological sample includes a housing, two or more test pads, and a sample pad. The sample pad and test pads are disposed within an interior portion of the housing. The sample pad is in fluid communication with an opening defined in an outer surface of the housing for receiving the biological sample. At least a portion of each test pad is in contact with the sample pad and is configured to test the biological sample. At least one window is defined in the outer surface of the housing adjacent the test pads such that the test pads are visible from outside of the housing. A first test pad may detect a threshold amount of CD44 in the biological sample, and a second test pad may detect total protein in the biological sample. The results are then used for early detection of cancers.

Abstract: A dry powder inhaler may include a housing having a lower housing part defining at least one air inlet and at least one air outlet. At least one container may be disposed in the lower housing part. The at least one container may include a cavity for a dry powder drug. A chamber may be disposed above the at least one container for deaggregation of the dry powder drug after emptying of the dry powder drug from the cavity. Upon inhalation by a user at the at least one air outlet, air may flow from the at least one air inlet into and through the chamber to empty the dry powder drug from the cavity and convey the dry powder drug to the at least one outlet.

Abstract: Disclosed herein are methods, for use in association with specially configured devices, systems, and kits, for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect at least progesterone or analytes of progesterone in a sample.

Abstract: A device for performing a multiplex lateral flow immunoassay is provided in which a liquid sample, such as a biological sample, is simultaneously tested for the presence of multiple analytes of interest. Methods that employ the device in the simultaneous detection of multiple analytes of interest within a liquid test sample are also provided.

Abstract: Many hand-held diagnostics are limited in their functionality due to the challenging physics associated with small dimensional systems. An example of this is capillary forces in hydrophilic systems, such as the tight retention of liquid passing through a small pore filtration membrane, or capillary force driven microfluidics where, to keep liquid flowing the dimensions of the system become so small that the flow rates are too low to be useful, or the manufacturing of such devices becomes uneconomical. This disclosure details methods to ‘reset’ the capillary force condition to avoid the requirement of transient pressure spikes associated with the breakthrough pressure of small pore membranes, and avoid the necessity of extremely small microfluidic channels, which can be useful in applications such as filtration of whole blood to plasma using only suction pressure or passive capillary pressure.

Abstract: The present invention provides systems, devices and methods for detecting the presence and/or absence of one or more allergens in a sample particularly a food sample. The detection system includes a separate sample pickup, one or more disposables for receiving and processing a test sample and a detection device that can execute an allergen detection testing in minutes. The present detection system and device is compact and portable.

Abstract: Disclosed is a biochemical-immunological hybrid biosensor. The biochemical-immunological hybrid biosensor includes a reaction strip in the form of a porous membrane through which a sample moves by capillary action. The reaction strip can simultaneously measure heterogeneous multiple biomarkers through both a biochemical analysis and an immunoassay in an independent manner based on membrane chromatography to diagnose a particular disease.

Abstract: An object of the present invention is, in the case when a specific substance that has expressed on cells to be detected in a liquid sample is to be specifically stained, to provide a convenient cell staining method by which the damage and loss (flow out) of the cells in the collected sample are prevented, and the time has been shortened in a procedure for staining the cells in the liquid sample. Furthermore, another object of the present invention is to provide a sample collection tube that is suitable for use in the above-mentioned cell staining method. A method for specifically staining a specific substance possessed by cells in a sample, including performing the following steps in one step: (A) a step of performing an immobilization treatment of the cells; and (B) a step of performing a permeabilization treatment of the cells.

Abstract: The present invention provides an apparatus for detecting an analyte in liquid sample, including a channel for arranging the test strip, with one opened end and the other end is closed, wherein the channel includes an anti-flooding structure where the cross sectional area of the channel is reduced. The apparatus provided in the present invention can prevent the flooding phenomenon of the test strip, and reduce the error rate.

Abstract: A system of detecting a blood analyte includes a lateral flow test strip and a test strip holder, the lateral flow test strip located in the test strip holder. The system further includes a meter for receiving the test strip holder.

Abstract: A lateral flow apparatus is provided.

Abstract: The present invention provides an improved diagnostic test strip system comprising one or more of the following safety features: (a) a test strip housing having a sample port of sufficient size to allow placement of a patient's finger or thumb therein, (b) a cover for the test strip housing, and (c) a lock to lock the test strip housing to the cover.

Abstract: Many hand-held diagnostics are limited in their functionality due to the challenging physics associated with small dimensional systems. An example of this is capillary forces in hydrophilic systems, such as the tight retention of liquid passing through a small pore filtration membrane, or capillary force driven microfluidics where, to keep liquid flowing the dimensions of the system become so small that the flow rates are too low to be useful, or the manufacturing of such devices becomes uneconomical. This disclosure details methods to ‘reset’ the capillary force condition to avoid the requirement of transient pressure spikes associated with the breakthrough pressure of small pore membranes, and avoid the necessity of extremely small microfluidic channels, which can be useful in applications such as filtration of whole blood to plasma using only suction pressure or passive capillary pressure.

Abstract: Provided is a fluidic device, including: a porous flow path member; an absorbent member contacting the flow path member and configured to absorb a liquid; and a barrier member covering at least a portion of the absorbent member, wherein the absorbent member contains a liquid-absorbent polymer that absorbs the liquid, and a lyophilic polymer having lyophilicity to the liquid.

Abstract: A cassette is disclosed that permits, with an instrument, quantitative analysis to be performed at the moment of sample testing without additional steps to the end user. The cassette includes a calibration strip and a sample strip. The calibration strip contains known quantities of analyte, from which a calibration curve can be created and applied to the analysis of the sample strip. The disclosed cassette can utilize light transmission or light reflectance techniques. The cassette may include a separate wash port for rapid washing of a high background sample. The disclosed cassette may perform diagnostic tests for humans, animals, environmental sample, and/or food samples. In some cases, the disclosed devices and techniques may be used to monitor efficacy of drug therapy and patient compliance with respect to physician-prescribed medication in a point of care setting.

Abstract: A system for determining chemistry of a molecule in a high background interfering liquid environment by application of an electronic signal at a biased metal-electrolyte interface is disclosed. One or more of a resonant exchange of energy between one or more electrons exchanged by the metal and the electrolyte and vibrating bonds of a molecular analyte, for example, may be sensed by measuring small signal conductivity of an electrochemical interface.

Abstract: Provided herein are methods and materials for the manufacture and use of wettability tracks on various substrates for rapid fluid transport and drainage, even in a condensing environment. The degree of wettability of the materials' surfaces range from superhydrophobic to superhydrophilic. The method centers on the formation of a dispersion of titanium dioxide and a fluoroacrylic co-polymer in an alcohol and water solution. The dispersion may then be deposited onto a surface to form a coating, which is then dried to evaporate the alcohol. The dried coating is exposed to radiation to produce a wedge-shaped track. The coating is exposed to the radiation through a photomask to produce the track. The radiation may be high energy, such as UV radiation. The radiation may be selectively exposed to designated areas on the coating. The hydrophilic wedge-shaped track may have a wedge angle of from 0 degrees to 45 degrees.

Abstract: The immunochromatographic kit includes an inspection strip which includes an insoluble carrier spreading the specimen liquid, a label-holding pad including a label substance modified with a first substance bondable to a test substance, a liquid-sending pad sending a first amplification liquid to the insoluble carrier, and an absorption pad disposed in contact with the other end of the insoluble carrier and sequentially has an inspection region including a second substance being bonded to the test substance, a confirmation region including a substance bondable to the first substance, and an amplification index region including a substance being reacted with the first amplification liquid between the label-holding pad and the absorption pad of the insoluble carrier, a first pot being disposed below the liquid-sending pad and enclosing the first amplification liquid, and a second pot being disposed above the absorption pad and enclosing a second amplification liquid in a housing case.

Abstract: The technology described in this document can be embodied in a test strip for use in measuring a level of an ST2 cardiac biomarker in a whole blood sample. The test strip includes a base, and a plurality of conjugates, wherein each conjugate includes a reporter group bound to a first antibody that binds to ST2. A conjugate pad holds the plurality of conjugates that bind with ST2 to produce conjugate-ST2 complexes. The test strip also includes a plurality of second antibodies that bind to ST2, and a plurality of third antibodies that bind to the conjugate-ST2 complexes. The plurality of second antibodies are bound to a membrane in a test location, and the plurality of third antibodies are bound to the membrane in a control location. A plasma separation pad passes blood plasma from a whole blood sample to the conjugate pad while inhibiting other components.

Abstract: A disposable test card configured to accept a fluid sample for an assay, and a method of manufacturing same, is disclosed herein. In a general example embodiment, a test card for analyzing a fluid sample includes a first substrate layer including an inlet port and an outlet port, a channel layer bonded to the first substrate layer, the channel layer including a microchannel placing the inlet port in fluid communication with the outlet port, and a second substrate layer bonded to the channel layer, the second substrate layer having electrodes printed adjacent to a target zone of the microchannel of the channel layer, wherein the electrodes are configured to raise the temperature of the fluid sample within the target zone of the microchannel when a current is applied thereto.

Abstract: A method of determining the stage (gestation) of a pregnancy—comprising the steps of quantifying the amount of the hormone hPL or a fragment thereof in a body fluid sample derived from a human female selected from a blood, plasma, serum and/or urine sample, and establishing the stage of pregnancy corresponding thereto. The disclosure also extends to a device adapted to detect the levels/amount of hPL or a fragment thereof in a body fluid sample, derived from a human female, selected from a blood, plasma, serum and/or urine sample, for establishing the stage of pregnancy.

Abstract: A liquid sample that is supplied to a detection device can be stored at the entry portion provided in a housing of the detection device having the housing; however, there is a problem that the detection device becomes bulky due to a volume of the entry. The testing device includes a flow path member for forming a flow path of a liquid test sample, a storage member for storing the liquid test sample to be supplied to the flow path, which contacts a portion of the flow path member, and a testing material for testing the liquid test sample supplied to the flow path. The storage member expands by contacting with the liquid test sample.

Abstract: The invention provides methods and systems for detecting a biomarker in a synovial fluid wherein the system also includes a control to ensure that the test sample is indeed synovial fluid. The biomarkers and the control for synovial fluid can be identified using proteomic methods, including but not limited to antibody based methods, such as an enzyme-linked immunosorbant assay (ELISA), a radioimmunoassay (RIA), or a lateral flow immunoassay.

Abstract: Methods and devices for the detection of food allergens using molecularly imprinted polymers that are imprinted for a target food allergen. A molecularly imprinted polymer may be imprinted using surface imprinting or other procedures. Detection of food allergens, such as peanut allergens, may be accomplished using all or a portion of a protein food allergen as a template to produce a molecularly imprinted polymer for food allergen detection. A portion utilized can be one that creates receptor sites in the molecularly imprinted polymer that are unique or more unique to the target food allergen than receptor sites that would be created if an entire food allergen molecule were utilized.

Abstract: A cartridge for processing a fluid which features a fluid-treatment element that is permeable to at least a part of the fluid, and a processing chamber that is disposed adjacent to the fluid-treatment element. The treated fluid which passes the fluid-treatment element is processed in the processing chamber.

Abstract: Devices, methods, and kits directed towards collecting and preparing cells using a separable sample collection layer may be configured to collect or treat cells from a liquid sample with mechanisms for easy transfer of the cells prior to analysis or imaging. The separable sample collection layer may comprise a porous membrane that cells may be collected on, and one or more support layers comprising tape with one or more adhesive coatings and release liner. The devices, methods and kits may be configured with support layers comprising cutouts that form vertically or horizontally oriented microchannels for efficiently removing undesirable liquid. Following collection and/or treatment, cells collected onto the porous membrane may be adhered to another surface for further processing or analysis.

Abstract: Microarray compositions suitable for analysis by one or several spectrographic methods are disclosed. In an embodiment, a microarray composition includes a three-dimensional solid support and a plurality of reactive microbeads positioned on the solid support in spatially distinct and addressable locations.

Abstract: Test elements are disclosed for detecting at least one analyte in a body fluid, where the test elements include a housing having at least one base element and at least one cover element. The test elements also include at least one fluid channel formed within the housing, where the fluid channel includes a capillary region and a measurement region. The capillary region and the measurement region have differing aspect ratios. The cover element includes at least one test field having at least one test chemical, where the test chemical is adapted to change at least one optically measurable property in the presence of the analyte. In addition, the cover element is mounted to the base element via at least one adhesive that contacts the test field.

Abstract: Described herein are a wearable apparatus and methods for detecting the presence of a targeted substance in a liquid. For example, the wearable apparatus can be a fingernail that detects illicit drugs in a beverage. The wearable apparatus comprises a detection layer comprising an indicator that is configured to display a signal upon the detection of an interaction with the targeted substance. In some examples, the wearable apparatus can include a lateral flow assay.

Abstract: The invention relates to sensors configured to include compositions disposed in specific regions of the sensor in order to provide the sensors with enhanced functional properties, for example faster start-up times. These compositions include, for example, hygroscopic compositions, gas generating compositions and gas solvating compositions. While typical embodiments of the invention pertain to glucose sensors, the systems, methods and materials disclosed herein can be adapted for use with a wide variety of sensors known in the art.

Abstract: A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.

Abstract: Diagnostic mouthpieces and separate pads for same allow dental devices of various types to have a dual purpose. The diagnostic mouthpieces allow frequent use and early intervention.

Abstract: A capturing device (20) and method for use in capturing a substance in a liquid, by feeding the liquid through a capturing device (20) including: a lateral capillary flow matrix (13) and a capturing matrix (26) in fluid communication with the lateral capillary flow matrix (13) such as to produce a lateral capillary flow in the capturing matrix having a lower velocity than that in the lateral capillary flow matrix. This produces by the Bernoulli effect, a lower pressure with respect to the two lateral flows sufficient to impart transverse oscillations to the lateral flow in the capturing matrix, such oscillations driving the liquid into the interior of the capturing matrix thereby exposing its interior, rather than merely a surface thereof, to the liquid. In the described preferred embodiments, the capturing device is a biological assay device, and each substance in the liquid to be captured in the capture zone of the capturing matrix is a biological substance.

Abstract: The test device is provided with a testing means for testing an added extraction solution utilizing immunochromatography or nucleic acid chromatography, an extraction solution container, and a tubular guiding member having an extraction solution inflow port communicating with the extraction container in a sealed manner at one end side and having an extraction solution outflow port at the other end side. The guiding member is configured so as to have inside the tube a rod-shaped extraction solution guide having capillary action and having one end at the extraction solution outflow port side able to contact the testing means and so that the extraction solution absorbed from the extraction solution inflow port side at the extraction solution guide moves by capillary action through the inside of the extraction solution guide and is added to the testing means through the one end of the extraction solution guide contacting the testing means.

Abstract: Provided is an analysis method in which increase in a background can be prevented in a simple manner without cost. The analysis method of the present invention is carried out using a sample analysis tool 10 including a development member 11 in which a developing solution supply portion 12, a sample supply portion 13, and a detection portion 14 in which a substance 17 that specifically binds to an analyte 16 in a sample is immobilized are provided in this order from upstream to downstream along the flow of a developing solution. A sample solution is supplied to the sample supply portion 13, and a developing solution is supplied to the developing solution supply portion 12 simultaneously with the supply of the sample solution or prior to the supply of the sample solution. By the development of the developing solution in the development member 11 in the presence of a labeled specifically binding substance 15, the sample solution is introduced to the detection portion 14.

Abstract: Provide is a sample analysis tool whose reactivity and reproducibility in analysis can be prevented from decreasing. The sample analysis tool 10 of the present invention includes a development member 11 and a plastic base 16, and at least part of the development member 11 is in contact with the plastic base 16. The sample analysis tool 10 further includes a hydrophilic component layer 15, and the hydrophilic component layer 15 is formed on part or the whole of at least one of a surface of the plastic base 16 and a surface of the development member 11. It is particularly preferable that the hydrophilic component layer 15 contains sucrose or N-methyl glucosamine. In the sample analysis tool 10 of the present invention, since the hydrophilic component layer 15 is formed on part or the whole of at least one of the surface of the plastic base 16 and the surface of the development member 11, it is possible to prevent the adhesion of a hydrophobic component(s) derived from the plastic base 16.

Abstract: The invention provides TIMP2 immunoassays with improved clinical performance, particularly when used in the evaluation of renal injuries. The immunoassays rely on the selection and use of antibodies and antibody pairs that exhibit improved assay performance when used in complex clinical specimens such as biological fluids, and particularly when used in rapid assay formats such as lateral flow test devices.

Abstract: Provided herein are methods and devices for the detection of conditions or disorders by detecting altered levels of stress response pathway biomarkers. Also provided are methods and reagents for identifying panels of biomarkers associated with a condition or disorder.

Abstract: A method for quantifying the intoxicating affect of natural and synthetic Cannabinoids on Humans. The method includes the capacity to measure a human's psychoactive intoxication as a function of Cannabinoid-Mediated Depolarization-Induced Suppression of Inhibition (C-DISI) relative to the Cannabinoid Receptors found in the Human brain. A Method incorporating the ability to also quantify the affects of Cannabinoids on the various Cannabinoid Receptors found in the Human body. Neurons are used as transistors in a solid state electronic configuration with an apparatus to measure the toxicity of a given aqueous solution comprised of one or more Cannabinoid analytes. Said method incorporates a novel recycling process affiliated with analyte acquisition & testing.