Abstract: A point of care immunization system based upon microfluidics and micro-titration technologies to rapidly test a patient in order to ascertain an immunization profile so that vaccinations can be administered to address identified gaps. A point of care system comprised of uniquely shaped and color distinguishing sample and test cartridges, with said test cartridges configured to meet healthcare requirements of national governing bodies. A point of care system including an easy access vaccine storage device with indicators to provide data on viability of stored vaccines.

Abstract: The invention provides a method of measuring the affinity of first and second biomolecules in which a first biomolecule is tethered by a first tether portion having a first tether portion length and a second biomolecule is tethered by a second tether portion having a second tether portion length, the method comprising determining binding of adjacent first and second biomolecules to each other, varying at least one of the first and second tether lengths and determining binding of the first and second biomolecules. The invention also provides apparatus suitable for use in the method of the invention.

Abstract: A patient or animal side method and assay for eliminating the hook effect in the detection of a target analyte such as an acute phase protein in a bodily fluid in which the target analyte comprises a member of a specific binding pair comprising applying the sample to a solid phase carrier material, generating a signal in accordance with downstream movement of the labelled first or second members and the target analyte to bind with the complimentary immobilised first or second members, and detecting the presence of the target analyte in accordance with the signal generated at the complimentary immobilised first or second members.

Abstract: A method for the risk detection, early diagnosis, prognosis, and monitoring of Parkinson's disease in an individual by measuring the amount of specific biomarkers present in a bodily fluid and comparing them to a reference level of biomarkers in a sample from a healthy person, a person previously diagnosed with Parkinson's disease, or an earlier sample from the individual of interest.

Abstract: Detection and/or quantitation of endotoxin using biolayer interferometry is disclosed.

Abstract: A chemical sensor comprising: a hydrogel layer, comprising one or more molecular recognition agents and a 2DPC self-assembling array; and a mirror layer. A method for analyzing a sample or bodily fluid, comprising: obtaining a sample or bodily fluid; placing an amount of the sample or bodily fluid onto a chemical sensor, comprising: a hydrogel layer, comprising a molecular recognition agent and a 2DPC self-assembling array; a tethering hydrogel layer; a mirror layer; and a membrane filter layer, allowing the bodily fluid to interact with the hydrogel layer; and allowing ambient or artificial light to pass through the hydrogel layer onto the mirror layer and observing a change in diffraction versus a control.

Abstract: 3-dimensional surface-enhanced Raman scattering (SERS), as well as absorption/fluorescence/luminescence detection is carried out using a platform based on nanoparticle-functionalized flow-through multi-hole capillaries for rapid analyte detection. The configuration provides an increased active area and fluidic channels for efficient sample delivery, and also confines and transmits light for a large signal accumulation. Using a capillary consisting of thousands of micron-sized holes adsorbed with gold nanoparticles, a detection limit better than 100 fM is achieved.

Abstract: Disclosed is a covalently-linked multilayered three-dimensional matrix comprising capture molecules, linkers and spacers (referred to as a Molecular Net) for specific and sensitive analyte capture from a sample. Also disclosed herein is a Molecular Net comprising covalently-linked multilayered three-dimensional matrix comprising more than one type of capture molecule and more than one type of linker and may comprise one or more spacer for specific and sensitive capture of more than one type of analyte from a sample. A Molecular Net may comprise a pseudorandom nature. Use of various capture molecules, linkers and spacers in a Molecular Net may confer unique binding properties to a Molecular Net. Porosity, binding affinity, size exclusion abilities, filtration abilities, concentration abilities and signal amplification abilities of a Molecular Net may be varied and depend on the nature of components used in its fabrication.

Abstract: A lignocellulosic detection device includes a lignocellulosic substrate and at least one detection reagent absorbed/coated to lignocellulosic tissue of the lignocellulosic substrate. A liquid specimen is in contact with the lignocellulosic substrate so as to be absorbed to the lignocellulosic tissue of the lignocellulosic substrate by capillary action and react with the detection reagent to achieve specimen detection. The lignocellulosic detection device of the present invention is provided with inherent advantages of the lignocellulosic substrate such as natural material, low cost, easy manipulation and capillary effect and results in a good preventive diagnosis platform. Also, users may achieve preventive disease diagnosis without spending additional time and/or money.

Abstract: A method for enhancing the detection sensitivity of a piezoelectric microcantilever sensor. The method may involve providing a piezoelectric microcantilever and inducing a change in the Young's modulus during detection of a species of interest. The change in the Young's modulus may be induced or enhanced by the application of a DC bias electric field to the piezoelectric layer that enhances non-180° polarization domain switching of the piezoelectric layer. The change in the Young's modulus may also result from binding of the species of interest to the piezelectric microcantilever sensor or a combination of binding and application of a DC bias electric field. Significantly enhanced detection sensitity results from the changed Young's modulus of the piezoelectric layer.

Abstract: A sample analysis cartridge and a sample cartridge reader are provided. In measuring a particular component included in a sample flowing in a microfluidic channel, a numerical value of hematocrit is reflected to thus improve the accuracy of measurement of the particular component.

Abstract: Systems and methods for improved measurement of absorbance/transmission through fluidic systems are described. Specifically, in one set of embodiments, optical elements are fabricated on one side of a transparent fluidic device opposite a series of fluidic channels. The optical elements may guide incident light passing through the device such that most of the light is dispersed away from specific areas of the device, such as intervening portions between the fluidic channels. By decreasing the amount of light incident upon these intervening portions, the amount of noise in the detection signal can be decreased when using certain optical detection systems.

Abstract: Methods and genetic sequences are described for use in determining the diagnosis, subtype, prognosis, and disease course of high-grade gliomas, such as glioblastoma multiforme. One such method includes determining increased expression of at least one gene on a chromosome segment in cells of the glioma, the segment being 17:57,851,812-17:57,973,757; 7:127,892,509-7:127,947,649; 12:33,854-12:264,310; or 19:33,329,393-19:35,322,055; and estimating, based on the expression, a predicted length of survival, a probability of survival, or a predicted response to a therapy for the glioma.

Abstract: A reversible reaction sensor provides for detecting medical, biologic or explosive airborne compounds. The sensor may be formed in semiconductor material and is activated by radiation from sources to provide sensing of particular airborne compounds optically detectable by detectors, and reversed by other radiation from a source (or removal of activating radiation) to take away such airborne compounds from the sensor. The reversible reaction sensor device has a sensing material of one or more photo-chromic or photo-biologic compounds for a specific compound(s) or analytic(s) having receptor sites which bound molecularly to specific compound(s) or analytic(s) when present, in which sensing relies only on the response time to saturation for the sensing material as measured by an optical property of the sensing material when exposed to radiation.

Abstract: Methods and devices for diagnosing, monitoring, or determining obstructive uropathy or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining obstructive uropathy or an associated disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.

Abstract: A nanosensor and methods to manufacture are disclosed. For example, a detection system for detecting the presence of a target substance can include a nanosensor that includes a sensing layer, and a plurality of sockets embedded within the body of the sensing layer, each socket having a physical profile matching a shape of the target substance such that, when target substances occupy the sockets, at least one measurable physical characteristic of the sensing layer changes.

Abstract: A biosensor with a dual gate structure is disclosed herein. The biosensor comprises: a transistor, a sensing pad, and a plurality of nanostructures. The sensing pad has a conductive area working as another gate and neighboring to the channel layer of the transistor, and a sensing area extended outward from the conductive area to be far away from the channel layer of the transistor, wherein the gate and the conductive area of the sensing pad are separated from each other by the channel layer. The plurality of nanostructures are utilized to bind a first protein to generate a drain current value, when the first protein is combined with the target protein and another drain current value is generated, whereby a variation between the two drain current values is calculated to obtain the concentration of the target protein in the protein solution.

Abstract: Determining a presence of a target analyte in a fluid sample includes mixing multiple magnetic particles with the fluid sample, in which the magnetic particles are each bound to one or more binding moieties that specifically bind to the target analyte, flowing the fluid sample containing the magnetic particles through a fluidic channel, exposing the fluid sample in the fluidic channel to a magnetic field, measuring a signal from a Hall effect sensor while the fluid sample flows through the fluidic channel, and determining whether the target analyte is present in the fluid sample when the measured signal is in a first range of values.

Abstract: A biochip includes a flat carrier and an array of spots containing catcher molecules which are arranged on the carrier. Each spot is associated with a microelectrode arrangement for impedance spectroscopic detection of binding events occurring between the catcher molecules and the target molecules applied via an analyte solution. In order to increase the sensitivity or the binding-specific measuring effects of the bio-chip, the electrode arrangement is at least partially embedded in a hydrophilic reaction layer containing catcher molecules and which is permeable to target molecules.

Abstract: The method for analyzing biomolecules, includes the steps of: immobilizing biomolecules to be analyzed on surfaces of magnetic microparticles; reacting labeled probe molecules with the biomolecules to be analyzed; collecting and immobilizing the microparticles on a support substrate; and measuring a label on the support substrate. Since single-molecule immobilized magnetic microparticles are used in the present invention, the number of biomolecules can be counted, and since hybridization and an antigen-antibody reaction are performed with the microparticles having biomolecules immobilized thereon dispersed, the reaction can be rapidly performed. Further, the type and the abundance of biomolecules of interest can be determined at a single molecular level, so as to evaluate, in particular, the absolute concentration of biomolecules.

Abstract: The present invention relates to a device for detecting a target molecule within a sample comprising a sample container for the measurement of the target molecule within a sample, a magnetic particle, wherein said particle is functionalized with a first binding molecule capable of specifically binding to said target molecule, wherein said first binding molecule is attached to the particle, and a repulsive surface structure, which is directly attached to the surface of said particle, wherein said repulsive surface structure covers the surface of the magnetic particle so as to result in a specific net charge and/or steric repulsion of the magnetic particle, and a sensor surface comprising a second binding molecule, wherein said magnetic particles are capable of binding said second binding molecule of the sensor surface directly or indirectly; wherein the number of bound particles is directly or inversely related to the amount of target molecules present in the sample; and wherein said repulsive surface structur

Abstract: A multiple-substance-responsive substance is disclosed, which is capable of simultaneously detecting a plurality of detection target substances by a single measurement. By a multiple-substance-responsive gel including: a plurality of kinds of complexes including (i) specifically binding substances, and (ii) binding partners each specifically and reversibly binding to a corresponding one of the specifically binding substances; and a polymer gel to which the plurality of kinds of complexes are immobilized so as to form cross-links, the plurality of kinds of complexes each being formed by binding between (i) a specifically binding substance among the specifically binding substances and (ii) a corresponding binding partner among the binding partners, a plurality of detection target substances can be simultaneously detected by a single measurement.

Abstract: A method and apparatus for assaying to detect the presence or quantity of an analyte in a test sample, comprising: forming an unbounded aqueous mixture of a first test sample with a defined amount of a nanosphere probe which is conjugate of an analyte capturing member and a long emission fluorescent label, contacting a contacting zone of a test strip with the aqueous mixture, the test area having bound thereat a test binding moiety that for a competition assay binds any sample in competition with the analyte capturing member; or for a sandwich assay binds any sample analyte non-competitively with the analyte capturing member, the control area having bound a control binding moiety to nanosphere probe, selectively measuring long emission fluorescence at the test and control areas, and for a given test strip, determining a test zone value normalized with the total of test and control area signals.

Abstract: Nanotube based lateral flow test device described herein is a lateral flow based diagnostic device, which uses arrays of fragments of single wall carbon nanotubes as sensor to detect the biomarkers at ultralow concentration (below picogram per milliliter). The device is consisted of the following components: (1). an lateral flow strip which typically is consisted of a backing film laminated with conjugate/sample pads, nitrocellulose membrane, wicking pad, (2). the arrays of single wall carbon nanotube conjugate with antibody which is immobilized on the membrane of the lateral flow device as the test line, (3). pairs of micro-electrode are installed on top part of the cassette, (4). a cassette which holds the lateral flow strip. The device can be used in clinical environments for biomarker detection.

Abstract: Provided is a method for manufacturing a multiple-diagnosis membrane sensor provided with multiple channels by using screen printing, and more specifically, to a method for manufacturing a membrane sensor capable of performing multiple-diagnosis by screen-printing hydrophobic ink on a membrane to form multiple channels. The membrane sensor according to the present invention may enable mass-production of sensors and secure reliability of detection by forming the plurality of channels on the membrane by a simple method.

Abstract: This disclosure is directed to a cap for obtaining a target analyte from a suspension. The cap introduces a magnetic field or a magnetic gradient to the tube to draw the target analyte bound to a particle to the cap. In one aspect, a cap includes a magnetic insert and a receiving piece. The magnetic insert includes a stopper and a magnet extending from the stopper; and, the receiving piece, which is configured to hold the magnetic insert, includes a receiving stopper and a sheath. The sheath may include imaging slides on opposite sides of the sheath. In another aspect, the cap may include a stopper and an embedded magnet. The cap may include an analysis piece on a bottom end of the stopper. In yet another aspect, the cap may include a fluid compartment and a filter at a bottom end of the stopper.

Abstract: The invention relates to a method and a sensor device (100) for the detection of magnetic particles (1) bound to the binding surface (111) of a sample chamber (112), wherein said detection is made during and/or immediately after the action of an attractive magnetic field. Preferably, the attractive magnetic field (B) is preceded by a repulsive magnetic field (B) which removes unbound magnetic particles away from the binding surface (111). Due to the attractive magnetic field (B), bound magnetic particles (1) come closer to the binding surface (111), which increases the signal of surface specific detection techniques like frustrated total internal reflection. A further enhancement of the signal can be achieved by an attractive magnetic field that is parallel to the binding surface (111), thus inducing the generation of chains between unbound and bound magnetic particles.

Abstract: The present invention provides devices and methods for detecting and capturing molecular biomarkers from a subject in situ. Specifically, the devices contain an array of microneedles to which are attached probes specific for one or more biomarkers of interest. The devices can be used directly on a subject (e.g., via skin piercing) in detecting the biomarkers in the body of the subject (e.g., tissues, blood stream).

Abstract: An in vitro diagnostic (IVD) device is used to detect the presence of and/or severity of liver injury in a subject. The IVD device relies on an immunoassay which identifies biomarkers that are diagnostic of liver injury in a biological sample, such as whole blood, plasma, serum. The inventive IVD device may measure one or more of several specific markers in a biological sample and output the results to a machine readable format wither to a display device or to a storage device internal or external to the IVD.

Abstract: A drug test device for bodily fluids, such as urine, includes a cup and a removable lid which houses one or more test strips. The lid is releasably locked onto the cup so as to align dipping ends of the test strips exposed through an underside of the lid with a position stabilizer, thereby causing the dipping ends to be located downwardly and submerged in fluid when the device is placed on its side in a reactive position. The position stabilizer may comprise a sidewall indentation that reduces the internal volume of the cup and keeps the cup from rolling when placed on its side.

Abstract: Methods, systems, and devices for the detection and notification of chemical, biological, radiological, nuclear, and/or explosive agent. The detection and notification system uses aptamers bound to a catalyst that is activated when the aptamer binds to the agent. The activated catalyst acts on a substrate to create a signal that is detected, indicating the presence of the agent. For example, the system can be a glove worn by a user that includes a catalyst/substrate pair that, in the presence of the target agent, produces a colorimetric and/or fluorescent signal in a time-efficient manner.

Abstract: The present disclosure relates to the field of laboratory diagnostics. Specifically, methods are disclosed for determining a patient's risk of suffering from heart failure (HF) based on the detection of NT-proBNP, troponin T, and/or a natriuretic peptide. Also disclosed are methods for improving both the accuracy and speed of HF risk models by incorporating biomarker data from patient samples.

Abstract: Provided herein is a sensing apparatus comprising, at least one LSPR light source, at least one detector, and at least one sensor for LSPR detection of a target chemical. The sensor comprises a substantially transparent, porous membrane having nanoparticles immobilized on the surface of its pores, the nanoparticles being functionalized with one or more capture molecules.

Abstract: An apparatus consisting of a ‘DNA/Nanoparticle Complex Enhanced Radio Frequency Transponder’ with unique features, said apparatus including an antenna pattern precursor, wherein the antenna pattern precursor includes a plurality of sensitive regions; and electromagnetically functionalized DNA/nanoparticle complex(es) that individualize the ability to transition between the precursor antenna electrical and resonant frequency characteristics, and activated antenna electrical and resonant frequency characteristics through DNA hybridization of the specific sequences contained in the electromagnetically functionalized DNA/nanoparticle complex(es).

Abstract: A method for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual includes measuring one or more biochemical markers in a blood sample obtained from the pregnant individual to determine one or more biomarker levels, where the one or more measured biochemical markers includes at least one of PAI-2 and sTNFR1, identifying, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level, and, responsive to the identifying, determining a prediction corresponding to a relative risk of the pregnant individual having or developing GDM.

Abstract: Electrokinetic devices and methods are described with the purpose of collecting assayable agents from a dielectric fluid medium. Electrokinetic flow may be induced by the use of plasma generation at high voltage electrodes and consequent transport of charged particles in an electric voltage gradient. Pulsed DC fields applied to electrodes result in enhanced flow by synchronizing the pulses between successive electrodes. The agents are directed by creation of an electrokinetic potential well, which will effect their capture on to an assay device.

Abstract: A sample collection device for a fluid sample includes: a body including a capillary channel having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; an air vent located in the vicinity of the second end and in fluid communication with the capillary channel; a barrier positioned within the capillary channel to prevent flow of the fluid by capillary action thereacross; and features on opposing sides of the body to form an axis of rotation, which is substantially perpendicular to the overall direction of the capillary channel from the first end to the second end. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a sample manipulation device to bring the first end into position with the sample manipulation device.

Abstract: An optical lateral flow fluid analyte testing device includes a test strip having at least one zone for measuring the concentration of a target analyte in a fluid sample. Devices and methods for facilitating a reliable reading are disclosed.

Abstract: Test strips for the detection of at least one analyte in a sample are shown and described. In one embodiment, the test strip includes a test zone, a control zone and a surface reflectance profile to monitor the test strip continuously until the presence or absence of an analyte is detected. In other embodiments, a lateral flow assay includes a surface reflectance profile to monitor the test strip prior to the detection. The surface reflectance profile may include at least one flow reference area and/or at least one test result reference area. The result is systems and methods to improve the detection of the presence and/or absence of at least one analyte in a sample.

Abstract: A diagnostic test system, apparatus and method for identifying individuals at risk for developing or having breast cancer by detection of at least one marker associated with increased breast cancer risk in nipple aspirate fluid is provided. A testing device for screening nipple aspirate fluid for the presence of biomarkers associated with breast cancer and methods of identifying individual biomarkers and biomarker panels for evaluating the risk that an individual has developed or will develop breast cancer by assaying nipple aspirate fluid is described.

Abstract: Detection units and methods for detecting one or more target analytes in a sample are disclosed. The detection unit provides a first and second surface connected by a filament which is capable of binding the target analyte in the sample. The methods provide for the detection of the target analyte through the generation of a detectable signal following the binding of the target analyte to the filament.

Abstract: The present disclosure provides a diffraction based biosensor containing at least two diffraction gratings. The first grating is referred to as an in-coupling diffraction grating and the coherent light source (laser) is directed to illuminate the in-coupling grating, and the biosensor is configured such that a selected order of the light beam diffracted from the in-coupling diffraction grating illuminates a second biosensor grating coated with analyte-specific receptors which are selected to preferentially bind with analytes being tested for that may or may not be located in a sample being tested.

Abstract: The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step.

Abstract: Disclosed herein is an immunochromatographic system for measuring albumin and creatinine in a urine sample and a reader that detects signals from the test cassette, calculates, and displays the results for albumin concentration, creatinine concentration, and albumin-creatinine ratio.

Abstract: The present disclosure relates to diagnostic test devices that provide increased comfort and ease of use. The diagnostic test device can include a test member, such as a lateral flow assay test strip. The test device can further comprise a housing that comprises a substantially arch shaped handle. The housing of the test device can comprise a base member that is attached to a curved lower surface of the housing and that can improve stability of the device in an upward facing position as well as enable angled positioning of the device relative to a flat, horizontal surface. The curvature of the test device in particular can provide secure handling of the device while also improving ease and comfort of use thereof. The disclosure further relates to methods of determining the presence of an analyte in a fluid sample and methods for evaluating a test result of a personal use diagnostic test device.

Abstract: An electro-immuno sensor includes a signal generator, a sensing chip and a sensing circuit. The signal generator is arranged for generating an electronic signal having a predetermined frequency and a waveform. The sensing chip is disposed in an electrical field that generates the electronic signal, and arranged for capturing target biomolecules in a solution using antibodies. The sensing circuit has a first electrode and a second electrode in contact with the solution, and arranged for measuring an electrical characteristic of a first state and the electrical characteristic of a second state between the first and second electrodes, due to the capture of the target biomolecules, and determining the concentration of the target biomolecules according to the variation of the electrical characteristic.

Abstract: A method and device for the rapid quantification of biomolecules (320) present in a nanochannel (210) is claimed. In particular, the present invention relates to a novel concept of liquid actuation and selectively functionalized surfaces in a nanochannel that create a concentration gradient of transitory immobilized biomolecules (340) across the nanochannel. The present concept enables the quantification of biomolecular interactions of interest (320).

Abstract: [Object] To provide a chemical sensor, a biomolecule detection apparatus, and a biomolecule detection method capable of detecting a biomolecule with high accuracy. [Solving Means] A chemical sensor according to the present invention includes a substrate, an optical layer, and an intermediate layer. On the substrate, a plurality of photodiodes is arranged in a planar form. The optical layer is laminated on the substrate and has a waveguide formed therein which guides incident light to each of the photodiodes. The intermediate layer is laminated on the optical layer and has a probe holding area formed thereon for each waveguide, and the probe holding area is capable of holding a probe material.

Abstract: Methods of diagnosing breast cancers are provided. The methods include analyzing the expression patterns of biomarkers in a plurality of cells to distinguish between invasive and non-invasive cancers, usual and atypical hyperplasias, and basal-like breast cancers. Breast cancers are diagnosed based upon different combinations of the biomarkers found in nipple aspirate fluid.

Abstract: This method for observing at least one object is applied by means of an imaging system. It includes the following steps: illuminating the object(s), with a light source, acquiring, by means of a photodetector array, a diffraction pattern, the diffraction pattern corresponding to an image of the waves diffracted by the object(s) when they are illuminated along an illumination direction, the object(s) such as biological entities, being positioned between the light source and the photodetector array along the illumination direction. The method further comprises, prior to the illumination step, addition of at least one marker in contact with the object(s), said or each marker being adapted to bind onto a corresponding object, the binding of said marker onto said object being adapted for increasing at least one characteristic quantity from among the absorption and the optical phase shift of said object.