Abstract: The disclosed subject matter provides a zero-mode waveguide (ZMW) including a substrate and at least one nano-well thereon and having a bottom surface and a side wall comprising gold. A surface of the side wall is passivated with a first functional molecule comprising polyethylene glycol. The bottom surface of the nano-well can be functionalized with at least one second molecule comprising polyethylene glycol, for example, a silane-PEG molecule. The second molecule can further include a moiety, such as biotin, which is capable of binding a target biomolecule, which in turn can bind to a biomolecule of interest for single molecule fluorescence imaging analysis. Fabrication techniques of the ZMW are also provided.

Abstract: Various embodiments are drawn to systems and methods for detecting an analyte of interest in a sample including an optical sensor, a capture probe attached to a surface of the optical sensor wherein the capture probe is capable of binding to the analyte to form a duplex or complex, and an antibody capable of binding to the analyte, duplex, or complex. In several embodiments, systems and methods further include a particle attached to the antibody or capable of binding to the antibody. In several embodiments, systems and methods for analyte detection feature one or more of the following: high detection sensitivity and specificity, scalability and multiplex capacity, ability to analyze large analytes, and ability to detect or measure multiple individual binding events in real-time.

Abstract: A method for diagnosing diabetes or a predisposition for diabetes is provided, which comprises determining the amount of glyoxylate in a test sample of a subject suspected to suffer from diabetes or to have a predisposition for diabetes and comparing said amount to a references, whereby diabetes or a predisposition for diabetes is to be diagnosed. Further, the use of glyoxylate or a detection agent for glyoxylate for diagnosing diabetes or a predisposition for diabetes is provided. Moreover, a device and a kit for diagnosing diabetes or a predisposition for diabetes are also provided.

Abstract: In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor has a base with first and second ends, a concave recess in the first end, a second end receiving surface, and a sidewall extending between the ends. An electrode may be provided on the receiving surface with an electrochemically-active region coupled to the electrode. A conductor in electrical contact with the electrode may extend along the sidewall and may be adapted to be in electrical contact with a first contact of an analyte meter. Manufacturing methods and systems utilizing and dispensing the analyte sensors are provided, as are numerous other aspects.

Abstract: The present invention describes (bio)chemo-functional waveguide grating structures consisting of at least one (bio)chemo-functional waveguide grating structure unit or at least one (bio)chemo-functional sensor location with beam guidance permitting light beam separation, as well as detection methods for parallel analysis which are marking-free or based on marking.

Abstract: In a magnetic immunoassay using AC magnetic susceptibility measurement, a signal from non-coupled magnetic particles is prevented to mix with a desired measurement signal from magnetic particles coupled with an object to be measured. A sample vessel in which a mixed solution of an inspection objective sample and the magnetic particles are included is carried by a sample support, such that a precipitation of the magnetic particle coupled with the object to be measured dispersed in the solution by a magnetic field from a dissociating coil is promoted. Next, the sample vessel is carried to the magnetizing coil and the magnetic signal from the non-coupled magnetic particle remaining in a supernatant in the vessel is peculiarly measured by an MR sensor to perform AC magnetic susceptibility measurement with high precision.

Abstract: The invention encompasses analyzers and analyzer systems that include a single molecule analyzer, methods of using the analyzer and analyzer systems to analyze samples, either for single molecules or for molecular complexes. The single molecule uses electromagnetic radiation that is translated through the sample to detect the presence or absence of a single molecule. The single molecule analyzer provided herein is useful for diagnostics because the analyzer detects single molecules with zero carryover between samples.

Abstract: A spinning force system and methods of operation are provided for measuring a characteristic of a sample. The system includes a detection module having a light source for illuminating the sample and an objective being aligned to the light source to define a light path for producing an image of the sample. A rotor is mechanically coupled to the detection module and configured to rotate the light path for applying a force to the sample. The force may include a centrifugal force and other forms of force (such as a viscous drag force) resulted from the rotation. In some examples, the force is applied in a direction that is not parallel to a surface of the sample.

Abstract: Disclosed herein are methods of estimating an analyte concentration which include generating a signal indicative of the analyte concentration, generating a signal indicative of a temperature, generating a signal indicative of a pH, and transforming the signal indicative of the analyte concentration utilizing an equation of the form of a modified Michaelis-Menten equation depending on Michaelis-Menten parameters, wherein values of the Michaelis-Menten parameters are set based upon data which includes temperature and pH calibration parameters, the signal indicative of a temperature, and the signal indicative of a pH. Also disclosed herein are measurement devices which employ the aforementioned methods.

Abstract: A molecular imprinted tetraethoxysilane polymer device for detecting secosteroids, or metabolites thereof, and a method for using the same are provided.

Abstract: An assay device (1) for determining the presence and/or amount of an analyte present or potentially present in a liquid sample comprises: (i) a capillary tube (2) having an upstream region (3) into which the sample to be assayed is introduced for transfer by capillary action along the capillary tube to a downstream region thereof; (ii) a collection of first binding partners (5) immobilised within the capillary tube (2), said first binding partners (5) being capable of specifically binding to the analyte; (iii) a collection of second binding partners (6) displaceabley bound to a fraction of said first binding partners (5) whereby there are free first binding partners (5) immobilised within the capillary tube, said second binding partners (6) having a label and being displaceable from the first binding partners (5) by the analyte to be detected; and (iv) a detection region (4) for sample that has transferred to said downstream region of said capillary tube, said detection region being adapted to generate a dete

Abstract: A test device comprises first and second indicia portions. The first indicia portion is configured to indicate the presence or absence of at least one medical condition based on identification of at least one biological entity in the biological sample. The second indicia portion is configured to display all or part of a code when the first indicia portion provides an indication of the presence of the medical condition, the code being substantially unique to the test device. The test device is employed in a medication dispensing system.

Abstract: Method of detecting Symmetrical dimethyl arginine (SDMA) in biological samples. SDMA analogs for generating anti-SDMA antibodies having little or no cross-reactivity with asymmetrical dimethyl arginine, arginine, and monomethylarginine. The analogs have a protected or free thiol (—SH) group or hydroxyl (—OH) group that allow them to be linked to a suitable conjugation target which can be, for example, a protein containing molecule of a label. The anti-SDMA antibodies can be used in diagnostic immunoassay for the diagnosis of SDMA associated disorders and/or diseases.

Abstract: Coated nanoparticles comprising a core surrounded by a shell that increases the reflectance of the nanoparticle, wherein the coated nanoparticle does not include a Raman-active molecule, are provided. Test devices and immunoassay methods utilizing the coated nanoparticles are provided.

Abstract: An object of the present invention is to provide a method and an apparatus by which PCBs in insulating oil can be analyzed with high accuracy in a convenient, inexpensive, and rapid manner. The method for analyzing polychlorobiphenyls by measuring the concentration of polychlorobiphenyls in insulating oil comprises a step of, as pretreatment, bringing particles of a copolymer that contains divinylbenzene and a methacrylate organic monomer as monomer components into contact with insulating oil containing polychlorobiphenyls, so as to separate polychlorobiphenyls in insulating oil from oil content that is an impurity. The methacrylate organic monomer preferably has a diol type hydroxyl group.

Abstract: Methods and apparatuses for predicting risk of prostate cancer and/or prostate gland volume are provided. More particularly, this disclosure relates to methods and apparatuses for providing the models and employing the models for predicting risk of prostate cancer and/or predicting prostate gland volume. The methods and apparatuses for predicting risk of prostate cancer and/or prostate gland volume are provided using, at least in part, information from a panel of kallikrein markers.

Abstract: An assay chip includes fluidic-channel member composed of a light-transmissive lower member and an upper member, forming a fluidic-channel therebetween, and a cover member fitted with the fluidic-channel member from the upper-member-side thereof. An inlet for injecting a sample solution into the fluidic-channel and a suction opening for sucking, from the downstream side, the injected sample solution, both communicating with the fluidic-channel, are formed on the upper surface of the upper member. A pot for carrying out predetermined pre-processing on the sample solution, a pot for first-reaction processing to bind a photoresponsive labeling substance to an analyte in the sample solution, an inlet insertion-hole for inserting the inlet, and a suction-opening insertion-hole for inserting the suction opening are linearly arranged on the upper surface of the cover member.

Abstract: Multi-directional microfluidic devices and methods for using the same are provided. Aspects of the present disclosure include microfluidic devices that include a chamber having a separation medium, a first binding medium, and a second binding medium. In addition, the devices include a flow field element configured to subject the chamber to two or more directionally distinct flow fields. Methods of using the devices, as well as systems and kits that include the devices are also provided. The devices, systems and methods find use in a variety of different applications, including diagnostic, research and validation assays.

Abstract: A microfluidic separation device is provided that includes a first sample channel region and a second sample channel region, where the first sample channel region has an array of channels that are smaller than the second channel region, a first detection region and a second detection region located at the interface of the first sample channel region, a detection channel, an illuminating electric field, Raman-scattering nanoparticles having surface plasmon resonances for detection when illuminated by the electric field, where the resonances create an enhanced local electric field along specific directions resulting in an enhanced Raman response, and a nanoparticle input channel disposed to input the nanoparticles into the second sample channel region, where the nanoparticles are larger than the cross-section of the first sample channel region and the cross-section of the second detection region, where the nanoparticles collect in the first detection region to form region of densely packed nanoparticles.

Abstract: To provide an analysis device capable of quantitatively measuring the concentration of a substance without diluting a sample containing the substance to be analyzed, detection portions (5) that detect the substance in different concentration ranges are formed in a plurality of minute flow paths (2), respectively, and the concentration of the substance to be detected can be obtained within a calibration range in any one of the detection portions (5).

Abstract: An optical biosensor includes a sensing block that receives a first optical signal and outputs a second optical signal through at least one channel of a plurality of channels that correspond to a sensed concentration of a biomaterial; and a detecting block that detects the second optical signal, converts the second optical signal into an electrical signal, and outputs the electrical signal.

Abstract: This invention features systems and methods for the detection of analytes, and their use in the treatment and diagnosis of disease.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound.

Abstract: Various embodiments are drawn to systems and methods for detecting an analyte of interest in a solution that also contains a plurality of magnetic particles. The system may include a first magnet configured to generate a first magnetic field that forces the magnetic particles in the solution toward an optical sensor with a capture probe. A detector may be included to detect a change in an optical property of the optical sensor, the change in the optical property resulting from the binding of at least the analyte, a magnetic particle, and the capture probe at the optical sensor.

Abstract: The invention relates to a method for diagnosis and/or complications and/or risk assessment of aging, in particular of aging process, wherein a determination of the marker procalcitonin (PCT: SEQ ID No. 1) or a partial peptide or fragment thereof or if contained in a marker combination (Panel, Cluster) is carried out on a patient within normal value ranges of leucocytes under investigation. The invention further relates to invent new drugs, a diagnostic device and a kit for carrying out said method.

Abstract: Disclosed is a device and method allowing a trace amount of a target substance to be detected. A metallic nanoparticle assembly structure is formed of metallic nanoparticles assembled together and modified with a host molecule allowing the target substance to specifically adhere thereto. A metallic nanorod is modified with a host molecule allowing the target substance to specifically adhere thereto. The metallic nanorod is conjugated to the metallic nanoparticle assembly structure by the target substance. An extinction spectrum of localized surface plasmon resonance or a surface enhanced Raman scattering (SERS) spectrum induced in the metallic nanoparticle assembly structure and the metallic nanostructure is measured with a spectroscope. The target substance is detected based on that spectrum.

Abstract: The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

Abstract: Hierarchical films with structurally regulated functionalities through the integration of two-dimensional and three-dimensional structures to achieve ultra low nonspecific binding and high loading of molecular recognition elements, and methods for making and using the films.

Abstract: The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

Abstract: A method and a device for the optical examination of a surface region are proposed. Fluorescence measurement is used to determine the amount of a substance bound to the surface region. Light interference is shut out thanks to the surface region being covered with an optically active liquid which filters, reflects, scatters and/or absorbs light with a wavelength at least substantially corresponding to the light radiated in and/or out.

Abstract: A system and method for determining the presence and/or concentration of one or more analytes in a sample that comprises a fluid, the system comprising a solid substrate comprising a sample inlet or inlets and one or more analyte determination flow paths, each analyte determination flow path comprising a defined beginning and a defined terminus and comprising at least one capture zone containing a capture agent for an analyte, the capture agent or agents being immobilized along a portion of the flow path or paths, the flow path or paths being designed so that the one or more analytes are depleted from the sample and bound in a non-linear manner to the portion of the flow path or paths containing immobilized capture agent or agents, producing an analyte depletion end region for each analyte between the beginning and the terminus of the analyte determination flow path.

Abstract: Among others, the present invention provides micro-devices for detecting or treating a disease, each comprising a first sorting unit capable of detecting a property of the biological subject at the microscopic level and sorting the biological subject by the detected property; a first detection unit capable of detecting the same or different property of the sorted biological subject at the microscopic level; and a first layer of material having an exterior surface and an interior surface, wherein the interior surface defines a first channel in which the biological subject flows from the first sorting unit to the first detection unit.

Abstract: A method of fabricating a biosensor chip includes: forming at least one metallic layer on a transparent substrate to form a composite member; disposing the composite member in a vacuumed chamber, and introducing a gas into the vacuumed chamber; applying microwave energy to the gas to produce a microwave plasma of the gas within the vacuumed chamber, and causing the microwave plasma to interact with the metallic layer so that the metallic layer is melted and formed into a plurality of metallic nanoparticles that are spaced apart from each other and that expose partially the surface of the transparent substrate; and disposing a receptor at the surface of the transparent substrate that is exposed among the metallic nanoparticles. A biosensor chip is also disclosed.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Abstract: A target substance detecting apparatus includes a photonic crystal biosensor configured to include a photonic crystal, which has a reflection surface including concave portions and convex portions formed regularly on its surface, covered by a metal film, and reflecting light irradiated to the reflection surface; an optical detecting unit configured to irradiate parallel light to the reflection surface, and to detect reflected light of the parallel light reflected on the reflection surface; and a processing unit configured to obtain a wavelength at an extreme value of the reflected light detected by the optical detecting unit, and to detect at least whether the target substance is present or not based upon a shift of the obtained wavelength at the extreme value.

Abstract: A lateral flow device includes a sample compressor and a test strip comprising a diverting zone. The diverting zone, which may include a barrier and/or a gap or ditch, stops or impedes flow. Flow is reinitiated and diverted into an alternate plane by compression of a sample compressor. Flow returns to the original, lateral plane, at the end of the diverting zone.

Abstract: A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences.

Abstract: A biosensor system and method of its use for detecting particles on the surface of an integrated circuit is disclosed. The system can include a light source and a plurality of optical sensors formed on an integrate circuit. The particles can be positioned the surface of the integrated circuit whereby the particles can cast a shadow or shadows that reduces the amount of light transmitted from the light source to the optical sensors. The surface of the integrated circuit can include one or more optical sensing areas whereby the presence of one or more particles may significantly or measurably reduce the amount of light incident on one or more optical sensor.

Abstract: Higher economic efficiency is ensured in a chromatographic measurement even when a chromatographic measurement apparatus is used at a place with risk of contamination of testing equipment. A chromatographic measurement apparatus includes an apparatus main body and a measurement unit, wherein the apparatus main body and the measurement unit are configured to be capable of wireless communication of a signal representing measurement information obtained by the measurement unit and capable of mutual pairing setting. The apparatus main body includes a storage section for storing the measurement information, an extracting section for extracting, from a signal obtained via wireless communication, a signal from the measurement unit paired with the apparatus main body based on the pairing setting, and a display section for displaying the measurement information.

Abstract: A biological molecule detecting apparatus capable of highly sensitive measurements is provided. A laser was emitted onto a solution, to impart external force onto free molecules and binding molecules within the solution. The external force inhibited Brownian motion of the free molecules and the binding molecules. The concentration of a detection target substance which is associated the binding molecules can be measured with high sensitivity, by measuring the Brownian motion of the free molecules and the binding molecules within the solution irradiated with the laser.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: A device that uses radiofrequency detection of the aggregation or disaggregation of magnetic nanoparticles without using nuclear magnetic resonance methods is described. The signals from one or more magnetic nanoparticle species in separate sample wells are compared to ascertain that aggregation or disaggregation has occurred. Depending on the specific reagents used, the detected aggregation or disaggregation event can be interpreted as an indicator of the presence of a molecule or microorganism of interest in a liquid sample.

Abstract: A biological molecule detecting apparatus capable of highly sensitive measurements is provided. The emission direction of an orientation controlling light beam was periodically switched, to periodically switch the orientation direction of binding molecules 15 within a solution. Components, which are synchronized with the orientation periods of the binding molecules are extracted from fluorescence emitted by fluorescent molecules within the solution, are extracted and detected. Thereby, the concentration of a detection target substance can be accurately measured with a simple configuration.

Abstract: Sensors include nano-porous alumina membranes that are sensitized by immobilization of antibodies in the nano-pores. The nano-membranes can be sensitized to respond to a single target compound, or different portions of the nano-membrane can be differently sensitized. Capture of the target compound can be detected based on a spectral signature associated with electrical conductance in the nano-pores.

Abstract: A device for performing a test to determine the presence or the absence of at least one analyte in a liquid sample includes: a support and a matrix, fixed on the support. The matrix includes: a liquid sample application zone, a marking zone and at least one reaction zone. The one reaction zone includes: a test results display zone having at least a second immobilized binding partner which is able to bind to at least one analyte, and a monitoring zone downstream of the results display zone or parallel with the results display zone which allows monitoring of the correct functioning of the device and which includes at least one analogue of the at least one analyte which is able to bind to at least a first marked binding partner. The liquid sample application zone, marking zone and reaction zone are in fluid communication.

Abstract: A configuration was adopted, in which the orientations of free molecules and binding molecules within a solution are switched by switching the vibration direction of orientation controlling light, thereby switching the amount of light emitted by each free molecule and each binding molecule. There is a difference in the amounts of time required for the orientations of the free molecules and the binding molecules to switch accompanying the switch in the emission direction of the orientation controlling light. Therefore, the timings at which the amounts of light emitted by each type of molecule increase differ. Accordingly, the fluorescence contributed by fluorescent molecules associated with free molecules and the fluorescent molecules associated with binding molecules can be respectively calculated, even if all of the fluorescent molecules within the solution emit fluorescence. Thereby, the concentration of a detection target substance can be accurately measured with a simple structure.

Abstract: Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent.

Abstract: The subject invention pertains to uses of HMGA2 as a diagnostic biomarker for ovarian cancer and for prediction of a subject's resistance to cancer therapy. The methods of the subject invention are particular useful for early detection of epithelial ovarian cancer.

Abstract: In an assay apparatus for performing an assay related to a specimen received from the outside thereof based on a reaction between the specimen and a reagent by using a reaction container that holds the reagent, the apparatus includes a detection means that detects a state in which an assay has ended before completion, and a mark providing means that provides a predetermined mark for the reaction container when the state in which the assay has ended before completion is detected by the detection means.

Abstract: The present disclosure relates to detection of the presence or absence of cerebrospinal fluid (CSF) in a sample by the detection of one or more antigens that are enriched in CSF compared to their levels in other bodily fluids. The devices and methods are suitable for the detection of the presence or absence of cerebrospinal fluid in samples of mixed bodily fluids from a wide variety of human populations crossing ethnicity, age, gender, health status and genetic variability.