Abstract: This invention relates to an improved version of paper-based analytical device and method for chromatographic chemical or immunoassays. Particularly, this present invention discloses a device and a method for reducing smears and improving sharpness and intensity of test sample readout for a multi-step chemical assay or immunoassay by introducing two additional elements, a time-delay pad (2) and a mixer (1), to the conventional two-dimensional paper network device (2DPN).

Abstract: A sample preparation device is provided for enriching a component of a sample. The sample preparation device includes a surface in fluid communication with the sample, an alkylsilyl coating disposed on the surface, and an affinity ligand or an enzyme covalently bonded to the alkylsilyl coating.

Abstract: A lateral flow assay device includes several test strips to receive a quantity of fluid that includes a quantity of exosomes and detect the presence of a target analyte on the surface of the exosomes. Each test strip includes a conjugate pad that contains binding reagent to one type of tetraspanin protein conjugated with a label. Each type of tetraspanin binding reagent is configured to bind with a corresponding type of exosome tetraspanin and form an immunocomplex comprising an exosome. Each conjugate pad is fluidly connected to a corresponding membrane. Each membrane includes a test line that includes an immobilized binding reagent to the target analyte. The immobilized binding reagent to the target analyte is configured to bind to a protein of the target analyte on the surface of an exosome in an immunocomplex comprising the exosome.

Abstract: A spectral reflectance imaging device for detecting nanoparticle exosome biomarker targets includes an illumination source that illuminates a substrate with a plurality of separate wavelengths of incoherent light. The substrate includes an oxide layer and a binding agent to selectively bind nanoparticle exosome biomarker targets to the substrate. An imaging device bindings the light reflected from or transmitted through the substrate and an image processing system detects the nanoparticle exosome biomarker targets a function of the change in reflective properties of the substrate.

Abstract: The invention generally relates to methods for quantifying an amount of enzyme molecules. Systems and methods of the invention are provided for measuring an amount of target by forming a plurality of fluid partitions, a subset of which include the target, performing an enzyme-catalyzed reaction in the subset, and detecting the number of partitions in the subset. The amount of target can be determined based on the detected number.

Abstract: The present invention relates to methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a method includes forming, in a biological sample, a first complex of signal antibodies and analyte, and a second complex of the first complex and capture antibodies immobilized on magnetic beads, and contacting a first immunosensor with the biological sample to form a third complex localized on or near a surface of the first immunosensor. The first immunosensor includes an immobilized layer of capture antibodies configured to bind to the analyte, and the third complex includes the first complex bound to the immobilized layer of capture antibodies. The method further includes contacting a magnetic field localized around a second immunosensor with the biological sample such that the second complex is localized on or near a surface of the second immunosensor.

Abstract: The present disclosure provides an immunochromatographic test piece which prevents a non-specific reaction by efficiently and continuously contacting and neutralizing a developing solution containing nitrous acid with a neutralizing reagent in an immunochromatography method of extracting and measuring a sugar chain antigen by nitrous acid extraction on the immunochromatographic test piece. The present disclosure also provides an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, which comprises: a sample pad; a label region; a detection region on which the antibody against the sugar chain antigen is immobilized; a region impregnated with a neutralizing reagent upstream of the label region, and a region impregnated with a solid acid reagent or a region impregnated with nitrite, upstream of the region impregnated with the neutralizing reagent.

Abstract: A method for initiating a telemedicine conference on a mobile device is provided. The method comprises receiving diagnostic test results in response to a diagnostic test, determining if the diagnostic test results include a positive result, storing the diagnostic test results on a server disposed on a network, presenting, if the diagnostic test results are positive, a telemedicine initiation option on a screen of the mobile device, determining whether the telemedicine initiation option is selected, sending the diagnostic test results from the server to the telemedicine provider, sending additional medical history information to the telemedicine provider, and initiating a telemedicine conference with the telemedicine provider. Some of these aspects also provide healthcare providers the ability to electronically send prescriptions and provide users the ability to use a mobile application to send prescriptions to pharmacies to be filled.

Abstract: Analytical assay reaction cartridges, kits containing same, and methods of production and use thereof are disclosed. These cartridges include a magnetic assembly that surrounds at least a portion of a sample read window on the cartridge. The cartridge also includes an analytical reagent positioned therewithin, wherein the analytical reagent comprises magnetic beads coated with at least one anti-red blood cell antibody.

Abstract: A method of preparing an antibody therapeutic is provided comprising: (a) providing a dissociated cell sample from at least one solid tumor sample obtained from a patient; (b) loading the dissociated cell sample into a microfluidic device having a flow region and at least one isolation region fluidically connected to the flow region; (c) moving at least one B cell from the dissociated cell sample into at least one isolation region in the microfluidic device, thereby obtaining at least one isolated B cell; and (d) using the microfluidic device to identify at least one B cell that produces antibodies capable of binding to cancer cells. The cancer cells can be the patient's own cancer cells. Also provided are methods of treating patients, methods of labeling or detecting cancer, engineered T or NK cells comprising antibodies or fragments thereof, and engineered antibody constructs.

Abstract: The present invention provides an analytical system comprising a sample management module. A pressure delivery assembly is configured to compress and deform a mixing chamber containing a sample preparation, and simultaneously open a plug of the mixing chamber to release the sample preparation. The system can be manufactured as a sample box combinable to a detector box, and is particularly convenient for patients to use at home, for example, screening colorectal cancer with their fecal sample.

Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.

Abstract: Disclosed is an assay device which comprises a liquid sample addition zone, a reagent zone, a detection zone, and a wicking zone, all defining a fluid flow path. The device further comprises a reagent addition zone along and in fluid communication with the fluid flow path downstream of the sample addition zone and upstream of the detection zone. An interrupting wash is added at this reagent addition zone in accordance with the method of the subject invention to control sample volume. The interrupting wash fluid is added at a predetermined fill volume on the chip device and also serves to wash the detection channel and fill the remaining chip volume.

Abstract: Microfluidic devices for use with reagents bound to microspheres for determination of the concentration of an analyte in a liquid sample are provided. The devices include two sequential mixing channels that promote rapid binding of microsphere-bound reagents with reagents in solution and a means for detecting labeled microsphere-bound reaction products. Also provided are methods for using the devices with microsphere-bound reagents to determine the concentration of an analyte in a liquid sample and to measure the binding affinity of antibody for an antigen.

Abstract: Methods and apparatus for detecting, quantifying, enriching, and/or separating bacterial species in fluid sample are provided. The fluid sample is provided as input to a microfluidic passage of a microfluidic device, wherein the microfluidic device comprises at least one electrode disposed adjacent to the microfluidic passage. The at least one electrode is activated to capture bacteria in the sample using dielectrophoresis, wherein the capture efficiency of bacteria is at least 99%.

Abstract: Disclosed herein are two related techniques for digital microfluidic (DMF) processing of liquids that rely on electrostatic actuation of fluid through a strip of solid, porous media. In the first technique, droplets in a DMF device containing particles of different sizes are driven through a solid porous medium, allowing for filtering, concentration, and recovery of the particles into droplets on the basis of size. In the second technique, an aliquot of liquid media is loaded directly onto a solid porous medium, where it is wicked into a DMF device, such that the filtrate can be collected into droplets. Both techniques may be useful for generating plasma from whole blood on a DMF device, an operation that will have far-reaching implications for diagnostic applications of digital microfluidics.

Abstract: A system and method, wherein the system includes: an array of wells defined at a substrate, each well including an open surface and a well cavity and a fluid delivery module including a fluid pathway through which fluid flow is controlled along a fluid path in a direction parallel to the broad face of the substrate; and wherein the method includes: generating a set of genetic complexes within individual wells of the array of wells.

Abstract: This disclosure describes a magnetic-field image sensor and method of use. In accordance with implementations of the magnetic-field image sensor, a sample can be placed on top of the magnetic field image sensor. An image of the magnetic nanoparticles or superparamagnetic nanoparticles can be created immediately afterwards based upon detection of a change in magnetic field caused by the magnetic nanoparticles or superparamagnetic nanoparticles. From this image, computer imaging algorithms can determine attributes (e.g., size, shape, type, quantity, distribution, etc.) of the target entity.

Abstract: Lateral flow devices, methods and kits for performing lateral flow assays are provided.

Abstract: A biosensor may provide a magnetoresistive (MR) film comprising a nonmagnetic layer may be sandwiched between the two ferromagnetic layers. The MR film may be positioned on a substrate, where the edges of the MR film are in contact with leads. Additionally, the leads may be in contact with pads. The sensors may provide quasi-digital readout that enable greatly enhanced sensitivity. In some embodiments, biosensors may be arranged as array of sensors. The array of sensors may be arranged as a symmetric or asymmetric N1×N2 array, where N1 and N2 are integers, N1 represents the number of sensors linked together in series, and N2 represents the number of sensor sets in parallel, where each sensor set may comprise one or more sensors. Further, the array of sensors may be coupled to a voltmeter, which may be a single voltmeter in some cases that allows the sensors to all be probed simultaneously.