Abstract: The present invention provides a method for detecting an antigen in an analysis sample, the method including: (a) contacting an analysis sample with a detection antibody with which a marker generating a detectable signal is combined and which specifically binds to the antigen; (b) contacting a capture antibody with the resultant product of step (a), the capture antibody specifically binding to an antigen to be detected; (c) contacting the detection antibody, with which the marker generating a detectable signal is combined, with a reference substance which is bound to a surface of a solid substrate and which includes an epitope to which the detection antibody specifically binds; (d) measuring signals generated from the markers of the resultant product of step (b) and the resultant product of step (c); and (e) analyzing the measured signals to determine the presence or absence and amount of the antigen in the analysis sample.

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: Described are embodiments of an invention for a sample assembly with an electrical conductor for detection of the antigens by electromagnetic read heads. In one embodiment, a sample assembly includes: a substrate; one or more base layers above the substrate; an outer layer above the one or more base layers; a plurality of sample trenches formed in the outer layer and/or the one or more base layers, each sample trench being characterized by an upper surface, a bottom surface, and a longitudinal axis; an electrical conductor disposed in the substrate, the electrical conductor being configured to generate an electromagnetic field in proximity to the plurality of sample trenches to enhance nanoparticle movement toward the bottom surface of the plurality of sample trenches; and at least one alignment trench formed above the substrate, each alignment trench having a longitudinal axis substantially parallel to a longitudinal axis of at least one of the sample trenches.

Abstract: Assay cassettes and testing devices that can be used to provide rapid, accurate, affordable, laboratory-quality testing at the point of care. Such assay cassettes and testing devices are designed to provide rapid, quantitative test results in a point-of-care setting or the like. Likewise, such assay cassettes and testing devices may eliminate or replace expensive, centralized clinical testing equipment and technical personnel. Such testing device may include automated data reporting and decision support. Methods for performing point of care diagnostic tests are also disclosed.

Abstract: The present invention, in part, relates to methods and apparatuses for on-chip amplification and/or detection of various targets, including biological targets and any amplifiable targets. In some examples, the microculture apparatus includes a single-use, normally-closed fluidic valve that is initially maintained in the closed position by a valve element bonded to an adhesive coating. The valve is opened using a magnetic force. The valve element includes a magnetic material or metal. Such apparatuses and methods are useful for in-field or real-time detection of targets, especially in limited resource settings.

Abstract: Microfluidic cartridges for agglutination reactions are provided. The cartridges include a microfluidic reaction channel with at least two intake channels, one for an antigen-containing fluid and the other for an antibody-containing fluid, conjoined to a reaction channel modified by incorporation of a downstream flow control channel. At low Reynolds Number, the two input streams layer one on top of the other in the reaction channel and form a flowing, unmixed horizontally-stratified laminar fluid diffusion (HLFD) interface for an extended duration of reaction. Surprisingly, the design, surface properties, and flow regime of microfluidic circuits of the present invention potentiate detection of antibody mediated agglutination at the stratified interface. Antigen:antibody reactions involving agglutination potentiated by these devices are useful in blood typing, in crossmatching for blood transfusion, and in immunodiagnostic agglutination assays, for example.

Abstract: There are provided methods, and devices for assaying for a binding interaction between a protein, such as a monoclonal antibody, produced by a cell, and a biomolecule. The method may include retaining the cell within a chamber having an aperture; exposing the protein produced by the cell to a capture substrate, wherein the capture substrate is in fluid communication with the protein produced by the cell and wherein the capture substrate is operable to bind the protein produced by the cell; flowing a fluid volume comprising the biomolecule through the chamber via said aperture, wherein the fluid volume is in fluid communication with the capture substrate; and determining a binding interaction between the protein produced by the cell and the biomolecule.

Abstract: A combination of mutually exclusive cell-based analytical techniques can be applied to the same group of cells for analysis. The same group of cells can be prepared for analysis by each technique resulting with candidate cells targeted for mass cytometry analysis. This configuration allows for the correlation of the information between each technique to produce a matrix of multi dimension of cellular information with the same group of cells.

Abstract: A centripetal microfluidic platform comprised of a microfluidics disc and a reader for testing LAL-reactive substances in fluid samples is provided. The microfluidic disc may comprise at least two testing areas wherein each testing area includes a reservoir portion for receiving at least one fluid sample. The disc may comprise a distribution network portion in fluid communication with the reservoir portion. Each distribution network portion may comprise a distribution network of at least four (4) channels, wherein each channel has a metering portion and at least one analysis chamber portion. The analysis chamber portion may comprise a mixing chamber for mixing samples and reagents and an optical chamber portion that is compatible with an optical reader. The metering portion may be sized to meter an aliquot of the fluid sample for analysis in the analysis chamber portion. At least one analysis chamber portion has at least one reagent isolated therein.

Abstract: Methods, devices and systems for handling sample liquids, encapsulating liquids and magnetic particles are disclosed.

Abstract: An apparatus for automated determining of at least two different process parameters of a process liquid of a process, especially a bioprocess, comprising: a first measuring cell, which is embodied to provide a first measurement signal dependent on a first process parameter of a first sample of the process liquid; a second measuring cell, which is embodied to provide a second measurement signal dependent on a second process parameter of a second sample of the process liquid; and a control and evaluation system, which serves for monitoring and/or controlling the process, and which is embodied to receive and to process the first and second measurement signals, especially based on the first measurement signal to determine a measured value of the first process parameter and based on the second measurement signal to determine a measured value of the second process parameter; wherein the first measurement signal and the second measurement signal serve different functions in the context of the monitoring and/or contr

Abstract: A lateral flow assay device includes a substrate having a top surface, as well as a sample receiving area disposed upon the top surface. At least one fluid flow path extends along the substrate from the sample receiving area, wherein the sample receiving area can be placed in contact with a peripheral reservoir formed at a sample addition area to draw sample therefrom in a controlled manner. The device can further include a reagent area that is designed to promote uniform dissolution of a deposited detection material by a sample moved through the device along the fluid flow path as well, as a flow channel configure to promote mixing of sample and reagent and an absorbing or wicking zone configured to affect various flow characteristics.

Abstract: Photonic devices, systems, and methods for detecting an analyte in a biological solution (e.g., whole blood) are provided. Representative photonic devices are optical ring resonators having nanoscale features and micron-sized diameters. Due to the compact size of these devices, many resonators can be disposed on a single substrate and tested simultaneously as a sample is passed over the devices. Typical analytes include blood cells, antibodies, and pathogens, as well as compounds indicative of the presence of blood cells or pathogens (e.g., serology). In certain embodiments, blood type can be determined through photonic sensing using a combination of direct detection of blood cells and serology. By combining the detection signals of multiple devices, the type of blood can be determined.

Abstract: The present invention provides a method for detecting a disease at a very low concentration of diseased biological subject by contacting the diseased biological subject with a micro-device which comprises: a first sorting unit capable of directly detecting an intrinsic property of the biological subject at the microscopic level and sorting the biological subject by the detected intrinsic 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 through the first sorting unit, and then the sorted biological subject flows from the first sorting unit to the first detection unit.

Abstract: The present invention provides for a system and method to detect low levels of the anthrax protective antigen (PA) exotoxin in biological fluids, wherein the system uses a metal-enhanced fluorescence (MEF)-PA assay in combination with microwave-accelerated PA protein surface absorption. Microwave irradiation rapidly accelerates PA deposition onto the surface adjacent to deposited metallic particles and significantly speeding up the MEF-PA assay and resulting in a total assay run time of less than 40 min with an analytical sensitivity of less than 1 pg/ml PA.

Abstract: The invention generally provides a sieve valve including: a substrate defining a channel; a flexible membrane adapted and configured for deployment at an intersection with the channel; and one or more protrusions extending into the channel from the substrate or the flexible membrane. The one or more protrusions define a plurality of recesses extending beyond the intersection between the channel and the flexible membrane; A microfluidic circuit including one or more sieve valves. In particular embodiments, the circuit comprises one or more input/output valves. The one or one or more input/output valves can include one or more input valves and one or more output valves. The microfluidic circuit can further include a mixing circuit. At least one of the sieve valves can be positioned between the one or more input/output valves and the mixing circuit. The invention further provides methods of using the device for the analysis of samples comprising cells.

Abstract: Disclosed is an integral label-free biosensor capable of analyzing a biomolecule with high sensitivity by integrating a light source, a photodetector, an optical waveguide, and a microcantilever on a substrate, and a method of detecting a bio-antigen by using the same. The integral label-free biosensor according to the present invention may be manufactured with low cost, be easily integrated with a silicon electron device, and detect a biomolecule with high sensitivity by using a label-free method.

Abstract: Sample analysis systems and methods are provided.

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: One aspect of the invention provides a device for detecting an analyte in a sample. The device includes: a sample loading region, an imaging window, a well, and an absorbent pad. The sample loading region is in fluid communication with the well. The well is in fluid communication with the absorbent pad, such that when a fluid sample comprising solid support structures and a liquid carrier are applied to the sample loading region, the fluid sample travels to the well and at least part of the liquid carrier is absorbed into the absorbent pad.