Abstract: Devices and methods for performing a point of care diagnostic test for detecting and quantifying at least one analyte in a biological sample. The device may include an immunoassay apparatus and a holder with a variable angle stage for positioning the immunoassay apparatus relative to a light source and a detector device. In one embodiment, the device is based upon elastic light scattering, so the variation in the angle of incidence and angle of reflection are optimized to maximize signal generation due to elastic light scattering. The detector device may include a wired or wireless connection to a computer network for communicating with an electronic medical records system, uploading the amount or concentration of at least one analyte present in the sample to the electronic medical records system, or querying a decision support algorithm stored in a computer readable format. The detector device may further include an onboard interpretive algorithm.

Abstract: A microfluidic device can comprise at least one swept region that is fluidically connected to unswept regions. The fluidic connections between the swept region and the unswept regions can enable diffusion but substantially no flow of media between the swept region and the unswept regions. The capability of biological micro-objects to produce an analyte of interest can be assayed in such a microfluidic device. Biological micro-objects in sample material loaded into a microfluidic device can be selected for particular characteristics and disposed into unswept regions. The sample material can then be flowed out of the swept region and an assay material flowed into the swept region. Flows of medium in the swept region do not substantially affect the biological micro-objects in the unswept regions, but any analyte of interest produced by a biological micro-object can diffuse from an unswept region into the swept region, where the analyte can react with the assay material to produce a localized detectable reaction.

Abstract: A system for isolating preselected cell types from a fluid sample that includes a plurality of cell types includes a cell-capture fluidic chip, and a chip holder configured to receive the cell-capture fluidic chip and to maintain the cell-capture fluidic chip with a substantially fluid-tight seal while in operation. The chip holder is further configured to release the cell-capture fluidic chip to be removed from the chip holder for further processing. The cell-capture fluidic chip includes a substrate, a laser micro-dissection membrane disposed on the substrate, and a channel-defining layer disposed on the laser micro-dissection membrane. The laser micro-dissection membrane has a surface adapted to capture preselected cell types preferentially over other cell types of the plurality of cell types. The channel-defining layer is removable from the laser micro-dissection membrane for further processing of the cell-capture fluidic chip.

Abstract: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.

Abstract: The present invention provides an apparatus for retaining solid state reagents and/or for processing sample for a diagnostic test, where the apparatus avoids liquid “hang-up” that would otherwise result in loss of sample or fluid volume during sample transfer. The invention further provides diagnostic methods that employ the apparatus, so as to provide sensitive and accurate analyte detection.

Abstract: When using an immunological analysis method wherein antigen-antibody reactions are used to form complexes of microparticles and a substance being measured, purifying, then measuring by spectroscopy, and a mass spectrometry method wherein antigen-antibody reactions are used to form complexes of microparticles and a substance being measured, purifying, then measuring with a mass spectrometer, the amount of the complex flowing in the flow path for immunological analysis and the amount of the complex flowing in the flow path for mass spectrometry are unknown, so the substance being measured cannot be accurately quantified even when merging information obtained from immunological analysis and information obtained from mass spectrometry. The invention provides a mechanism for quantifying the complexes after formation of the complexes, on the flow path for mass spectrometry and the flow path for immunological analysis.

Abstract: Systems and methods are described for isolation, separation and detection of a molecular species using a low resource device for processing of samples. Methods include isolation, separation and detection of whole cells.

Abstract: The present invention relates to a method for the visual examination of biological material ex vivo and an apparatus for the sterical orientation of biological material which can be used in said method.

Abstract: An immunochromatographic method for detecting a specific substance contained in milk, which comprises (1) the step of contacting the milk with a test strip having a first part retaining a labeled first antibody directed to the specific substance or the specific substance that is labeled, a second part disposed downstream from the first part, on which a second antibody directed to the specific substance is immobilized, and a third part disposed upstream from the first part or the second part and having voids enabling removal of milk fat globules contained in the milk, at the third part or a further upstream part, and (2) the step of flowing the milk up to the second part or a further downstream part to obtain a detectable signal of the label at the second part or a further downstream part.

Abstract: Devices for detecting particle sizes and distributions using focused light scattering techniques, by passing a sample through a focused beam of light, are disclosed. In one embodiment, the devices include one or more lasers, whose light is focused into a narrow beam and into a flow cell, and dispersions are passed through the flow cell using hydrodynamic sample injection. In another embodiment, a plurality of lasers is used, optionally with hydrodynamic sample injection. Particles pass through and scatter the light. The scattered light is then detected using scatter and extinction detectors, and, optionally, fluorescence detectors, and the number and size of the particles is determined. Particles in the size range of 0.1 to 10 ?m can be measured. Using the device, significantly smaller particles can be detected than if techniques such as EQELS, flow cytometry, and other conventional devices for measuring biological particles.

Abstract: The present invention provides a method, wherein the method classifies a subject as suffering from dry eye, the method consisting of: a. obtaining demographic data, consisting of the age and gender of the subject; b. obtaining a tear sample from the patient, and determining the level of human serum albumin; c. from the determined level of human serum albumin, assigning a score for the determined amount of human serum albumin; and d. from the assigned score, calculating a cutoff probability score, according to the following equation: wherein the subject has dry eye, if the calculated cutoff probability score is from 50% to 60%. exp ? ( - 0.6491 - 1.1142 * Albumin ) 1 + exp ? ( - 0.6491 - 1.

Abstract: This disclosure relates to methods and devices to count particles of interest, such as cells. The methods include obtaining a fluid sample that may contain particles of interest; counting all types of particles in a portion of the sample using a first electrical differential counter to generate a first total; removing any particles of interest from the portion of the fluid sample; counting any particles remaining in the portion of the fluid sample using a second electrical differential counter after the particles of interest are removed to generate a second total; and calculating a number of particles of interest originally in the fluid sample by subtracting the second total from the first total, wherein the difference is the number of particles of interest in the sample. These methods and related devices can be used, for example, to produce a robust, inexpensive diagnostic kit for CD4+ T cell counting in whole blood samples.

Abstract: Provided herein, among other aspects, are methods and apparatuses for analyzing particles in a sample. In some aspects, the particles can be analytes, cells, nucleic acids, or proteins and contacted with a tag, partitioned into aliquots, detected by a ranking device, and isolated. The methods and apparatuses provided herein may include a microfluidic chip. In some aspects, the methods and apparatuses may be used to quantify rare particles in a sample, such as cancer cells and other rare cells for disease diagnosis, prognosis, or treatment.

Abstract: Disclosed herein are methods and systems for controlled ejection of desired material onto surfaces including in single cells using nanopipettes, as well as ejection onto and into cells. Some embodiments are directed to a method and system comprising nanopipettes combined with an xyz controller for depositing a user defined pattern on an arbitrary substrate for the purpose of controlled cell adhesion and growth. Alternate embodiments are directed to a method and system comprising nanopipettes combined with an xyz controller and electronic control of a voltage differential in a bore of the nanopipette electroosmotically injecting material into a cell in a high-throughput manner and with minimal damage to the cell. Yet other embodiments are directed to method and system comprising functionalized nanopipettes combined with scanning ion conductance microscopy for studying molecular interactions and detection of biomolecules inside a single living cell.

Abstract: An assay method and device can perform at least one (e.g., at least two) assays on a single aliquot of a sample liquid. The device can mix a sample liquid with assay reagents including magnetically susceptible particles. The device is configured to create a sample liquid-air interface with the sample liquid. The magnetically susceptible particles can be located (via an applied magnetic field) at the liquid-air interface when a second liquid contacts the interface to form a liquid-liquid interface. The magnetic particles travel across the liquid-liquid interface to the second liquid. The magnetically susceptible particles are configured to trans-port an analyte across the interface into the second liquid. An assay for the analyte is performed in the second liquid. An assay for another analyte can also be performed in the sample liquid.

Abstract: A system and method provide for high through put determination of agglutination states. The system includes a rotating table and multiple plate tilting stations. The system also includes one or more optical paths positioned to image entire plate arrays in tilted and/or untitled configurations. The system preferably includes image analysis software to analyze an image of an array of test wells and determine an agglutination state of each well based on the image analysis.

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 method for performing contactless ODEP for separation of CTCs is provided with the steps of obtaining patients' blood with rare cell suspected CTCs; adding at least one fluorescent antibody binding to CTCs into the blood; staining the blood; injecting the stained blood with fluorescent dye into an ODEP device and then performing fluorescent image identification; trapping the CTCs with at least one fluorescent antibody in the ODEP device by creating an image pattern and then generating an ODEP force; Separating the trapped CTCs from other non-CTCs cells; absorbing the trapped CTCs; and obtaining a high purity of CTCs. An apparatus for performing contactless ODEP for separation of CTCs is also provided.

Abstract: The invention provides a method for producing prion protein having an aggregated conformation by contacting native conformation prion protein with aggregated conformation prion protein in a liquid preparation and subjecting this to at least one cycle or to a number of cycles of application of shear-force for fragmenting aggregates of prion protein, wherein the shear-force applied is precisely controlled. In addition to this process for amplification of aggregated state prion protein from native conformation prion protein, the invention relates to the aggregated state prion protein obtained by the amplification process, which aggregated state prion protein has one conformation, which is e.g. identical within one batch and reproducible between batches, e.g. as detectable by proteinase resistance in a Western blot.

Abstract: The current invention relates to the method and apparatus to magnetically separate biological entities with magnetic labels from a fluid sample. The claimed methods separate biological entities with magnetic labels by using a magnetic device. The claimed methods further include processes to dissociate biological entities magnetic conglomerate after magnetic separation.