Abstract: The present disclosure relates to apparatus, systems, compositions, and methods for analyzing a sample containing particles. A particle imaging system or analyzer can include a flowcell through which a urine sample containing particles is caused to flow, and a high optical resolution imaging device which captures images for image analysis. A contrast pattern for autofocusing is provided on the flowcell. The image processor assesses focus accuracy from pixel data contrast. A positioning motor moves the microscope and/or flowcell along the optical axis for autofocusing on the contrast pattern target. The processor then displaces microscope and flowcell by a known distance between the contrast pattern and the sample stream, thus focusing on the sample stream. Cell or particle images are collected from that position until autofocus is reinitiated, periodically, by input signal, or when detecting temperature changes or focus inaccuracy in the image data.

Abstract: Aspects and embodiments of the instant disclosure provide a particle and/or intracellular organelle alignment agent for a particle analyzer used to analyze particles contained in a sample. An exemplary particle and/or intracellular organelle alignment agent includes an aqueous solution, a viscosity modifier, and/or a buffer.

Abstract: The present disclosure relates to a staining methodology employing a particle contrast agent composition capable of rapidly staining cells in a single step. The particle contrast agent composition can be comprised of a combination of one or more particle contrast agents and one or more permeabilizing agents, optionally including one or more fixing agents and other components. The particle contrast agent composition can include Crystal Violet, 5PD-Lytic, and Proclin 300.

Abstract: Particles such as blood cells can be categorized and counted by a digital image processor. A digital microscope camera can be directed into a flowcell defining a symmetrically narrowing flowpath in which the sample stream flows in a ribbon flattened by flow and viscosity parameters between layers of sheath fluid. A contrast pattern for autofocusing is provided on the flowcell, for example at an edge of a rear illumination opening. The image processor assesses focus accuracy from pixel data contrast. A positioning motor moves the microscope and/or flowcell along the optical axis for autofocusing on the contrast pattern target. The processor then displaces microscope and flowcell by a known distance between the contrast pattern and the sample stream, thus focusing on the sample stream. Blood cell images are collected from that position until autofocus is reinitiated, periodically, by input signal, or when detecting temperature changes or focus inaccuracy in the image data.

Abstract: The present disclosure relates to apparatus, systems, compositions, and methods for analyzing a sample containing particles. In some aspects the system comprises an analyzer which may be a visual analyzer. In one aspect, this disclosure relates to a particle imaging system comprising a flowcell through which a sample containing particles is caused to flow, and a high optical resolution imaging device which captures images for image analysis of samples. Other compositions, methods and features of this disclosure are disclosed herein.

Abstract: For analyzing a sample containing particles of at least two categories, such as a sample containing blood cells, a particle counter subject to a detection limit is coupled with an analyzer capable of discerning particle number ratios, such as a visual analyzer, and a processor. A first category of particles can be present beyond detection range limits while a second category of particles is present within respective detection range limits. The concentration of the second category of particles is determined by the particle counter. A ratio of counts of the first category to the second category is determined on the analyzer. The concentration of particles in the first category is calculated on the processor based on the ratio and the count or concentration of particles in the second category.

Abstract: The present disclosure relates to a staining methodology employing a particle contrast agent composition capable of rapidly staining cells in a single step. The particle contrast agent composition can be comprised of a combination of one or more particle contrast agents, one or more permeabilizing agents, and one or more fixing agents. The particle contrast agent composition can include Crystal Violet, New Methylene Blue, Saponin, and Gluteraldehyde.

Abstract: The present invention relates to methods, compositions and kits for affinity isolation, affinity purification and affinity assay based on microbubbles coated with an affinity molecule. Particularly, the invention provides protein microbubbles coated with an affinity molecule. In addition, the invention provides glass microbubbles coated with an affinity molecule. Methods of using the microbubbles of the invention for isolating analytes and cells are specifically provided.

Abstract: This invention describes compositions and methods for use in PSA assays having low functional sensitivity which are useful, for example, in the detection of early stage recurrence of prostate disease following treatment and in the determination of whether patients have prostate cancer recurrence or stable disease.

Abstract: A centrifugal assembly is provided that can be used in common laboratory fixed angle or swinging bucket centrifuges for the separation of material, such as parasitic ova, based on particle density. The centrifugal assembly allows the fluid level to be gently adjusted to form a meniscus without disruption of the buoyant matter, such as ova. The centrifugal assembly also enables a user to easily and hygienically collect and transfer a measured amount of a sample, such as fecal material, and to break apart and mix the sample with a floatation fluid contained in a centrifuge tube.

Abstract: This invention describes compositions and methods for use in PSA assays having low functional sensitivity which are useful, for example, in the detection of early stage recurrence of prostate disease following treatment and in the determination of whether patients have early stage biochemical reoccurrence (ES-BCR) or stable disease.

Abstract: The present invention relates to methods, compositions and kits for affinity isolation, affinity purification and affinity assay based on microbubbles coated with an affinity molecule. Particularly, the invention provides protein microbubbles coated with an affinity molecule. In addition, the invention provides glass microbubbles coated with an affinity molecule. Methods of using the microbubbles of the invention for isolating analytes and cells are specifically provided.

Abstract: The invention is a state machine having a host controller that controls a level-1 controller, wherein the level-1 controller controls the level-2 controller. The level-2 controller controls system component controllers, which in turn control system components to execute a process segment. For example, the machine includes a host controller that selects a set of states to be executed, a level-1 controller that activates the set of states in a predetermined order, wherein each state includes commands, and a level-2 controller that controls system components according to the commands. A method of executing a process includes identifying a set of states to be executed, issuing state commands that need to be issued to execute the current state in the set of states, and activating a next state only after all expected status reports have been received for the current state.

Abstract: A system and method for analyzing a specimen containing particles that can be difficult to differentiate. The system and method determines a first collective count of a selected group of particles in the specimen, treats at least a portion of the specimen to alter a subgroup of the selected group of particles, determines a second collective count of any of the selected group of particles in the treated portion of the specimen, and subtracts the second collective count from the first collective count to determine a differentiation count for the subgroup of particles altered by the treating of the specimen. The system and method is described with the example of determining concentrations of red and white blood cells in a specimen (e.g. spinal fluid), using auto-particle recognition techniques, without attempting to distinguish and count red versus white blood cells co-existing in the same specimen portion.

Abstract: The present invention provides a streamline-based device and a method for using the device for continuous separation of particles including cells in biological fluids. The device includes a main microchannel and an array of side microchannels disposed on a substrate. The main microchannel has a plurality of stagnation points with a predetermined geometric design, for example, each of the stagnation points has a predetermined distance from the upstream edge of each of the side microchannels. The particles are separated and collected in the side microchannels.

Abstract: A chemistry strip reader and method for analyzing chemistry strips. A conveyor moves chemical strips through different imaging positions at discrete points in time across the field of view of a camera, which captures images of each chemistry strip at different discrete times. A processor determines reflectance values for each of the chemical strips from the captured images at the discrete points in time. Calibration targets adjacent the chemistry strips can be used to adjust the determined reflectance values. The light source can sequentially illuminate each chemistry strip with three different wavelengths of light, where the processor calculates a concentration determination associated with the chemistry strip by calculating different chromaticity coordinates for the different wavelengths of light, and comparing them to known chromaticity coordinates for known analyte concentrations.

Abstract: A system and method for analyzing a specimen containing particles that can be difficult to differentiate. The system and method determines a first collective count of a selected group of particles in the specimen, treats at least a portion of the specimen to alter a subgroup of the selected group of particles, determines a second collective count of any of the selected group of particles in the treated portion of the specimen, and subtracts the second collective count from the first collective count to determine a differentiation count for the subgroup of particles altered by the treating of the specimen. The system and method is described with the example of determining concentrations of red and white blood cells in a specimen (e.g. spinal fluid), using auto-particle recognition techniques, without attempting to distinguish and count red versus white blood cells co-existing in the same specimen portion.