Abstract: A mechanical lysis method includes (a) spinning a mixing head at a spin rate in a liquid sample, containing cells and beads, such that the mixing head cooperates with the beads to lyse the cells, wherein the spin rate exceeds a threshold rate associated with a predefined lysis efficiency, and (b) preventing the mixing head from spinning if the spin rate cannot be maintained above the threshold rate. A lysis apparatus includes (a) a receptacle for holding a container containing a liquid sample with cells and beads, (b) a mixing head configured to spin in the liquid sample, (c) a motor configured to spin the mixing head such that the mixing head cooperates with the beads to lyse the cells, and (d) a switch configured to prevent spinning of the mixing head at a spin rate lower than a threshold rate associated with a predefined lysis efficiency.

Abstract: A device for analyzing an analyte in a sample includes a first substrate, a second substrate, a fluidic channel, an inlet port and an outlet port. Each of the first substrate and the second substrate has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, the lower wall of the fluidic channel, and the inner surface of the second substrate forming, at least in part, the upper wall of the fluidic channel. The fluidic channel is connected to the inlet port and the outlet port. The fluidic channel includes a reagent region and a detection region, at least a portion of the reagent region being coated with one or more dried reagents. The device further includes a wicking pad located on the outer surface of the second substrate, the wicking pad being positioned at a pre-determined distance from the outlet port.

Abstract: A particle identification system includes: a cartridge for containing a sample with fluorescently labeled particles; illumination for illuminating a region within the cartridge to stimulate emission from particles; imager for generating wavelength-filtered electronic images of the emission within at least one measurement field of the region; and particle identifier for processing the electronic images to determine a superset of particles of interest, and fluorescently labeled particles within the superset based on properties of the particles in the at least one measurement field.

Abstract: A cartridge for detecting a target analyte in a sample includes (a) a capillary channel with a detection region configured for detection of the target analyte, (b) an inlet port configured to hold the sample before entering the capillary channel and including a dried reagents for rehydrating into the sample, the inlet port and the capillary channel being shaped in part by a common structure, and (c) a vent having a frangible seal configured to prevent flow of the sample into the capillary channel until the frangible seal is broken, the capillary channel being airtight between the inlet port and the vent.

Abstract: An assay cartridge processing system includes an agitation source for agitating assay components within an assay cartridge, and a timing module for controlling timing of agitation. An assay cartridge processing method includes applying agitation to an assay cartridge to mix assay components, and electronically controlling timing of agitation. An assay cartridge processing system includes a puncture device for puncturing an assay cartridge to allow fluid flow, and a timing module for controlling timing of puncturing. An assay cartridge processing method includes puncturing a vent of a capillary channel of an assay cartridge to allow fluid flow from an inlet port of the assay cartridge into the capillary channel, and electronically controlling timing of the step of puncturing. An assay cartridge includes a capillary channel, an inlet port, and a vent including a frangible seal for preventing fluid flow from into the capillary channel when the frangible seal is intact.

Abstract: A fluidic cartridge (110) with passively driven fluid flow is disclosed. The disclosed device and method solve problems associated with passive-flow fluidics by using a wicking pad (510) and/or a tilting means to prevent channel draining and backflow. The disclosure further provides means for adding liquid to the cartridge in multiple steps, without requiring liquid aspiration or removal.

Abstract: A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge, including an integral lens portion coupled to a planar waveguide, and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.

Abstract: A particle identification system includes: a cartridge for containing a sample with fluorescently labeled particles; illumination for illuminating a region within the cartridge to stimulate emission from particles; imager for generating wavelength-filtered electronic images of the emission within at least one measurement field of the region; and particle identifier for processing the electronic images to determine a superset of particles of interest, and fluorescently labeled particles within the superset based on properties of the particles in the at least one measurement field.

Abstract: A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.

Abstract: A fluidic cartridge (110) with passively driven fluid flow is disclosed. The disclosed device and method solve problems associated with passive-flow fluidics by using a wicking pad (510) and/or a tilting means to prevent channel draining and backflow. The disclosure further provides means for adding liquid to the cartridge in multiple steps, without requiring liquid aspiration or removal.

Abstract: A device for analyzing an analyte in a sample includes a first substrate, a second substrate, a fluidic channel, an inlet port and an outlet port. Each of the first substrate and the second substrate has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, the lower wall of the fluidic channel, and the inner surface of the second substrate forming, at least in part, the upper wall of the fluidic channel. The fluidic channel is connected to the inlet port and the outlet port. The fluidic channel includes a reagent region and a detection region, at least a portion of the reagent region being coated with one or more dried reagents. The device further includes a wicking pad located on the outer surface of the second substrate, the wicking pad being positioned at a pre-determined distance from the outlet port.

Abstract: A system for enumeration of objects such as cells in a sample is disclosed. The system uses a low-cost cartridge and a reader instrument, based on planar waveguide imaging technology. Cells of a blood sample may be stained with fluorescence-tagged antibodies and are loaded onto the cartridge where the differentially labeled cells may be distinguished and quantified.

Abstract: A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.