Abstract: A method for performing a high dynamic range immunoassay includes (a) measuring a first signal from a sandwich immunoassay to detect a target analyte in a fluidic sample in a fluidic channel and a second signal from a competitive immunoassay associated with the target analyte in the same fluidic sample in the fluidic channel, and (b) determining ratio of the first signal to the second signal to provide a measure of concentration of the target analyte in the fluidic sample, wherein the measure is applicable to a high dynamic range of concentrations of the target analyte.

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: A cartridge for processing a sample includes (a) a planar waveguide with upper and lower planar surfaces defining an optical axis therebetween, wherein the upper planar surface has a plurality of capture molecules bound thereto, (b) a lens portion, coupled to the planar waveguide, for focusing and refracting a light beam propagating parallel to, but offset from, the optical axis such that the light beam couples into the planar waveguide and propagates therein along the optical axis at a non-zero, internal propagation angle ? relative to the upper planar surface, and (c) a sample chamber for positioning the sample in contact with the plurality of capture molecules such that a target analyte of the sample is detectable through (i) an assay involving the target analyte and the capture molecules and (ii) evanescent illumination of the assay using the light beam within the planar waveguide.

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 cartridge for processing a sample includes (a) a planar waveguide with upper and lower planar surfaces defining an optical axis therebetween, wherein the upper planar surface has a plurality of capture molecules bound thereto, (b) a lens portion, coupled to the planar waveguide, for focusing and refracting a light beam propagating parallel to, but offset from, the optical axis such that the light beam couples into the planar waveguide and propagates therein along the optical axis at a non-zero, internal propagation angle ? relative to the upper planar surface, and (c) a sample chamber for positioning the sample in contact with the plurality of capture molecules such that a target analyte of the sample is detectable through (i) an assay involving the target analyte and the capture molecules and (ii) evanescent illumination of the assay using the light beam within the planar waveguide.

Abstract: A method for performing a high dynamic range immunoassay includes (a) measuring a first signal from a sandwich immunoassay to detect a target analyte in a fluidic sample in a fluidic channel and a second signal from a competitive immunoassay associated with the target analyte in the same fluidic sample in the fluidic channel, and (b) determining ratio of the first signal to the second signal to provide a measure of concentration of the target analyte in the fluidic sample, wherein the measure is applicable to a high dynamic range of concentrations of the target analyte.

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 method for determining fluorescently labeled particles within a sample in presence of sample movement includes determining spatial shift between sequentially captured first and second images of the sample by using a third image of the sample, wherein the spatial shift is at least partially induced by the sample movement; and spatially correlating events between the first and second images, while accounting for the spatial shift. A method for providing a fluidic assay cartridge with dried reagents includes depositing a plurality of mutually incompatible liquid reagents in a respective plurality of mutually separated areas of the fluidic assay cartridge, and drying the plurality of mutually incompatible liquid reagents to form the dried reagents.

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 system for sample preparation and analyte detection includes a cartridge, with a fluidic channel, a waveguide, and a capture spot. The system further includes a force field generator, an imaging system, and a fluid, which includes a sample potentially containing a target analyte, first type particles, which include binding moieties specific for the target analyte and are responsive to a force field, and second type particles, which include binding moieties specific for the target analyte and are capable of generating a signal. When the sample contains the target analyte, specific binding interactions between the target analyte and binding moieties link first and second type particles via the target analyte to form multiple-particle complex capturable at a capture spot. The force field allows manipulation of the particles and multiple-particle complex such that the detected signal from the second type particles is indicative of the target analyte within the sample.

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: Disclosed here is a system and method for analyzing and/or detecting one or more target analytes in a sample by using a competitive assay. A standard curve may be constructed using known amounts of a molecule that is identical or substantially identical to the target analyte. Signals obtained from the target analyte can be compared against the standard curve in order to determine the level of the target analyte in the sample. The disclosed methods may be used in a multiplexed analyte detection and quantitation system.

Abstract: Compositions and methods of preparing functional thin films or surface coatings with low non-specific binding are described. The thin films contain specified functional groups and non-specific binding repellant components. The thin films are either covalently bound to or passively adsorbed to various solid substrates. The specified functional group provides specified activity for the thin film modified solid surfaces and non-specific binding repellant components significantly reduce the non-specific binding to the thin film modified solid surfaces. Non-specific binding repellant components do not affect specified functional group's activity in the thin films. In these methods, specified functional groups are anchored to the solid substrates through a spacer.

Abstract: A sample can be illuminated for analysis using apparatus including a light source, a planar waveguide, and a refractive volume. The light source provides light along a propagation vector. The planar waveguide is oriented such that the propagation vector is perpendicular to the normal vector of the planar waveguide and offset from the planar waveguide in a direction parallel to the normal vector of the planar waveguide. The refractive volume is positioned proximate to the planar waveguide and can optically coupling light provided by the light source to the planar waveguide.