Mbio Diagnostics, Inc.

Accelr8 Technology Corporation

Accelerate Diagnostics, Inc.

Michael J Lochhead

Kurt Richard Vogel

Kevin D Moll

Steven W Metzger

Keagan B Rowley

Marie J Delaney

Christopher J Myatt

Guoqiang Mao

Jeffrey T Ives

John S Dunn

Charles Greef

Guoqiano Mao

David A Goldberg

Daniel T Nieuwlandt

Gregory M Husar

Sarah Rachel Bickman

James R Heil

Kathryn Todorof

Evelyn S Woodruff

David W Grainger

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.

Methods and devices for performing high dynamic range immunoassays

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.

System and device for analyzing a fluidic sample

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. A method determines fluorescently labeled particles within a sample, by: processing at least one electronic image from at least one focal position within the sample; determining dimmest separation lines between brighter areas in the electronic image; and, for each of the brighter areas, determining local background level based on pixel values of the separation lines forming a perimeter therearound, to determine each of the fluorescently labeled particles.

Particle identification system, cartridge and associated methods

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 &#x3b2; 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.

Planar waveguide based cartridges and associated methods for detecting target analyte

A fluidic cartridge () with passively driven fluid flow is disclosed. The disclosed device and method solve problems associated with passive-flow fluidics by using a wicking pad () 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.

Fluidic assay cartridge with controlled passive flow

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.

System and method for detecting multiple molecules in one assay

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.

Integrated sample preparation and analyte detection

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.

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.

Waveguide with integrated lens

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. Surface coatings are also described having both non-specific protein binding properties combined with functional groups for specific binding activity thereby providing surface coating that specifically recognize target proteins but limit binding to non-specific protein.

Growing community of inventors

Boulder, CO, United States of America

Michael J Lochhead