Mesa Biotech, Inc.

Los Alamos National Security, LLC

Triad National Security, LLC

Robert B Cary

Nathan Jeremy Cobb

Marc Dejohn

Michael Mao Wang

Hong Cai

Conrad Lindberg

Donald J Thomas

Mark Nowakowski

Martin Bouliane

Michael Wang

An automated method for performing an assay of the present disclosure can be performed in a microfluidic device that is a lateral flow device having numerous features to ensure correct operation of the device under gravity, such as vent pockets for enabling the flow of sample fluid from one chamber to the next when the vent pocket is unsealed. Each chamber can have a reagent recess proximal to an inlet end of the chamber. A reagent pellet formed in a reagent recess can be effectively mixed with a sample as the sample flows into the chamber. A flexible circuit with patterned metallic electrical components disposed on a heat stable material can be in direct contact with fluid in the chambers and has resistive heating elements aligned with, for example, a chamber for performing an amplification reaction. A lateral flow detection chamber can include a capillary pool proximal to a sample receiving end of a lateral flow strip, providing effective mixing and dispersion of a sample with detection particles, as well as enhancing, uniformity of particle migration on the detection strip. The microfluidic device can be configured to be hermetically sealed, thereby preventing contamination of a testing environment.

Automated method for performing an assay

A lateral flow assay device of the present disclosure has numerous features to ensure correct operation of the device under gravity, such as vent pockets for enabling the flow of sample fluid from one chamber to the next when the vent pocket is unsealed. The vent pockets have protrusions to help prevent accidental resealing. The device also can have a gasket to ensure free air movement between open vent pockets. Flow control features that protrude horizontally into a chamber proximal to an outlet act to deflect the flow to the side of the chamber opposite from the outlet, prior to the flow entering the outlet. Such features can reduce the flow velocity of the sample fluid and increase the effective fluid flow path length, enhance mixing of reagents with a sample, and enabling more accurate control of fluid flow in the device. A flexible circuit with patterned metallic electrical components disposed on a heat stable material can be in direct contact with fluid in the chambers and has resistive heating elements aligned with the vent pockets and the chambers.

Fluidic test cassette

A disposable assay platform for detecting a target nucleic acid comprising multiple chambers and a method for operating the assay platform. Solutions containing the target nucleic acid move from one chamber to the next chamber by opening a vent pocket. The resulting pressure change enables the solution to flow to the next chamber. The platform comprises an electronic layer and one or more fluid layers bonded together. All heating operations can be performed by using resistive heating elements in the platform. All cooling operations are preferably passive. The platform is preferably operated when in a vertical orientation and can be docked to an external docking station that controls the operation of the platform.

Integrated device for nucleic acid detection and identification

The invention provides miniaturized lateral flow chromatographic and lateral flow chromatographic microarray devices (LFM). The miniaturization of lateral flow nucleic acid detection achieved by the present invention offers reduced reagent use, femtomole sensitivity, excellent linear dynamic range, and rapid detection. Moreover, the small feature sizes of capture oligonucleotides renders the potential information capacity of the platform comparable to more traditional spotted fluorescence microarrays as well as improving sensitivity. The LFM devices exemplified herein enable analytes to be detected within 10 seconds from the time of sample introduction to the LFM device. Sample volumes may be as low as about 10 microliters, significantly reducing assay costs and ameliorating reagent storage logistics. Additionally, the miniaturization of lateral flow opens the door to highly multiplexed assays, allowing many proteins or nucleic acids to be detected in a single assay.

Miniaturized lateral flow device for rapid and sensitive detection of proteins or nucleic acids

Highly simplified lateral flow chromatographic nucleic acid sample preparation methods, devices, and integrated systems are provided for the efficient concentration of trace samples and the removal of nucleic acid amplification inhibitors. Methods for capturing and reducing inhibitors of nucleic acid amplification reactions, such as humic acid, using polyvinylpyrrolidone treated elements of the lateral flow device are also provided. Further provided are passive fluid control methods and systems for use in lateral flow assays.

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Santa Fe, NM, United States of America

Robert B Cary