Lucira Health, Inc.

Pfizer Corporation

University of California

Diassess Inc.

John Robert Waldeisen

Debkishore Mitra

Frank B Myers, Iii

Ivan Krastev Dimov

Clay David Reber

Ragheb El Khaja

Christopher Frank Kelly

Frank B Myers

Luke P Lee

Bruce J Richardson

Ryan Griswold

Ivan Dimov

Jixiao Liu

Benjamin M Ross

Wei Hsuan Ho

Frank B Iii Myers

Lvan Krastev Dimov

Systems and methods for performing biological assays are provided herein. The systems and methods determine one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample. The nucleic acid amplification sample is reacted with an optical property modifying reagent in a reaction chamber of within a sample preparation device.

Systems and methods for performing biological assays

Devices and methods for modifying optical properties of biological samples or aspects thereof are provided. The subject methods include generating a reaction product with a device and reacting the reaction product to sufficiently modify an optical property to allow detection of the modified optical property.

Devices and methods for modifying optical properties

Selectively vented biological assay devices and methods of performing biological assays with such devices are provided herein. Disclosed devices include a selective venting element having passively tunable porosity. The methods include controlling fluid flow within the subject devices with the selective venting element.

Selectively vented biological assay devices and associated methods

A diagnostic system performs disease diagnostic tests using at least an optical property modifying device and a mobile device. A user provides a biological sample from a patient to the optical property modifying device that reacts with a reagent in one or more reaction chambers of the device. The user captures one or more images of the one or more reaction chambers using an optical sensor of the mobile device. The diagnostic system can determine a quality level of the images based on factors such as skew, scale, focusing, shadowing, or white-balancing. Based on an analysis of the captured image, the diagnostic system can determine a test result of a disease diagnostic test for the patient. The diagnostic system may communicate the test result, as well as instructions for the disease diagnostic test, to the user via the mobile device.

Image-based disease diagnostics using a mobile device

Colorimetry is used to detect amplification reaction products. A sample is contacted with a reaction mix under conditions such that an amplification reaction occurs and produces an amplification reaction product if the sample contains a target nucleic acid template molecule. The reaction mix includes an enzyme for catalyzing the amplification reaction, and at least one halochromic agent. If the target nucleic acid template molecule is present, the amplification reaction changes the starting pH of the reaction mix to cause a detectable colorimetric change of the halochromic agent, thereby indicating the presence of the target nucleic acid. If the target nucleic acid template molecule is not present, the amplification reaction does not generate an adequate number of protons to sufficiently change the starting pH of the reaction mix to cause a detectable colorimetric change of the halochromic agent, thereby indicating that the amplification reaction product has not been produced.

Colorimetric detection of nucleic acid amplification

Medical testing device

Selectively vented biological assay devices and methods of performing biological assays with such devices are provided herein. Disclosed devices include (a) a sample receiving cartridge comprising a sample inlet and one or more reaction chambers and (b) a selective venting element having passively tunable porosity. The methods include controlling fluid flow within the subject devices with the selective venting element.

Devices and methods for preparing and delivering biological assay samples are provided herein. Components of such devices include a sample receiving module within which a biological assay sample can be prepared and a cap, which when operatively coupled with the sample receiving module, pressurizes the module. These devices can be employed for subsequently delivering a biological assay sample.

Devices and methods for biological assay sample preparation and delivery

Systems and methods for performing biological assays are provided herein. The systems and methods determine one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample.

Growing community of inventors

Berkeley, CA, United States of America

John Robert Waldeisen