University of California

Phase Scientific International, Ltd.

Phase Diagnostics, Inc.

Yin To Chiu

Benjamin Ming Wu

Daniel Takashi Kamei

Garrett L Mosley

Brian Sangwoo Lee

Garrett Lee Mosley

Benjamin M Wu

Beatrice S Lim

Daniel T Kamei

Disclosed herein are devices and methods that use aqueous two phase systems and lateral flow assays to detect target analytes in a sample. These devices and methods may be used to diagnose a disease or condition in a biological sample, such as blood or serum. In addition, these devices and methods may be used to detect allergens in a food samples or contaminants, such as environmental toxins, in water samples. Device and kit components may be conveniently assembled in a portable container and are amenable to actuation in most settings. The devices are simple to use, requiring a non-trained operator to simply add the sample to the device. Conveniently, the time it takes to detect the target analyte is very short. Thus, the devices and methods disclosed herein provide novel and useful means for point-of-care.

Methods and devices for integrating analyte extraction, concentration and detection

In various embodiments devices and methods for the detection and/or quantification of clinically relevant pathogens (e.g., bacteria, fungi, viruses, etc.) are provided. In certain embodiments the device comprises a lateral-flow assay that detects the bacterium at a concentration of less than about 6×10cells/mL, less than about 3×10cells/ml, less than about 1×10CFU/mL, or less than about 50 μg/mL. In certain embodiments the device comprises an aqueous two-phase system (ATPS) comprising a mixed phase solution that separates into a first phase solution and a second phase solution; and a lateral-flow assay (LFA). In certain embodiments the device comprises a flow-through system comprising a concentration component comprising an aqueous two-phase system (ATPS) comprising a mixed phase solution that separates into a first phase solution and a second phase solution; and a detection component disposed beneath said concentration component.

Methods and devices for analyte collection, extraction, concentration, and detection for clinical applications

The present invention provides a method and a system for the isolation and purification of nucleic acids from nucleic acid-containing material using a modified porous material containing cationic groups in a solid-liquid phase system. In some embodiments, the present invention is capable of obtaining nucleic acids with sufficient purity and quantity in a relatively simple way to enable accurate subsequent analysis or processing. In some embodiments, the liquid phase comprises an aqueous two-phase system (ATPS), comprising a first phase and a second phase, and the solid phase comprises a porous material, wherein the two phases travel through the porous material. In some embodiments, the nucleic acids enter the pores of the porous material and subsequently travel through the porous material while preferentially partitioning into one of the phases.

Method for isolating and purifying nucleic acids using a solid-liquid phase system

The present invention relates to a method and/or device for improving the separation behaviors and performance of aqueous two-phase system (ATPS) for the isolation and/or concentration of one or more target analytes from a sample. In one embodiment, the present method and device comprise ATPS components within a porous material and one or more phase separation behavior modifying agents that improve the separation behavior and performance characteristics of ATPS, including but not limited to the increasing the stability or reducing fluctuations of ATPS thought the adjustment of total volume of a sample solution that undergoes phase separation, volume ratio of the two phases of the ATPS, fluid flow rates, and concentrations of ATPS components.

Phase separation behavior modifying agents for aqueous two-phase separation within porous material

This invention relates to a method and device for improving the accuracy and performance of detecting or diagnosing sexually transmitted infections (STIs) or STI-causing pathogens. In one embodiment, the present method and device are related to removing one or more interfering molecules such as urea from urine sample, where these interfering molecules alter the performance of Lateral-Flow Immunoassay (LFA). In one embodiment, an aqueous two-phase system (ATPS) embedded entirely within a porous material allows spontaneous phase separation and the target STI-causing pathogens is concentrated in one of the separated phases. In one embodiment, a detection module such as the Lateral-Flow Immunoassay (LFA) is used in connection with other modules so as to detect or diagnose the sexually transmitted infections or the pathogens associated with STIs with an improved performance.

Method and device of using aqueous two-phase systems (ATPS) for enhancing diagnostics for sexually transmitted infections

The present disclosure relates to a method/system for preparing encapsulated exosomes from a biological sample containing exosomes, said method comprising: a) dispersing inorganic oxide particles into a buffer solution comprising a polymer and a biological sample comprising exosomes, b) allowing the polymer to react with the inorganic oxide particles to form capsules, wherein the exosomes are inside the capsules. The present disclosure also relates to a method/system for isolating and purifying encapsulated exosomes, said method comprising: a) preparing an aqueous micellar system comprising at least one surfactant, and at least one salt; b) mixing a biological sample containing encapsulated exosomes with the aqueous micellar system from step a); c) allowing the aqueous micellar system to phase separate, wherein the surfactant partitions substantially into one phase, and the other phase has a lower concentration of surfactant; and d) obtaining the encapsulated exosomes from the capsule-rich phase.

Method of isolating exosomes using encapsulation and aqueous micellar system

The present invention relates to a method for improving the detection and diagnosis targeting biomarkers using an aqueous two-phase system (ATPS). In one embodiment, the present invention provides a method for improving a diagnostic procedure involving the detection or quantification of one or more biomarkers in liquid biopsy, the method comprises contacting a porous material embedded with ATPS components with a liquid biopsy containing the biomarkers, purifying and concentrating the target biomarkers, and providing a product comprising the target biomarkers for performing the diagnostic procedure.

Method for accurate diagnosis of a disease targeting biomarkers in liquid biopsy

The present invention relates to a fast and efficient method of isolating nucleic acids in high yield and in high concentration from biological samples, using an aqueous two phase system without the need for instrumentation. The isolated nucleic acids can be used to facilitate the screening, prognosis and monitoring of disease progression.

Composition and method for concentration and enrichment of nucleic acids

In various embodiments devices and methods for the detection and/or quantification of clinically relevant pathogens (e.g., bacteria, fungi, viruses, etc.) are provided. In certain embodiments the device comprises a lateral-flow assay that detects the bacterium at a concentration of less than about 6&#xd7;10cells/mL, less than about 3&#xd7;10cells/ml, less than about 1&#xd7;10CFU/mL, or less than about 50 &#x3bc;g/mL. In certain embodiments the device comprises an aqueous two-phase system (ATPS) comprising a mixed phase solution that separates into a first phase solution and a second phase solution; and a lateral-flow assay (LFA). In certain embodiments the device comprises a flow-through system comprising a concentration component comprising an aqueous two-phase system (ATPS) comprising a mixed phase solution that separates into a first phase solution and a second phase solution; and a detection component disposed beneath said concentration component.

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Irvine, CA, United States of America

Yin To Chiu