Abstract: 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 6×106 cells/mL, less than about 3×106 cells/ml, less than about 1×106 CFU/mL, or less than about 50 ?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.

Abstract: Devices and methods are provided for the detection of CSF in a biological sample.

Abstract: 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.

Abstract: In various embodiments methods and devices are provided for the detection and/or quantification of an analyte. In certain embodiments a device is provided comprising an aqueous two-phase system (ATPS) comprising a mixed phase solution that separates into a first phase solution and a second phase where, in use, said first phase solution becomes a leading phase and said second phase solution becomes a lagging phase; a lateral-flow assay (LFA); and a probe and/or a development reagent, where in use, said probe associates with said first phase solution in said leading phase of said ATPS and/or said development reagent associates with said second phase solution in said lagging phase of said ATPS. In certain embodiments a “one-pot” system of purifying and amplifying a nucleic acid is provided utilizing, e.g., an ATPS and isothermal amplification reagents.

Abstract: In various embodiments methods to improve the detection of a lateral-flow immunoassay for the sensitive detection of the SARS-CoV-2 nucleocapsid protein or other analytes, as well as devices that incorporate those methods are provided.

Abstract: 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.

Abstract: 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 6×106 cells/mL, less than about 3×106 cells/ml, less than about 1×106 CFU/mL, or less than about 50 ?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.

Abstract: Devices and methods are provided for the detection of CSF in a biological sample.

Abstract: It was discovered that hydrogel scaffolds can be used to induce phase separation as aqueous two-phase systems (ATPSs) pass through and/or rehydrate the scaffolds, allowing for concentration of target analyte(s) (e.g., biomolecule(s)) into a particular phase of the ATPS or into a leading front. Accordingly, in various embodiments methods and devices are provided that utilize aqueous two-phase systems and hydrogel scaffolds to improve the sensitivity of assays (e.g., of point-of-care assays) without sacrificing cost or ease of use.

Abstract: 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.

Abstract: In various embodiments single-step ATPS paper-based diagnostic assays are provided that exploit the concept of sequential resolubilization of ATPS components to give rise to the desired phase separation behavior within paper. In one illustrative embodiment, a wick is provided for concentrating an analyte within an aqueous two-phase extraction system in a paper, where the wick comprises a paper configured to receive a sample where the paper comprises a first region containing a first component of an aqueous two-phase system (ATPS) where the first component is in a dry form, and a second region containing a second component of an aqueous two-phase system (ATPS) where the second component is in a dry form; and where said first region and the second region are disposed so that when said wick is contacted with a fluid sample, the first component of said ATPS is hydrated before the second component. In certain embodiments the first and second component are disposed so they are hydrated substantially simultaneously.

Abstract: 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.

Abstract: 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.

Abstract: In various embodiments methods and devices are provided for the detection and/or quantification of an analyte. In certain embodiments a device is provided comprising an aqueous two-phase system (ATPS) comprising a mixed phase solution that separates into a first phase solution and a second phase where, in use, said first phase solution becomes a leading phase and said second phase solution becomes a lagging phase; a lateral-flow assay (LFA); and a probe and/or a development reagent, where in use, said probe associates with said first phase solution in said leading phase of said ATPS and/or said development reagent associates with said second phase solution in said lagging phase of said ATPS. In certain embodiments a “one-pot” system of purifying and amplifying a nucleic acid is provided utilizing, e.g., an ATPS and isothermal amplification reagents.

Abstract: It was discovered that hydrogel scaffolds can be used to induce phase separation as aqueous two-phase systems (ATPSs) pass through and/or rehydrate the scaffolds, allowing for concentration of target analyte(s) (e.g., biomolecule(s)) into a particular phase of the ATPS or into a leading front. Accordingly, in various embodiments methods and devices are provided that utilize aqueous two-phase systems and hydrogel scaffolds to improve the sensitivity of assays (e.g., of point-of-care assays) without sacrificing cost or ease of use.