The present invention provides an Enzyme-Linked Immunosorbent Assay (ELISA) method for detecting and quantifying analytes. The present invention is advantageous over conventional methods, because the detection limit is not constrained by the sample volume or the length of time needed to perform quantitative ELISA.

A lateral flow diagnostic testing apparatus including a measurement assembly in which a cartridge is loaded and which is inclined with respect to a main body housing in a lateral flow direction of the cartridge is disclosed. The main body housing and the measurement assembly is rotatably hinge-coupled to adjust an inclination angle. The inclination of the measurement assembly is adjustable by an inclination driving unit. A vibration actuator can be further included on a cartridge loading surface. In addition, a heating unit fixed to face the cartridge can be further included.

A method and kit for detecting SARS-CoV-2 virus antigen present in an oropharyngeal lavage includes swishing and gargling a mouth rinse to distribute the same around the inside of the oral cavity and throughout an oropharyngeal space of the user. An absorbent end of a test stick is inserted into the oral cavity to collect liquid contents therefrom, the liquid contents including the mouth rinse and particles retrieved therefrom. The absorbent stick is removed and positioned vertically in a support stand while results are determined. Alternatively, the liquid contents are deposited from the oral cavity into a collection device, and the absorbent end of the test stick is inserted into the collection device and positioned vertically such that the test stick is retained in the collection device with the absorbent end of the test stick facing downwardly. An indicator on the test stick displays whether SARS-CoV-2 virus antigen is detected.

Provided herein are vertical flow assay devices for detecting presence or an amount of cytokines in a sample. Also provided herein are immunoassay methods for detecting presence or an amount of cytokines in a sample, using the vertical flow assay devices.

A method for providing variable function medical tests, comprising providing by a mobile device application a plurality of selectable medical test functions, receiving information from the mobile device application regarding test results from a test performed using a testing device, wherein the testing device includes an alignment target disposed on the testing device and a plurality of immunoassay test strips receiving at the server an image of the testing device from the mobile device application, determining by the server RGB values for a plurality of pixels of the image, normalizing by the server the RGB values into a single value, comparing by the server the single value to a control value stored on the server, and providing by the server a risk indicator, wherein the risk indicator indicates a likelihood of a presence of a medical condition.

This present disclosure provides devices, systems, and methods for performing point-of-care analysis of a target analyte in a biological fluid via a binding assay. The present disclosure includes a cartridge for collecting the target analyte contained in a fluid sample and performing an assay. The cartridge includes an assay stack having a first separation layer, a second separation layer, and a detection membrane. The cartridge also includes a plurality of first complexes comprising a capture molecule and a magnetic bead and a plurality of second complexes comprising a detection molecule and a detection label. Further, the detection membrane includes a substrate that interacts with the detection label to elicit a quantifiable response in the presence of the target analyte. The quantifiable response corresponds to an amount of detection antibody present in the detection membrane, and the amount of detection antibody present corresponds to an amount of the target analyte present.

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 6×10.sup.6 cells/mL, less than about 3×10.sup.6 cells/ml, less than about 1×10.sup.6 CFU/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.

A biomarker detection device having a detection layer configured to detect one or more biomarkers in a biological sample and a transfer layer in direct contact with a first surface of the detection layer; wherein the transfer layer is configured to deliver the biological sample directly to the detection layer and wherein an observation window is provided on a second surface of the detection layer opposite the transfer layer and wherein there is no adhesive between the transfer layer and the detection layer in the region in register with the observation window. The detection layer may comprise two or more detection zones. The biomarker detection device may be part of a medical device, such as a swab receptacle. The device may comprise any one or more of: an adhesive layer, a label comprising a printed marking, a fixing element configured to attach or adhere the device to another object.

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 6×10.sup.6 cells/mL, less than about 3×10.sup.6 cells/ml, less than about 1×10.sup.6 CFU/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.

A sample loading bottom plate (300,600, 810, 820, 831) and an immunochromatography detection apparatus (10) containing the sample loading bottom plate (300, 600, 810, 820, 831). During design of the sample loading bottom plate (300, 600, 810, 820, 831), a sample loading portion (310, 833) having a multistage-step structure is additionally provided on a sample loading region and comprises multistage steps having different heights, wherein a base surface (311) is used for carrying a sample solution. After a cover plate (100, 500, 834) is covered, the sample solution falls on the base surface (311) and then flows upwardly, and by means of the flow-intercepting and buffering effects of the multistage-step structure, the sample solution which finally flows to a top surface (342, 642) of the highest step (340, 640) can basically flow to sample loading regions of immunochromatography detection members synchronously, so that the multiple immunochromatography detection members can basically receive the sample solution synchronously, the unifying problem of time and sample horizontal lines is solved, and the test accuracy is high; moreover, only one-time sample adding is needed, the detection efficiency is high, and the risk of errors is low. During detection, the immunochromatography detection members perform detection individually and perform sample loading synchronously without mutual interference, and the accuracy of a detection result is high.