Disclosed is a nitrocellulose sheet having immobilized antibodies and lipid based antigens. Also disclosed is a kit including the nitrocellulose sheet. and a method using the sheet for detection of antibodies indicative of an infection.

A diagnostic device for analysing properties of an analyte in a sample liquid including: a distribution zone having at least two hydrophilic layers placed one on top of the other, wherein one layer is a top layer (12) and the other is a bottom layer (13); and a detection zone located under the distribution zone, the detection zone having a detection layer (14), wherein: the top layer has one or more openings (15) through which the sample liquid is introduced into the device; the bottom layer having one or more openings (16) connecting the distribution zone to the detection zone; the bottom layer also having a means by which the sample liquid is distributed from the top layer's opening to the detection layer through the bottom layer's opening; and a visual indication results on the detection layer when the sample liquid comes into contact with the detection layer.

A system and method are provided for presenting self-diagnostic test instructions in the form of audiovisual messages. The system and method include collecting by a user of a testing device a biologic sample for use with a testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects of the system and method present test instructions to the user in the form of audiovisual messages. The audiovisual messages are provided to the user as a response to an interaction with a retail diagnostic product. In some aspects, the complete audiovisual message is presented before the user may complete a self-diagnostic test.

The present disclosure provides a paper-based vertical flow test platform including: a detection portion; a movable conjugation portion having an enzyme-labelled protein; and an absorbent portion. The present disclosure further provides a detection method by using the same. With the folding and sliding design, the present disclosure can reduce the volume of specimen fluids used, and prevent the interference problem. Also, a portable diagnostic test platform is provided with ease of use, lower cost, higher sensitivity and longer storage period to meet requirements of point-of-care for the fast, simple and stable detection.

A lateral flow immunoassay (LFIA) strip comprises a sample pad (2) for receiving a sample and at least one conjugate pad (3) in operable contact with the sample pad. The at least one conjugate pad is loaded with a first antibody specific against ferritin and tagged with detectable label. A flow-through assay device for detecting ferritin levels in a sample is also provided comprising a sample pad (10) for receiving a sample and at least one conjugate pad (11) in operable contact with the sample pad. The at least one conjugate pad is loaded with a first antibody specific against ferritin and tagged with detectable label. An assay platform (12) is in operable contact with the at least one conjugate pad. The assay platform comprises a substrate having a test region onto which the first test antibody to the ferritin is immobilized. A method for measuring the level of ferritin in a sample is also provided. The sample may be a blood or saliva sample.

Provided are vertical flow detection devices and related methods. The devices may comprise a membrane having a first surface and a second surface with a plurality of porous structures extending between the first and second surfaces to form fluid conduits from a first fluid chamber formed by the first surface and a second fluid chamber formed by the second fluid surface. A capture agent is immobilized on and/or in the membrane. A rigid porous membrane support mechanically supports the membrane and to provide a relatively uniform flow across the membrane. Various gaskets or holder elements are positioned around an outer edge of the membrane to prevent fluid leakage around the membrane. A fluid pump is configured to force a fluid sample flow in a direction from the first fluid chamber to the second fluid chamber.

A system and method are provided for collection and testing of a biologic sample. The system and method comprise collecting by a user of a testing device a biologic sample for use with the testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects further include presenting advertisements and other messages to users through a mobile application operating on a mobile device. These aspects take into account the results of the self-diagnostic test and present different advertisements to the user based on the results of the test.

A method for providing immunoassay test results includes collecting at least one biologic with a testing device, conjugating the biologic with particles on a conjugate pad of a test strip to create an immune complex, binding antigens or antibodies of the immune complex to antigens or antibodies of a test line, providing a software application to be stored on a mobile device having a camera; capturing an image of the testing device, including a color mosaic having at least one color value corresponding to a positive test result, comparing the color values of the test line image to the color values of the image of the color mosaic, determining if the color values of the image of the test line are within a predetermined range of the at least one color value of the image of the color mosaic corresponding to a positive test result; and presenting test results on the viewing screen.

The present disclosure is directed to a thin-film element that enables analytes to be analyzed on separate surfaces. In an example, a thin-film element includes a first layer for processing a fluid sample to generate a first analyte and a second analyte. The thin-film element also includes a second layer configured to be impermeable to the first analyte to enable the first analyte to be retained by the first layer and permeable to the second analyte to enable the second analyte to pass through the second layer. The thin-film element further includes a third layer configured to retain the second analyte. The second layer includes a first reflective surface and a second reflective surface to provide reflectance signals indicative of analytes present in the first and third layers to sensors located on opposite sides of the thin-film element.

Lateral flow assay devices, systems, and methods described herein separate components of a fluid sample, including small volume, undiluted, unprocessed samples. In one aspect, components are retained in a separation membrane that is spatially above and in fluid communication with a conjugate pad of a lateral flow assay. Devices, systems, and methods described herein can retain particles from a fluid sample that obstruct flow of the fluid sample through the conjugate pad to a detection zone and/or interfere with detection of an analyte of interest in the detection zone.