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.

Methods and assays for performing a lateral flow test are disclosed. A sample is applied to a receiving portion of a lateral flow device such that the sample flows to at least a first test zone and a second test zone. First and second signals levels at the first and second test zones over an assay period are monitored. If a first analyte of interest is present in the sample, the first analyte is labelled and the presence of labelled first analyte in the sample causes one of the first and second signals levels to increase during the assay period. A change between the first and second signal levels over a period of time during the assay period is monitored. The sample can be incubated prior to application to the receiving portion to provide homogeneity to labelling and therefore a substantially linear increase of the signal level at one of the test zones and a substantially constant signal level at the other one of the test zones.

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.

The present invention provides an analyte detection system for detecting target analytes in a sample. In particular, the invention provides a detection system in a rotor or disc format that utilizes a centrifugal force to move the sample through the detection system. Methods of using the rotor detection system to detect analytes in samples, particularly biological samples, and kits comprising the rotor detection system are also disclosed.

A system for providing immunoassay test results for multiple medical conditions, comprising a testing device having thereon an alignment target and having a plurality of immunoassay test strips, the plurality of immunoassay test strips each including a sample pad capable of receiving a biologic sample, a conjugate pad containing particles for conjugating with antibodies or antigens present in the biologic sample, and a membrane strip having a test line and a control line, wherein the test line and the control line are viewable, and a mobile device having a camera, a viewing screen, and a software application stored thereon, wherein the software application provides executable instructions to capture an image of the testing device, process an image to determine pixel count and line intensity of the test line of each of the plurality of immunoassay test strips, and present test results on the viewing screen.

A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

A system for providing immunoassay test results for multiple medical conditions, comprising a testing device having thereon an alignment target and having a plurality of immunoassay test strips, the plurality of immunoassay test strips each including a sample pad capable of receiving a biologic sample, a conjugate pad containing particles for conjugating with antibodies or antigens present in the biologic sample, and a membrane strip having a test line and a control line, wherein the test line and the control line are viewable, and a mobile device having a camera, a viewing screen, and a software application stored thereon, wherein the software application provides executable instructions to capture an image of the testing device, process an image to determine pixel count and line intensity of the test line of each of the plurality of immunoassay test strips, and present test results on the viewing screen.

One aspect of the present disclosure relates to an immunochromatographic detection method for a target antigen in a biological sample, comprising the step of joining a linker having a first antibody and a quantum dot bead having a second antibody, with respect to the target antigen. By using the quantum dot beads and the linker, the method can successfully amplify detection strength and significantly increase detection sensitivity through a simple process without causing the loss of antigens participating in the detection when using only quantum dot beads. Furthermore, the present disclosure can significantly amplify detection strength without an additional washing step, thus enabling excellent detection and identification of a physiological substance in a biological sample, even in an actual product, and can be used to provide a product with a competitive price.

In one aspect, the present disclosure relates to a quantum dot bead comprising a multifunctional ligand having a first binding material and a second antibody, and an immunochromatographic detection method for a target antigen in a biological sample, comprising forming multiple bonds with a quantum dot having a second binding material. In addition, the present disclosure has the effect of remarkably amplifying the detection intensity and significantly improving the detection sensitivity without a separate washing step, and thus enables the detection and diagnosis of physiological materials in a biological sample even in an actual product, and may be used to provide a product with excellent competitiveness in price.

A device for detecting and/or quantifying a coronavirus comprising a paper microfluidic chip, and the use thereof.