Provided herein are multiplex assays for detecting antibodies indicative of presence and stage of syphilis infection in an individual. Individuals infected with syphilis produce antibodies directed to syphilis components and the lipid cellular debris associated with the infection. The present disclosure represents the first combination of these diverse antibody targets in a single assay.

Provided herein are multiplex assays for detecting antibodies indicative of presence and stage of syphilis infection in an individual. Individuals infected with syphilis produce antibodies directed to syphilis components and the lipid cellular debris associated with the infection. The present disclosure represents the first combination of these diverse antibody targets in a single assay.

A multiplexed lateral flow device includes an impermeable internal reservoir having an opening to receive a sample deposition. A fluid distributor pad is arranged in fluid communication with a lower surface of the internal reservoir. The fluid distributor pad includes a paper based microfluidic element having a pattern of a hydrophobic material to distribute a portion of the sample deposition substantially equally among a plurality of flow paths. Lateral flow assays having a plurality of flow lines are aligned with flow paths of the distributor pad. An impermeable top cover has a first window arranged over the opening of the internal reservoir, and at least a second window arranged over the test results of the lateral flow assays. A housing element houses the reservoir, the distributor pad and lateral flow assays. The housing element includes an impermeable bottom cover and a spacer element arranged between the top and bottom covers and, provides a gap between the lateral flow assays and the impermeable top cover.

A multiplexed lateral flow device includes an impermeable internal reservoir having an opening to receive a sample deposition. A fluid distributor pad is arranged in fluid communication with a lower surface of the internal reservoir. The fluid distributor pad includes a paper based microfluidic element having a pattern of a hydrophobic material to distribute a portion of the sample deposition substantially equally among a plurality of flow paths. Lateral flow assays having a plurality of flow lines are aligned with flow paths of the distributor pad. An impermeable top cover has a first window arranged over the opening of the internal reservoir, and at least a second window arranged over the test results of the lateral flow assays. A housing element houses the reservoir, the distributor pad and lateral flow assays. The housing element includes an impermeable bottom cover and a spacer element arranged between the top and bottom covers and, provides a gap between the lateral flow assays and the impermeable top cover.

Disclosed is an accurate and stable immunoassay reagent using a glycerophospholipid and a method for stabilizing the reagent. The reagent for assaying an analyte in blood by immune reaction with an antigen when the analyte is an antibody or with an antibody when the analyte is an antigen, wherein a glycerophospholipid and a polyvinylpyrrolidone are incorporated into the immune reaction system.

Disclosed is an accurate and stable immunoassay reagent using a glycerophospholipid and a method for stabilizing the reagent. The reagent for assaying an analyte in blood by immune reaction with an antigen when the analyte is an antibody or with an antibody when the analyte is an antigen, wherein a glycerophospholipid and a polyvinylpyrrolidone are incorporated into the immune reaction system.

Diagnostic systems, methods, and devices employing low-cost handheld components are disclosed herein. A diagnostic system can include a diagnostic device that is configured to perform one or more assays on a fluid sample, such as a whole blood sample, in one or more microfluidic channels or chambers. The diagnostic device can move the fluid sample into or through the one or more microfluidic channels or chambers without using any electrical power, for example, using manual actuation to generate a positive or negative pressure within the diagnostic device. The diagnostic device can have a connector for interfacing with a separate handheld unit that can provide power and data processing. For example, the separate handheld unit can be a smartphone or PDA, and the connector can interface with an existing input/output port of the unit to draw power and/or transmit data.

Diagnostic systems, methods, and devices employing low-cost handheld components are disclosed herein. A diagnostic system can include a diagnostic device that is configured to perform one or more assays on a fluid sample, such as a whole blood sample, in one or more microfluidic channels or chambers. The diagnostic device can move the fluid sample into or through the one or more microfluidic channels or chambers without using any electrical power, for example, using manual actuation to generate a positive or negative pressure within the diagnostic device. The diagnostic device can have a connector for interfacing with a separate handheld unit that can provide power and data processing. For example, the separate handheld unit can be a smartphone or PDA, and the connector can interface with an existing input/output port of the unit to draw power and/or transmit data.

In one aspect, a method of detecting a pathogen, e.g., listeria bacterium, chlamydia bacteria, gonorrhea bacteria and/or HPV, in a sample is disclosed, which comprises bringing a sample into contact with a graphene layer functionalized with an antibody exhibiting specific binding to the pathogen, monitoring electrical resistance of said antibody-functionalized graphene layer in response to interaction with said sample, and detecting presence of the pathogen in said sample by detecting a change in said electrical resistance indicative of interaction of the pathogen with said antibody-functionalized graphene layer. For example, a decrease of the electrical resistance of the graphene layer can indicate the presence of the pathogen in the sample under study. In some embodiments, a method according to the present teachings is capable of detecting pathogens, such as listeria bacteria, chlamydia bacteria, gonorrhea bacteria and HPV in a sample at a concentration as low as 4 cfu per 100 grams of a sample.

Provided herein are multiplex assays for detecting antibodies indicative of presence and stage of syphilis infection in an individual. Individuals infected with syphilis produce antibodies directed to syphilis components and the lipid cellular debris associated with the infection. The present disclosure represents the first combination of these diverse antibody targets in a single assay.