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 system and method for detecting status of a health condition in a single-step process includes: a signal output device including a) a loading zone; b) a reaction zone fluidly coupled to the loading zone and including one or more reaction substances conjugated to labels, configured to enable detection of target material associated with the health condition; c) a testing zone fluidly coupled to the reaction zone and including one or more testing substances corresponding to the target material; and d) a control zone including a control substance retained at the control zone. The system and methods can be adapted for assessment of sexual health of one or more subjects, in relation to pregnancy, fertility, and/or sexually transmitted infections caused by one or more agents including, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, and herpes simplex virus.

A system and method for detecting status of a health condition in a single-step process includes: a signal output device including a) a loading zone; b) a reaction zone fluidly coupled to the loading zone and including one or more reaction substances conjugated to labels, configured to enable detection of target material associated with the health condition; c) a testing zone fluidly coupled to the reaction zone and including one or more testing substances corresponding to the target material; and d) a control zone including a control substance retained at the control zone. The system and methods can be adapted for assessment of sexual health of one or more subjects, in relation to pregnancy, fertility, and/or sexually transmitted infections caused by one or more agents including, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, and herpes simplex virus.

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.

This invention relates to a method and device for improving the accuracy and performance of detecting or diagnosing sexually transmitted infections (STIs) or STI-causing pathogens. In one embodiment, the present method and device are related to removing one or more interfering molecules such as urea from urine sample, where these interfering molecules alter the performance of Lateral-Flow Immunoassay (LFA). In one embodiment, an aqueous two-phase system (ATPS) embedded entirely within a porous material allows spontaneous phase separation and the target STI-causing pathogens is concentrated in one of the separated phases. In one embodiment, a detection module such as the Lateral-Flow Immunoassay (LFA) is used in connection with other modules so as to detect or diagnose the sexually transmitted infections or the pathogens associated with STIs with an improved performance.

This invention relates to a method and device for improving the accuracy and performance of detecting or diagnosing sexually transmitted infections (STIs) or STI-causing pathogens. In one embodiment, the present method and device are related to removing one or more interfering molecules such as urea from urine sample, where these interfering molecules alter the performance of Lateral-Flow Immunoassay (LFA). In one embodiment, an aqueous two-phase system (ATPS) embedded entirely within a porous material allows spontaneous phase separation and the target STI-causing pathogens is concentrated in one of the separated phases. In one embodiment, a detection module such as the Lateral-Flow Immunoassay (LFA) is used in connection with other modules so as to detect or diagnose the sexually transmitted infections or the pathogens associated with STIs with an improved performance.

A system and method for detecting status of a health condition in a single-step process includes: a signal output device including a) a loading zone; b) a reaction zone fluidly coupled to the loading zone and including one or more reaction substances conjugated to labels, configured to enable detection of target material associated with the health condition; c) a testing zone fluidly coupled to the reaction zone and including one or more testing substances corresponding to the target material; and d) a control zone including a control substance retained at the control zone. The system and methods can be adapted for assessment of sexual health of one or more subjects, in relation to pregnancy, fertility, and/or sexually transmitted infections caused by one or more agents including, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, and herpes simplex virus.

A system and method for detecting status of a health condition in a single-step process includes: a signal output device including a) a loading zone; b) a reaction zone fluidly coupled to the loading zone and including one or more reaction substances conjugated to labels, configured to enable detection of target material associated with the health condition; c) a testing zone fluidly coupled to the reaction zone and including one or more testing substances corresponding to the target material; and d) a control zone including a control substance retained at the control zone. The system and methods can be adapted for assessment of sexual health of one or more subjects, in relation to pregnancy, fertility, and/or sexually transmitted infections caused by one or more agents including, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, and herpes simplex virus.

Methods of treating a head and neck cancer are disclosed.