Project Details

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Rapid Biodiagnostics for Adult and Congenital Syphilis

Company: PSU CDC

Major(s):
Primary: BME
Secondary: EE
Optional: CMPSC

Non-Disclosure Agreement: NO

Intellectual Property: NO

Data from the Centers for Disease Control (CDC) and Prevention show that more than 3,700 cases of congenital syphilis were reported in 2022, which is more than ten times the number reported a decade ago. The etiologic agent of syphilis, Treponema pallidum subsp. pallidum, causes a multistage sexually transmitted infection (STI). During the last decade, there has been an increase in the reported incidence of syphilis in industrialized countries, emphasizing the need for reliable diagnostics for syphilis. But currently there is no FDA-approved point-of-care (POC) test that can directly detect Treponema pallidum DNA at any stages of syphilis, especially at its primary and secondary stages. In this CDC funded project, a rapid point-of-care (POC) in vitro diagnostic (IVD) device for direct molecular and electrochemical detection of Treponema pallidum (T. pallidum), ideally for multiple stages of syphilis, is being developed here. This nucleic acid-based molecular recognition test is amplification-free, requires minimal sample processing, and has a turnaround time of <10 minutes from sample to result. The deliverables for the capstone design project is 1) design and build a working prototype for the device and 2) develop an algorithm for analysis and display of the results.