STTR Phase I: Next Generation high sensitivity, rapid immunoassays

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop a highly sensitive, accurate, disposable, and affordable point-of-care diagnostic for detecting protein biomarkers. The transformational aspects of the technology are in enabling health care workers, or even consumers directly, to receive diagnoses in less than 10 minutes with an inexpensive, simple to operate diagnostic test that operate similar to over the counter pregnancy tests. We are focusing on the diagnosis of Chlamydia Trachomitis (CT). There is not point-of-care test available for CT which infects more than 300 million people each year. CT is asymptomatic and can have long term repercussions including pelvic inflammatory disease (PID), an infection that can damage the uterus, cervix, and ovaries, potentially causing women to become infertile. For this reason, the Center for Diseases Control recommends all women younger than 25 receive yearly screening. Once demonstrated, the LID technology will be broadly applied to other illnesses and indications that would also benefit from immediate diagnoses. The proposed project will demonstrate the feasibility of utilizing lateral flow isotachophoresis diagnostic (LID) technology for chlamydia, which currently does not have a POC test available in the US. The proposed technology applies an electric field across a lateral flow test to perform isotachophoresis (ITP), a powerful method for extracting and concentrating target biomolecules. LID improves assay sensitivity by more than 100x, making it suitable for a variety of indications that are currently not practical for existing lateral flow assays. The increased sensitivity is expected to allow clinicians to make confident diagnoses using these tests. This STTR will address key technical hurdles by developing the required chemistry and protocols for high accuracy chlamydia diagnostics using LID. The ultimate objective of the project is to show that the required electronics can be made at low cost and meet regulatory guidelines such as FCC emissions.