SBIR Phase II:Label Free Nucleic Acid Assays for POC Diagnostics

This Small Business Innovation Research (SBIR) Phase II project proposes to develop a for point-of-care (POC) nucleic acid assay for STD (sexually transmitted diseases) diagnostics using Electrochemical Impedance Spectroscopy (EIS). Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections are two of the most common sexually transmitted diseases worldwide. The company proposes to develop a multiplex assay and testing platform for the direct detection of CT and GC rRNA using EIS-based assays and a sensor array. In a final product for clinical settings, collected sample (e.g., swab or urine) will be processed on-cartridge, with all cartridges provided in a sealed, RNase-free package. The broader impact/commercial potential of this project will address the unmet market needs for a rapid and cost-effective nucleic acid based POC system to diagnose individuals with infectious disease-causing agents or toxins in nontraditional health care settings. Often persons who present to a clinic for STD testing never return to the clinic to receive their STD test result. Thus, the availability of a POC test that can immediately provide results at the clinic is highly desirable. Current POC tests lack sensitivity, which may lead to high false negative as well as false positive results. The company proposes to develop an inexpensive, highly sensitive, easy-to-use POC STD device to address this compelling market need. In addition, the EIS-based biosensor system could be adapted for the POC detection of other infectious diseases.