SBIR Phase I: A Handheld, One Step Paper-Based Device for Rapid Self-Testing of Sexually Transmitted Infections

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to create a new gold standard diagnostic for the detection of sexually transmitted infections (STIs). The project proposes to replace slow and expensive lab-based assays and expand regular testing to previously unreachable settings. The proposed technology combines the ease-of-use and very low cost of rapid point-of-care diagnostics with the very high accuracy of lab-based tests, enabling unprecedented reliability at the clinics and at home. Chlamydia is the leading sexually transmitted infection in the United States. An estimated 4 million new cases occur each year with direct annual medical costs of greater than $3.5 billion. Due to the asymptomatic nature of the infections, along with the social stigma and embarrassment for testing, sexually active individuals undergo limited screening. This inadequate screening and the inability to provide same visit testing and treatment results in continued transmission to and from partners. If successful, the proposed technology will enable same visit testing and treatment in clinics, overcoming a major hurdle towards controlling treatable STIs. Furthermore, the ability to provide at home self screening will eliminate the embarrassment of testing, thereby increasing the current inadequate rate of screening in the United States. The proposed project is to develop a novel diagnostic that can achieve lab-based sensitivity at the point-of-care. Existing rapid point-of-care technologies, such as the lateral-flow immunoassay utilized by consumer pregnancy tests, are simple, fast, and inexpensive, however are severely limited when the concentrations of the target biomarkers in the sample are low. To overcome this problem, we integrated proprietary paper-based sample concentration components prior to the conventional lateral-flow immunoassay to significantly enhance its performance without additional equipment, training, or increased time-to-result. The proposed device is aimed at simultaneously and seamlessly concentrate and detect target pathogens within a single device that is made entirely with paper materials. This paper-based platform technology is expected to create countless new applications for clinical, safety, and resource-poor needs. This project will investigate the feasibility of the technology for the detection of chlamydia. The proposed technology will be compared with lab assays and existing rapid tests in the market.