Nanodroplet PCR Lab-Chip for Clinical Pathogen Detection

DESCRIPTION (provided by applicant): It is estimated that 2 million health-care associated infections are acquired each year by hospitalized patients resulting in 90,000 deaths and about 4.5 billion in excess health care costs. A large and growing percentage of these infections can be attributed to Staphylococcus aureus and, in particular, to methicillin-resistant S. aureus (MRSA). Rapid PCR-based tests have been developed for screening MRSA in health-care settings, but the high cost and complexity of existing nucleic acid testing platforms have limited their acceptance for routine screening in most health-care settings. The goal of this project is to develop a rapid, low-cost, easy-to-use nucleic acid testing platform that can be deployed for MRSA screening in a wide range of health-care settings. The proposed testing platform is based on Advanced Liquid Logic's digital microfluidics technology which enables programmable micro-manipulation of sub-microliter sized droplets using an electrode array formed on a low-cost and disposable printed circuit board substrate. In Phase I of this project Advanced Liquid Logic developed chip-based methods for rapid thermocycling, real-time PCR detection, magnetic-bead based sample preparation, and reaction preparation and mixing. In Phase II, these results will serve as the foundation for the development of a product prototype nucleic acid analysis system for near-patient and point-of-care use. An MRSA screening test will be developed on the platform and extensively validated in preparation for an FDA submission. Ultimately, additional cartridges could be developed for screening and detection of other health-care associated infections. This lab-on-a-chip platform will offer significant advantages over other approaches in terms of flexibility, scalability, performance and cost. PUBLIC HEALTH RELEVANCE: A system for the detection of methicillin-resistant Staphylococcus aureus will be developed to help control the spread of antibiotic-resistant bacteria in hospital settings.