A Rapid, Handheld, Flexible Use Detection System for Bacterial Contamination

DESCRIPTION (provided by applicant): There exists a need for a small, portable, rapid, highly selective, widely adaptable, biosensor platform for the detection of bacterial contamination in a range of healthcare related samples (body, fluid, blood stores, potentially contaminated surfaces), that can be used by minimally trained healthcare givers as an onsite, screening diagnostic tool, allowing for a more immediate and responsive treatment, and a lower overall risk of hospital acquired infections. A sensing technology that: can be adapted to broadly detect bacteria presence or specific types, is low cost enough to be effectively disposable, requires no special user performed sample preparation or additional component/reagent handling, would be highly advantageous. The long-term objective of this proposed work is to design, build, demonstrate, and characterize such a device/technology. The crux of the technical approach for this work is to utilize proven molecular detection elements (MDEs) combined with novel optoelectronics, packaging and signal conditioning hardware to realize the long-term objectives. The core element of the hardware design is the optoelectronics "smart" sensor element design, which uses a standard micro-electronics package containing properly integrated semiconductor lasers, filters and photodiodes, such that the lid of the package, containing a window, can be queried optically for pathogen detection signals. The objective of this proposed work is not to test a specific hypothesis, but to strongly emphasize the development, and the reduction to practice, of a new technology. This effort will include: the development and demonstration of potential molecular detection elements (MDEs), evaluation and development of potential optical sensor hardware/packaging design configurations, evaluation and development of the signal conditioning, display, and human interface hardware, proof of principle prototyping, and laboratory scale testing of components. While our technical approach can be flexibly adapted to sense any number of bacterial pathogens specifically, for the phase I effort we will target broad microbial indicator antigens to sense with this initial sensor module, and a handheld detection system as the initial target application system. Bacterial contamination is a costly and dangerous problem of great concern in the healthcare industry. The estimated incidence of nosocomial infections alone is more than 2 million cases per year, resulting in an added expenditure in excess of $2 billion. The proposed technology could be broadly adapted to be a low cost, near real time detection, reliable replacement for slow cell culture tests currently used in the clinical environments. In addition to reducing the incidence/risks of infection, the technology also has the potential to reduce health care costs by streamlining the testing process and by reducing the number of false positives/negatives associated with current testing methods. The societal impact of the proposed technology would be seen in hospitals personnel, first responders, emergency medical services, pharmaceutical companies, and blood banks.