Physical Optics Corporation — Department of Agriculture SBIR Phase II: 8.5

Description

Approximately 47.8 million episodes of foodborne illnesses (to one in six Americans), occur each year and result in roughly 128,000 hospitalizations and 3,000 deaths in the U.S. Approximately half of the reported foodborne illnesses occur in children, with the majority occurring in children under 15 years of age. The development of reliable and effective methods to detect foodborne hazards (pathogens, microorganisms, chemicals, toxins) is therefore of paramount importance. To address the USDA's need for a field-ready device to rapidly detect foodborne hazards on site during pre- and post-harvest processing and distribution, Physical Optics Corporation (POC) proposes to continue the development of a novel rapid Foodborne Illness Detection (FOBID) system based on POC's established sandwich enzyme-linked immunosorbent assay (ELISA) and lab-on-a-chip technologies. The use of microfluidic chips to perform ELISA allows reagent volumes of <1 mL and assay times of <60 min, leading to a significant reduction of reagent-associated costs and technician-hours typically required for the time-consuming laboratory-based testing. Importantly, the early knowledge about a food's condition can stop the tainted food from reaching the public, thus ensuring more efficient processing and a healthier food supply. The new FOBID system design allows for quantitative identification, agnostic sample preparation, process automation with little training, multiplex assay capability, and high portability. In Phase I, POC demonstrated FOBID feasibility by assembling a benchtop prototype and detecting and identifying two selected pathogens. Phase II will be devoted to developing a commercially viable FOBID system, demonstrating the assembled portable prototype for rapid and easy-to-use foodborne pathogen detection. We will extend the capabilities demonstrated in Phase I by enhancing accuracy, sensitivity, and the preconcentration process; reducing costs; improving configurability for customizable assays; and automating the system. We will also focus on thorough evaluation of FOBID's ability to detect and identify multiple foodborne pathogens spiked into various types of food matrices to mimic realistic situations. Its ease of use and applicability to practical situations will be evaluated with input from end users in the food value chain, such as producers, processors, and distributors.The overall goal of the proposed effort is to develop and demonstrate the capability of the FOBID system to rapidly identify targeted microbial pathogens/toxins in a format that is compatible with on-site detection in pre- and postharvest processing and distribution environments. The following specific objectives have been established to reach this goal: (1) Refinement of the FOBID system; (2) Optimization of the FOBID assays; (3) Assembly of the FOBID prototype; (4) Demonstration of FOBID performance in efficient pathogen identification; and (5) Definition of the commercial market for FOBID technology.With the fully developed FOBID, we anticipate that the nation will have a cost-effective and efficient platform for rapid on-site identification of microbial pathogens and biological toxins in food, water, or environmental samples. While such capability is essential to those involved in the food value chain, including producers, aggregators/processors, distributors, food service and retailers, and service providers of food testing, it can also be implemented by the local, state, and federal agencies, such as the Centers for Disease Control and Prevention (CDC) for easy monitoring and control of food illness outbreaks.