A High-performance Food Pathogen Detection Instrument

描述（由申请人提供）：该二期项目的主要目标是开发一种创新的台式仪器，用于食品加工设施现场使用，具有高性能、易用性和低样品成本，用于快速、特异和敏感地检测即食食品（如加工肉类和家禽产品以及新鲜水果和蔬菜）中的多种病原体，包括大肠杆菌O157:H7、单核细胞增生李斯特菌和鼠伤寒沙门氏菌。我们提出的技术提供了在不到一小时内将致病菌定量到小于10个细胞/mL的能力，并且具有最小的假阳性或阴性。该仪器是完全集成的，包括一个包含多个毛细管柱生物分离器/生物反应器（用于病原体捕获）的药筒，以及一个液芯波导（LCW）光学检测器（用于病原体检测）。它不需要在培养基中对目标细菌进行预富集，并且检测的所有步骤对操作人员的技能要求最低。致病菌对食品的微生物污染是我们社会关注的主要问题。据估计，在美国，受污染的食品每年导致7600万人患病，32.5万人患重病住院，5000人死亡。食源性疾病的经济影响估计每年高达100亿美元。公共利益科学中心报告说，水果和蔬菜是美国食源性疾病确诊病例的罪魁祸首。特别令人关切的是进口农产品中存在病原体。由于这些病原体在新鲜农产品上的持久性，FDA和USDA都支持开发标准化方法的研究，以确定拟议的消毒策略在新鲜农产品上灭活这些病原体的功效。对于这类食品，热灭步骤是不可行的。在美国食品安全计划中，一个明显的配套需求是一种快速、简单的方法，如本文所建议的，以确定消毒步骤实施后仍然存在的病原体数量。

DESCRIPTION (provided by applicant): The primary objective of this Phase II project is to develop an innovative benchtop instrument for use on-site at food processing facilities with high performance, ease-of-use, and a low per sample cost for rapid, specific, and sensitive detection of multiple pathogens including Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella Typhimurium in ready-to-eat (RTE) foods, such as processed meat and poultry products and fresh fruits and vegetables. Our proposed technique provides the ability to quantify pathogenic bacteria down to less than 10 cells/mL in less than one hour with a minimum of false positives or negatives. The proposed instrument is fully integrated and includes a cartridge containing multiple capillary column-based bioseparator/bioreactors (for pathogen capture), and a liquid core waveguide (LCW) optical detector (for pathogen detection). It will not require pre-enrichment of target bacteria in growth medium and all steps of the assay will require minimal operator skill. Microbial contamination of food products by pathogenic bacteria is a major concern of our society. Contaminated food is estimated to cause 76 million illnesses, 325,000 serious illnesses resulting in hospitalization, and 5,000 deaths in the United States each year. The economic impact of foodborne illness has been estimated as high as $10 billion annually. The Center for Science in the Public Interest reported that fruits and vegetables are the leading culprits in confirmed cases of foodborne illness in the United States. Of particular concern is the presence of pathogens in imported produce. Because of the persistence of these pathogens on fresh produce, both FDA and USDA have supported research on developing standardized methods to determine the efficacy of proposed sanitizer strategies for inactivating these pathogens on fresh produce. A heat kill step is not feasible for such foods. An obvious companion need in the U.S. food safety program is a rapid, simple method, such as is proposed here, to determine the number of pathogens that persist after the sanitizing step has been administered.