Adaptation of enrichment-free Listeria diagnostic to food matrices

点击翻译按钮获取中文摘要

 DESCRIPTION (provided by applicant): Foodborne illnesses devastate on the gastrointestinal microflora of millions of Americans each year, often resulting in dysbiosis and increase risk of other diseases, namely irritable bowel syndrome, kidney failure, pancreatitis and diabetes. Furthermore, diabetics are at increased risk of developing a foodborne illness, and they often take longer to recover. To realize the scale of the impact that foodborne pathogens have on the U.S. population, contemplate these figures: 48 million illnesses, 28,000 hospitalizations, and at least 3,000 deaths per year. The impact on healthcare, business and industry is no less pronounced, resulting in annual costs of $14-$16 billion, including direct medical costs and value of time lost to illness. Bacteria account for the majority of foodborne pathogens that cause morbidity and mortality. More to this point: bacteria are four of the top five pathogens that contribute to illness, three of the top five that cause hospitalizations, and three of the top five that cause mortality. Contaminated food is the cause of these illnesses, having entered the public supply due to a lack of detection at a manufacturing/packaging plant, distribution warehouse or retail location. Current tests are inadequate because they require a prolonged enrichment step to reduce the likelihood of false negatives and false positives. This enrichment causes tremendous delays in providing actionable results to the food processor, who are left with one of two choices: store the products until the test result comes back, resulting in older, lower-quality food; or shipping the food before receiving test results, putting the consuming public at increased risk. Sample6 is developing the world's first enrichment-free foodborne pathogen detection system. DETECT/L is a rapid screening assay that detects a single Listeria spp. cell on environmental surfaces in less than one work shift (<7h). Our proprietary Bioillumination Platform enables this expeditious turnaround. DETECT/L enables food manufacturers and packagers to quickly and accurately detect and remediate contaminated environmental surfaces, and solely retain product that is at risk of contamination. However, food can become contaminated internally during production, shipping, or in wholesale and retail environments downstream in the supply chain. It is of vital importance to develop a second testing modality that assays the foodstuff as rapidly and sensitively as DETECT/L does for environmental surfaces. To this end, the proposed Phase I study will adapt the DETECT/L assay for finished product testing, by directly detecting Listeria on five food products that are especially prone to Listeria contamination: deli ham, smoked salmon, queso fresco, spinach and ice cream. First, the researchers will determine the inhibitory effect that the food can have on DETECT/L's sensitivity. Next, the lower limit of detection (LLOD) of a gold-standard assay (USDA or FDA) in detecting Listeria will be determined, followed by a head-to-head comparison of DETECT/L with the gold-standard assays.