Adaptation of enrichment-free Listeria diagnostic to food matrices

免富集李斯特菌诊断对食品基质的适应

• 批准号: 9046705
• 负责人: Michael Sandor Koeris
• 金额: $ 15万
• 依托单位: SAMPLE6 TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-15 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9046705
• 关键词: Adaptation; enrichment; free; Listeria; diagnostic

 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.

 描述（由申请人提供）：食源性疾病每年都会破坏数百万美国人的胃肠道微生物群，常常导致生态失调并增加其他疾病的风险，即肠易激综合症、肾衰竭、胰腺炎和糖尿病。此外，糖尿病患者的患病率也有所增加。要了解食源性病原体对美国人口的影响规模，请考虑以下数字：每年有 4,800 万人患病、28,000 人住院、至少 3,000 人死亡，这对医疗保健、商业和工业的影响同样明显，导致每年造成 14-160 亿美元的损失，包括直接医疗费用和因病损失的时间价值。细菌是引起发病和死亡的食源性病原体的主体。更重要的是：细菌是导致疾病的前五名病原体中的四种，是导致住院的前五名病原体中的三种。前五名中的三名 受污染的食品是导致这些疾病的原因，由于制造/包装工厂、分销仓库或零售地点缺乏检测，这些食品已进入公共供应，目前的检测还不够充分，因为它们需要长时间的浓缩步骤来减少。这种浓缩会导致向食品加工商提供可操作结果的极大延迟，食品加工商只能选择以下两种选择之一：储存产品直至检测结果返回，从而导致食品陈旧、质量较差。或在接受检测前运送食品； Sample6 正在开发世界上第一个无浓缩食源性病原体检测系统，它是一种快速筛查方法，可在不到一个工作班次的时间内检测环境表面上的单个李斯特菌细胞。 <7h)。我们专有的生物照明平台可实现快速周转，使食品制造商和包装商能够快速、准确地检测和修复受污染的环境表面，并仅保留有风险的产品。然而，食品在生产、运输或供应链下游的批发和零售环境中可能会受到内部污染，因此开发第二种能够像 DETECT/L 一样快速、灵敏地检测食品的检测方式至关重要。为此，拟议的第一阶段研究将采用 DETECT/L 测定法进行成品测试，直接检测特别容易受到李斯特菌污染的五种食品：熟食火腿、熏鲑鱼、首先，研究人员将确定食物对 DETECT/L 灵敏度的抑制作用，然后确定金标准检测（USDA 或 FDA）的检测下限 (LLOD)。将确定检测李斯特菌的效果，然后将 DETECT/L 与金标准检测进行头对头比较。