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）：食源性疾病每年对数百万美国人的胃肠道微生物群落造成损害，通常导致生态失调并增加其他疾病的风险，即肠易激综合征，肾衰竭，胰腺炎和糖尿病。此外，糖尿病患者患食源性疾病的风险增加，并且他们通常需要更长的时间才能恢复。为了了解食源性病原体对美国人口的影响程度，请考虑这些数字：每年有4800万人患病，28，000人住院治疗，以及至少3，000人死亡。对医疗保健、商业和工业的影响也同样明显，每年造成140亿至160亿美元的成本，包括直接医疗成本和因疾病损失的时间价值。细菌占引起发病和死亡的食源性病原体的大多数。更重要的是：细菌是导致疾病的五大病原体中的四种，导致住院的五大病原体中的三种， 导致死亡受污染的食品是这些疾病的原因，由于在制造/包装厂、分销仓库或零售地点缺乏检测，这些食品进入了公共供应。目前的测试是不够的，因为它们需要一个延长的富集步骤，以减少假阴性和假阳性的可能性。这种浓缩导致向食品加工商提供可操作结果的巨大延迟，食品加工商只有两种选择之一：储存产品直到检测结果回来，导致食品老化，质量较低;或者在收到检测结果之前运输食品，使消费者面临更大的风险。Sample 6正在开发世界上第一个免富集食源性病原体检测系统。DETECT/L是一种快速筛查检测试剂盒，可检测单个李斯特菌属。在不到一个工作班次（<7小时）的环境表面上的细胞。我们专有的生物照明平台可以实现这种快速周转。DETECT/L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，并仅保留有污染风险的产品。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。开发第二种检测模式至关重要，它可以像DETECT/L检测环境表面一样快速灵敏地检测食品。为此，拟议的第一阶段研究将通过直接检测五种特别容易受到李斯特菌污染的食品上的李斯特菌，使DETECT/L检测方法适用于成品检测：熟食火腿、熏鲑鱼、奶酪、菠菜和冰淇淋。首先，研究人员将确定食物对DETECT/L灵敏度的抑制作用。接下来，将确定金标准检测试剂盒（USDA或FDA）检测李斯特菌的检测下限（LLOD），然后将DETECT/L与金标准检测试剂盒进行头对头比较。