Adaptation of an enrichment-free Listeria diagnostic to food matrices

将无富集李斯特菌诊断方法应用于食品基质

基本信息

批准号：
9346485
负责人：
Michael Sandor Koeris
金额：
$ 51.69万
依托单位：
SAMPLE6 TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-04-01 至 2017-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9346485
关键词：
American Area Back Bacterial Infections Bacteriophages Biological Assay Businesses Campylobacter Cantaloupes Case Study Categories Cause of Death Cells Centers for Disease Control and Prevention (U.S.)Cessation of life Clinical Collection Consumption Data Detection Development Diabetes Mellitus Diagnostic Disease Disease Outbreaks Eating Engineering Environment Enzymes Escherichia coli Etiology Food Food Contamination Food Safety Guidelines Health Health Care Costs Healthcare Hospitalization Human Ice Cream Incidence Individual Industrialization Industry Infection Irritable Bowel Syndrome Kidney Failure Laboratories Left Life Listeria Listeria monocytogenes Location Manufacturer Name Measures Meat Medical Methods Modality Pancreatitis Pathogen detection Persons Phase Plants Population Process Production Public Health Reagent Reporting Research Personnel Risk Safety Salmonella Sampling Shipping Signal Transduction Source Specificity Surface System Technology Test Result Testing Time United States Food and Drug Administration Validation Water Work assay development base clinically relevant cost diabetic disorder prevention food quality foodborne foodborne illness foodborne pathogen gastrointestinal microbial mortality new technology novel offender pathogen phase 2 study safety testing screening shift work surveillance network

项目摘要

Abstract Foodborne illnesses devastate 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. Each year, 1 in 6 people in the U.S. are sickened by foodborne pathogens. In 2014, there were 19,542 laboratory confirmed infections, 4,445 hospitalizations and 71 deaths attributed to the 9 major pathogens transmitted commonly through food. Listeria is the one of the most serious offenders, with a 96% hospitalization rate and a 12.9% mortality rate. The impact on healthcare, business and industry is no less pronounced, resulting in annual costs of $14.1 to $16.3 billion, including direct medical costs and value of time lost to illness. Moreover, the cost of keeping food safe from Listeria contamination was estimated to range between $2.4-$2.6 billion. 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). Sample6’s proprietary Bioillumination Platform enables this expeditious turnaround, enabling 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 II study will continue the work begun in Phase I to adapt the DETECT/L assay for finished product testing. First, the researchers will expand the number of Listeria strains to 10. Next, assay development will be completed for the six foods begun in Phase I, plus 30 more foods. Finally, Sample6 will develop high-throughput methods so that food manufacturers and packagers can test multiple food samples at a time for efficiency.

抽象的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，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、胰腺炎此外，糖尿病患者患食源性疾病的风险增加，并且他们经常服用药物。 2014 年，美国有六分之一的人感染食源性病原体。共有 19,542 例实验室确诊感染、4,445 例住院治疗和 71 例死亡归因于 9 个主要疾病通常通过食物传播的病原体是最严重的致病菌之一，占 96%。住院率和 12.9% 的死亡率对医疗保健、商业和工业的影响也不小。明显，导致每年 14.1 至 163 亿美元的费用，包括直接医疗费用和时间价值此外，据估计，保持食品安全免受李斯特菌污染的成本也很高。 2.4-26 亿美元之间的受污染食品是这些疾病的原因，已进入公共供应。由于制造/包装工厂、分销仓库或零售地点缺乏检测。测试是不充分的，因为它们需要长时间的富集步骤以减少错误的可能性这种丰富性导致向提供可操作结果的过程中出现巨大的延迟。食品加工商，他们有两个选择之一：储存产品直到测试结果返回，结果在收到测试结果之前运送食品，使消费者处于危险之中 Sample6 正在开发世界上第一个无浓缩食源性病原体检测系统。 DETECT/L 是一种快速筛查方法，可在更短的时间内检测环境表面上的单个李斯特菌细胞。 Sample6 的专有生物照明平台只需一个工作班次（<7 小时）即可实现这一快速周转，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物质环境表面，并仅保留有污染风险的产品。但是，食品可能会受到污染。在生产、运输或下游批发和零售环境中内部受到污染开发第二种快速检测食品的检测方式至关重要。并像 DETECT/L 对环境表面所做的那样敏感。为此，拟议的第二阶段研究将进行。继续第一阶段开始的工作，使 DETECT/L 适合成品测试。研究人员将把李斯特菌菌株的数量扩大到 10 个。下一步，该检测方法的开发将完成第一阶段开始的六种食物，加上另外 30 种食物，最后，Sample6 将开发高通量方法，以便食品制造商和包装商可以一次测试多个食品样品以提高效率。