Hollow Fiber Concentrating Pipette Tip for Improved Pathogen Detection in Foods

描述（由申请人提供）：快速微生物方法在提高食品中病原体检测的可靠性方面具有很大的潜力，同时降低了劳动力成本和产品放置时间，然而，小的分析体积限制了这些方法的实用性。通常使用预富集来克服这一限制，但这些方法的显著时间优势随后丧失。机械浓缩或浓缩方法有希望，但其发展滞后。为了填补这一空白，InnovaPrep开发了一种快速浓缩方法，采用一次性膜过滤器吸头和一种新型洗脱工艺，可以直接、用户友好地浓缩食品中的病原体，同时消除样品之间的交叉污染。通过内部和I期项目支持，InnovaPrep于2012年3月发布了商业浓缩移液器（CP）装置和平膜过滤器浓缩移液器吸头（CPT），反应强烈-销售了35台装置，两台租赁，五台借出用于评估。在第一阶段和商业CP系统发布后的最初几个月，很明显这种方法是可行的，市场已经准备好接受这种方法。然而，还显而易见的是，由于仅8.5cm2的相对小的膜过滤器表面积，当前装置的有用范围受到一定限制。特别是，当处理困难的食物基质时，上限样品体积大小可能会受到显著限制。在第二阶段，InnovaPrep提出开发中空纤维膜过滤器CPT（hf-CPT），其表面积比目前的平膜过滤器CPT大15倍。表面积的增加将极大地扩大设备的使用范围，从而允许更大的处理体积、更大的浓缩系数、缩短新食品方法的开发时间，以及允许引入病毒性CPT。以符合食品安全实验室要求的成本生产hf-CPT将需要可以自动化的创新制造工艺。InnovaPrep已经获得了两位中空纤维模块设计和生产领域的专家Pierre Cote博士和Steven Pederson先生的帮助，以协助开发一种新型的静态灌封方法，以实现这些目标。将开发一种新的静态灌封方法和新的制造工艺，并将生产3，500个β hf-CPT，用于项目的最终目标。InnovaPrep将使用beta hf-CPT开发11种浓缩方法，涵盖11种高优先级食品，5种生物和6种快速检测方法。开发的方法将证明CP在一系列食品类型、生物体和快速检测方法上的价值，并奠定广泛的基础，作为其他用户开发其他方法的起点。所开发的方法将由密苏里州-哥伦比亚大学进行评估。

DESCRIPTION (provided by applicant): Rapid microbiological methods offer great potential for increasing the reliability of pathogen detection in foods while reducing labor costs and product hold times, however, small analysis volumes limit the usefulness of these methods. Pre-enrichment is often used to overcome this limitation, but the significant time advantage of these methods is then lost. Mechanical concentration or enrichment approaches hold promise, but their development has lagged. In an effort to fill this void, InnovaPrep has developed a rapid concentration approach with single-use membrane filter tips and a novel elution process to allow for straightforward, user- friendly concentration of pathogens from foods while eliminating cross contamination between samples. Through internal and Phase I project support InnovaPrep was able to release a commercial Concentrating Pipette (CP) device and flat membrane filter Concentrating Pipette Tips (CPTs) in March 2012 and the response has been strong - with 35 devices sold, two leased, and five loaned for evaluation. During Phase I and during the early months after release of the commercial CP system, it became clear that the approach was viable and that the market was ready to embrace this approach. It was, however, also apparent that the useful range of the current device was somewhat limited due to a relatively small membrane filter surface area of only 8.5 cm2. In particular, the upper sample volume size can be significantly limited when working with difficult food matrices. In Phase II, InnovaPrep proposes development of hollow fiber membrane filter CPTs (hf-CPTs) with up to 15 times more surface area than current flat membrane filter CPTs. This increased surface area will dramatically expand the useful range of the device, allowing for larger process volumes, greater concentration factors, reduced development time for new food methods, as well as allowing for the introduction of viral CPTs. Producing hf-CPTs at costs that fit the requirements of the food safety laboratory will require innovative manufacturing processes that can be automated. InnovaPrep has secured the help of Dr. Pierre Cote and Mr. Steven Pederson, two experts in the field of hollow fiber module design and production, to assist in the development of a novel static potting method in order to achieve these goals. A novel static potting method and new manufacturing processes will be developed and 3,500 beta hf-CPTs will be produced for use during the final Aims of the project. Using beta hf-CPTs, InnovaPrep will develop eleven concentration methods covering 11 high priority foods, five organisms, and six rapid detection methods. The developed methods will demonstrate the value of the CP over a range of food types, organisms and rapid detection methods and lay a broad based groundwork that serves as a starting point for development of additional methods by other users. The developed methods will be evaluated by at the University of Missouri - Columbia.