Hollow Fiber Concentrating Pipette Tip for Improved Pathogen Detection in Foods

描述(申请人提供)：快速微生物方法在降低劳动力成本和产品保存时间的同时，为提高食品中病原体检测的可靠性提供了巨大的潜力，然而，较小的分析量限制了这些方法的有效性。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就会丧失。机械集中或浓缩的方法很有希望，但它们的发展一直滞后。为了填补这一空白，InnovaPrep开发了一种快速浓缩方法，它带有一次性使用的膜滤嘴和一种新的洗脱工艺，允许直接、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。通过内部和第一阶段项目支持，InnovaPrep于2012年3月发布了商用浓缩吸管(CP)设备和平板膜过滤器浓缩吸管喷嘴(CPT)，反响强烈-售出35台，租赁2台，借出5台进行评估。在第一阶段和商业CP系统发布后的最初几个月里，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，也很明显，由于相对较小的膜过滤器表面积仅为8.5 cm2，当前装置的使用范围在某种程度上是有限的。特别是，在处理难处理的食品基质时，上样体积大小可能会受到显著限制。在第二阶段，InnovaPrep建议开发中空纤维膜过滤器CPTS(HF-CPTS)，其表面积比目前的平板膜过滤器CPTS大15倍。这种增加的表面积将极大地扩大该设备的使用范围，允许更大的过程体积、更大的浓缩系数、减少新食品方法的开发时间，以及允许引入病毒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已经获得了中空纤维模块设计和生产领域的两位专家Pierre Cote博士和Steven Pederson先生的帮助，以协助开发一种新的静态灌封方法，以实现这些目标。将开发一种新的静态盆栽方法和新的制造工艺，并将生产3,500个贝塔HF-CPT，供项目最终目标期间使用。使用贝塔HF-CPTS，InnovaPrep将开发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。开发的方法将展示CP在一系列食品类型、生物体和快速检测方法中的价值，并为其他用户开发其他方法奠定广泛的基础。开发的方法将由密苏里大学哥伦比亚分校进行评估。

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.