Paper-based Breastmilk Collection System for Facile, In-Home Use

项目总结/摘要 本项目将进行一项以纸张为基础的设备的早期开发， 从母乳中回收高质量核酸用于乳腺癌风险评估、检测 隐匿性疾病的研究，以及旨在揭示疾病发展过程中最早期事件的流行病学研究。 乳腺癌收集母乳，其中含有数百万的上皮细胞从乳房 腺体，是获得乳腺组织的唯一非侵入性方法。目前的母乳收集方法 需要昂贵的隔夜运输母乳在冰上，大大限制了研究使用这一重要的 生物标本拟议的设备将有助于收集和加载母乳的一个小文件 可以通过邮件发送并在室温下长期存放的卡片，或 无限期地，允许随后的核酸回收。因为女性可以装载标本 在他们家中的隐私，因为该设备是基于纸张和廉价，我们预计它将 促进从不同地理区域的大量妇女的乳腺细胞中收集核酸， 地点 虽然母乳收集装置的灵感来自采血卡， 大量的母乳，需要获得大量的核酸， 癌症风险评估。因此，该装置将实现几个功能： 母乳通过毛细作用进入纸内，多余的液体分离成一次性层 以及富核级分在主装置基质内的保留。去除多余的液体 体积将加速捕获的流体的随后干燥 在运输前不能彻底干燥卡片。该器械还将加入防腐剂 以促进在室温下的长期稳定性。该计划的重点是 便于保留核酸和任何细胞（也含有核酸）的装置设计 在处理窗口中保持未裂解，同时从该处理窗口中去除过量的流体， 设备的组成部分。由于我们的目标是一个基于纸张的矩阵，拟议的研究将集中在 评估母乳与不同孔径和表面化学的纸的相互作用， 不添加防腐剂。这些研究将使材料的优先次序，为不同的 设备的组件、层的工作配置和其他设备特征，以及 加速测试，以衡量极端运输和储存温度的影响。

Project Summary / Abstract This project will conduct early-stage development of a paper-based device to facilitate the efficient recovery of high-quality nucleic acids from breastmilk for use in breast cancer risk assessment, detection of occult disease, and epidemiologic studies designed to uncover the earliest events in the development of breast cancer. Collecting breastmilk, which contains millions of epithelial cells from the mammary gland, is the only noninvasive method of obtaining breast tissue. Current breastmilk collection methods require expensive overnight shipping of breastmilk on ice and greatly limit studies using this important biospecimen. The proposed device will facilitate the collection and loading of breastmilk on a small paper card that can be sent through the mail and stored flat at room temperature for long periods of time, or indefinitely, allowing subsequent recovery of nucleic acids. Because specimens can be loaded by women in the privacy of their homes, and because the device is paper-based and inexpensive, we anticipate it will facilitate collection of nucleic acids from the breast cells of large numbers of women in diverse geographic locations. While the breastmilk-collection device is inspired by blood-collection cards, it is designed to process substantially larger volumes of breastmilk, needed to obtain a large quantity of nucleic acids required for cancer risk assessment. The device therefore will accomplish several functions: the manipulation of breastmilk into the paper through capillary action, the separation of excess fluid into a disposable layer and the retention of a nucleic-rich fraction within the primary device matrix. Removal of the excess fluid volume will expedite subsequent drying of the captured fluid and simplify transport in the event the user cannot thoroughly dry the card before transport. The device will additionally incorporate preservatives into the specimen to facilitate long term stability at room temperature. This program focuses on the design of the device to facilitate retention of nucleic acids and any cells (also containing nucleic acids) remaining unlysed in the processing window, at the same time removing excess fluid from this component of the device. As we target a paper-based matrix, the proposed studies will focus on evaluating the interaction of breastmilk with papers of varied pore size and surface chemistry with and without added preservatives. These studies will enable the prioritization of materials for different components of the device, a working configuration for the layers and other device features, and accelerated testing to gauge the impact of extreme transport and storage temperatures.