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

该项目将进行基于纸张的设备的早期开发，以促进从母乳中有效回收高质量的核酸，用于乳腺癌风险评估，隐匿性疾病检测和旨在揭示乳腺癌发展早期事件的流行病学研究。收集含有数百万乳腺上皮细胞的母乳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。所提出的装置将有助于收集母乳并将其装载在一张小的纸质卡片上，该卡片可以通过邮件发送并在室温下长期或无限期地储存，从而允许随后回收核酸。由于样本可以由妇女在家中秘密装载，并且由于该设备是纸质的且价格低廉，我们预计它将有助于从不同地理位置的大量妇女的乳腺细胞中收集核酸。 虽然母乳收集装置的灵感来自采血卡，但它的设计是为了处理大量母乳，以获得癌症风险评估所需的大量核酸。因此，该装置将实现几个功能：通过毛细作用将母乳操纵到纸中，将多余的流体分离到一次性层中，并将富含核的部分保留在主要装置基质中。如果用户在运输之前不能彻底干燥卡，则去除多余的流体体积将加快捕获的流体的后续干燥并简化运输。该器械还将在样本中加入防腐剂，以促进在室温下的长期稳定性。该程序侧重于器械的设计，以便于将核酸和任何未裂解的细胞（也含有核酸）保留在处理窗口中，同时从器械的该组件中去除多余的液体。由于我们的目标是基于纸张的基质，因此拟议的研究将重点评估母乳与不同孔径和表面化学的纸张（添加和不添加防腐剂）的相互作用。这些研究将能够优先考虑设备不同组件的材料，层和其他设备功能的工作配置，以及加速测试，以衡量极端运输和储存温度的影响。

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.