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

该项目将进行一种纸质设备的早期开发，以促进从母乳中有效地回收高质量核酸，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。母乳中含有数以百万计的乳腺上皮细胞，采集母乳是唯一一种获取乳腺组织的无创方法。目前的母乳收集方法需要花费昂贵的隔夜运输，并且极大地限制了使用这一重要生物标本的研究。该装置将有助于收集和装载母乳在一个小纸卡上，可以通过邮件发送，并在室温下长时间或无限期地扁平储存，允许随后的核酸恢复。由于标本可以由妇女在家中自行装载，而且该装置是纸质的，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。

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.