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

方便家庭使用的纸质母乳收集系统

• 批准号: 10113199
• 负责人: MARIA M. SANTORE
• 金额: $ 21.79万
• 依托单位: UNIVERSITY OF MASSACHUSETTS AMHERST
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10113199
• 关键词: Blood; Blood capillaries; Breast; Breast Cancer Risk Factor; Breast Epithelial Cells; Cells; Chemistry; Collection; Detection; Development; Device Designs; Devices; Disease; Event; Excision; Geographic Locations; Home; Human Milk; Ice; Liquid substance; Mammary Gland Parenchyma; Mammary gland; Methods; Nucleic Acids; Paper; Privacy; Process; Recovery; Research Design; Risk Assessment; Shipping; Specimen; Surface; System; Temperature; Testing; Time; Woman; base; cancer risk; design; epidemiology study; malignant breast neoplasm; programs

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.

该项目将进行纸基设备的早期开发，以促进从母乳中高效地回收高质量的核酸，用于乳腺癌风险评估、隐匿性疾病的检测以及旨在揭示乳腺癌发展最早事件的流行病学研究。采集母乳是获取乳腺组织的唯一非侵入性方法，母乳中含有数百万个乳腺上皮细胞。目前的母乳采集方法需要昂贵的冰上母乳隔夜运输，极大地限制了使用这种重要的生物检验剂的研究。拟议的装置将有助于将母乳收集和装载在一张小纸卡上，可以通过邮件发送，并在室温下长期或无限期地平放储存，以便随后回收核酸。由于女性可以在家中私密地装载标本，而且该设备是纸质的，价格低廉，我们预计它将有助于从不同地理位置的大量女性的乳房细胞中收集核酸。 虽然母乳采集设备的设计灵感来自采血卡，但它的设计目的是处理数量大得多的母乳，这些母乳需要获得癌症风险评估所需的大量核酸。因此，该装置将完成几个功能：通过毛细作用将母乳送入纸张，将多余的液体分离到一次性层中，以及将富含核酸的部分保留在主要装置基质中。移除多余的流体体积将加快捕获的流体的后续干燥，并在用户在运输之前不能彻底干燥卡片的情况下简化运输。该装置还将在标本中加入防腐剂，以促进在室温下的长期稳定性。该计划的重点是设备的设计，以促进核酸和任何在处理窗口中保持未裂解的细胞(也包含核酸)的保留，同时从设备的这个组件中去除多余的液体。由于我们的目标是纸基基质，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张在添加和不添加防腐剂的情况下的相互作用。这些研究将为设备的不同组件确定材料的优先顺序，为各层和其他设备功能确定工作配置，并加快测试以衡量极端运输和存储温度的影响。