Microengineered Lollipop for Patient-Centric Saliva Collection

用于以患者为中心的唾液收集的微工程棒棒糖

• 批准号: 10636771
• 负责人: Gregory P DeMuri
• 金额: $ 19.44万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-06 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10636771
• 关键词: Adult; Affect; Anxiety; Area; Bacteria; Bacterial Infections; Biological; Characteristics; Child; Childhood; Clinic; Clinical; Clinical Research; Collection; Complex; Development; Devices; Diagnosis; Diagnostic; Disease; Engineering; Feasibility Studies; Flavoring; Food; Fright; Future; Home; In Vitro; Incentives; Influenza; Instruction; Intuition; Left; Liquid substance; Mechanics; Methods; Microfluidics; Nature; Nose; Oral; Oral cavity; Outcome; Pain; Parents; Particulate Matter; Patient Self-Report; Patients; Performance; Persons; Pharyngitis; Pneumonia; Polymerase Chain Reaction; Procedures; Process; Respiratory Disease; Risk; Saliva; Sampling; Sensitivity and Specificity; Specimen; Sputum; Streptococcus pyogenes; Surface; Surveys; System; Techniques; Technology; Telemedicine; Testing; Time; Tongue; Trauma; Upper respiratory tract; Virus; Virus Diseases; Work; design; disease diagnosis; disease diagnostic; experience; human subject; improved; innovation; interest; microbial; microorganism; novel; oral commensal; pathogen; pediatric patients; pharyngeal swab; prevent; prototype; remote health care; respiratory; response; saliva sample; sample collection; technology platform; usability; willingness

PROJECT SUMMARY/ABSTRACT Oral samples for respiratory disease diagnosis are essential as certain bacterial and viral infections can lead to serious long-term conditions when left untreated. However, accessing these samples is challenging in some cases, such as in young children and remote patients where telemedicine is essential. Currently, oral sample collection relies on traditional naso- and pharyngeal swabs that are difficult, painful, and traumatic for young children and potentially result in delayed access to diagnostic results, leading to negative outcomes. We designed a novel, micro-engineered, lollipop-inspired platform (LolliTest) to improve on at-home oral sample collection capabilities. The LolliTest was designed with two key features, (1) functionalized open microchannels for pathogen capture and concentration and (2) time-controlled flavoring release to make the platform more patient-centric. The use of open microfluidics (i.e., microfabricated channels without a ceiling) is advantageous as it allows optimal saliva exchange and access to the capture areas while preventing mechanical abrasion by the tongue or other surfaces of the mouth, which could dislodge captured bacteria. The time-controlled flavoring release enables the user to intuitively know how long to use the LolliTest device, eliminating the need for complex instructions in a home setting. To establish the platform, we propose two specific aims. Aim 1 will optimize the LolliTest platform to capture known oral commensal microorganisms in healthy subjects. This enables safe testing and development cycles with simple access to human subjects who have a range of bacterial concentrations in their saliva. We will specifically adapt and optimize key features of the LolliTest, such as the open-fluidic functionalized capture channels and the time-tailored flavor-release function, to enable the capture of a selected microorganism in concentration commensurate with typical pathogens. This aim also allows iteration to improve ease-of-use and subject experience based on user surveys. Aim 2 will demonstrate functionality of the LolliTest platform to capture and detect Group A Streptococcus (GAS) in vitro and in a small- scale clinical study to demonstrate the potential of the platform for acquisition of samples from children in the clinic. We will compare results of the LolliTest sampling (followed by real time-polymerase chain reaction) with conventional pharyngeal swabs and clinical analysis, validating the ability of the LolliTest to determine if a patient is positive or negative for GAS. With deliberate design to maximize collection performance from saliva sampling, our long-term vision is that our LolliTest platform will achieve better sensitivity and specificity than can be obtained with current biospecimen collection techniques, while providing a platform that is preferred by patients and usable in home settings. Ultimately, the LolliTest has the potential to make saliva sampling a new gold standard for respiratory disease diagnostics.

项目总结/摘要 用于呼吸道疾病诊断的口腔样本至关重要，因为某些细菌和病毒感染可导致 如果不治疗的话，会导致严重的长期疾病。然而，在某些情况下，获取这些样本具有挑战性。 在某些情况下，如幼儿和偏远地区的病人，远程医疗至关重要。目前，口腔样本 采集依赖于传统的鼻咽拭子，这对年轻人来说是困难、痛苦和创伤性的 这可能导致延迟获得诊断结果，从而导致负面结果。我们 设计了一个新颖的，微工程，棒棒糖启发平台（LolliTest），以改善在家里的口腔样本 收集能力。LolliTest的设计具有两个关键特征：（1）功能化的开放微通道 用于病原体捕获和浓缩，以及（2）时间控制的调味剂释放，以使平台更 以病人为中心开放式微流体的使用（即，没有天花板的微制造通道）是有利的 因为它允许最佳的唾液交换和进入捕获区域， 舌头或口腔的其他表面，这可能会驱逐捕获的细菌。时间控制的调味品 发布使用户能够直观地知道多久使用LolliTest设备，消除了复杂的 在家里的指示。为了建立这个平台，我们提出了两个具体目标。目标1将优化 LolliTest平台，用于捕获健康受试者中已知的口腔微生物。这使得安全 测试和开发周期与简单的访问人类受试者谁拥有一系列的细菌 唾液中的浓度。我们将特别调整和优化LolliTest的关键功能，例如 开放的流体功能化捕获通道和时间定制的风味释放功能，以使得能够捕获 所选微生物的浓度与典型病原体相当。这一目标还允许 迭代以基于用户调查改进易用性和主题体验。目标2将展示 LolliTest平台在体外和小范围内捕获和检测A组链球菌（GAS）的功能 大规模临床研究，以证明该平台在儿童样本采集方面的潜力， 诊所我们将比较LolliTest采样（随后进行真实的时间聚合酶链反应）的结果与 常规咽拭子和临床分析，验证LolliTest确定患者是否 对GAS是阳性还是阴性。通过精心设计以最大限度地提高唾液采样的收集性能， 我们的长期愿景是，我们的LolliTest平台将实现更好的灵敏度和特异性， 使用当前的生物样本采集技术获得，同时提供患者首选的平台 并且在家庭设置中可用。最终，LolliTest有可能使唾液采样成为一种新的黄金 呼吸系统疾病诊断标准。