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

基本信息

批准号：
10350255
负责人：
Gregory P DeMuri
金额：
$ 24.71万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-06 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10350255
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 Gold Home In Vitro Incentives Instruction Intuition Lead Left Liquid substance Mechanics Methods Microfluidics Nature Nose Oral Oral cavity Outcome Pain Parents Particulate Matter Patient Self-Report Patients Performance Persons Pharyngitis Polymerase Chain Reaction Procedures Process Respiratory Disease Risk Saliva Sampling Sensitivity and Specificity Specimen Sputum Streptococcus pyogenes Surface Surveys Swab System Techniques Technology Telemedicine Testing Time Tongue Trauma Upper respiratory tract Virus Virus Diseases Vision Work base design disease diagnosis disease diagnostic experience human subject improved influenza pneumonia innovation interest microbial microorganism novel oral commensal pathogen pediatric patients prevent prototype remote health care respiratory response saliva sample sample collection willingness

项目摘要

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.

项目概要/摘要口腔样本对于呼吸道疾病诊断至关重要，因为某些细菌和病毒感染可能导致如果不及时治疗，会导致严重的长期病症。然而，在某些情况下访问这些样本具有挑战性案例，例如对于幼儿和远程患者来说，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、痛苦和创伤性的儿童，并可能导致延迟获得诊断结果，从而导致负面结果。我们设计了一种新颖的、微工程的、受棒棒糖启发的平台 (LolliTest)，以改进家庭口腔样本收集能力。 LolliTest 的设计具有两个关键特征，(1) 功能化开放微通道用于病原体捕获和浓缩，以及 (2) 时间控制的调味品释放，使平台更加以患者为中心。使用开放式微流体（即没有天花板的微加工通道）是有利的因为它可以实现最佳的唾液交换和进入捕获区域，同时防止机械磨损舌头或口腔的其他表面，这可能会清除捕获的细菌。时间控制调味发布使用户能够直观地知道LolliTest设备的使用时间，从而无需复杂的操作家庭环境中的说明。为了建立该平台，我们提出了两个具体目标。目标 1 将优化 LolliTest 平台可捕获健康受试者中已知的口腔共生微生物。这使得安全测试和开发周期，可轻松接触携带多种细菌的人类受试者他们唾液中的浓度。我们将专门调整和优化 LolliTest 的关键功能，例如开放流体功能化捕获通道和时间定制的风味释放功能，以实现捕获选定微生物的浓度与典型病原体相当。这一目标也使得根据用户调查进行迭代，以提高易用性和主题体验。目标 2 将展示 LolliTest 平台的功能是在体外和小规模环境中捕获和检测 A 组链球菌 (GAS) 规模临床研究，以证明该平台从儿童身上获取样本的潜力诊所。我们将 LolliTest 采样（随后进行实时聚合酶链反应）的结果与常规咽拭子和临床分析，验证 LolliTest 确定患者是否有能力 GAS 为正或负。通过精心设计，最大限度地提高唾液采样的采集性能，我们的长期愿景是我们的 LolliTest 平台将实现比现有平台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可在家庭环境中使用。最终，LolliTest 有潜力使唾液采样成为新的黄金呼吸系统疾病诊断标准。