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: 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
• 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

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.

项目摘要/摘要 用于呼吸道疾病诊断的口服样本至关重要，因为某些细菌和病毒感染可能导致 未经治疗时，严重的长期条件。但是，访问这些样品在某些人中具有挑战性 病例，例如远程医疗至关重要的幼儿和远程患者。目前，口头样本 收集依赖于传统的鼻和咽拭子，这些拭子很困难，痛苦和创伤 儿童并可能导致诊断结果延迟访问，从而导致负面结果。我们 设计了一个新颖的，微型工程，棒棒糖风格的平台（Lollitest），以改善在家的口服样本 收集功能。 collitest的设计具有两个关键特征：（1）功能化的开放微通道 用于病原体的捕获和浓度以及（2）时间控制的调味释放，以使平台更加 以患者为中心。使用开放的微流体（即，无天花板的微生物通道）的使用是有利的 因为它允许最佳的唾液交换并进入捕获区域，同时防止通过 口腔的舌头或其他表面，可能会驱动捕获的细菌。时间控制的调味料 释放使用户能够直观地知道使用collitest设备多长时间，从而消除了复杂的需求 家庭环境中的说明。为了建立平台，我们提出了两个具体目标。 AIM 1将优化 捕获健康受试者中已知的口腔共生微生物的最终平台。这使得安全 对具有一系列细菌的人类受试者进行简单访问的测试和开发周期 唾液的浓度。我们将专门适应和优化collitest的关键特征，例如 开放式功能化捕获通道和时列的风味释放功能，以实现捕获 与典型病原体相称的浓度中选定的微生物。这个目标也允许 基于用户调查，改善易用性和主题经验的迭代。 AIM 2将证明 collitest平台在体外和在小型中捕获和检测A组链球菌（气）的功能 比例临床研究，以证明平台从儿童中获取样品的潜力 诊所。我们将比较collitest采样的结果（然后是实时聚合酶链反应） 常规的咽拭子和临床分析，验证了collitest的能力 气体为正或阴性。采用故意设计以最大程度地提高唾液抽样的收集性能， 我们的长期愿景是，我们最帅气的平台将获得更好的灵敏度和特异性 使用当前的生物循环收集技术获得，同时提供患者首选的平台 在家庭环境中可用。最终，最终的最终有可能使唾液取样新黄金 呼吸道疾病诊断标准。