PFI-TT: A Rapid Multiplexed Diagnostic Tool for Serology of Tick-Borne Diseases

该创新-技术转化伙伴关系（PFI-TT）项目旨在通过创新的、多重的、血清学护理点（POC）检测来改善蜱传疾病（TBD）的血液检测。针对目前TBD诊断方法中的一个关键空白，该项目将为莱姆病、巴贝虫病、无形体病和回归热开发一个综合平台。通过包含位于相似地理区域的不同TBD，该平台提供了一个单一的测试解决方案，以确定对多种TBD的暴露，从而占据了可用市场的重要部分。该工具的简单性和可负担性使其对资源有限的农村地区有益，这些地区受贸易障碍的影响最大。此外，该平台预计将具有显着的社会和医疗保健效益，允许患者和医生进行及时的测试，以测量对多种TBD的免疫反应，这对于确定患者护理和治疗方案至关重要。该项目的商业潜力在于满足对全面且具有成本效益的TBD诊断的大量市场需求，有望在各种医疗保健环境中广泛采用，包括诊所和现场工作站。通过提高医学诊断领域的科学认识和技术，该项目与改善全球健康的更广泛目标相一致。该项目侧重于开发能够同时检测多种TBD的POC、多重血清学检测。该技术解决了交叉反应性、流行地区不同TBD的共感染以及当前血清学检测的有限灵敏度和特异性的挑战。通过将各种TBD的特异性抗原表位整合到单个多重检测中并采用先进的机器学习算法，该解决方案旨在显著提高血清学诊断的准确性。该研究涉及迭代表位选择和优化的纸基免疫反应平台，包括多重面板。该技术还涉及开发一种强大的基于机器学习的诊断算法，将不同的生物标志物特异性信号分析为可解释和可操作的诊断，供医生用于治疗患者。该项目解决了目前缺乏TBD的护理点（POC）多重检测的问题，患者通常需要在不同的集中实验室进行多次检测。该项目的预期成果包括提高各种TBD的血清学诊断能力，为医疗诊断和公共卫生领域做出重大贡献，特别是在蜱媒感染高发地区。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This Partnerships for Innovation - Technology Translation (PFI-TT) project seeks to improve blood-based detection of tick-borne diseases (TBDs) through an innovative, multiplexed, serological point-of-care (POC) assay. Addressing a critical gap in current TBD diagnostic methods, this project will develop a comprehensive platform for Lyme disease, Babesia, Anaplasma, and relapsing fever. By encompassing different TBDs co-located in similar geographical areas, the platform provides a single test solution to determine exposure to multiple TBDs, thus capturing a significant segment of the available market. The simplicity and affordability of the tool make it beneficial for resource-limited and rural areas, most impacted by TBDs. Furthermore, the platform is expected to have significant societal and healthcare benefits, allowing patients and physicians to conduct timely testing to measure immune response against multiple TBDs, which is critical in determining patient care and treatment regimens. The commercial potential of this project lies in filling a substantial market need for comprehensive and cost-effective TBD diagnostics, promising widespread adoption in various healthcare settings, including clinics and field-stations. By enhancing scientific understanding and technology in the medical diagnostics field, this project aligns with the broader goal of improving global health.This project focuses on the development of a POC, multiplexed, serological assay capable of detecting multiple TBDs simultaneously. The technology addresses the challenge of cross-reactivity, co-infection of different TBDs in endemic regions and limited sensitivity and specificity in current serological tests. By integrating specific antigen epitopes for various TBDs into a single multiplexed assay and employing advanced machine learning algorithms, this solution aims to significantly enhance serodiagnostic accuracy. The research involves iterative epitope selection and optimization of the paper-based immunoreaction platform comprising the multiplexed panel. The technology also involves developing a robust, machine learning-based diagnostic algorithm to analyze different biomarker-specific signals into interpretable and actionable diagnoses that can be used by physicians to treat patients. This project addresses the current lack of a point-of-care (POC) multiplexed test for TBDs, where patients typically require multiple tests at different centralized labs. The project's anticipated outcomes include improved serodiagnostic capabilities for various TBDs, contributing significantly to the fields of medical diagnostics and public health, particularly in areas with a high prevalence of tick-borne infections.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.