I-Corps: Multiplexed paper-based test for rapid diagnosis of early-stage Lyme Disease

I-Corps项目的更广泛影响/商业化潜力是开发一种低成本快速诊断工具，能够在一次测试中测量多种健康标志物。该平台的开发可以通过改善需要测量面板的诊断和预后测试的可及性，从而使医疗保健系统受益。具体来说，有潜在的早期莱姆病（LD）诊断。每年约有30万人感染LD，给医疗系统带来13亿美元的费用。不幸的是，由于目前疾病控制中心（CDC）推荐的检测方案的低灵敏度，LD的大部分社会和经济成本源于误诊，在疾病早期通常是50%，这是许多患者寻求治疗的时期。因此，一种准确而快速的检测方法的商业化可能为在护理点识别早期感染提供一种低成本但有效的工具，从而实现更快、更有效的治疗。这个潜在的I-Corps项目的结果也可能有利于诊断和医学界，因为它展示了数据驱动的多路快速测试方法的价值。I-Corps项目的基础是开发早期莱姆病（LD）的即时诊断检测方法。此前，已经完成了一种低成本、基于纸张的垂直流动试验（VFA）的设计和验证。与标准的快速检测格式不同，拟议的VFA技术能够（从患者血液中）对早期LD感染的大量抗体进行即时测量。然后使用数据驱动的诊断算法从测量面板推断LD诊断，从而能够在具有不同免疫反应的不同人群中对疑似早期莱姆病患者进行敏感和特异性测试。与使用所有早期LD样本的严格临床金标准相比，原型分析和诊断算法的初步同行评议临床研究报告的灵敏度和特异性分别为87.5%和96.7%。这些初步的技术结果表明，有可能在护理点进行有效的早期LD诊断，从而实现更快、更有效的治疗，减轻使人衰弱的晚期症状，并降低医疗保健系统的相关成本。该奖项反映了美国国家科学基金会的法定使命，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。

The broader impact/commercialization potential of this I-Corps project is the development of a low-cost rapid diagnostic tool with the ability to measure multiple health markers in a single test. Development of this platform may benefit the healthcare system by improving the accessibility of diagnostic and prognostic testing that requires a panel of measurements. Specifically, there is potential for an early-stage Lyme disease (LD) diagnostic. Approximately 300,000 people contract LD each year, incurring a $1.3 billion cost to the medical system. Unfortunately, much of the societal and economic costs of LD stem from misdiagnosis due to the low sensitivity of the current Centers for Disease Control (CDC)-recommended testing protocol, which is typically 50% for the early-stage of disease, a time when many patients seek care. Therefore, the commercialization of an accurate and rapid test may provide a low-cost yet effective tool for identifying early-stage infection at the point-of-care, leading to faster and more effective treatment. The results from this potential I-Corps project also may benefit the diagnostics and medical community by demonstrating the value of a data-driven approach to multiplexed rapid testing.This I-Corps project is based on the development of a point-of-care diagnostic assay for early-stage Lyme disease (LD). Previously, the design and validation of a low-cost, paper-based vertical flow assay (VFA) was completed. Unlike standard rapid testing formats, the proposed VFA technology enables the point-of-care measurement (from patient blood) of a large panel of antibodies specific to the early-stage LD infection. A data-driven diagnostic algorithm is then used to infer a LD diagnosis from the panel of measurements, enabling sensitive and specific testing of suspected early-stage Lyme patients across a diverse population with varying immune responses. An initial peer-reviewed clinical study of the prototype assay and diagnostic algorithm reported sensitivity and specificity of 87.5% and 96.7%, respectively, when compared to a rigorous clinical gold standard using all early-stage LD samples. These initial technical results show potential for effective early-stage LD diagnosis at the point-of-care, enabling faster and more effective treatment that could mitigate debilitating late-stage symptoms and associated costs to the healthcare system.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.