A novel robotic wastewater analysis system to quantify opioid exposure and treatment in residential communities

项目摘要 这个拟议的第一阶段/第二阶段FastTrack SBIR项目将导致演示 强大的废水测试和分析平台，政府利益相关者可以使用该平台来指导 应对阿片类药物流行的本地化行动。阿片类药物的流行是最大的毒品 美国历史上最大的一场危机，每天造成130多人死亡。目前，利益相关者使用 过量死亡数据，以指导他们的阿片类药物反应策略。然而，这种数据很少出现 更新，通常聚集在太大而无法由公众采取行动的地理级别 卫生官员，很少提供对特定药物类型的洞察(例如，处方药与非法药物 阿片类药物、芬太尼等)。提供本地化、实时和特定于药物的新型数据源 在这一迅速变化的流行病中，需要洞察力来为应对工作提供信息。 基于废水的测试是测量人群水平药物的一种很有前途的方法 风险敞口，但在对利益相关者有用之前有很大的技术限制 疫情的前线。具体地说，目前的废水测试方法依赖于采样 在废水处理厂，最多只能产生市级数据。这表示一个 样本不均匀，对指导本地化干预没有用处。 生物机器人是第一个设计和建造的商业废水测试技术，以提供 为应对阿片类药物流行的市政利益攸关方提供可操作的公共卫生见解。我们的 机器人废水分析系统测量阿片类药物的暴露和治疗(区分 人类使用(从厕所中丢弃)，并在社区层面上操作- 与市政利益相关者相关的地理分辨率。我们平台的首发版本 包括(1)选择代表住宅的采样点(检修孔)的算法 市政社区；(2)可安装在下水道下的机器人采样装置 进入入口(如井盖)以24小时采集复合样品；(3)高效液相色谱-质谱仪/质谱仪 一种检测处方类阿片、美沙酮、 丁丙诺啡和纳洛酮；以及(4)打印报告中的可视化。 此Fast Track第一阶段/第二阶段应用程序的目标是改进我们的平台，使其 可在全国各地的城市采用。与布里格姆大学领先的毒物学家合作 妇女医院和哈佛医学院，我们将解决技术差距，以提高 数据可靠性，并从阿片类药物暴露的检测转移到一致的量化 治疗。在第一阶段，我们将改进和扩展我们的LC-MS/MS方法，开发 模拟模型，以优化样本收集，并解决变异性挑战 24小时采样。在第二阶段，我们将开发数据校正方法，以实现集成 利用所有现有的下水道基础设施，在试点中对照报告的过量验证我们的数据 研究六个马萨诸塞州市政当局，并建立数据分析和可视化 为我们的最终用户提供平台。 拟议项目的成功完成将导致优化和验证 废水测试技术，提供准确、空间粒度和更实时的 关于阿片类药物暴露和治疗的数据。在技术发展的同时，这笔赠款 将使我们能够向两个主要客户展示我们产品的价值：波士顿 和马萨诸塞州。这两个政府组织是 为我们的目标客户长期采用铺平道路。

Project Summary This proposed Phase I/Phase II FastTrack SBIR project will lead to the demonstration of a robust wastewater testing and analytics platform that government stakeholders can use to guide localized actions to respond to the opioid epidemic. The opioid epidemic is the biggest drug crisis in American history, resulting in over 130 deaths every day. Currently, stakeholders use overdose death data to guide their opioid response strategies. However, this data is infrequently updated, often aggregated at geographic levels which are too large to be actionable by public health officials, and rarely provides insight into specific drug types (e.g. prescription vs. illicit opioids, fentanyl, etc.). Novel data sources which provide localized, real-time, and drug-specific insights are needed to inform response efforts in this rapidly changing epidemic. Wastewater-based testing is a promising approach for measuring population-level drug exposure, but has significant technical limitations before it can be useful to stakeholders on the frontlines of the epidemic. Specifically, current wastewater testing approaches rely on sampling at wastewater treatment plants, which yields city-level data at best. This represents a heterogenous sample and is not useful to guide localized interventions. Biobot is the first commercial wastewater testing technology designed and built to provide actionable public health insights for municipal stakeholders tackling the opioid epidemic. Our robotic wastewater analysis system measures opioid exposure and treatment (distinguishing human use from discarding in the toilet), and operates at the neighborhood-level — the geographic resolution relevant to municipal stakeholders. The premiere version of our platform includes (1) an algorithm to select sampling sites (manholes) that represent residential communities in a municipality; (2) a robotic sampling device that can be installed under sewer access portals (e.g. manhole covers) to collect 24-hour composite samples; (3) a HPLC-MS/MS method that detects a variety of urinary metabolites of prescription opioids, methadone, buprenorphine, and naloxone; and (4) visualization in printed reports. The goal of this Fast Track Phase I/Phase II application is to improve our platform to make it adoptable in cities across the nation. In collaboration with leading toxicologists at Brigham and Women’s Hospital and Harvard Medical School, we will address technological gaps to improve data reliability and move from detection to consistent quantification of opioid exposure and treatment. In Phase I, we will improve and expand our HPLC-MS/MS method, develop simulation models to optimize sample collection, and address the variability challenge of 24-hour sampling. In Phase II, we will develop data correction methods to enable integration with all existing sewer infrastructures, validate our data against reported overdoses in a pilot study across six Massachusetts municipalities, and build a data analytics and visualization platform for our end users. Successful completion of the proposed project will lead to an optimized and validated wastewater testing technology that provides accurate, spatially granular, and more real-time data on opioid exposure and treatment. In parallel with the technological development, this grant will allow us to demonstrate the value of our product to two key customers: the City of Boston and the State of Massachusetts. These two government organizations are key champions to pave the way for long-term adoption by our target customers.