A SARS-CoV-2 Breathalyzer for Direct Virus Detection

项目摘要 越来越多的证据表明，新冠肺炎是通过人类排放的东西传播的 空气中的颗粒物；因此，对个人进行快速筛查以确定他们是否有患上 在他人进入大型场馆(如机场、学校)和较小场馆之前将疾病传播给他们 需要长时间接触或接近的地方(如牙科诊所、美发沙龙)。考虑到大的 无症状病例数、红外线体温计和健康调查问卷 用来筛查个体的方法显然是不够的。现有的SARS-CoV-2检测技术非常耗时-- 使用复杂、昂贵且不便于携带，因此不适合用作护理点(POC) 筛查工具。FDA最近根据紧急使用授权批准的测试面临一些 同样的挑战。 本项目的目标是开发和测试一种新型的用于检测SARS-CoV-2病毒雾化感染的呼气测定仪。 通过与成熟的尖端气溶胶采样技术相结合，近乎实时地从呼气中直接释放出来 配备了一种新颖而廉价的病毒检测器。这项创新是直接检测呼吸中的病毒，而其他 呼气测定仪依靠间接检测(VOCs和人工智能算法)来推断病毒的存在。 在这个快速通道STTR项目中，气溶胶设备公司(ADev)将改装其商业生物气溶胶收集器， 用来从周围环境中采集样本，使其能够从呼气样本中收集病毒进入 浓缩的液体样品。明尼苏达大学(UMN)将修改其磁粒谱- TER(MPS)，其版本以前曾用于检测甲型H1N1流感病毒，因此液体 采集器的样本可以进行分析，以检测SARS-CoV-2。 具体目标包括开发将环境采样器转换为呼气采样器的硬件， 在测试之间签署快速净化收集器的方法，集成收集器和检测器 将磁性纳米颗粒与SARS-CoV-2抗体进行功能化，增加了信号强度 MPS电子器件的NaL/噪声比，减少了分析时间，提高了分析的灵敏度/特异度， 检测临床敏感度/特异度，并与RT-qPCR进行临床前检测比较。 所提出的技术平台是灵活的和可扩展的，并且可以定制以检测其他病原体 (例如鼻病毒、呼吸道合胞病毒、副流感病毒和其他冠状病毒等)。这种灵活性是 这很有价值，因为(1)这不会是最后一次大流行(未来会有新的病原体)，以及(2)发展可能 如果疫苗或其他控制措施使当前的新冠肺炎大流行不是 在这种SARS-CoV-2呼气测定仪上市之前，DER控制。

Project Summary A substantial and growing body of evidence has demonstrated that COVID-19 is transmitted by human-emitted airborne particles; therefore, it is critical to rapidly screen individuals to determine whether they are at risk of transmitting the disease to others before they enter large venues (e.g., airports, schools) and smaller ones where extended exposure or close proximity is expected (e.g., dental offices, hair salons). Given the large number of asymptomatic cases of the disease, the infrared thermometers and health questionnaires frequently used to screen individuals are plainly inadequate. Existing SARS-CoV-2 detection technology is time consum- ing and complicated to use, expensive and not portable and therefore ill-suited to use as point of care (POC) screening tools. Tests recently approved by the FDA under the Emergency Use Authorization face some of the same challenges. The goal of this project is to develop and test a novel breathalyzer for detecting aerosolized SARS-CoV-2 di- rectly from exhaled breath in near real-time by marrying a proven, cutting-edge aerosol sampling technology with a novel and inexpensive virus detector. The innovation is directly detecting virus in the breath, while other breathalyzers depend on indirect detection (VOCs and AI algorithms) to infer the presence of the virus. In this Fast-track STTR project, Aersol Devices Inc (ADev) will modify its commercial bioaerosol collector, which is used to sample from the ambient environment, to enable it to collect viruses from breath samples into a concentrated liquid sample. The University of Minnesota (UMN) will modify its Magnetic Particle Spectrome- ter (MPS), a version of which has previously been used to detect Influenza A H1N1 virus, so that the liquid samples from the collector can be analyzed to detect SARS-CoV-2. Specific aims include developing the hardware for transforming an ambient sampler into a breath sampler, de- signing a rapid means of decontaminating the collector between tests, integrating the collector and the detector into a robust package, functionalizing magnetic nanoparticles with SARS-CoV-2 antibodies, increasing the sig- nal/noise ratio of the MPS electronics, reducing the assay time, improving the analytical sensitivity/specificity, measuring the clinical sensitivity/specificity and comparing to RT-qPCR in pre-clinical testing. The technology platform proposed is flexible and extensible and could be tailored to detect other pathogens (e.g., rhinoviruses, respiratory syncytial virus, parainfluenza virus other coronaviruses, etc.). This flexibility is valuable since (1) this will not be the last pandemic (new pathogens in the future) and (2) development could pivot to a different pathogen if a vaccine or other control measures bring the current COVID-19 pandemic un- der control before this SARS-CoV-2 breathalyzer is commercially available.