A SARS-CoV-2 Breathalyzer for Direct Virus Detection

用于直接病毒检测的 SARS-CoV-2 呼气分析仪

• 批准号: 10266353
• 负责人: Patricia Bea Keady
• 金额: $ 25.4万
• 依托单位: AEROSOL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-21 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266353
• 关键词: 2019-nCoV; Aerosols; Air; Algorithms; Antibodies; Antibody Specificity; Assisted Living Facilities; Biological Assay; Breath Tests; Breathalyzer Tests; COVID-19; COVID-19 detection; COVID-19 pandemic; Clinical Sensitivity; Collection; Coronavirus; Decontamination; Dental Offices; Detection; Development; Devices; Diagnostic; Diagnostic Sensitivity; Disease; Electronics; Ensure; Environment; Enzyme-Linked Immunosorbent Assay; Exhalation; FDA Emergency Use Authorization; FDA approved; Face; Future; Goals; Hair; Health; Hospitals; Human; Individual; Influenza A Virus, H1N1 Subtype; Influenza A virus; Liquid substance; Lung diseases; Magnetic nanoparticles; Magnetism; Measures; Mechanics; Military Personnel; Minnesota; Noise; Nucleocapsid Proteins; Performance; Phase; Preclinical Testing; Questionnaires; Rapid screening; Readiness; Respiratory syncytial virus; Rhinovirus; Risk; SARS-CoV-2 antibody; SARS-CoV-2 transmission; Saliva; Sampling; Schools; Screening procedure; Sensitivity and Specificity; Signal Transduction; Small Business Technology Transfer Research; Stress Tests; System; Technology; Temperature; Testing; Thermometers; Time; Universities; Vaccines; Viral Antigens; Virion; Virus; Virus Inactivation; Vulnerable Populations; aerosolized; base; biosafety level 3 facility; design; detector; digital; emerging pathogen; experimental study; flexibility; improved; innovation; instrument; laboratory equipment; manufacturability; novel; pandemic disease; parainfluenza virus; particle; particle detector; particle spectroscopy; pathogen; performance tests; point of care; pre-clinical; response; screening; software systems; tool; viral detection

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.

项目摘要 大量和越来越多的证据表明，COVID-19是通过人类排放的 空气中的颗粒;因此，快速筛查个体以确定他们是否有 在他们进入大型场所之前将疾病传播给他人（例如，机场、学校）和较小的机场 在预期延长暴露或紧密接近的情况下（例如，牙科诊所、发廊）。开大宗 一些无症状的疾病病例，红外线体温计和健康问卷调查频繁 用于筛选个人的方法显然不够。现有的SARS-CoV-2检测技术耗时- 昂贵且使用复杂，昂贵且不便携，因此不适合用作护理点（POC） 筛选工具FDA最近根据紧急使用授权批准的测试面临一些问题， 同样的挑战。 该项目的目标是开发和测试一种新型的呼吸测醉器，用于检测雾化的SARS-CoV-2二- 通过结合成熟的尖端气溶胶采样技术， 一种新颖而廉价的病毒检测器。创新是直接检测呼吸中的病毒，而其他 呼吸测醉仪依赖于间接检测（VOC和AI算法）来推断病毒的存在。 在这个快速通道STTR项目中，Aersol设备公司（ADev）将修改其商业生物气溶胶收集器， 用于从周围环境中采样，使其能够从呼吸样本中收集病毒， 浓缩的液体样品。明尼苏达大学（UMN）将修改其磁粒子光谱仪， ter（MPS），其一个版本以前曾用于检测甲型H1N1流感病毒，因此液体 可以分析来自收集器的样本以检测SARS-CoV-2。 具体目标包括开发硬件，用于将环境采样器转换为呼吸采样器， 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SARS-CoV-2抗体功能化磁性纳米颗粒， MPS电子器件的最终/噪声比，减少测定时间，提高分析灵敏度/特异性， 测量临床灵敏度/特异性，并与临床前测试中的RT-qPCR进行比较。 所提出的技术平台是灵活的和可扩展的，并且可以被定制以检测其他病原体 (e.g.,鼻病毒、呼吸道合胞病毒、副流感病毒、其他冠状病毒等）。这种灵活性是 有价值的，因为（1）这不会是最后一次大流行（未来的新病原体），（2）发展可能 如果疫苗或其他控制措施使当前的COVID-19大流行不受影响， 在这种SARS-CoV-2呼吸测醉器商业化之前，