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 大量证据表明，Covid-19是由人类发射的 空气颗粒；因此，迅速筛选个人以确定他们是否有风险是至关重要的 在进入大型场所（例如机场，学校）和较小的场所之前，将疾病传播给其他人 预计会扩展暴露或接近近端的地方（例如，牙科办公室，美发沙龙）。给出大 疾病的无症状病例，红外温度计和健康问卷的数量 用于筛选个人的人显然不足。现有的SARS-COV-2检测技术是时期消耗的 - 使用，使用昂贵且不便宜，因此不适合用作护理点（POC） 筛选工具。 FDA最近在紧急使用授权下批准的测试面临一些 同样的挑战。 该项目的目的是开发和测试一种新型的呼吸分析仪来检测雾化的SARS-COV-2 di-di- 通过嫁给经过验证的尖端气溶胶采样技术，从呼气的呼吸中纯粹从呼气的呼吸中 带有新颖且廉价的病毒检测器。该创新直接检测到呼吸中的病毒，而其他 呼吸分析仪依靠间接检测（VOC和AI算法）来推断病毒的存在。 在这个快速跟踪的STTR项目中，Aersol设备公司（ADEV）将修改其商业生物Aerosol收集器， 它用于从环境环境中取样，使其能够从呼吸样品中收集病毒 浓缩液体样品。明尼苏达大学（UMN）将修改其磁性颗粒光谱 - TER（MPS），该版本以前已被用于检测流感A H1N1病毒，因此液体 可以分析来自收集器的样品以检测SARS-COV-2。 具体目的包括开发用于将环境采样器转换为呼吸采样器的硬件 签署一种对测试之间的收集器进行取代的快速方法，整合收集器和检测器 进入坚固的包装，用SARS-COV-2抗体功能化磁性纳米颗粒，从而增加Sig- MPS电子的NAL/噪声比，减少了测定时间，提高了分析灵敏度/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。 提出的技术平台是灵活的，可扩展的，可以量身定制以检测其他病原体 （例如，鼻病毒，呼吸道综合病毒，副氟氟萨病毒其他冠状病毒等）。这种灵活性是 有价值，因为（1）这将不是最后一个大流行（未来的新病原体），并且（2）发展可能 如果疫苗或其他控制措施使当前的COVID-19大流行期非 - 在此SARS-COV-2呼吸分析仪上之前，DER Control已商购。