Very rapid, low cost multiplexed test for SARS, Influenza A and Influenza B Resubmission

针对 SARS、甲型流感和乙型流感重新提交的快速、低成本多重检测

• 批准号: 10490209
• 负责人: GREGORY W FARIS
• 金额: $ 28.56万
• 依托单位: NUMENTUS TECHNOLOGIES INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-15 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10490209
• 关键词: 2019-nCoV; Address; Antibodies; Base Sequence; Biological Assay; Blood; Buffers; Businesses; Butterflies; COVID-19; COVID-19 assay; COVID-19 pandemic; Clinical; Collection; Computer software; Coronavirus; Cytolysis; Detection; Development; Diagnostic; Disease; Disease Outbreaks; Economics; Employee; Essential worker; Food Processing; Freeze Drying; Future; Government; Health care facility; Heating; Hospitals; Immune response; Immunoassay; Infection; Influenza; Influenza A virus; Influenza B Virus; International; Investigation; Laboratories; Life; Long-Term Care; Measurement; Methods; Microfluidics; Middle East Respiratory Syndrome; Molecular Diagnostic Testing; Monitor; Morbidity - disease rate; Optics; Patients; Pattern; Pensions; Persons; Phase; Plasma; Population; Preparation; Prisons; Procedures; Production; RNA; Reaction; Reagent; Reporting; Respiratory Disease; Reverse Transcriptase Polymerase Chain Reaction; SARS coronavirus; Safety; Saliva; Sampling; Sensitivity and Specificity; Severe Acute Respiratory Syndrome; Societies; Speed; Sputum; Swab; Symptoms; System; Testing; Time; Transportation; Tube; Viral; Virus; Virus Diseases; Work; Workplace; antigen test; base; biosafety level 3 facility; brass; cost; diagnostic platform; diagnostic screening; diagnostic technologies; disease diagnostic; disease transmission; economic impact; gamma irradiation; improved; influenzavirus; instrument; instrumentation; lateral flow assay; melting; molecular diagnostics; mortality; multiplex assay; multiplex detection; nasopharyngeal swab; novel; novel diagnostics; pandemic disease; point of care; point-of-care diagnostics; prevent; respiratory; routine screening; screening; seal; synthetic construct; synthetic nucleic acid; viral detection; virtual; virus envelope

PROJECT SUMMARY The objective of this project is to develop a point-of-contact molecular diagnostic technology (test) for multi- plexed detection of a coronavirus (SARS-CoV-2) and influenza virus. While a point-of-care diagnostic might be performed in a period of 10-20 minutes in a clinical setting, we envision a point-of-contact test being performed about 10 times faster and before someone passes through a door, checkpoint, airport gate, or border. We have identified a strategy for performing PCR that uses a new format to speed thermal cycling while achieving ap- proximately 1,000,000-fold sample partitioning to accelerate sample preparation, without micro-patterning or microfluidics. As described below, we have already established critical strategies for the project including (1) rapid, uniform cycling using optical heating; (2) large scale sample partitioning; and (3) a one-step lysis/RT- PCR assay for enveloped viruses, including SARS-CoV-2 (the virus responsible for COVID-19). This project will provide the basis for a multiplexed point-of-contact diagnostic that can be performed in as little as 2 minutes and at a cost as low as $2/test for Bill of Material (BOM) consumables. When available, this diagnostic platform could be used routinely for detecting hidden spreaders of disease at, e.g., airports, en- trances to hospitals, or at long-term care facilities. Availability of the diagnostic would be transformative. Be- cause of its speed and low cost, the platform could provide the first point-of-contact molecular diagnostic for diseases such as COVID-19, which could detect asymptomatic spreaders, e.g., as they embark or disembark at airports. Rapid deployment of the test at borders or entry points could prevent disease from spreading be- yond an initial outbreak. Similarly, the test could be used to screen employees when they arrive to work at health care facilities to protect patients and essential workers. Finally, the test could be used for routine screening at large facilities such as factories, food processing or distribution facilities, and large government buildings, reducing the economic impact of a addressing a viral pandemic such as COVID-19.

项目摘要 该项目的目的是开发一种连接点分子诊断技术（测试） 冠状病毒（SARS-COV-2）和流感病毒的伪造检测。虽然可能的诊断可能是 在临床环境中进行10-20分钟的时间内，我们设想进行的接触点测试 在有人穿过门，检查站，机场门或边界之前，大约10倍。我们有 确定了执行PCR的策略，该策略使用新格式来加快热循环的速度，同时实现AP- 大约有1,000,000倍的样品分区，以加速样品制备，而无需微观或 微流体学。如下所述，我们已经为该项目建立了关键策略，包括（1） 使用光学加热快速，均匀的循环； （2）大规模样本分区； （3）一步裂解/RT- 包括SARS-COV-2在内的包膜病毒的PCR分析（导致COVID-19的病毒）。 该项目将为可以在AS中执行的多重接触点诊断提供基础 仅2分钟，费用低至$ 2/测试材料账单（BOM）消耗品。如果有的话，这个 诊断平台可通常用于检测疾病隐藏的散布器，例如机场，启动 到医院或长期护理设施。诊断的可用性将具有变革性。是- 该平台的速度和低成本的原因可以提供第一个连接点分子诊断 诸如Covid-19之类的疾病，可以检测到无症状的散布器，例如，它们出发或下船时 在机场。在边界或入口点快速部署测试可以防止疾病传播 YOND首次爆发。同样，测试可以用于筛查员工到达工作时 保护患者和重要工人的医疗保健设施。最后，测试可用于例行 在大型设施，例如工厂，食品加工或配送设施以及大型政府进行筛查 建筑物，减少了解决病毒大流行（例如Covid-19）的经济影响。