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 本项目的目标是开发一种接触点分子诊断技术（测试），用于多种 冠状病毒（SARS-CoV-2）和流感病毒的复合检测。虽然即时诊断可能 在临床环境中进行10-20分钟的时间内，我们设想进行接触点测试 大约快10倍，在有人通过门、检查站、机场大门或边境之前。我们有 确定了执行PCR的策略，该策略使用新的格式来加速热循环，同时实现ap-PCR。 可提供1，000，000倍的样品分配，以加速样品制备，无需微图案化或 微流体。如下文所述，我们已经为该项目制定了关键战略，包括（1） 使用光学加热的快速、均匀循环;（2）大规模样品分配;和（3）一步裂解/RT- PCR检测包膜病毒，包括SARS-CoV-2（导致COVID-19的病毒）。 该项目将提供一个多路复用的接触点诊断的基础，可以在作为 只需2分钟，材料清单（BOM）耗材的成本低至2美元/测试。如果可用， 诊断平台可以常规地用于检测隐藏的疾病传播者，例如，机场，en- 送到医院或长期护理机构。诊断的可用性将是变革性的。是-- 由于其速度和低成本，该平台可以提供第一个接触点的分子诊断， 疾病，如COVID-19，它可以检测无症状的传播者，例如，当他们上船或下船时 在机场。在边境或入境点快速部署测试可以防止疾病传播， 在最初的爆发中。同样，当员工到达工作地点时， 卫生保健设施，以保护病人和基本工作人员。最后，该测试可用于常规测试 在工厂、食品加工或分销设施等大型设施以及大型政府机构进行筛查 建筑物，减少应对COVID-19等病毒大流行的经济影响。