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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要该项目的目标是开发一种用于多点接触的分子诊断技术（测试）。冠状病毒（SARS-CoV-2）和流感病毒的复合检测。虽然护理点诊断可能是在临床环境中进行 10-20 分钟，我们设想进行接触点测试在有人通过大门、检查站、机场大门或边境之前，速度大约快 10 倍。我们有确定了一种执行 PCR 的策略，该策略使用新的格式来加速热循环，同时实现 a- 大约 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学。如下所述，我们已经为该项目制定了关键策略，包括 (1) 使用光学加热进行快速、均匀的循环； (2)大规模样本划分； (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）。该项目将为多路接触点诊断提供基础，该诊断可以在以下情况下执行：只需 2 分钟，物料清单 (BOM) 耗材测试成本低至 2 美元/测试。当可用时，这诊断平台可常规用于检测隐藏的疾病传播者，例如机场、去医院或长期护理机构。诊断的可用性将是变革性的。是- 由于其速度快且成本低，该平台可以为以下疾病提供第一个接触点分子诊断： COVID-19 等疾病，可以检测无症状传播者，例如在他们登船或下船时在机场。在边境或入境点快速部署检测可以防止疾病传播超越最初的爆发。同样，该测试可用于在员工到达工作场所时对其进行筛查保护患者和重要工作人员的医疗保健设施。最后，该测试可用于日常工作在工厂、食品加工或分销设施以及大型政府等大型设施中进行筛查建筑物，减少应对 COVID-19 等病毒大流行的经济影响。