RADX TECH PROJECT #2620 ACCELERATED MANUFACTURING SCALE-UP FOR ANP TECHNOLOGIES' NANO-INTELLIGENT DETECTION SYSTEM(NIDS)COVID-19 ANTIGEN RAPID TEST

RADX 技术项目

• 批准号: 10505940
• 负责人: GREG WITHAM
• 金额: $ 1972.78万
• 依托单位: ANP TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-11 至 2021-12-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505940
• 关键词: 2019-nCoV; Antigens; Area; Benchmarking; Biological Assay; COVID-19 outbreak; Disease Outbreaks; Disease Progression; Frequencies; Home; Individual; Infection; Intelligence; Nanotechnology; Nucleic Acids; Nucleocapsid; Nucleocapsid Proteins; Patients; Quarantine; RADx Tech; Recovery; Resources; Reverse Transcriptase Polymerase Chain Reaction; SARS-CoV-2 antigen; Severe Acute Respiratory Syndrome; Severities; Specimen; Testing; Time; Viral; Viral Antigens; Virus; Vulnerable Populations; base; clinically relevant; combat; cost; detection platform; manufacturing scale-up; mortality; novel coronavirus; novel virus; point of care; rapid test; rapid testing

The extreme severity of the current COVID-19 outbreak represents the single worst outbreak in recent years. Exacerbated by the fast moving, highly contagious, asymptomatic disease progression and high mortality in vulnerable populations, particularly those in low resource areas, the need for a rapid, low-cost, easy to use, highly sensitive/clinical relevant, home-use or Point of Care (POC) test to qualitatively detect SARS-nCoV-2 virus is paramount. To combat such a novel virus, it would be highly useful to deploy rapid testing at high frequency using an easy-to-use assay that targets multiple antigens of the virus, yet can return results in only a matter of minutes. The current benchmark of RT-PCR-based testing, although highly sensitive, is only capable of detecting the presence of viral nucleic acids in the patient specimen, unable to provide any information regarding the potential infectiousness of an individual. Moreover, the turnaround time for these tests is abysmal – often taking 3 or more days to get the results and subsequently quarantine these individuals. By then, they have already transmitted the virus to countless others. Currently approved antigen rapid tests, targeting the SARS-CoV-2 nucleocapsid protein, suffer a similar drawback, detecting a single antigen (nucleocapsid). Therefore, an intelligent multiplexed rapid test that can not only detect the nucleocapsid protein antigen, but in addition, distinguish active or potentially highly infectious individuals versus those whom are in the recovery or low state of infectiousness through the added multiplexing of the spike antigen into a single assay is essential to mitigate further infections.

当前的 COVID-19 疫情极其严重，是近年来最严重的一次疫情，由于易感人群（特别是资源匮乏地区的人群）的快速传播、高度传染性、无症状的疾病进展和高死亡率，需要迅速、低成本、易于使用、高度敏感/临床相关、家庭使用或护理点 (POC) 测试来定性检测 SARS-nCoV-2 病毒至关重要。使用一种易于使用的针对病毒多种抗原的检测方法来进行高频率的快速检测非常有用，而且只需几分钟即可返回结果，尽管这是基于 RT-PCR 的检测的当前基准。高度敏感，只能检测患者样本中是否存在病毒核酸，无法提供有关个体潜在传染性的任何信息，而且这些检测的周转时间非常短——通常需要 3 次或更多时间。获得结果和随后隔离的天数到那时，他们已经将病毒传播给了无数其他人。目前批准的针对 SARS-CoV-2 核衣壳蛋白的抗原快速测试也存在类似的缺点，即检测单一抗原（核衣壳）。快速检测不仅可以检测核衣壳蛋白抗原，还可以通过添加的方法区分活跃或潜在高传染性个体与处于恢复或低传染性状态的个体将刺突抗原多重化到单一测定中对于减轻进一步的感染至关重要。