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

目前新冠肺炎疫情的极端严重性是近年来最严重的一次疫情。在脆弱人群中，特别是在低资源地区，由于快速移动、高传染性、无症状的疾病进展和高死亡率，对快速、低成本、易于使用、高度敏感/临床相关的家庭使用或护理点(POC)测试的需求至关重要。为了对抗这样一种新型病毒，使用针对病毒多种抗原的易于使用的测试以高频部署快速测试将是非常有用的，但可以在几分钟内返回结果。目前基于RT-PCR的检测基准虽然高度敏感，但只能检测到患者样本中是否存在病毒核酸，无法提供任何关于个人潜在传染性的信息。此外，这些检测的周转时间非常糟糕“，通常需要3天或更长时间才能得到结果，然后对这些人进行隔离。到那时，他们已经将病毒传播给了无数其他人。目前批准的抗原快速检测，除了针对SARS-CoV-2核衣壳蛋白，也会遇到类似的缺点，只能检测单一抗原(核衣壳)。因此，建立一种智能的多重快速检测方法，不仅可以检测核衣壳蛋白抗原，而且通过将尖峰抗原添加到单一检测中，区分活跃的或潜在的高传染性个体与那些处于恢复或低传染性状态的个体，对于缓解进一步的感染至关重要。

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.