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

当前COVID-19疫情的极端严重程度是近年来最严重的一次疫情。由于脆弱人群（特别是资源匮乏地区的人群）的快速传播、高传染性、无症状疾病进展和高死亡率加剧，迫切需要一种快速、低成本、易于使用、高度敏感/临床相关、家庭使用或护理点（POC）检测方法来定性检测SARS-nCoV-2病毒。为了对抗这种新型病毒，使用一种易于使用的检测方法进行高频快速检测是非常有用的，这种检测方法可以针对病毒的多种抗原，而且只需几分钟就能得出结果。目前基于rt - pcr的检测基准虽然高度敏感，但只能检测患者标本中病毒核酸的存在，无法提供有关个体潜在传染性的任何信息。此外，这些检测的周转时间非常糟糕<e:1>——通常需要3天或更长时间才能得到结果，随后还要对这些人进行隔离。到那时，他们已经把病毒传染给了无数人。目前批准的针对SARS-CoV-2核衣壳蛋白的抗原快速检测也存在类似的缺点，只能检测单一抗原（核衣壳）。因此，一种智能的多路快速检测，不仅可以检测核衣壳蛋白抗原，而且可以通过在单个检测中添加刺突抗原的多路复用来区分活跃或潜在的高传染性个体与处于恢复或低传染性状态的个体，对于减轻进一步感染至关重要。

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.