I-Corps: Development of a rapid point-of-care test for coronavirus (COVID-19) and antibody testing

I-Corps项目的更广泛影响/商业潜力是开发基于侧流检测（LFA）的COVID-19快速床旁（POC）诊断测试。 其目标是减少社区感染传播，并帮助减轻全球流行病的负面经济影响。与使用基于聚合酶链反应（PCR）的测试相比，拟议的诊断可能允许通过与病毒粒子和抗体的蛋白质-蛋白质相互作用同时对冠状病毒感染和免疫力进行普遍测试，该测试依赖于耗时的RNA逆转录来检测病毒。 公共卫生专家的共识是，安全地摆脱封锁将需要对数百万美国人进行定期检测。目前的测试技术由于假阴性的比例很大（高达20%）而受到限制。此外，在缺乏可靠的电力服务、自来水、诊断设备和操作人员的低资源环境中，获得冠状病毒和抗体检测的机会有限。虽然目前采用的技术，如在家里鼻咽采样的测试能力正在增加，建立一个快速，简单的POC测试还没有得到解决。拟议技术可减少感染的社区传播，并有助于减轻COVID-19大流行的负面经济影响。这个I-Corps项目是基于侧流检测（LFA）诊断COVID-19测试的翻译，类似于妊娠测试，它将报告患者样本中病毒及其抗体的存在。因为LFA在具有检测区的聚合物条上利用毛细管力，所以它们易于使用，消除了对专用设备的需要，并且可以作为单个步骤进行，减少了样品处理的量。使用商业上可获得的计算软件，已经设计了具有高灵敏度和高特异性的检测蛋白。初步的实验结果证实了高灵敏度和计算结果证实了高特异性。DNA构建体与LFA试纸条的优化同时进行开发。为了精确、快速和大规模加载，对来自市售的多重侧向流测试条（MLFTS）工艺设计的要求，该奖项反映了NSF的法定使命，并被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

The broader impact/commercial potential of this I-Corps project is the development of a rapid point-of-care (POC) diagnostic test for COVID-19 based on a lateral flow assay (LFA). The goal is to decrease community spread of infection and help mitigate the negative economic impacts of world-wide pandemics. The proposed diagnostic may allow for universal access to testing of both coronavirus infection and immunity via protein-protein interactions with virions and antibodies at once as compared with using a polymerase chain reaction (PCR)-based test that relies on time-consuming reverse transcription of RNA to detect the virus only. The consensus among public health experts is that safely emerging from a lockdown will require regular testing of millions of Americans. Current testing technologies are limited due to a large percentage of false negatives (up to 20%). Additionally, access to coronavirus and antibody testing is limited in low resource settings that lack reliable electrical services, running water, and diagnostic devices and personnel to operate them. Although testing capabilities are increasing among currently employed technologies such as at-home nasopharyngeal sampling, the creation of a rapid, simple POC test has not been addressed. The proposed technology may decrease community spread of infection and help mitigate the negative economic impacts of the COVID-19 pandemic. This I-Corps project is based on the translation of a lateral flow assay (LFA) diagnostic COVID-19 test, akin to a pregnancy test, that will report the presence of both the virus and its antibody in patient samples. Because LFAs employ capillary force on a polymeric strip with detection zones, they are easy-to-use, eliminate the need for specialized equipment, and may be carried out as a single step, reducing the amount of sample handling. Using commercially available computational software, detector proteins with high sensitivity and high specificity have been designed. Preliminary experimental results confirm the high sensitivity and computational results confirm high specificity. DNA constructs are concurrently under development with optimization of LFA test strips. For precise, rapid and large-scale loading, the requirements for aa multiplex lateral flow test strip (MLFTS) process design from a commercially-available, drop-on-demand printer that will accommodate the protein designs and facilitate scale-up and manufacturing will be evaluated.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.