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

I-Corps：开发冠状病毒 (COVID-19) 快速护理点测试和抗体测试

基本信息

批准号：
2041364
负责人：
Jin Montclare
金额：
$ 5万
依托单位：
New York University
依托单位国家：
美国
项目类别：
Standard Grant
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-15 至 2022-07-31
项目状态：
已结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=2041364&HistoricalAwards=false
关键词：
Corps Development rapid point care

项目摘要

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.

该I-Corps项目的更广泛的影响/商业潜力是开发基于横向流量测定法（LFA）的COVID-19的快速护理（POC）诊断测试。目的是减少社区感染的传播，并有助于减轻全球大流行的负面影响。与使用聚合酶链反应（PCR）的测试相比，提出的诊断可能可以通过蛋白质 - 蛋白质与病毒蛋白和抗体的相互作用（PCR）测试（PCR）测试（依赖于时间耗时的RNA仅检测病毒的反向转录来检测），可以立即通过蛋白质 - 蛋白质相互作用来普遍访问冠状病毒感染和免疫。公共卫生专家的共识是，从锁定中安全出现将需要定期测试数百万美国人。当前的测试技术由于很大比例的假否定因素而受到限制（最高20％）。此外，在缺乏可靠的电气服务，自来水以及诊断设备和人员操作的低资源设置中，使用冠状病毒和抗体测试受到限制。尽管在当前使用的技术（例如鼻咽抽样）中，测试功能正在增强，但尚未解决快速，简单的POC测试的创建。拟议的技术可能会减少社区感染的传播，并有助于减轻19009年大流行的负面经济影响。该I-Corps项目基于类似于妊娠试验的横向流量测定法（LFA）诊断COVID-19测试的翻译，该测试将报告病毒及其抗体在患者样品中的存在。由于LFA在带有检测区的聚合物带上使用毛细管力，因此它们易于使用，消除了对专用设备的需求，并且可以作为单步执行，从而减少样品处理量。使用市售的计算软件，已经设计了具有高灵敏度和高特异性的检测器蛋白。初步实验结果证实了高灵敏度，计算结果证实了高特异性。通过优化LFA测试条，DNA构建体同时正在开发中。为了精确，快速和大规模的加载，AA多重侧向流程测试条（MLFTS）过程设计的要求是从商业上可用的，掉线的需求的打印机来适应蛋白质设计并促进扩大规模和制造业的要求，将评估NSF的法定任务和范围的范围。