Design, development, and validation of an end-user assay for low-cost, on-site, and rapid quantification of COVID-19 antigen and antibodies

2020年底COVID-19疫苗的引入为战胜疫情带来了希望，但很快就清楚地看到，人类预计将与SARS-CoV-2作斗争，直到世界人口（包括儿童）大规模免疫接种。达到这一目标预计需要几年时间，在此期间：1）接种疫苗的人群需要保持免疫力; 2）更有效的方法（例如，低成本、可获得、准确），以便更早地识别受感染的个体，以防止未来的感染高峰。要成功实现这两个目标，需要开展全人群血清学研究，而这在实践中只能通过低成本和广泛使用的技术来实现，这些技术用于灵敏地检测和定量COVID-19抗体（Ab）和病毒/抗原（Ag）。该合作伙伴关系的目标是设计、开发和验证一种低成本的终端用户快速检测技术，用于灵敏地检测和定量COVID-19抗体和抗原/病毒。通过该项目产生的工程知识和创新技术将使加拿大政府能够实施大规模，可访问和公平的定量测试，通过这些测试可以做出受过良好教育的决策和政策。对于加拿大企业，拟议的项目为雇主提供了低成本，但准确的解决方案，以确保工作场所的安全，无论是通过敏感的检测感染的个人，或通过监测接种疫苗的员工的抗体水平。在经济方面，拟议项目旨在解决具有重大社会经济影响的现有全球挑战。鉴于快速测试开发伙伴和全球营销的记录，预计将在加拿大开发的技术将通过创造就业机会和全球销售为加拿大经济做出重大贡献。

Introduction of COVID-19 vaccines in late 2020 created hope for overcoming the pandemic, but soon it became clear that mankind is expected to struggle with SARS-CoV-2 until a time when world population (including children) is mass immunized. Reaching this goal is expected to take several years during which: 1) the vaccinated population need to maintain their immunity; 2) more effective approaches (e.g., low-cost, accessible, accurate) should be implemented for earlier identification of infected individuals to prevent future infection peaks. Successful implementation of these two objectives requires population-wide serological studies which in practice can only be realized through low-cost and widely accessible technologies for sensitive detection and quantification of COVID-19 antibodies (Ab) and virus/antigen (Ag). Such technologies currently do not exist.The goal of this partnership is to design, develop, and validate a low-cost end-user rapid test technology for sensitive detection and quantification of COVID-19 antibodies and antigen/virus. The engineering knowledge and innovative technologies generated through this project will enable the government of Canada to implement large scale, accessible and equitable quantitative testing through which well-educated decisions and policies can be made. For Canadian businesses, proposed project provides employers with low-cost, yet accurate, solutions to ensure workplace safety either through sensitive detection of infected individuals, or through monitoring of antibody levels of vaccinated employees. In terms of economy, proposed project aims to solve an existing worldwide challenge with significant socio-economic impact. Given the track record of partner in development and global marketing of rapid tests, the technology to be developed in Canada is expected to make significant contribution to Canadian economy through creation of jobs and global sales.