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

2020年末推出的新冠肺炎疫苗为战胜这种大流行带来了希望，但很快事情变得清晰起来，人类预计将与SARS-CoV-2作斗争，直到世界人口(包括儿童)大规模接种疫苗。实现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其免疫力；2)应采取更有效的方法(例如，低成本、可获得、准确)，以便更早地识别感染者，以防止未来的感染高峰。要成功实现这两个目标，就需要进行全人群的血清学研究，而实际上，只有通过对新冠肺炎抗体(抗体)和病毒/抗原(Ag)进行灵敏检测和量化的低成本和可广泛获取的技术，才能实现这一目标。这一合作伙伴关系的目标是设计、开发和验证一种低成本的最终用户快速检测技术，用于对新冠肺炎抗体和抗原/病毒进行灵敏检测和量化。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、可获得和公平的量化测试，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，无论是通过敏感地检测受感染的个人，还是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世界性挑战。鉴于合作伙伴在快速测试的开发和全球营销方面的过往记录，预计加拿大将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.