A portable agglutination test with automated serial dilution for COVID-19 infection and immunity

我们建议开发一种可用于非传统环境的COVID-19手持式床旁（POC）诊断测试-例如，在扩展护理设施，工作场所，机场和边境口岸以及家中。这笔赠款将资助优化鼻咽样本中发现的病毒和血液样本中发现的抗体的微流控凝集试验，重点是通过连续稀释和平行分析进行定量。我们注意到，有许多团体正在开发COVID-19的护理点测试-为什么支持这一个？我们的系统有几个关键的技术优势，包括：（1）我们的测试在一分钟内报告结果（比我们所知道的任何其他测试都快得多），以及（2）与基于核酸的测试不同，我们的测试报告感染和免疫。但同样重要的是，我们的计划是高度可信的。在实验室中演示新奇测试的概念验证结果是“容易的”;然而，在现场产生高质量的结果更具挑战性，因为不可预测的条件可能会影响到这一天。鉴于COVID-19危机的严重性，我们投资于具有良好往绩记录的团队以在现场提供即时检验结果至关重要。我们的团队，包括一个学术研究小组和两个行业合作伙伴，有这样的背景。该学术小组开发了一种系统，该系统已在肯尼亚的一个偏远难民营[Science Translational Medicine 2018，10，eaar 6076]和刚果民主共和国遭受病毒爆发的社区的户外测试点进行了严格验证。位于安大略的初创公司Industry Partner One销售一种手持式仪器，可以进行新的COVID-19检测。行业合作伙伴二是加拿大领先的医疗器械服务提供商，将提供独特的经验和资源，以协助设计一次性使用的墨盒，以实现可扩展的生产。总之，该团队有能力开展本文所述的工作，这有可能改变加拿大和世界各地诊断、跟踪和报告COVID-19感染和免疫的方式。

We propose to develop a hand-held point-of-care (POC) diagnostic test for COVID-19 that can be used in non-traditional settings - for example, at extended care facilities, at the workplace, in airports and at border crossings, and at home. This grant will fund the optimization of microfluidic agglutination assays for virus found in nasopharyngeal samples and antibody found in blood samples, with a focus on quantitation by means of serial dilution and parallel analysis. We note that there are many groups developing point of care tests for COVID-19 - why support this one? There are several key technical advantages of our system, including: (1) our test reports results within one minute (much faster than any other that we are aware of), and (2) unlike nucleic-acid-based tests, our test reports both infection and immunity. But equally as important, our plan is highly credible. It is "easy" to demonstrate proof-of-concept results for fancy new tests in a laboratory; however, it is far more challenging to generate high-quality results in the field, where unpredictable conditions can carry the day. Given the serious nature of the COVID-19 crisis, it is critical that we invest in teams with established track-records for delivering point-of-care test results in the field. Our team, which includes an academic research group and two industry partners, has this background. The academic group has developed a system that has been rigorously validated for viral diagnostic testing in a remote refugee camp in Kenya [Science Translational Medicine 2018, 10, eaar6076] and in outdoor testing sites in communities suffering from viral outbreaks in Democratic Republic of Congo (not yet published). Industry partner one, a startup company based in Ontario, sells a hand-held instrument that will run the new COVID-19 tests. Industry partner two is Canada's leading medical device service provider, and will contribute unique experience and resources to assist in designing the single-use cartridge for scalable manufacture. Together, this team is well positioned to carry out the work described here, which has the potential to transform how COVID-19 infection and immunity is diagnosed, tracked and reported in Canada and around the world.