Development of Aptamer Based Biosensing Platform Technologies for Rapid Responses to Future Global Pandemics

我们的团队最近开发了一种基于唾液的快速检测SARS-CoV-2的方法，使用高亲和力的DNA适体来识别SARS-CoV-2刺突蛋白。该测试已获得Zentek有限公司的许可，该公司目前正致力于将该测试推向市场。鉴于传染性病原体对人类生命的巨大威胁，迅速发现它们对于改善人类健康至关重要。就SARS-CoV-2等病毒性病原体而言，大规模检测、接触者追踪和隔离已被证明是控制病毒传播的有效方法。然而，目前大多数检测都是基于PCR的核酸检测，这种方法虽然灵敏度高，特异性强，但周转时间慢，成本高。快速、准确和廉价的测试平台可以提供出色的解决方案。不幸的是，目前的快速抗原测试虽然相对快速，但仍然昂贵，而且对唾液拭子等容易获得的样本不够敏感。为了解决这些问题，我们建议扩大适体诊断方法，以开发一种平台技术，以便快速提供一种简单、快速、具有成本效益的大规模诊断测试，并在未来大流行的早期投入商业使用。该平台将包括：(1)高效的适体工程方法，可以在数周内为病原体的目标提供高性能的适体；(2)简化的样品处理平台，能够高效处理唾液、鼻黏液或其他相关临床样品，提供高质量的检测样品；(3)一个优化的电化学传感平台，适合在聚集环境中使用，有效地将病原体的存在转化为电子读数（如血糖仪），以及；(4)优化的横向流动装置，适合在家庭环境中使用，可以快速提供简单的“是”或“否”答案（如孕检）。Zentek将进一步开发这些组件，包括快速制造和测试验证组件，以便新的测试能够及时获得监管部门的批准，并大规模生产，以确保在全球大流行爆发时快速商业化。

Our team has recently developed a rapid saliva-based test for SARS-CoV-2 using a high-affinity DNA aptamer to recognize the SARS-CoV-2 spike protein. This test has been licensed by Zentek Ltd., who is currently working to bring the test to market. Given the incredible threat of infectious pathogens to human lives, their rapid detection is vital for improving human health. In the case of viral pathogens such as SARS-CoV-2, large-scale testing, contact tracing and isolation have been shown to be effective in controlling the viral spread. However, the majority of current testing is based on nucleic acid detection using PCR, which, while highly sensitive and specific, suffers from a slow turnaround time and high cost. Rapid, accurate and inexpensive testing platforms can offer excellent solutions. Unfortunately, current rapid antigen tests, although relatively rapid, are still expensive and not sufficiently sensitive for easily available samples like saliva swabs. To address these issues, we propose to expand our aptamer diagnostic approach towards the development of a platform technology to allow quick delivery of a simple, fast, cost-effective large-scale diagnostic test that can become commercially available early in a future pandemic. This platform will consist of: (1) efficient aptamer engineering methodologies that can provide high-performing aptamers for a target of a pathogen in weeks; (2) a simplified sample processing platform capable of efficiently processing saliva, nasal mucus or other relevant clinical samples to deliver high-quality samples for testing; (3) an optimized electrochemical sensing platform suitable for use in congregate settings that efficiently converts pathogen presence into an electric readout (like a glucose meter), and; (4) optimized lateral flow devices suitable for use in home settings that provide a simple yes or no answer quickly (like a pregnancy test). Each of these components will be further developed by Zentek to include rapid manufacturing and test validation components so that new tests can obtain timely regulatory approval and be manufactured at scale to ensure rapid commercialization at the onset of a global pandemic.