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SARS-CoV-2快速检测方法，该方法使用高亲和力DNA适体识别SARS-CoV-2刺突蛋白。本测试已获得Zentek Ltd.的许可，他目前正致力于将测试推向市场。鉴于传染性病原体对人类生命的威胁令人难以置信，它们的快速检测对于改善人类健康至关重要。对于SARS-CoV-2等病毒病原体，大规模检测、接触者追踪和隔离已被证明可有效控制病毒传播。然而，目前大多数检测是基于使用PCR的核酸检测，其虽然高度敏感和特异，但存在周转时间慢和成本高的问题。快速、准确、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，并且对于容易获得的样品如唾液拭子不够敏感。为了解决这些问题，我们建议将我们的适体诊断方法扩展到平台技术的开发，以允许快速提供简单，快速，具有成本效益的大规模诊断测试，可以在未来大流行的早期商业化。该平台将包括：（2）简化的样品处理平台，其能够有效地处理唾液、鼻粘液或其他相关临床样品以递送高质量样品用于测试;（三）一种适用于聚集环境的优化电化学传感平台，（如血糖仪），以及（4）适合在家庭环境中使用的优化的侧向流动装置，其快速提供简单的是或否的答案（如妊娠测试）。 Zentek将进一步开发这些组件中的每一个，以包括快速制造和测试验证组件，以便新的测试可以及时获得监管批准并进行大规模制造，以确保在全球大流行开始时快速商业化。

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.