A Rapid Saliva Antigen Test for SARs-CoV-2 Detection

The pandemic caused by COVID-19 has been associated with a very high disease burden as well as high global financial costs. With this pandemic came massive shut downs of both private and public businesses including schools, retail stores, and restaurants. In order to be able to safely open these places of business and have millions of workers return to work and children return to school safely, there is a dire need for a rapid, simple, and inexpensive test which can be administered in non-clinical settings including businesses, schools, and even at home. There are over 600 tests currently being developed, including potentially promising tests using saliva samples and nasopharyngeal swabs. However, these tests have several disadvantages including requirement of instruments, discomfort with nasopharyngeal swabs, and/or long processing time.

In this proposal we aim to develop a simple, low-cost, rapid saliva-based test using test strips that incorporate novel high affinity SARS-CoV-2 binder nanodiscs. Our aims are focused on producing and optimizing the test strip components and performing a feasibility study on archived patient samples. By completing these goals, we hope to produce test strips that have the capability of use in office settings, schools, sports events, and potentially at home. To achieve these goals, we have established a partnership between bioActive Labs LLC, led by Dr Jeff Hall who has more than 25 years of experience in design and development of medical diagnostics, and our lab which has engineered the new binder proteins and developed the SARS-CoV-2 assays.

由新型冠状病毒（COVID-19）引发的全球大流行，不仅造成了极为沉重的疾病负担，还带来了高昂的全球经济损失。此次大流行致使大量私营与公立经营实体停业，涵盖学校、零售门店及餐饮场所等。为安全恢复各类经营场所运营，让数百万劳动者重返工作岗位、学生安全返校，我们亟需一种快速、简便且成本低廉的检测手段，可在非临床环境中开展，包括商业场所、学校乃至家庭。目前已有超过600种检测手段处于研发阶段，其中包括基于唾液样本与鼻咽拭子（nasopharyngeal swabs）的极具潜力的检测方案。但此类检测存在诸多缺陷：需依赖专业检测仪器、鼻咽拭子采样会引发受试者不适，且检测处理耗时较长。

本研究提案旨在开发一款基于唾液的简便、低成本快速检测试剂盒，其核心组件为搭载新型高亲和力新型冠状病毒（SARS-CoV-2）结合剂纳米圆盘（nanodiscs）的检测试条。本项目的研究目标为制备并优化检测试条的核心组分，并利用存档的患者临床样本开展可行性验证研究。若能达成上述目标，我们将有望开发出可在办公场所、学校、体育赛事乃至家庭中使用的检测试条。

为实现上述目标，我们已与由拥有25年以上医学诊断产品设计开发经验的杰夫·霍尔（Jeff Hall）博士领衔的bioActive Labs有限责任公司达成合作；本实验室则负责工程化制备新型结合蛋白，并开发了SARS-CoV-2检测方法。