Market translation of a rapid aptamer-based COVID-19 saliva test

基于适配体的快速 COVID-19 唾液检测的市场转化

• 批准号: 571001-2022
• 负责人: Soleymani, LeylaL
• 金额: $ 25.38万
• 依托单位: McMaster University
• 依托单位国家: 加拿大
• 项目类别: Idea to Innovation
• 财政年份: 2022
• 资助国家: 加拿大
• 起止时间: 2022-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=752910
• 关键词: Market; translation; rapid; aptamer; based

The proposed project is focused on commercializing a rapid COVID-19 saliva test prototype developed at McMaster University and licensed by the Canadian company, Zentek. In this test, saliva is deposited on a chip that is inserted into an electrical reader for rapid, 10 minute, COVID-19 testing. This is a reliable rapid test with no discomfort to the user that is tested with more than 70 patients, demonstrating sensitivity of >80%, specificity of 100%, and concordance value of 92% (total agreement of the test result with the gold standard PCR test). Despite the availability of a wide range of COVID-19 tests, there is no regulatory-approved rapid saliva test due to the deterioration of test performance in saliva. Our test combines two technologies for high reliability testing in saliva: dimeric aptamers and electrochemical readout. Aptamers are DNA molecules selected from a large DNA library using in vitro selection to specifically bind target analytes, in this case the spike protein of SARS-CoV-2. Because dimeric aptamers bind the target spike protein from two locations, they result in high affinity binding. Additionally, dimeric aptamers can be rapidly generated in response to new viral variants. We use an ultrasensitive readout method, electrochemical impedance spectroscopy, for translating this target binding to an electrochemical signal. We have developed the test prototype using commercially-available screen printed electrodes coupled to a USB-sized phone dongle as a signal reader to enable rapid technology translation.Technical issues related to scalable fabrication, stability, detection of emerging viral variants, sample collection, and simple assay operation will be addressed in this project. The development of this technology in Canada will create more than 100 direct jobs at Zentek and will contribute to keeping the economy open while maintaining low infection rates. Zentek intends to develop this technology for detecting other infectious diseases, further growing job creation and contribution to the health and economic wellbeing of Canadians.

拟议的项目重点是将麦克马斯特大学开发的快速COVID-19唾液测试原型商业化，并由加拿大公司Zentek授权。在这项测试中，唾液被沉积在一个芯片上，该芯片被插入电子阅读器中，进行10分钟的快速COVID-19测试。这是一种可靠的快速检测方法，使用者不会感到不适，对70多名患者进行了测试，证明灵敏度> 80%，特异性为100%，一致性值为92%（测试结果与金标准PCR测试完全一致）。尽管有各种COVID-19检测方法可用，但由于唾液中的检测性能下降，因此没有监管机构批准的快速唾液检测。我们的测试结合了两种在唾液中进行高可靠性测试的技术：二聚体适体和电化学读出。适体是使用体外选择从大的DNA文库中选择的DNA分子，以特异性结合靶分析物，在这种情况下是SARS-CoV-2的刺突蛋白。因为二聚体适体从两个位置结合靶刺突蛋白，所以它们导致高亲和力结合。此外，二聚体适体可以响应于新的病毒变体而快速产生。我们使用一种超灵敏的读出方法，电化学阻抗谱，用于将该目标结合到电化学信号。我们开发了测试原型，使用市售的丝网印刷电极连接到USB大小的手机加密狗作为信号读取器，以实现快速技术转换。本项目将解决与可扩展制造、稳定性、新病毒变体检测、样本收集和简单检测操作相关的技术问题。这项技术在加拿大的发展将为Zentek创造100多个直接就业机会，并将有助于保持经济开放，同时保持低感染率。Zentek打算开发这项技术来检测其他传染病，进一步增加就业机会并为加拿大人的健康和经济福祉做出贡献。