RAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM: TECH PROJECT # 6808: SALIVA-BASED SARS-COV-2 RAPID DIAGNOSTIC TEST

Salignostics正在应用尖端技术，将唾液转化为可靠的体液，用于侧流免疫测定（LFIA），以检测和诊断包括SARS-CoV-2病毒在内的一系列疾病。唾液含有超过5000种不同的蛋白质，其组成使其成为具有重要诊断潜力的体液，但基于唾液的诊断测试目前几乎不存在。salignotics开发的基于lfa的技术解决了识别口腔液中生物标志物的固有挑战。该平台价格低廉，安全，制造简单，不需要特殊设备。由于唾液是由最终用户通过临床批准的非侵入性收集装置插入口腔收集的。对于该项目，我们的目标是开发该设备的专用分析单元，包括用于检测SARS-CoV-2病毒的独特诊断LFIA试纸。通过唾液诊断疾病的能力是COVID-19快速诊断测试（RDT）领域的一项独特创新，因为它是一种易于执行、随时可用且不需要熟练人员的测试。Salignostics的颠覆性技术已成功应用于检测怀孕的设备原型。检测心肌肌钙蛋白和疟疾的初步试验已经成功进行，并将为拟议解决方案的原型设计提供信息。

Salignostics is applying cutting-edge technology which transforms saliva into a reliable body-fluid for lateral flow immunoassays (LFIA) for the detection and diagnosis of a range of medical conditions, including the SARS-CoV-2 virus. Saliva has over 5,000 different proteins and its composition makes it a body fluid with significant diagnostic potential, yet saliva-based diagnostic tests are at present virtually non-existent. The LFA-based technology developed by Salignostics addresses the challenges in inherent in identifying biomarkers in oral fluid. The platform  is inexpensive, safe, simple to manufacture and does not require special equipment. since saliva is collected by the end user through the insertion of a clinically approved non-invasive collection unit into the oral cavity. For this project, we aim to develop a dedicated analytical unit of the device including a unique diagnostic LFIA strip for SARS-CoV-2 virus detection. The ability to diagnose medical conditions through saliva represents a unique innovation within the COVID-19 Rapid Diagnostic Testing (RDT) space because it is an easy test to perform, always available, and does not require skilled personnel. Salignostics' disruptive technologies have been successfully applied as a device prototype to detect pregnancy. Preliminary trials for the detection of Cardiac Troponin and Malaria have been carried out successfully and will inform prototyping for the proposed solution.