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），用于检测和诊断一系列医疗状况，包括SARS-CoV-2病毒。唾液有超过5,000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，但目前基于唾液的诊断测试几乎不存在。Salignostics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。该平台便宜、安全、制造简单，并且不需要特殊设备。因为唾液是由最终用户通过将临床认可的非侵入性收集单元插入口腔中来收集的。对于这个项目，我们的目标是开发一个专用的分析单元的设备，包括一个独特的诊断LFIA条SARS-CoV-2病毒检测。通过唾液诊断医疗状况的能力代表了COVID-19快速诊断测试（RDT）领域的独特创新，因为它是一种易于执行的测试，始终可用，并且不需要熟练的人员。Salignostics的颠覆性技术已成功应用于检测怀孕的设备原型。心肌肌钙蛋白和疟疾检测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.