A Lateral Flow Assay for Rapid Saliva Fentanyl Detection (sFENTANYL)

项目摘要 芬太尼是阿片类药物流行的主要贡献者。致病药物的快速鉴定 因为芬太尼对于纳洛酮的迅速和适当的给药是至关重要的，而正确的水平 临床护理。从公共卫生的角度来看，快速识别芬太尼也是 医疗保健专业人员之间的过量监测、暴发识别和沟通。 在持续增长的推动下，全球护理点(POC)药物滥用测试市场 全世界的非法药物使用，特别是芬太尼及其衍生物，估计为38亿美元 2023年，复合年增长率(CAGR)为5.4%。滥用口服液药物 2023年测试市场估计为3880万美元。然而，目前还没有FDA批准的 或在POC通过了芬太尼筛查的快速诊断。在这一阶段的STTR提案中， Instansis Inc.将与宾夕法尼亚大学合作开发一种快速 现场筛查诊断(SFENTANYL)，可部署在患者身边以快速 确定唾液中的芬太尼。在sFentanyl，唾液是用拭子收集的，快速提取和 应用于唾液侧向流动分析(SFENTANYL)试条，可有效检测0.1 ng/mL 唾液中的芬太尼在5分钟内。读数是肉眼可见的，不需要外部 乐器。这一快速诊断工具可满足POC芬太尼检测的临床需求： 快速、灵敏、便携、低成本，可用于包括急救在内的多种环境 车辆、急诊科、戒毒诊所、戒毒诊所和病人之家。 在第一阶段，我们将开发具有所需分析灵敏度和读出时间的sFENTANYL， 并使用已确认的临床唾液样本进行初步验证。

Project Summary Fentanyl is a major contributor to the Opioid Epidemic. Rapid identification of the causative drug as fentanyl is critical for prompt and appropriate administration of naloxone, and the right level of clinical care. From the public health perspective, rapid identification of fentanyl is also key to overdose surveillance, outbreak recognition and communication among healthcare professionals. The global market for point-of-care (POC) drug of abuse testing, fueled by the continued growth of illicit drug use worldwide, especially fentanyl and its derivatives, is estimated to be $3.8 billion in 2023, growing at a compound annual growth rate (CAGR) of 5.4%. Oral fluid drugs of abuse testing market is estimated at $38.8 million in 2023. However, there is currently no FDA-approved or cleared rapid diagnostic for fentanyl screening at the POC. In this phase I STTR proposal, Instanosis Inc will partner with University of Pennsylvania to develop and commercialize a rapid onsite screening diagnostics (sFENTANYL) that can be deployed at the patient’s side to quickly identify fentanyl in saliva. In sFENTANYL, saliva is collected using swabs, quickly extracted and applied to the saliva lateral flow assay (sFENTANYL) strip that can effectively detect 0.1 ng/mL fentanyl in saliva within 5 min. Readout is visual with naked eyes, with no need for external instruments. This rapid diagnostic tool meets the clinical needs of fentanyl detection at the POC: rapid, sensitive, portable and low cost, and can be used in many settings, including first response vehicles, emergency departments, detoxification clinics, drug treatment clinics and patient homes. In Phase I, we will develop sFENTANYL with the needed analytical sensitivity and readout time, and conduct preliminary validation using deidentified clinical saliva samples.