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施用是至关重要的， 临床护理从公共卫生的角度来看，快速识别芬太尼也是关键， 过量监测、疫情识别和医疗保健专业人员之间的沟通。 全球床旁（POC）滥用药物检测市场，受持续增长的推动， 全球非法药物使用，特别是芬太尼及其衍生物，估计为38亿美元 到2023年，复合年增长率（CAGR）为5.4%。滥用口服液体药物 到2023年，测试市场估计为3880万美元。然而，目前还没有FDA批准的 或者通过快速诊断法进行芬太尼筛查在第一阶段STTR提案中， Instanosis公司将与宾夕法尼亚大学合作，开发和商业化快速 现场筛查诊断（sFentanyl），可部署在患者身边， 在唾液中发现芬太尼在sFentanyl中，使用拭子收集唾液，快速提取， 适用于唾液侧流检测（sFentanyl）试纸条，可有效检测0.1 ng/mL 唾液中芬太尼在5分钟内。读数是肉眼可见的，无需外部 仪器.这种快速诊断工具满足了POC芬太尼检测的临床需求： 快速、灵敏、便携和低成本，可用于许多环境，包括第一反应 车辆、急症室、戒毒诊所、戒毒诊所及病人之家。 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， 并使用去识别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.